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‘Fibro-fog’ confirmed with objective ambulatory testing
MILWAUKEE – Individuals with fibromyalgia had worse cognitive functioning than did a control group without fibromyalgia, according to both subjective and objective ambulatory measures.
For study participants with fibromyalgia, aggregate self-reported cognitive function over an 8-day period was poorer than for their matched controls without fibromyalgia. Objective measures of working memory, including mean and maximum error scores on a dot memory test, also were worse for the fibromyalgia group (P less than .001 for all).
Objective measures of processing speed also were slower for those with fibromyalgia, but the difference did not reach statistical significance.
These findings are “generally consistent with findings from lab-based studies of people living with [fibromyalgia], Anna Kratz, PhD, and her coauthors wrote in a poster at the scientific meeting of the American Pain Society. by using smartphone-based capture of momentary subjective and objective cognitive functioning.
In a study of 50 adults with fibromyalgia and 50 matched controls, Dr. Kratz and her colleagues at the University of Michigan, Ann Arbor, had participants complete baseline self-report and objective measures of cognitive functioning in an in-person laboratory session. Then, participants were sent home with a wrist accelerometer and a smartphone; apps on the smartphone administered objective cognitive tests as well as subjective questions about cognitive function.
Both the subjective and objective portions of the ambulatory study were completed five times daily (on waking, and on a “quasi-random” schedule throughout the day), for at least 8 days. Day 1 was considered a “training day,” and data from that day were excluded from analysis.
To assess subjective cognitive function, patients were asked to give a momentary assessment of how slow, and how foggy, their thinking was, using a 0-100 scale. These two questions were drawn from the PROMIS Applied Cognition – General Concerns item bank. Objective measures included processing speed, captured by a 16-trial exercise of matching symbol pairs. Also, working memory was tested by completing four trials of remembering the placement of three dots in a 5x5 dot matrix.
Among the participants, 88% were female. The mean age was 45 years, and about 80% of the subjects were white. Fibromyalgia patients had more pain than did their matched controls and had poorer baseline performance on four neurocognitive tasks drawn from the National Institutes of Health Toolbox. For a flanker test, a list sorting task, a dimensional change card sort test, and a pattern comparison task, mean scores for participants with fibromyalgia ranged from 39.08 to 49.76; for the control group, mean scores ranged from 43.78 to 57.36 (P less than .05 for all).
Some people with fibromyalgia report subjective diurnal variation in cognitive function, so Dr. Kratz and her coauthors were interested in tracking performance on the ambulatory cognitive tasks over the course of the day. “Diurnal patterns and associations between objective/subjective functioning were similar across the groups,” said the authors, with no hallmark diurnal pattern for the participants with fibromyalgia. Generally, participants in both groups had the highest subjective and objective levels of performance in the morning, a dip at the first reporting time, and a gradual recovery to a level somewhat below the first morning test point by the end of the day.
Dr. Kratz and her colleagues found that in both groups, “significant associations were observed between within-person momentary changes in subjective cognitive functioning and processing speed.” This association did not hold true for working memory, however.
The findings were overall generally consistent with lab-based testing of cognitive function in individuals living with fibromyalgia, the authors said.
Dr. Kratz and her colleagues reported no outside sources of funding, and reported no conflicts of interest.
SOURCE: Kratz A et al. APS 2019, Poster 117.
MILWAUKEE – Individuals with fibromyalgia had worse cognitive functioning than did a control group without fibromyalgia, according to both subjective and objective ambulatory measures.
For study participants with fibromyalgia, aggregate self-reported cognitive function over an 8-day period was poorer than for their matched controls without fibromyalgia. Objective measures of working memory, including mean and maximum error scores on a dot memory test, also were worse for the fibromyalgia group (P less than .001 for all).
Objective measures of processing speed also were slower for those with fibromyalgia, but the difference did not reach statistical significance.
These findings are “generally consistent with findings from lab-based studies of people living with [fibromyalgia], Anna Kratz, PhD, and her coauthors wrote in a poster at the scientific meeting of the American Pain Society. by using smartphone-based capture of momentary subjective and objective cognitive functioning.
In a study of 50 adults with fibromyalgia and 50 matched controls, Dr. Kratz and her colleagues at the University of Michigan, Ann Arbor, had participants complete baseline self-report and objective measures of cognitive functioning in an in-person laboratory session. Then, participants were sent home with a wrist accelerometer and a smartphone; apps on the smartphone administered objective cognitive tests as well as subjective questions about cognitive function.
Both the subjective and objective portions of the ambulatory study were completed five times daily (on waking, and on a “quasi-random” schedule throughout the day), for at least 8 days. Day 1 was considered a “training day,” and data from that day were excluded from analysis.
To assess subjective cognitive function, patients were asked to give a momentary assessment of how slow, and how foggy, their thinking was, using a 0-100 scale. These two questions were drawn from the PROMIS Applied Cognition – General Concerns item bank. Objective measures included processing speed, captured by a 16-trial exercise of matching symbol pairs. Also, working memory was tested by completing four trials of remembering the placement of three dots in a 5x5 dot matrix.
Among the participants, 88% were female. The mean age was 45 years, and about 80% of the subjects were white. Fibromyalgia patients had more pain than did their matched controls and had poorer baseline performance on four neurocognitive tasks drawn from the National Institutes of Health Toolbox. For a flanker test, a list sorting task, a dimensional change card sort test, and a pattern comparison task, mean scores for participants with fibromyalgia ranged from 39.08 to 49.76; for the control group, mean scores ranged from 43.78 to 57.36 (P less than .05 for all).
Some people with fibromyalgia report subjective diurnal variation in cognitive function, so Dr. Kratz and her coauthors were interested in tracking performance on the ambulatory cognitive tasks over the course of the day. “Diurnal patterns and associations between objective/subjective functioning were similar across the groups,” said the authors, with no hallmark diurnal pattern for the participants with fibromyalgia. Generally, participants in both groups had the highest subjective and objective levels of performance in the morning, a dip at the first reporting time, and a gradual recovery to a level somewhat below the first morning test point by the end of the day.
Dr. Kratz and her colleagues found that in both groups, “significant associations were observed between within-person momentary changes in subjective cognitive functioning and processing speed.” This association did not hold true for working memory, however.
The findings were overall generally consistent with lab-based testing of cognitive function in individuals living with fibromyalgia, the authors said.
Dr. Kratz and her colleagues reported no outside sources of funding, and reported no conflicts of interest.
SOURCE: Kratz A et al. APS 2019, Poster 117.
MILWAUKEE – Individuals with fibromyalgia had worse cognitive functioning than did a control group without fibromyalgia, according to both subjective and objective ambulatory measures.
For study participants with fibromyalgia, aggregate self-reported cognitive function over an 8-day period was poorer than for their matched controls without fibromyalgia. Objective measures of working memory, including mean and maximum error scores on a dot memory test, also were worse for the fibromyalgia group (P less than .001 for all).
Objective measures of processing speed also were slower for those with fibromyalgia, but the difference did not reach statistical significance.
These findings are “generally consistent with findings from lab-based studies of people living with [fibromyalgia], Anna Kratz, PhD, and her coauthors wrote in a poster at the scientific meeting of the American Pain Society. by using smartphone-based capture of momentary subjective and objective cognitive functioning.
In a study of 50 adults with fibromyalgia and 50 matched controls, Dr. Kratz and her colleagues at the University of Michigan, Ann Arbor, had participants complete baseline self-report and objective measures of cognitive functioning in an in-person laboratory session. Then, participants were sent home with a wrist accelerometer and a smartphone; apps on the smartphone administered objective cognitive tests as well as subjective questions about cognitive function.
Both the subjective and objective portions of the ambulatory study were completed five times daily (on waking, and on a “quasi-random” schedule throughout the day), for at least 8 days. Day 1 was considered a “training day,” and data from that day were excluded from analysis.
To assess subjective cognitive function, patients were asked to give a momentary assessment of how slow, and how foggy, their thinking was, using a 0-100 scale. These two questions were drawn from the PROMIS Applied Cognition – General Concerns item bank. Objective measures included processing speed, captured by a 16-trial exercise of matching symbol pairs. Also, working memory was tested by completing four trials of remembering the placement of three dots in a 5x5 dot matrix.
Among the participants, 88% were female. The mean age was 45 years, and about 80% of the subjects were white. Fibromyalgia patients had more pain than did their matched controls and had poorer baseline performance on four neurocognitive tasks drawn from the National Institutes of Health Toolbox. For a flanker test, a list sorting task, a dimensional change card sort test, and a pattern comparison task, mean scores for participants with fibromyalgia ranged from 39.08 to 49.76; for the control group, mean scores ranged from 43.78 to 57.36 (P less than .05 for all).
Some people with fibromyalgia report subjective diurnal variation in cognitive function, so Dr. Kratz and her coauthors were interested in tracking performance on the ambulatory cognitive tasks over the course of the day. “Diurnal patterns and associations between objective/subjective functioning were similar across the groups,” said the authors, with no hallmark diurnal pattern for the participants with fibromyalgia. Generally, participants in both groups had the highest subjective and objective levels of performance in the morning, a dip at the first reporting time, and a gradual recovery to a level somewhat below the first morning test point by the end of the day.
Dr. Kratz and her colleagues found that in both groups, “significant associations were observed between within-person momentary changes in subjective cognitive functioning and processing speed.” This association did not hold true for working memory, however.
The findings were overall generally consistent with lab-based testing of cognitive function in individuals living with fibromyalgia, the authors said.
Dr. Kratz and her colleagues reported no outside sources of funding, and reported no conflicts of interest.
SOURCE: Kratz A et al. APS 2019, Poster 117.
REPORTING FROM APS 2019
FDA to expand opioid labeling with instructions on proper tapering
The Food and Drug Administration is making changes to opioid analgesic labeling to give better information to clinicians on how to properly taper patients dependent on opioid use, according to Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research.
, such as withdrawal symptoms, uncontrolled pain, and suicide. Both the FDA and the Centers for Disease Control and Prevention offer guidelines on how to properly taper opioids, Dr. Throckmorton said, but more needs to be done to ensure that patients are being provided with the correct advice and care.
The changes to the labels will include expanded information to health care clinicians and are intended to be used when both the clinician and patient have agreed to reduce the opioid dosage. When this is discussed, factors that should be considered include the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient.
Other actions the FDA is pursuing to combat opioid use disorder include working with the National Academies of Sciences, Engineering, and Medicine on guidelines for the proper opioid analgesic prescribing for acute pain resulting from specific conditions or procedures, and advancing policies that make immediate-release opioid formulations available in fixed-quantity packaging for 1 or 2 days.
“The FDA remains committed to addressing the opioid crisis on all fronts, with a significant focus on decreasing unnecessary exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those involved in the illegal importation and sale of opioids,” Dr. Throckmorton said.
Find the full statement by Dr. Throckmorton on the FDA website.
The Food and Drug Administration is making changes to opioid analgesic labeling to give better information to clinicians on how to properly taper patients dependent on opioid use, according to Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research.
, such as withdrawal symptoms, uncontrolled pain, and suicide. Both the FDA and the Centers for Disease Control and Prevention offer guidelines on how to properly taper opioids, Dr. Throckmorton said, but more needs to be done to ensure that patients are being provided with the correct advice and care.
The changes to the labels will include expanded information to health care clinicians and are intended to be used when both the clinician and patient have agreed to reduce the opioid dosage. When this is discussed, factors that should be considered include the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient.
Other actions the FDA is pursuing to combat opioid use disorder include working with the National Academies of Sciences, Engineering, and Medicine on guidelines for the proper opioid analgesic prescribing for acute pain resulting from specific conditions or procedures, and advancing policies that make immediate-release opioid formulations available in fixed-quantity packaging for 1 or 2 days.
“The FDA remains committed to addressing the opioid crisis on all fronts, with a significant focus on decreasing unnecessary exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those involved in the illegal importation and sale of opioids,” Dr. Throckmorton said.
Find the full statement by Dr. Throckmorton on the FDA website.
The Food and Drug Administration is making changes to opioid analgesic labeling to give better information to clinicians on how to properly taper patients dependent on opioid use, according to Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research.
, such as withdrawal symptoms, uncontrolled pain, and suicide. Both the FDA and the Centers for Disease Control and Prevention offer guidelines on how to properly taper opioids, Dr. Throckmorton said, but more needs to be done to ensure that patients are being provided with the correct advice and care.
The changes to the labels will include expanded information to health care clinicians and are intended to be used when both the clinician and patient have agreed to reduce the opioid dosage. When this is discussed, factors that should be considered include the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient.
Other actions the FDA is pursuing to combat opioid use disorder include working with the National Academies of Sciences, Engineering, and Medicine on guidelines for the proper opioid analgesic prescribing for acute pain resulting from specific conditions or procedures, and advancing policies that make immediate-release opioid formulations available in fixed-quantity packaging for 1 or 2 days.
“The FDA remains committed to addressing the opioid crisis on all fronts, with a significant focus on decreasing unnecessary exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those involved in the illegal importation and sale of opioids,” Dr. Throckmorton said.
Find the full statement by Dr. Throckmorton on the FDA website.
Romosozumab gets FDA approval for treating osteoporosis
“These are women who have a history of osteoporotic fracture or multiple risk factors or have failed other treatments for osteoporosis,” according to a news release from the agency.
The monthly treatment of two injections (given one after the other at one visit) mainly works by increasing new bone formation, but these effects wane after 12 doses. If patients still need osteoporosis therapy after that maximum of 12 doses, it’s recommended they are put on treatments that reduce bone breakdown. Romosozumab-aqqg is “a monoclonal antibody that blocks the effects of the protein sclerostin,” according to the news release.
The treatment’s efficacy and safety was evaluated in two clinical trials of more than 11,000 women with postmenopausal osteoporosis. In one trial, women received 12 months of either romosozumab-aqqg or placebo. The treatment arm had a 73% lower risk of vertebral fracture than did the placebo arm, and this benefit was maintained over a second year when both groups were switched to denosumab, another osteoporosis therapy. In the second trial, one group received romosozumab-aqqg for 1 year and then a year of alendronate, and the other group received 2 years of alendronate, another osteoporosis therapy, according to the news release. In this trial, the romosozumab-aqqg arm had 50% less risk of vertebral fractures than did the alendronate-only arm, as well as reduced risk of nonvertebral fractures.
Romosozumab-aqqg was associated with higher risks of cardiovascular death, heart attack, and stroke in the alendronate trial, so the treatment comes with a boxed warning regarding those risks and recommends that the drug not be used in patients who have had a heart attack or stroke within the previous year, according to the news release. Common side effects include joint pain and headache, as well as injection-site reactions.
“These are women who have a history of osteoporotic fracture or multiple risk factors or have failed other treatments for osteoporosis,” according to a news release from the agency.
The monthly treatment of two injections (given one after the other at one visit) mainly works by increasing new bone formation, but these effects wane after 12 doses. If patients still need osteoporosis therapy after that maximum of 12 doses, it’s recommended they are put on treatments that reduce bone breakdown. Romosozumab-aqqg is “a monoclonal antibody that blocks the effects of the protein sclerostin,” according to the news release.
The treatment’s efficacy and safety was evaluated in two clinical trials of more than 11,000 women with postmenopausal osteoporosis. In one trial, women received 12 months of either romosozumab-aqqg or placebo. The treatment arm had a 73% lower risk of vertebral fracture than did the placebo arm, and this benefit was maintained over a second year when both groups were switched to denosumab, another osteoporosis therapy. In the second trial, one group received romosozumab-aqqg for 1 year and then a year of alendronate, and the other group received 2 years of alendronate, another osteoporosis therapy, according to the news release. In this trial, the romosozumab-aqqg arm had 50% less risk of vertebral fractures than did the alendronate-only arm, as well as reduced risk of nonvertebral fractures.
Romosozumab-aqqg was associated with higher risks of cardiovascular death, heart attack, and stroke in the alendronate trial, so the treatment comes with a boxed warning regarding those risks and recommends that the drug not be used in patients who have had a heart attack or stroke within the previous year, according to the news release. Common side effects include joint pain and headache, as well as injection-site reactions.
“These are women who have a history of osteoporotic fracture or multiple risk factors or have failed other treatments for osteoporosis,” according to a news release from the agency.
The monthly treatment of two injections (given one after the other at one visit) mainly works by increasing new bone formation, but these effects wane after 12 doses. If patients still need osteoporosis therapy after that maximum of 12 doses, it’s recommended they are put on treatments that reduce bone breakdown. Romosozumab-aqqg is “a monoclonal antibody that blocks the effects of the protein sclerostin,” according to the news release.
The treatment’s efficacy and safety was evaluated in two clinical trials of more than 11,000 women with postmenopausal osteoporosis. In one trial, women received 12 months of either romosozumab-aqqg or placebo. The treatment arm had a 73% lower risk of vertebral fracture than did the placebo arm, and this benefit was maintained over a second year when both groups were switched to denosumab, another osteoporosis therapy. In the second trial, one group received romosozumab-aqqg for 1 year and then a year of alendronate, and the other group received 2 years of alendronate, another osteoporosis therapy, according to the news release. In this trial, the romosozumab-aqqg arm had 50% less risk of vertebral fractures than did the alendronate-only arm, as well as reduced risk of nonvertebral fractures.
Romosozumab-aqqg was associated with higher risks of cardiovascular death, heart attack, and stroke in the alendronate trial, so the treatment comes with a boxed warning regarding those risks and recommends that the drug not be used in patients who have had a heart attack or stroke within the previous year, according to the news release. Common side effects include joint pain and headache, as well as injection-site reactions.
NIH’s HEAL initiative seeks coordinated effort to tackle pain, addiction
MILWAUKEE – Congress has allocated a half billion dollars annually to the National Institutes of Health for a program that seeks to end America’s opioid crisis. The agency is putting in place over two-dozen projects spanning basic and translational research, clinical trials, and implementation of new strategies to address pain and fight addiction.
The , said Walter Koroshetz, MD, speaking at the scientific meeting of the American Pain Society. This represents carryover from 2018, a planning year for the initiative, along with the 2019 $500 million annual supplement to the NIH’s base appropriation.
In 2018, NIH and other federal agencies successfully convinced Congress that funding a coordinated use of resources was necessary to overcome the country’s dual opioid and chronic pain crises. “Luck happens to the prepared,” said Dr. Koroshetz, director of the National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Md., adding that many hours went into putting together a national pain strategy that is multidisciplinary and multi-layered, and involves multiple players.
The two aims of research under the initiative are to improve treatments for misuse and addiction, and to enhance pain management. Focusing on this latter aim, Dr. Koroshetz said that the initiative has several research priorities to enhance pain management.
First, the biological basis for chronic pain needs to be understood in order to formulate effective therapies and interventions. “We need to understand the transition from acute to chronic pain,” he commented. “We need to see if we can learn about the risk factors for developing chronic pain; if we get really lucky, we might identify some biological markers” that identify who is at risk for this transition “in a high-risk acute pain situation.”
Next, a key request of industry and academia will be development of more drugs that avoid the dual-target program of opioids, which affect reward circuitry along with pain circuitry. “Drugs affecting the pain circuit and the reward circuit will always result in addiction” potential, said Dr. Koroshetz. “We’re still using drugs for pain from the poppy plant that were discovered 8,000 years ago.”
The hope with the HEAL initiative is to bring together academic centers with patient populations and research capabilities with industry, to accelerate moving nonaddictive treatments through to phase 3 trials.
The initiative also aims to promote discovery of new biologic targets for safe and effective pain treatment. New understanding of the physiology of pain has led to a multitude of candidate targets, said Dr. Koroshetz: “The good news is that there are so many potential targets. When I started in neurology in the ‘90s, I wouldn’t have said there were many, but now I’d say the list is long.”
Support for this work will require the development of human cell and tissue models, such as induced pluripotent stem cells, 3D printed organoids, and tissue chips. Several HEAL-funded grant mechanisms also seek research-industry collaboration to move investigational drugs for new targets through the pipeline quickly. The agency is hoping to see grantees apply new technologies, such as artificial intelligence, which can help identify new chemical structures and pinpoint new therapeutic targets for drug repurposing.
In addition to rapid drug discovery and accelerated clinical trials, Dr. Koroshetz said that HEAL leaders are hoping to see cross-pollination from two other NIH initiatives to boost pain-targeted medical device development. Both the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) and the Stimulating Peripheral Activity to Relieve Conditions (SPARC) initiatives have already shown promise in identifying targets for effective, noninvasive pain relief devices, he said. Technologies being developed from these programs are “truly amazing,” he added.
A new focus on data and asset sharing among industry, academia, and NIH will “improve the quality, consistency, and efficiency of early-phase pain clinical trials,” Dr. Koroshetz continued. The Early Phase Pain Investigation Clinical Network (EPPIC-Net) will coordinate data and biosample hosting.
Through a competitive submission process, EPPIC-net will review dossiers from institutions or consortia that can serve as assets around which clinical trials can be designed and executed. These early-phase trials will focus on well-defined pain conditions with unmet need, such as chronic regional pain syndrome and tic douloureux, he said.
“We want to find patients who have well-defined conditions. We know the phenotypes, we know the natural history. We’re looking for clinical sites to work on these projects as part of one large team to bring new therapies to patients,” noted Dr. Koroshetz.
Further along the spectrum of research, comparative effectiveness research networks will provide a reality check to compare both pharmacologic and nonpharmacologic interventions all along the spectrum from acute to chronic pain. Here, data elements and storage will also be coordinated through EPPIC-Net.
Implementation science research will fine-tune the practicalities of bringing research to practice as the final piece of the puzzle, said Dr. Koroshetz.
Under NIH director Francis Collins, MD, PhD, Dr. Koroshetz is co-leading the HEAL initiative, along with Nora Volkow, MD, director of the National Institute on Drug Abuse. They wrote about the initiative in JAMA last year (JAMA. 2018 Jul 10;320[2]:129-30).
Dr. Koroshetz reported no conflicts of interest.
MILWAUKEE – Congress has allocated a half billion dollars annually to the National Institutes of Health for a program that seeks to end America’s opioid crisis. The agency is putting in place over two-dozen projects spanning basic and translational research, clinical trials, and implementation of new strategies to address pain and fight addiction.
The , said Walter Koroshetz, MD, speaking at the scientific meeting of the American Pain Society. This represents carryover from 2018, a planning year for the initiative, along with the 2019 $500 million annual supplement to the NIH’s base appropriation.
In 2018, NIH and other federal agencies successfully convinced Congress that funding a coordinated use of resources was necessary to overcome the country’s dual opioid and chronic pain crises. “Luck happens to the prepared,” said Dr. Koroshetz, director of the National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Md., adding that many hours went into putting together a national pain strategy that is multidisciplinary and multi-layered, and involves multiple players.
The two aims of research under the initiative are to improve treatments for misuse and addiction, and to enhance pain management. Focusing on this latter aim, Dr. Koroshetz said that the initiative has several research priorities to enhance pain management.
First, the biological basis for chronic pain needs to be understood in order to formulate effective therapies and interventions. “We need to understand the transition from acute to chronic pain,” he commented. “We need to see if we can learn about the risk factors for developing chronic pain; if we get really lucky, we might identify some biological markers” that identify who is at risk for this transition “in a high-risk acute pain situation.”
Next, a key request of industry and academia will be development of more drugs that avoid the dual-target program of opioids, which affect reward circuitry along with pain circuitry. “Drugs affecting the pain circuit and the reward circuit will always result in addiction” potential, said Dr. Koroshetz. “We’re still using drugs for pain from the poppy plant that were discovered 8,000 years ago.”
The hope with the HEAL initiative is to bring together academic centers with patient populations and research capabilities with industry, to accelerate moving nonaddictive treatments through to phase 3 trials.
The initiative also aims to promote discovery of new biologic targets for safe and effective pain treatment. New understanding of the physiology of pain has led to a multitude of candidate targets, said Dr. Koroshetz: “The good news is that there are so many potential targets. When I started in neurology in the ‘90s, I wouldn’t have said there were many, but now I’d say the list is long.”
Support for this work will require the development of human cell and tissue models, such as induced pluripotent stem cells, 3D printed organoids, and tissue chips. Several HEAL-funded grant mechanisms also seek research-industry collaboration to move investigational drugs for new targets through the pipeline quickly. The agency is hoping to see grantees apply new technologies, such as artificial intelligence, which can help identify new chemical structures and pinpoint new therapeutic targets for drug repurposing.
In addition to rapid drug discovery and accelerated clinical trials, Dr. Koroshetz said that HEAL leaders are hoping to see cross-pollination from two other NIH initiatives to boost pain-targeted medical device development. Both the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) and the Stimulating Peripheral Activity to Relieve Conditions (SPARC) initiatives have already shown promise in identifying targets for effective, noninvasive pain relief devices, he said. Technologies being developed from these programs are “truly amazing,” he added.
A new focus on data and asset sharing among industry, academia, and NIH will “improve the quality, consistency, and efficiency of early-phase pain clinical trials,” Dr. Koroshetz continued. The Early Phase Pain Investigation Clinical Network (EPPIC-Net) will coordinate data and biosample hosting.
Through a competitive submission process, EPPIC-net will review dossiers from institutions or consortia that can serve as assets around which clinical trials can be designed and executed. These early-phase trials will focus on well-defined pain conditions with unmet need, such as chronic regional pain syndrome and tic douloureux, he said.
“We want to find patients who have well-defined conditions. We know the phenotypes, we know the natural history. We’re looking for clinical sites to work on these projects as part of one large team to bring new therapies to patients,” noted Dr. Koroshetz.
Further along the spectrum of research, comparative effectiveness research networks will provide a reality check to compare both pharmacologic and nonpharmacologic interventions all along the spectrum from acute to chronic pain. Here, data elements and storage will also be coordinated through EPPIC-Net.
Implementation science research will fine-tune the practicalities of bringing research to practice as the final piece of the puzzle, said Dr. Koroshetz.
Under NIH director Francis Collins, MD, PhD, Dr. Koroshetz is co-leading the HEAL initiative, along with Nora Volkow, MD, director of the National Institute on Drug Abuse. They wrote about the initiative in JAMA last year (JAMA. 2018 Jul 10;320[2]:129-30).
Dr. Koroshetz reported no conflicts of interest.
MILWAUKEE – Congress has allocated a half billion dollars annually to the National Institutes of Health for a program that seeks to end America’s opioid crisis. The agency is putting in place over two-dozen projects spanning basic and translational research, clinical trials, and implementation of new strategies to address pain and fight addiction.
The , said Walter Koroshetz, MD, speaking at the scientific meeting of the American Pain Society. This represents carryover from 2018, a planning year for the initiative, along with the 2019 $500 million annual supplement to the NIH’s base appropriation.
In 2018, NIH and other federal agencies successfully convinced Congress that funding a coordinated use of resources was necessary to overcome the country’s dual opioid and chronic pain crises. “Luck happens to the prepared,” said Dr. Koroshetz, director of the National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Md., adding that many hours went into putting together a national pain strategy that is multidisciplinary and multi-layered, and involves multiple players.
The two aims of research under the initiative are to improve treatments for misuse and addiction, and to enhance pain management. Focusing on this latter aim, Dr. Koroshetz said that the initiative has several research priorities to enhance pain management.
First, the biological basis for chronic pain needs to be understood in order to formulate effective therapies and interventions. “We need to understand the transition from acute to chronic pain,” he commented. “We need to see if we can learn about the risk factors for developing chronic pain; if we get really lucky, we might identify some biological markers” that identify who is at risk for this transition “in a high-risk acute pain situation.”
Next, a key request of industry and academia will be development of more drugs that avoid the dual-target program of opioids, which affect reward circuitry along with pain circuitry. “Drugs affecting the pain circuit and the reward circuit will always result in addiction” potential, said Dr. Koroshetz. “We’re still using drugs for pain from the poppy plant that were discovered 8,000 years ago.”
The hope with the HEAL initiative is to bring together academic centers with patient populations and research capabilities with industry, to accelerate moving nonaddictive treatments through to phase 3 trials.
The initiative also aims to promote discovery of new biologic targets for safe and effective pain treatment. New understanding of the physiology of pain has led to a multitude of candidate targets, said Dr. Koroshetz: “The good news is that there are so many potential targets. When I started in neurology in the ‘90s, I wouldn’t have said there were many, but now I’d say the list is long.”
Support for this work will require the development of human cell and tissue models, such as induced pluripotent stem cells, 3D printed organoids, and tissue chips. Several HEAL-funded grant mechanisms also seek research-industry collaboration to move investigational drugs for new targets through the pipeline quickly. The agency is hoping to see grantees apply new technologies, such as artificial intelligence, which can help identify new chemical structures and pinpoint new therapeutic targets for drug repurposing.
In addition to rapid drug discovery and accelerated clinical trials, Dr. Koroshetz said that HEAL leaders are hoping to see cross-pollination from two other NIH initiatives to boost pain-targeted medical device development. Both the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) and the Stimulating Peripheral Activity to Relieve Conditions (SPARC) initiatives have already shown promise in identifying targets for effective, noninvasive pain relief devices, he said. Technologies being developed from these programs are “truly amazing,” he added.
A new focus on data and asset sharing among industry, academia, and NIH will “improve the quality, consistency, and efficiency of early-phase pain clinical trials,” Dr. Koroshetz continued. The Early Phase Pain Investigation Clinical Network (EPPIC-Net) will coordinate data and biosample hosting.
Through a competitive submission process, EPPIC-net will review dossiers from institutions or consortia that can serve as assets around which clinical trials can be designed and executed. These early-phase trials will focus on well-defined pain conditions with unmet need, such as chronic regional pain syndrome and tic douloureux, he said.
“We want to find patients who have well-defined conditions. We know the phenotypes, we know the natural history. We’re looking for clinical sites to work on these projects as part of one large team to bring new therapies to patients,” noted Dr. Koroshetz.
Further along the spectrum of research, comparative effectiveness research networks will provide a reality check to compare both pharmacologic and nonpharmacologic interventions all along the spectrum from acute to chronic pain. Here, data elements and storage will also be coordinated through EPPIC-Net.
Implementation science research will fine-tune the practicalities of bringing research to practice as the final piece of the puzzle, said Dr. Koroshetz.
Under NIH director Francis Collins, MD, PhD, Dr. Koroshetz is co-leading the HEAL initiative, along with Nora Volkow, MD, director of the National Institute on Drug Abuse. They wrote about the initiative in JAMA last year (JAMA. 2018 Jul 10;320[2]:129-30).
Dr. Koroshetz reported no conflicts of interest.
REPORTING FROM APS 2019
Nonopioid Alternatives to Addressing Pain Intensity: A Retrospective Look at 2 Noninvasive Pain Treatment Devices
Chronic pain is common among veterans treated in Veterans Health Administration (VHA) facilities, and optimal management remains challenging in the context of the national opioid misuse epidemic. The Eastern Oklahoma VA Health Care System (EOVAHCS) Pain Program offers a range of services that allow clinicians to tailor multimodal treatment strategies to a veteran’s needs. In 2014, a Modality Clinic was established to assess the utility of adding noninvasive treatment devices to the pain program’s armamentarium. This article addresses the context for introducing these devices and describes the EOVAHCS Pain Program and Modality Clinic. Also discussed are procedures and findings from an initial quality improvement evaluation designed to inform decision making regarding retention, expansion, or elimination of the EOVAHCS noninvasive, pain treatment device program.
Opioid prescriptions increased from 76 million in 1991 to 219 million in 2011. In 2011, the annual cost of chronic pain in the US was estimated at $635 billion.1-6 The confluence of an increasing concern about undertreatment of pain and overconfidence for the safety of opioids led to what former US Surgeon General Vivek H. Murthy, MD, called the opioid crisis.7 As awareness of its unintended consequences of opioid prescribing increased, the VHA began looking for nonopioid treatments that would decrease pain intensity. The 1993 article by Kehlet and Dahl was one of the first discussions of a multimodal nonpharmacologic strategy for addressing acute postoperative pain.8 Their pivotal literature review concluded that nonpharmacologic modalities, such as acupuncture, cranial manipulation, cranial electrostimulation treatment (CES), and low-level light technologies (LLLT), carried less risk and produced equal or greater clinical effects than those of drug therapies.8
Multimodal treatment approaches increasingly are encouraged, and nonopioid pain control has become more common across medical disciplines from physical therapy to anesthesiology.8-10 Innovative, noninvasive devices designed for self-use have appeared on the market. Many of these devices incorporate microcurrent electrical therapy (MET), CES, and/or LLLT (also known as cold laser).11-16 LLLT is a light modality that seems to lead to increased ATP production, resulting in improved healing and decreased inflammation.13-16 Although CES has been studied in a variety of patient populations, its effectiveness is not well understood.16 Research on the effects of CES on neurotransmitter levels as well as activation of parts of the brain involved in pain reception and transmission should clarify these mechanisms. Research has shown improvements in sleep and mood as well as overall pain reduction.11,16 Research has focused primarily on individual modalities rather than on combination devices and has been conducted on populations unlike the veteran population (eg, women with fibromyalgia).
Most of the devices that use electrical or LLLT cannot be used safely by patients who have implantable electrical devices or have medical conditions such as unstable seizures, pregnancy, and active malignancies.
The most common adverse effects (AEs) of CES—dizziness and headaches—are minimal compared with the AEs of pain medications. MET and LLLT AEs generally are limited to skin irritation and muscle soreness.11 Most devices require a prescription, and manufacturers provide training for purchase.
The Pain Program
EOVAHCS initially established its consultative pain program in 2013 to provide support, recommendations, and education about managing pain in veterans to primary care providers (PCPs). Veterans are referred to the pain program for a face-to-face assessment and set of recommendations to assist in developing a comprehensive pain treatment plan. Consistent with its multimodal, biopsychosocial rehabilitation model approach, the program also offers several chronic pain treatment services, including patient education courses, cognitive behavioral therapy (CBT) for chronic pain, chiropractic care, biofeedback, relaxation training, steroid injections, pain coaching, and a pain modality (noninvasive device) clinic. During their assessment, veterans are evaluated for the appropriateness of these programs, including treatment through the Pain Modality Clinic.
Pain Modality Clinic
The EOVAHCS Pain Modality Clinic was created in 2014 as a treatment and device-trial program to provide veterans access to newer noninvasive, patient-driven treatment devices as part of an active chronic pain self-management plan. A crucial innovation is that these devices are designed to be used by patients in their homes. These devices can be expensive, and not every patient will benefit from their use; therefore, clinic leaders recommended a trial before a device is issued to a veteran for home use.
The Pain Modality Clinic coordinator trains clinic facilitators on the device according to manufacturer’s guidelines. Each participating veteran takes part in a device trial to confirm that he or she is able to use the recommended device independently and is likely to benefit from its use. When appropriate, veterans who do not respond to the initial device trial could test the potential benefit of another device. Although data from these device trials are collected primarily to inform clinical decision making, this information also is useful in guiding local policy regarding continued support for each of the modalities.
Veterans who have chronic or persistent pain (≥ 3 months) that interferes with function or quality of life are considered good candidates for a device trial if they are actively involved in pain self-care, logistically able to participate, able to use a device long-term, and have no contraindications. “Active involvement” could be met by participation in any pain management effort, whether a specific exercise program, CBT, or other treatment.
The Modality Clinic currently offers device trials for persistent pain with Alpha-Stim-M (AS-M; Electromedical Products International, Mineral Wells, TX), Laser Touch One (LTO; Renewal Technologies, LLC, Phoenix, AZ), and Neurolumen (Oklahoma City, OK). Neurolumen devices were not available in the clinic initially and will not be discussed further in this article.
The first Alpha-Stim machine using MET and CES technology was created in 1981 for in-office pain management. In 2012, the currently used AS-M became available.11 AS-M is FDA approved for treating pain, anxiety, depression, and sleep problems and is the device used in the EOVAHCS Modality Clinic. AS-M uses probes or electrodes to send a MET waveform through the body area in pain. The device uses ear clips to provide CES, which is thought to increase alpha waves in the brain.11 The LTO is a device that combines LLLT and MET technologies in a home-use design.14 LTO is FDA approved for treating painand is a portable personal pain-relief device applied to the area of pain using electroconductive gel.
Both devices are designed for long-term, self-use, making them viable parts of a multimodal, chronic pain treatment plan. Contraindications for AS-M and LTO include having a pacemaker or an implantable defibrillator, pregnancy, current malignancy, or seizures. Eligible veterans with persistent pain and high levels of depression, anxiety, and/or sleep problems generally are triaged to AS-M, whereas those who have only pain intensity issues usually are assigned to LTO. Referral to the Modality Clinic is not limited to a specific type of pain; common pain conditions seen in the clinic are spine and joint pain, arthritis pain, myofascial pain, headaches, and neuropathy.
Training and Device Trials
Eligible veterans are educated about the device and complete clinical informed consent, which is documented in the electronic health record. The veterans’ primary care and/or specialist providers are contacted for concurrence regarding veterans’ participation in the treatment.
Protocols for the device trials are based on the manufacturers’ recommendations, adjusted to what is feasible in the clinic (manufacturers approved the changes). The number of treatments per trial varies by device. For AS-M, veterans come to the clinic 5 days a week for 2 weeks. For LTO, veterans attend the clinic 5 days a week for 1 week.
At the beginning of a device trial, a trained facilitator teaches each veteran and caregiver to use the device, sets functional goals for the trial, and provides education on the trial questionnaires and daily pain logs. The veteran then follows the device protocol in the clinic where the facilitator can respond to questions and address any issues. With support from their caregivers, veterans are expected to become independent on their device use by the end of the trial. Clinic staff or the veteran can stop the device trial at any point, without affecting the veteran’s participation in or eligibility for other EOVAHCS pain programs.
This project was submitted to the University of Oklahoma Health Sciences Center Institutional Review Board and was exempted from institutional review board oversight as a retrospective, quality improvement effort. Before data analysis, the EOVAHCS Coordinator for Research and Development reviewed the procedures to ensure that all policies were being followed.
Methods
Data for veterans who completed valid treatments of AS-M or LTO from May 9, 2014 to August 20, 2016, were included in the analyses. For an AS-M treatment to be considered valid, the veteran must have attended at least 8 sessions and completed assessment instruments at baseline (preintervention) and following completion (postintervention). For an LTO treatment to be considered valid, the veteran must have attended at least 4 sessions and completed assessment measures at baseline and after completion.
Measures
Veterans completed the following measures at baseline and after trial completion:
The Beck Depression Inventory (BDI-II) is a 21-item measure designed to assess depressive symptoms. Each item assesses intensity on a 0-to-3 scale. Scores from 0 to 13 indicate minimum depression; 14 to 19, mild depression; 20 to 28, moderate depression, and 29 to 63, severe depression.17
The Beck Anxiety Inventory (BAI) is a 21-item measure of anxiety symptoms that uses a 0-to-3 scale to assess severity of subjective, somatic, or panic-related symptoms of anxiety. Scores ranging from 0 to 9 indicate minimal anxiety; 10 to 16, mild anxiety; 17 to 29, moderate anxiety, and 30 to 63, severe anxiety.18
The Pain Catastrophizing Scale (PCS) is a 13-item measure of pain catastrophizing, a crucial marker of how individuals experience pain. Items are scored on a 0-to-4 scale; scores of ≥ 30 indicate a clinically relevant level of catastrophizing.19
The Subjective Units of Distress Scale (SUD) is a single-item measure of the subjective intensity of disturbance or distress currently being experienced. It is scored from 0 to 10; 1 to 4 is mild, 5 to 6 is moderate, and 7 to 10 is severe.20
The Brief Pain Inventory (BPI) measures pain intensity and the impact of pain on functioning. Four items assess pain intensity at its worst, least, and average over the previous 24 hours and at the time of assessment; responses are on a 0-to-10 scale with 10 being most severe. The pain intensity measure is the average of scores on these 4 items. Pain interference is measured with respect to 7 daily activities; general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. Each of these items is scored on a 0-to-10 scale with 10 being the most severe. The pain interference measure is the average of scores on these 7 items.21
Participants completed a daily pain log and recorded self-ratings (0-to-10 scale) of pain and relaxation levels before and after using the device. These scores were primarily used to assist in determining whether goals, set collaboratively by the clinician and the veteran at the first session, had been met.
Analysis
Descriptive statistics were used to characterize the sample overall and by modality. Paired t tests were used to assess changes on each assessment measure over time and for each device separately. The significance of change was assessed for 8 outcomes for each device. In this context, using a conservative Bonferroni correction, significance was set at P < .006. Because AS-M is designed to address depression, anxiety, and sleep as well as pain, whereas LTO is not, device assignments were based on clinical considerations rather than randomization. Therefore, no comparisons were made between devices, and outcomes were assessed independently for the 2 devices. Analyses were performed using SAS 9.4 (Cary, NC).
Results
Device trials were initiated for 161 veterans (LTO, 70; AS-M, 91). Distribution of devices was unequal because veterans are assigned to 1 device or the other based on clinical presentation. Failure to complete a trial (n = 46; 28.6%) typically was because of travel barriers, lack of interest in continuing, and for 3 veterans, reports of headaches that they attributed to the AS-M treatment. Of the 115 participants who completed valid trials, 88 (76.5%) also completed assessment measures at pre- and postintervention (LTO = 38; AS-M = 50). None of the participants in this study completed trials with both the AS-M and LTO devices.
Most participants were male (84.1%) and rural residents (85.5%) (Table 1). 
Pain Reduction
Treatment with AS-M or LTO was associated with statistically significant reductions in pain severity (BPI), pain interference (BPI), daily pain intensity scores (daily pain log), and pain catastrophizing (PCS) (Tables 2 and 3). 
Impact on Mood
Use of AS-M was associated with statistically significant improvements in depression (BDI-II), anxiety (BAI), and distress (SUD) scores. In addition, veterans completing AS-M treatment showed a statistically significant improvement in self-reported relaxation scores. Interestingly, use of LTO also resulted in a statistically significant decrease in anxiety (BAI) and a nonstatistically significant decrease in depression (BDI-II).
Figure 1 and 2 illustrates the clinical impact of each device in shifting participants from 1 level of symptom severity to another. 
Discussion
Use of both AS-M and LTO at EOVAHC was associated with reduced pain intensity. The devices also had positive effects beyond pain in areas such as depression, anxiety, and distress. Remission of depression and anxiety symptoms has been associated with significant decline in pain symptoms, suggesting that pain is best treated through multimodal approaches.22
In the context of the opioid crisis, the availability of effective nonopioid, nonpharmacologic, noninvasive treatments for chronic pain is needed. The Joint Commission recently expanded its pain management guidelines to support hospitals offering nonpharmacologic pain treatments.23 Integrating AS-M, LTO, or similar products into standard pain management practices allows for other treatment pathways with positive outcomes for providers and patients. The Joint Commission also recommends an interdisciplinary approach, defined as a process whereby health care professionals from different disciplines collaborate to diagnose and treat patients experiencing difficult pain conditions. This approach facilitates multimodal management because these disciplines contribute knowledge about a variety of treatment options. Devices such AS-M and LTO are well suited to interdisciplinary pain management because they are not seen as being under the purview of a specific health care specialty.
Limitations
Our findings are limited because they are derived from a retrospective, quality improvement evaluation of outcomes from a single clinic. Findings must be considered in the context of the relatively small samples of veterans. Because analyses were conducted as part of a quality improvement effort, veterans were offered a specific device based on clinical indications, there were no comparisons between devices, and there was no comparison group. Although most participants were using medication and other treatments as part of their pain treatment plan, all reported continued pain intensity before use of a device. Analyses did not control for variation in treatments received concurrently. Last, the logs used to collect self-report data on daily pain and relaxation levels were not validated.
The data highlight a clear need for research to better understand the long-term effects of these devices as well as the characteristics of patients who respond best to each device. Noninvasive treatments for pain often are dismissed as placebos. Rigorously designed, controlled studies will help demonstrate that these devices offer a statistically significant benefit beyond any placebo effect.
Conclusion
Understanding of chronic pain and its treatment will continue to evolve. It is clear that each person dealing with chronic pain requires a tailored combination of treatments and multimodal approaches, which is more effective than any single treatment. Nonpharmacologic, noninvasive devices pose fewer risks and seem to be more effective in reducing pain intensity than traditional treatments, including medications or surgical intervention. In light of the current emphasis on evidence-based health care and as the evidence for the effectiveness of noninvasive pain devices modalities grows, it is likely that treatments incorporating modalities such as MET, CES, and LLLT will become common options for managing chronic pain.
1. US Department of Veterans Affairs. Pain as the 5th Vital Sign Toolkit. https://www.va.gov/PAINMANAGEMENT/docs/Pain_As_the_5th_Vital_Sign_Toolkit.pdf. Published October 2000. Accessed February 11, 2019.
2. Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: National Academies Press; 2011.
3. Rosenblum A, Marsch LA, Joseph H, Portenoy RK. Opioids and the treatment of chronic pain: Controversies, current status, and future directions. Exp Clin Psychopharmacol. 2008;16(5):405-416.
4. Moayedi M, Davis KD. Theories of pain: from specificity to gate control. J Neurophysiol. 2013;109(1):5-12.
5. Mosher HJ, Krebs EE, Carrel M, Kaboli PJ, Weg MW, Lund BC. Trends in prevalent and incident opioid receipt: an observational study in Veterans Health Administration 2004-2012. J Gen Intern Med. 2015;30(5):597-604.
6. Reuben DB, Alvanzo AAH, Ashikaga T, et al. National Institutes of Health Pathways to Prevention Workshop: The role of opioids in the treatment of chronic pain. Ann Intern Med. 2015;162(4):295-300.
7. Murthy VH. Opioid epidemic: we all have a role in turning the tide. https://obamawhitehouse.archives.gov/blog/2016/10/05/opioid-epidemic-we-all-have-role-turning-tide. Published October 5, 2016. Accessed February 12, 2019.
8. Kehlet H, Dahl JB. The value of “multimodal” or “balanced analgesia” in postoperative pain treatment. Anesth Analg. 1993;77(5):1048-1056.
9. Crane P, Feinberg L, Morris J. A multimodal physical therapy approach to the management of a patient with temporomandibular dysfunction and head and neck lymphedema: a case report. J Man Manip Ther. 2015;23(1): 37-42.
10. Arnstein P. Multimodal approaches to pain management. Nurs. 2011;41(3): 60-61.
11. Alpha-Stim. http://www.alpha-stim.com. Accessed March 22, 2019
12. Shekelle PG, Cook IA, Miake-Lye IM, Booth MS, Beroes JM, Mak S. Benefits and harms of cranial electrical stimulation for chronic painful conditions, depression, anxiety, and insomnia. Ann Intern Med. 2018;168(6):414-421.
13. Chow RT, Heller GZ, Barnsley L. The effect of 300 mW, 830 nm laser on chronic neck pain: a double-blind, randomized, placebo-controlled study. Pain. 2006;124(1):201-210.
14. Kulkarni AD, Smith RB. The use of microcurrent electrical therapy and cranial electrotherapy stimulation in pain control. Clin Pract Alternative Med. 2001;2(2):99-102.
15. Chow RT, Johnson MI, Lopes-Martins RA, Bjordal JM. Efficacy of low-level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or active-treatment controlled trials. Lancet. 2009;374(9705):1897-1908.
16. Taylor AG, Anderson JG, Riedel SL, et al. Cranial electrical stimulation improves symptoms and functional status in individuals with fibromyalgia. Pain Manag Nurs. 2013;14(4):327-335.
17. Beck, AT, Steer, RA, Brown, GK. Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation; 1996.
18. Beck AT, Steer RA. Beck Anxiety Inventory: Manual. San Antonio, TX: Psychological Corporation; 1993.
19. Sullivan MJL, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychol Assess. 1995;7(4):524-532.
20. Wolpe J. The Practice of Behavior Therapy. 4th ed. Elmsford, NY: Pergamon; 1990.
21. Cleeland CS. The Brief Pain Inventory User Manual. https://www.mdanderson.org/research/departments-labs-institutes/departments-divisions/symptom-research/symptom-assessment-tools/brief-pain-inventory.html. Published 2009. Accessed February 12, 2019.
22. Gerrits MM, van Marwijk HW, van Oppen P, Horst HVD, Penninx BW. Longitudinal association between pain, and depression and anxiety over four years. J Psychosom Res. 2015;78(1):64-70.
23. The Joint Commission. Joint Commission enhances pain assessment and management requirements for accredited hospitals. The Joint Commission Perspectives. https://www.jointcommission.org/assets/1/18/Joint_Commission_Enhances_Pain_Assessment_and_Management_Requirements_for_Accredited_Hospitals1.PDF. Published July 2017. Accessed March 21, 2019.
Chronic pain is common among veterans treated in Veterans Health Administration (VHA) facilities, and optimal management remains challenging in the context of the national opioid misuse epidemic. The Eastern Oklahoma VA Health Care System (EOVAHCS) Pain Program offers a range of services that allow clinicians to tailor multimodal treatment strategies to a veteran’s needs. In 2014, a Modality Clinic was established to assess the utility of adding noninvasive treatment devices to the pain program’s armamentarium. This article addresses the context for introducing these devices and describes the EOVAHCS Pain Program and Modality Clinic. Also discussed are procedures and findings from an initial quality improvement evaluation designed to inform decision making regarding retention, expansion, or elimination of the EOVAHCS noninvasive, pain treatment device program.
Opioid prescriptions increased from 76 million in 1991 to 219 million in 2011. In 2011, the annual cost of chronic pain in the US was estimated at $635 billion.1-6 The confluence of an increasing concern about undertreatment of pain and overconfidence for the safety of opioids led to what former US Surgeon General Vivek H. Murthy, MD, called the opioid crisis.7 As awareness of its unintended consequences of opioid prescribing increased, the VHA began looking for nonopioid treatments that would decrease pain intensity. The 1993 article by Kehlet and Dahl was one of the first discussions of a multimodal nonpharmacologic strategy for addressing acute postoperative pain.8 Their pivotal literature review concluded that nonpharmacologic modalities, such as acupuncture, cranial manipulation, cranial electrostimulation treatment (CES), and low-level light technologies (LLLT), carried less risk and produced equal or greater clinical effects than those of drug therapies.8
Multimodal treatment approaches increasingly are encouraged, and nonopioid pain control has become more common across medical disciplines from physical therapy to anesthesiology.8-10 Innovative, noninvasive devices designed for self-use have appeared on the market. Many of these devices incorporate microcurrent electrical therapy (MET), CES, and/or LLLT (also known as cold laser).11-16 LLLT is a light modality that seems to lead to increased ATP production, resulting in improved healing and decreased inflammation.13-16 Although CES has been studied in a variety of patient populations, its effectiveness is not well understood.16 Research on the effects of CES on neurotransmitter levels as well as activation of parts of the brain involved in pain reception and transmission should clarify these mechanisms. Research has shown improvements in sleep and mood as well as overall pain reduction.11,16 Research has focused primarily on individual modalities rather than on combination devices and has been conducted on populations unlike the veteran population (eg, women with fibromyalgia).
Most of the devices that use electrical or LLLT cannot be used safely by patients who have implantable electrical devices or have medical conditions such as unstable seizures, pregnancy, and active malignancies.
The most common adverse effects (AEs) of CES—dizziness and headaches—are minimal compared with the AEs of pain medications. MET and LLLT AEs generally are limited to skin irritation and muscle soreness.11 Most devices require a prescription, and manufacturers provide training for purchase.
The Pain Program
EOVAHCS initially established its consultative pain program in 2013 to provide support, recommendations, and education about managing pain in veterans to primary care providers (PCPs). Veterans are referred to the pain program for a face-to-face assessment and set of recommendations to assist in developing a comprehensive pain treatment plan. Consistent with its multimodal, biopsychosocial rehabilitation model approach, the program also offers several chronic pain treatment services, including patient education courses, cognitive behavioral therapy (CBT) for chronic pain, chiropractic care, biofeedback, relaxation training, steroid injections, pain coaching, and a pain modality (noninvasive device) clinic. During their assessment, veterans are evaluated for the appropriateness of these programs, including treatment through the Pain Modality Clinic.
Pain Modality Clinic
The EOVAHCS Pain Modality Clinic was created in 2014 as a treatment and device-trial program to provide veterans access to newer noninvasive, patient-driven treatment devices as part of an active chronic pain self-management plan. A crucial innovation is that these devices are designed to be used by patients in their homes. These devices can be expensive, and not every patient will benefit from their use; therefore, clinic leaders recommended a trial before a device is issued to a veteran for home use.
The Pain Modality Clinic coordinator trains clinic facilitators on the device according to manufacturer’s guidelines. Each participating veteran takes part in a device trial to confirm that he or she is able to use the recommended device independently and is likely to benefit from its use. When appropriate, veterans who do not respond to the initial device trial could test the potential benefit of another device. Although data from these device trials are collected primarily to inform clinical decision making, this information also is useful in guiding local policy regarding continued support for each of the modalities.
Veterans who have chronic or persistent pain (≥ 3 months) that interferes with function or quality of life are considered good candidates for a device trial if they are actively involved in pain self-care, logistically able to participate, able to use a device long-term, and have no contraindications. “Active involvement” could be met by participation in any pain management effort, whether a specific exercise program, CBT, or other treatment.
The Modality Clinic currently offers device trials for persistent pain with Alpha-Stim-M (AS-M; Electromedical Products International, Mineral Wells, TX), Laser Touch One (LTO; Renewal Technologies, LLC, Phoenix, AZ), and Neurolumen (Oklahoma City, OK). Neurolumen devices were not available in the clinic initially and will not be discussed further in this article.
The first Alpha-Stim machine using MET and CES technology was created in 1981 for in-office pain management. In 2012, the currently used AS-M became available.11 AS-M is FDA approved for treating pain, anxiety, depression, and sleep problems and is the device used in the EOVAHCS Modality Clinic. AS-M uses probes or electrodes to send a MET waveform through the body area in pain. The device uses ear clips to provide CES, which is thought to increase alpha waves in the brain.11 The LTO is a device that combines LLLT and MET technologies in a home-use design.14 LTO is FDA approved for treating painand is a portable personal pain-relief device applied to the area of pain using electroconductive gel.
Both devices are designed for long-term, self-use, making them viable parts of a multimodal, chronic pain treatment plan. Contraindications for AS-M and LTO include having a pacemaker or an implantable defibrillator, pregnancy, current malignancy, or seizures. Eligible veterans with persistent pain and high levels of depression, anxiety, and/or sleep problems generally are triaged to AS-M, whereas those who have only pain intensity issues usually are assigned to LTO. Referral to the Modality Clinic is not limited to a specific type of pain; common pain conditions seen in the clinic are spine and joint pain, arthritis pain, myofascial pain, headaches, and neuropathy.
Training and Device Trials
Eligible veterans are educated about the device and complete clinical informed consent, which is documented in the electronic health record. The veterans’ primary care and/or specialist providers are contacted for concurrence regarding veterans’ participation in the treatment.
Protocols for the device trials are based on the manufacturers’ recommendations, adjusted to what is feasible in the clinic (manufacturers approved the changes). The number of treatments per trial varies by device. For AS-M, veterans come to the clinic 5 days a week for 2 weeks. For LTO, veterans attend the clinic 5 days a week for 1 week.
At the beginning of a device trial, a trained facilitator teaches each veteran and caregiver to use the device, sets functional goals for the trial, and provides education on the trial questionnaires and daily pain logs. The veteran then follows the device protocol in the clinic where the facilitator can respond to questions and address any issues. With support from their caregivers, veterans are expected to become independent on their device use by the end of the trial. Clinic staff or the veteran can stop the device trial at any point, without affecting the veteran’s participation in or eligibility for other EOVAHCS pain programs.
This project was submitted to the University of Oklahoma Health Sciences Center Institutional Review Board and was exempted from institutional review board oversight as a retrospective, quality improvement effort. Before data analysis, the EOVAHCS Coordinator for Research and Development reviewed the procedures to ensure that all policies were being followed.
Methods
Data for veterans who completed valid treatments of AS-M or LTO from May 9, 2014 to August 20, 2016, were included in the analyses. For an AS-M treatment to be considered valid, the veteran must have attended at least 8 sessions and completed assessment instruments at baseline (preintervention) and following completion (postintervention). For an LTO treatment to be considered valid, the veteran must have attended at least 4 sessions and completed assessment measures at baseline and after completion.
Measures
Veterans completed the following measures at baseline and after trial completion:
The Beck Depression Inventory (BDI-II) is a 21-item measure designed to assess depressive symptoms. Each item assesses intensity on a 0-to-3 scale. Scores from 0 to 13 indicate minimum depression; 14 to 19, mild depression; 20 to 28, moderate depression, and 29 to 63, severe depression.17
The Beck Anxiety Inventory (BAI) is a 21-item measure of anxiety symptoms that uses a 0-to-3 scale to assess severity of subjective, somatic, or panic-related symptoms of anxiety. Scores ranging from 0 to 9 indicate minimal anxiety; 10 to 16, mild anxiety; 17 to 29, moderate anxiety, and 30 to 63, severe anxiety.18
The Pain Catastrophizing Scale (PCS) is a 13-item measure of pain catastrophizing, a crucial marker of how individuals experience pain. Items are scored on a 0-to-4 scale; scores of ≥ 30 indicate a clinically relevant level of catastrophizing.19
The Subjective Units of Distress Scale (SUD) is a single-item measure of the subjective intensity of disturbance or distress currently being experienced. It is scored from 0 to 10; 1 to 4 is mild, 5 to 6 is moderate, and 7 to 10 is severe.20
The Brief Pain Inventory (BPI) measures pain intensity and the impact of pain on functioning. Four items assess pain intensity at its worst, least, and average over the previous 24 hours and at the time of assessment; responses are on a 0-to-10 scale with 10 being most severe. The pain intensity measure is the average of scores on these 4 items. Pain interference is measured with respect to 7 daily activities; general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. Each of these items is scored on a 0-to-10 scale with 10 being the most severe. The pain interference measure is the average of scores on these 7 items.21
Participants completed a daily pain log and recorded self-ratings (0-to-10 scale) of pain and relaxation levels before and after using the device. These scores were primarily used to assist in determining whether goals, set collaboratively by the clinician and the veteran at the first session, had been met.
Analysis
Descriptive statistics were used to characterize the sample overall and by modality. Paired t tests were used to assess changes on each assessment measure over time and for each device separately. The significance of change was assessed for 8 outcomes for each device. In this context, using a conservative Bonferroni correction, significance was set at P < .006. Because AS-M is designed to address depression, anxiety, and sleep as well as pain, whereas LTO is not, device assignments were based on clinical considerations rather than randomization. Therefore, no comparisons were made between devices, and outcomes were assessed independently for the 2 devices. Analyses were performed using SAS 9.4 (Cary, NC).
Results
Device trials were initiated for 161 veterans (LTO, 70; AS-M, 91). Distribution of devices was unequal because veterans are assigned to 1 device or the other based on clinical presentation. Failure to complete a trial (n = 46; 28.6%) typically was because of travel barriers, lack of interest in continuing, and for 3 veterans, reports of headaches that they attributed to the AS-M treatment. Of the 115 participants who completed valid trials, 88 (76.5%) also completed assessment measures at pre- and postintervention (LTO = 38; AS-M = 50). None of the participants in this study completed trials with both the AS-M and LTO devices.
Most participants were male (84.1%) and rural residents (85.5%) (Table 1).
Pain Reduction
Treatment with AS-M or LTO was associated with statistically significant reductions in pain severity (BPI), pain interference (BPI), daily pain intensity scores (daily pain log), and pain catastrophizing (PCS) (Tables 2 and 3).
Impact on Mood
Use of AS-M was associated with statistically significant improvements in depression (BDI-II), anxiety (BAI), and distress (SUD) scores. In addition, veterans completing AS-M treatment showed a statistically significant improvement in self-reported relaxation scores. Interestingly, use of LTO also resulted in a statistically significant decrease in anxiety (BAI) and a nonstatistically significant decrease in depression (BDI-II).
Figure 1 and 2 illustrates the clinical impact of each device in shifting participants from 1 level of symptom severity to another.
Discussion
Use of both AS-M and LTO at EOVAHC was associated with reduced pain intensity. The devices also had positive effects beyond pain in areas such as depression, anxiety, and distress. Remission of depression and anxiety symptoms has been associated with significant decline in pain symptoms, suggesting that pain is best treated through multimodal approaches.22
In the context of the opioid crisis, the availability of effective nonopioid, nonpharmacologic, noninvasive treatments for chronic pain is needed. The Joint Commission recently expanded its pain management guidelines to support hospitals offering nonpharmacologic pain treatments.23 Integrating AS-M, LTO, or similar products into standard pain management practices allows for other treatment pathways with positive outcomes for providers and patients. The Joint Commission also recommends an interdisciplinary approach, defined as a process whereby health care professionals from different disciplines collaborate to diagnose and treat patients experiencing difficult pain conditions. This approach facilitates multimodal management because these disciplines contribute knowledge about a variety of treatment options. Devices such AS-M and LTO are well suited to interdisciplinary pain management because they are not seen as being under the purview of a specific health care specialty.
Limitations
Our findings are limited because they are derived from a retrospective, quality improvement evaluation of outcomes from a single clinic. Findings must be considered in the context of the relatively small samples of veterans. Because analyses were conducted as part of a quality improvement effort, veterans were offered a specific device based on clinical indications, there were no comparisons between devices, and there was no comparison group. Although most participants were using medication and other treatments as part of their pain treatment plan, all reported continued pain intensity before use of a device. Analyses did not control for variation in treatments received concurrently. Last, the logs used to collect self-report data on daily pain and relaxation levels were not validated.
The data highlight a clear need for research to better understand the long-term effects of these devices as well as the characteristics of patients who respond best to each device. Noninvasive treatments for pain often are dismissed as placebos. Rigorously designed, controlled studies will help demonstrate that these devices offer a statistically significant benefit beyond any placebo effect.
Conclusion
Understanding of chronic pain and its treatment will continue to evolve. It is clear that each person dealing with chronic pain requires a tailored combination of treatments and multimodal approaches, which is more effective than any single treatment. Nonpharmacologic, noninvasive devices pose fewer risks and seem to be more effective in reducing pain intensity than traditional treatments, including medications or surgical intervention. In light of the current emphasis on evidence-based health care and as the evidence for the effectiveness of noninvasive pain devices modalities grows, it is likely that treatments incorporating modalities such as MET, CES, and LLLT will become common options for managing chronic pain.
Chronic pain is common among veterans treated in Veterans Health Administration (VHA) facilities, and optimal management remains challenging in the context of the national opioid misuse epidemic. The Eastern Oklahoma VA Health Care System (EOVAHCS) Pain Program offers a range of services that allow clinicians to tailor multimodal treatment strategies to a veteran’s needs. In 2014, a Modality Clinic was established to assess the utility of adding noninvasive treatment devices to the pain program’s armamentarium. This article addresses the context for introducing these devices and describes the EOVAHCS Pain Program and Modality Clinic. Also discussed are procedures and findings from an initial quality improvement evaluation designed to inform decision making regarding retention, expansion, or elimination of the EOVAHCS noninvasive, pain treatment device program.
Opioid prescriptions increased from 76 million in 1991 to 219 million in 2011. In 2011, the annual cost of chronic pain in the US was estimated at $635 billion.1-6 The confluence of an increasing concern about undertreatment of pain and overconfidence for the safety of opioids led to what former US Surgeon General Vivek H. Murthy, MD, called the opioid crisis.7 As awareness of its unintended consequences of opioid prescribing increased, the VHA began looking for nonopioid treatments that would decrease pain intensity. The 1993 article by Kehlet and Dahl was one of the first discussions of a multimodal nonpharmacologic strategy for addressing acute postoperative pain.8 Their pivotal literature review concluded that nonpharmacologic modalities, such as acupuncture, cranial manipulation, cranial electrostimulation treatment (CES), and low-level light technologies (LLLT), carried less risk and produced equal or greater clinical effects than those of drug therapies.8
Multimodal treatment approaches increasingly are encouraged, and nonopioid pain control has become more common across medical disciplines from physical therapy to anesthesiology.8-10 Innovative, noninvasive devices designed for self-use have appeared on the market. Many of these devices incorporate microcurrent electrical therapy (MET), CES, and/or LLLT (also known as cold laser).11-16 LLLT is a light modality that seems to lead to increased ATP production, resulting in improved healing and decreased inflammation.13-16 Although CES has been studied in a variety of patient populations, its effectiveness is not well understood.16 Research on the effects of CES on neurotransmitter levels as well as activation of parts of the brain involved in pain reception and transmission should clarify these mechanisms. Research has shown improvements in sleep and mood as well as overall pain reduction.11,16 Research has focused primarily on individual modalities rather than on combination devices and has been conducted on populations unlike the veteran population (eg, women with fibromyalgia).
Most of the devices that use electrical or LLLT cannot be used safely by patients who have implantable electrical devices or have medical conditions such as unstable seizures, pregnancy, and active malignancies.
The most common adverse effects (AEs) of CES—dizziness and headaches—are minimal compared with the AEs of pain medications. MET and LLLT AEs generally are limited to skin irritation and muscle soreness.11 Most devices require a prescription, and manufacturers provide training for purchase.
The Pain Program
EOVAHCS initially established its consultative pain program in 2013 to provide support, recommendations, and education about managing pain in veterans to primary care providers (PCPs). Veterans are referred to the pain program for a face-to-face assessment and set of recommendations to assist in developing a comprehensive pain treatment plan. Consistent with its multimodal, biopsychosocial rehabilitation model approach, the program also offers several chronic pain treatment services, including patient education courses, cognitive behavioral therapy (CBT) for chronic pain, chiropractic care, biofeedback, relaxation training, steroid injections, pain coaching, and a pain modality (noninvasive device) clinic. During their assessment, veterans are evaluated for the appropriateness of these programs, including treatment through the Pain Modality Clinic.
Pain Modality Clinic
The EOVAHCS Pain Modality Clinic was created in 2014 as a treatment and device-trial program to provide veterans access to newer noninvasive, patient-driven treatment devices as part of an active chronic pain self-management plan. A crucial innovation is that these devices are designed to be used by patients in their homes. These devices can be expensive, and not every patient will benefit from their use; therefore, clinic leaders recommended a trial before a device is issued to a veteran for home use.
The Pain Modality Clinic coordinator trains clinic facilitators on the device according to manufacturer’s guidelines. Each participating veteran takes part in a device trial to confirm that he or she is able to use the recommended device independently and is likely to benefit from its use. When appropriate, veterans who do not respond to the initial device trial could test the potential benefit of another device. Although data from these device trials are collected primarily to inform clinical decision making, this information also is useful in guiding local policy regarding continued support for each of the modalities.
Veterans who have chronic or persistent pain (≥ 3 months) that interferes with function or quality of life are considered good candidates for a device trial if they are actively involved in pain self-care, logistically able to participate, able to use a device long-term, and have no contraindications. “Active involvement” could be met by participation in any pain management effort, whether a specific exercise program, CBT, or other treatment.
The Modality Clinic currently offers device trials for persistent pain with Alpha-Stim-M (AS-M; Electromedical Products International, Mineral Wells, TX), Laser Touch One (LTO; Renewal Technologies, LLC, Phoenix, AZ), and Neurolumen (Oklahoma City, OK). Neurolumen devices were not available in the clinic initially and will not be discussed further in this article.
The first Alpha-Stim machine using MET and CES technology was created in 1981 for in-office pain management. In 2012, the currently used AS-M became available.11 AS-M is FDA approved for treating pain, anxiety, depression, and sleep problems and is the device used in the EOVAHCS Modality Clinic. AS-M uses probes or electrodes to send a MET waveform through the body area in pain. The device uses ear clips to provide CES, which is thought to increase alpha waves in the brain.11 The LTO is a device that combines LLLT and MET technologies in a home-use design.14 LTO is FDA approved for treating painand is a portable personal pain-relief device applied to the area of pain using electroconductive gel.
Both devices are designed for long-term, self-use, making them viable parts of a multimodal, chronic pain treatment plan. Contraindications for AS-M and LTO include having a pacemaker or an implantable defibrillator, pregnancy, current malignancy, or seizures. Eligible veterans with persistent pain and high levels of depression, anxiety, and/or sleep problems generally are triaged to AS-M, whereas those who have only pain intensity issues usually are assigned to LTO. Referral to the Modality Clinic is not limited to a specific type of pain; common pain conditions seen in the clinic are spine and joint pain, arthritis pain, myofascial pain, headaches, and neuropathy.
Training and Device Trials
Eligible veterans are educated about the device and complete clinical informed consent, which is documented in the electronic health record. The veterans’ primary care and/or specialist providers are contacted for concurrence regarding veterans’ participation in the treatment.
Protocols for the device trials are based on the manufacturers’ recommendations, adjusted to what is feasible in the clinic (manufacturers approved the changes). The number of treatments per trial varies by device. For AS-M, veterans come to the clinic 5 days a week for 2 weeks. For LTO, veterans attend the clinic 5 days a week for 1 week.
At the beginning of a device trial, a trained facilitator teaches each veteran and caregiver to use the device, sets functional goals for the trial, and provides education on the trial questionnaires and daily pain logs. The veteran then follows the device protocol in the clinic where the facilitator can respond to questions and address any issues. With support from their caregivers, veterans are expected to become independent on their device use by the end of the trial. Clinic staff or the veteran can stop the device trial at any point, without affecting the veteran’s participation in or eligibility for other EOVAHCS pain programs.
This project was submitted to the University of Oklahoma Health Sciences Center Institutional Review Board and was exempted from institutional review board oversight as a retrospective, quality improvement effort. Before data analysis, the EOVAHCS Coordinator for Research and Development reviewed the procedures to ensure that all policies were being followed.
Methods
Data for veterans who completed valid treatments of AS-M or LTO from May 9, 2014 to August 20, 2016, were included in the analyses. For an AS-M treatment to be considered valid, the veteran must have attended at least 8 sessions and completed assessment instruments at baseline (preintervention) and following completion (postintervention). For an LTO treatment to be considered valid, the veteran must have attended at least 4 sessions and completed assessment measures at baseline and after completion.
Measures
Veterans completed the following measures at baseline and after trial completion:
The Beck Depression Inventory (BDI-II) is a 21-item measure designed to assess depressive symptoms. Each item assesses intensity on a 0-to-3 scale. Scores from 0 to 13 indicate minimum depression; 14 to 19, mild depression; 20 to 28, moderate depression, and 29 to 63, severe depression.17
The Beck Anxiety Inventory (BAI) is a 21-item measure of anxiety symptoms that uses a 0-to-3 scale to assess severity of subjective, somatic, or panic-related symptoms of anxiety. Scores ranging from 0 to 9 indicate minimal anxiety; 10 to 16, mild anxiety; 17 to 29, moderate anxiety, and 30 to 63, severe anxiety.18
The Pain Catastrophizing Scale (PCS) is a 13-item measure of pain catastrophizing, a crucial marker of how individuals experience pain. Items are scored on a 0-to-4 scale; scores of ≥ 30 indicate a clinically relevant level of catastrophizing.19
The Subjective Units of Distress Scale (SUD) is a single-item measure of the subjective intensity of disturbance or distress currently being experienced. It is scored from 0 to 10; 1 to 4 is mild, 5 to 6 is moderate, and 7 to 10 is severe.20
The Brief Pain Inventory (BPI) measures pain intensity and the impact of pain on functioning. Four items assess pain intensity at its worst, least, and average over the previous 24 hours and at the time of assessment; responses are on a 0-to-10 scale with 10 being most severe. The pain intensity measure is the average of scores on these 4 items. Pain interference is measured with respect to 7 daily activities; general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. Each of these items is scored on a 0-to-10 scale with 10 being the most severe. The pain interference measure is the average of scores on these 7 items.21
Participants completed a daily pain log and recorded self-ratings (0-to-10 scale) of pain and relaxation levels before and after using the device. These scores were primarily used to assist in determining whether goals, set collaboratively by the clinician and the veteran at the first session, had been met.
Analysis
Descriptive statistics were used to characterize the sample overall and by modality. Paired t tests were used to assess changes on each assessment measure over time and for each device separately. The significance of change was assessed for 8 outcomes for each device. In this context, using a conservative Bonferroni correction, significance was set at P < .006. Because AS-M is designed to address depression, anxiety, and sleep as well as pain, whereas LTO is not, device assignments were based on clinical considerations rather than randomization. Therefore, no comparisons were made between devices, and outcomes were assessed independently for the 2 devices. Analyses were performed using SAS 9.4 (Cary, NC).
Results
Device trials were initiated for 161 veterans (LTO, 70; AS-M, 91). Distribution of devices was unequal because veterans are assigned to 1 device or the other based on clinical presentation. Failure to complete a trial (n = 46; 28.6%) typically was because of travel barriers, lack of interest in continuing, and for 3 veterans, reports of headaches that they attributed to the AS-M treatment. Of the 115 participants who completed valid trials, 88 (76.5%) also completed assessment measures at pre- and postintervention (LTO = 38; AS-M = 50). None of the participants in this study completed trials with both the AS-M and LTO devices.
Most participants were male (84.1%) and rural residents (85.5%) (Table 1).
Pain Reduction
Treatment with AS-M or LTO was associated with statistically significant reductions in pain severity (BPI), pain interference (BPI), daily pain intensity scores (daily pain log), and pain catastrophizing (PCS) (Tables 2 and 3).
Impact on Mood
Use of AS-M was associated with statistically significant improvements in depression (BDI-II), anxiety (BAI), and distress (SUD) scores. In addition, veterans completing AS-M treatment showed a statistically significant improvement in self-reported relaxation scores. Interestingly, use of LTO also resulted in a statistically significant decrease in anxiety (BAI) and a nonstatistically significant decrease in depression (BDI-II).
Figure 1 and 2 illustrates the clinical impact of each device in shifting participants from 1 level of symptom severity to another.
Discussion
Use of both AS-M and LTO at EOVAHC was associated with reduced pain intensity. The devices also had positive effects beyond pain in areas such as depression, anxiety, and distress. Remission of depression and anxiety symptoms has been associated with significant decline in pain symptoms, suggesting that pain is best treated through multimodal approaches.22
In the context of the opioid crisis, the availability of effective nonopioid, nonpharmacologic, noninvasive treatments for chronic pain is needed. The Joint Commission recently expanded its pain management guidelines to support hospitals offering nonpharmacologic pain treatments.23 Integrating AS-M, LTO, or similar products into standard pain management practices allows for other treatment pathways with positive outcomes for providers and patients. The Joint Commission also recommends an interdisciplinary approach, defined as a process whereby health care professionals from different disciplines collaborate to diagnose and treat patients experiencing difficult pain conditions. This approach facilitates multimodal management because these disciplines contribute knowledge about a variety of treatment options. Devices such AS-M and LTO are well suited to interdisciplinary pain management because they are not seen as being under the purview of a specific health care specialty.
Limitations
Our findings are limited because they are derived from a retrospective, quality improvement evaluation of outcomes from a single clinic. Findings must be considered in the context of the relatively small samples of veterans. Because analyses were conducted as part of a quality improvement effort, veterans were offered a specific device based on clinical indications, there were no comparisons between devices, and there was no comparison group. Although most participants were using medication and other treatments as part of their pain treatment plan, all reported continued pain intensity before use of a device. Analyses did not control for variation in treatments received concurrently. Last, the logs used to collect self-report data on daily pain and relaxation levels were not validated.
The data highlight a clear need for research to better understand the long-term effects of these devices as well as the characteristics of patients who respond best to each device. Noninvasive treatments for pain often are dismissed as placebos. Rigorously designed, controlled studies will help demonstrate that these devices offer a statistically significant benefit beyond any placebo effect.
Conclusion
Understanding of chronic pain and its treatment will continue to evolve. It is clear that each person dealing with chronic pain requires a tailored combination of treatments and multimodal approaches, which is more effective than any single treatment. Nonpharmacologic, noninvasive devices pose fewer risks and seem to be more effective in reducing pain intensity than traditional treatments, including medications or surgical intervention. In light of the current emphasis on evidence-based health care and as the evidence for the effectiveness of noninvasive pain devices modalities grows, it is likely that treatments incorporating modalities such as MET, CES, and LLLT will become common options for managing chronic pain.
1. US Department of Veterans Affairs. Pain as the 5th Vital Sign Toolkit. https://www.va.gov/PAINMANAGEMENT/docs/Pain_As_the_5th_Vital_Sign_Toolkit.pdf. Published October 2000. Accessed February 11, 2019.
2. Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: National Academies Press; 2011.
3. Rosenblum A, Marsch LA, Joseph H, Portenoy RK. Opioids and the treatment of chronic pain: Controversies, current status, and future directions. Exp Clin Psychopharmacol. 2008;16(5):405-416.
4. Moayedi M, Davis KD. Theories of pain: from specificity to gate control. J Neurophysiol. 2013;109(1):5-12.
5. Mosher HJ, Krebs EE, Carrel M, Kaboli PJ, Weg MW, Lund BC. Trends in prevalent and incident opioid receipt: an observational study in Veterans Health Administration 2004-2012. J Gen Intern Med. 2015;30(5):597-604.
6. Reuben DB, Alvanzo AAH, Ashikaga T, et al. National Institutes of Health Pathways to Prevention Workshop: The role of opioids in the treatment of chronic pain. Ann Intern Med. 2015;162(4):295-300.
7. Murthy VH. Opioid epidemic: we all have a role in turning the tide. https://obamawhitehouse.archives.gov/blog/2016/10/05/opioid-epidemic-we-all-have-role-turning-tide. Published October 5, 2016. Accessed February 12, 2019.
8. Kehlet H, Dahl JB. The value of “multimodal” or “balanced analgesia” in postoperative pain treatment. Anesth Analg. 1993;77(5):1048-1056.
9. Crane P, Feinberg L, Morris J. A multimodal physical therapy approach to the management of a patient with temporomandibular dysfunction and head and neck lymphedema: a case report. J Man Manip Ther. 2015;23(1): 37-42.
10. Arnstein P. Multimodal approaches to pain management. Nurs. 2011;41(3): 60-61.
11. Alpha-Stim. http://www.alpha-stim.com. Accessed March 22, 2019
12. Shekelle PG, Cook IA, Miake-Lye IM, Booth MS, Beroes JM, Mak S. Benefits and harms of cranial electrical stimulation for chronic painful conditions, depression, anxiety, and insomnia. Ann Intern Med. 2018;168(6):414-421.
13. Chow RT, Heller GZ, Barnsley L. The effect of 300 mW, 830 nm laser on chronic neck pain: a double-blind, randomized, placebo-controlled study. Pain. 2006;124(1):201-210.
14. Kulkarni AD, Smith RB. The use of microcurrent electrical therapy and cranial electrotherapy stimulation in pain control. Clin Pract Alternative Med. 2001;2(2):99-102.
15. Chow RT, Johnson MI, Lopes-Martins RA, Bjordal JM. Efficacy of low-level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or active-treatment controlled trials. Lancet. 2009;374(9705):1897-1908.
16. Taylor AG, Anderson JG, Riedel SL, et al. Cranial electrical stimulation improves symptoms and functional status in individuals with fibromyalgia. Pain Manag Nurs. 2013;14(4):327-335.
17. Beck, AT, Steer, RA, Brown, GK. Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation; 1996.
18. Beck AT, Steer RA. Beck Anxiety Inventory: Manual. San Antonio, TX: Psychological Corporation; 1993.
19. Sullivan MJL, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychol Assess. 1995;7(4):524-532.
20. Wolpe J. The Practice of Behavior Therapy. 4th ed. Elmsford, NY: Pergamon; 1990.
21. Cleeland CS. The Brief Pain Inventory User Manual. https://www.mdanderson.org/research/departments-labs-institutes/departments-divisions/symptom-research/symptom-assessment-tools/brief-pain-inventory.html. Published 2009. Accessed February 12, 2019.
22. Gerrits MM, van Marwijk HW, van Oppen P, Horst HVD, Penninx BW. Longitudinal association between pain, and depression and anxiety over four years. J Psychosom Res. 2015;78(1):64-70.
23. The Joint Commission. Joint Commission enhances pain assessment and management requirements for accredited hospitals. The Joint Commission Perspectives. https://www.jointcommission.org/assets/1/18/Joint_Commission_Enhances_Pain_Assessment_and_Management_Requirements_for_Accredited_Hospitals1.PDF. Published July 2017. Accessed March 21, 2019.
1. US Department of Veterans Affairs. Pain as the 5th Vital Sign Toolkit. https://www.va.gov/PAINMANAGEMENT/docs/Pain_As_the_5th_Vital_Sign_Toolkit.pdf. Published October 2000. Accessed February 11, 2019.
2. Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: National Academies Press; 2011.
3. Rosenblum A, Marsch LA, Joseph H, Portenoy RK. Opioids and the treatment of chronic pain: Controversies, current status, and future directions. Exp Clin Psychopharmacol. 2008;16(5):405-416.
4. Moayedi M, Davis KD. Theories of pain: from specificity to gate control. J Neurophysiol. 2013;109(1):5-12.
5. Mosher HJ, Krebs EE, Carrel M, Kaboli PJ, Weg MW, Lund BC. Trends in prevalent and incident opioid receipt: an observational study in Veterans Health Administration 2004-2012. J Gen Intern Med. 2015;30(5):597-604.
6. Reuben DB, Alvanzo AAH, Ashikaga T, et al. National Institutes of Health Pathways to Prevention Workshop: The role of opioids in the treatment of chronic pain. Ann Intern Med. 2015;162(4):295-300.
7. Murthy VH. Opioid epidemic: we all have a role in turning the tide. https://obamawhitehouse.archives.gov/blog/2016/10/05/opioid-epidemic-we-all-have-role-turning-tide. Published October 5, 2016. Accessed February 12, 2019.
8. Kehlet H, Dahl JB. The value of “multimodal” or “balanced analgesia” in postoperative pain treatment. Anesth Analg. 1993;77(5):1048-1056.
9. Crane P, Feinberg L, Morris J. A multimodal physical therapy approach to the management of a patient with temporomandibular dysfunction and head and neck lymphedema: a case report. J Man Manip Ther. 2015;23(1): 37-42.
10. Arnstein P. Multimodal approaches to pain management. Nurs. 2011;41(3): 60-61.
11. Alpha-Stim. http://www.alpha-stim.com. Accessed March 22, 2019
12. Shekelle PG, Cook IA, Miake-Lye IM, Booth MS, Beroes JM, Mak S. Benefits and harms of cranial electrical stimulation for chronic painful conditions, depression, anxiety, and insomnia. Ann Intern Med. 2018;168(6):414-421.
13. Chow RT, Heller GZ, Barnsley L. The effect of 300 mW, 830 nm laser on chronic neck pain: a double-blind, randomized, placebo-controlled study. Pain. 2006;124(1):201-210.
14. Kulkarni AD, Smith RB. The use of microcurrent electrical therapy and cranial electrotherapy stimulation in pain control. Clin Pract Alternative Med. 2001;2(2):99-102.
15. Chow RT, Johnson MI, Lopes-Martins RA, Bjordal JM. Efficacy of low-level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or active-treatment controlled trials. Lancet. 2009;374(9705):1897-1908.
16. Taylor AG, Anderson JG, Riedel SL, et al. Cranial electrical stimulation improves symptoms and functional status in individuals with fibromyalgia. Pain Manag Nurs. 2013;14(4):327-335.
17. Beck, AT, Steer, RA, Brown, GK. Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation; 1996.
18. Beck AT, Steer RA. Beck Anxiety Inventory: Manual. San Antonio, TX: Psychological Corporation; 1993.
19. Sullivan MJL, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychol Assess. 1995;7(4):524-532.
20. Wolpe J. The Practice of Behavior Therapy. 4th ed. Elmsford, NY: Pergamon; 1990.
21. Cleeland CS. The Brief Pain Inventory User Manual. https://www.mdanderson.org/research/departments-labs-institutes/departments-divisions/symptom-research/symptom-assessment-tools/brief-pain-inventory.html. Published 2009. Accessed February 12, 2019.
22. Gerrits MM, van Marwijk HW, van Oppen P, Horst HVD, Penninx BW. Longitudinal association between pain, and depression and anxiety over four years. J Psychosom Res. 2015;78(1):64-70.
23. The Joint Commission. Joint Commission enhances pain assessment and management requirements for accredited hospitals. The Joint Commission Perspectives. https://www.jointcommission.org/assets/1/18/Joint_Commission_Enhances_Pain_Assessment_and_Management_Requirements_for_Accredited_Hospitals1.PDF. Published July 2017. Accessed March 21, 2019.
In sickle cell disease, opioid prescribing starts early, study finds
MILWAUKEE – A new study of for them.
The Medicaid claims database analysis looked at a one-year snapshot of prescriptions filled for a variety of opioids among children and young adults in North Carolina, said Nancy Crego, PhD, in an interview at a poster session of the scientific meeting of the American Pain Society.
Dr. Crego and her colleagues at Duke University School of Nursing, Durham, N.C., studied 1,560 children and young adults aged 0-22 years with sickle cell disease who received Medicaid; in all, 586 (38%) had an opioid prescription filled during the year-long study period.
Among adolescents and young adults with sickle cell disease, outpatient opioid prescriptions were common, with increasing prescription fills seen through the middle years and young adulthood. “Opioid prescription claims were prevalent across all age groups,” wrote Dr. Crego and her associates.
Though 20% of preschoolers (87 of 428) had had a prescription filled for opioids, the rates of opioid prescribing increased with age. Of adolescents aged 15-18 years, 54% (154 of 284) had filled an opioid prescription, as had 50% (110 of 221) of those aged 19-22 years.
For the 366 school-aged children aged 6-10 years, 117 (32%) had an opioid prescription filled. The number of prescriptions filled per patient on an annual basis for this age group ranged from one to 10.
There was a wide variation in the number of prescriptions filled in all other age groups over the study period as well. For school-aged children, the range was 1 to 10, and 1 to 18 for middle schoolers aged 11-14 years. Adolescents filled from 1-30 prescriptions, and for young adults, the range was 1-24.
Though the rates of opioid prescribing increased with age, the number of doses per prescription actually fell throughout the adolescent and young adult years. In an interview at the poster presentation, Dr. Crego speculated that this decrease observed with increasing age might reflect provider concern about opioid misuse and diversion, though the study methodology didn’t allow them to examine this.
Dr. Crego said that she was surprised by the high numbers of children who were receiving opioid prescriptions in the preschool years. “I wonder what their parents are being taught about how to administer these medications” to this very young age group, she commented.
Opioids included in the claims database analysis included morphine, hydromorphone, hydrocodone, oxycodone, oxymorphone, methadone, fentanyl, codeine, and tramadol.
Children with sickle cell disease are exposed to opioids in early childhood,” Dr. Crego and her colleagues wrote in the poster, but they acknowledged that “it is unknown if this early exposure increases the risk of opioid misuse later in life in this population ... Prescribers should incorporate continuous assessments for potential misuse and abuse in all age groups.”
“Most of the data that we have on opioid prescription claims in children usually exclude chronically ill children; they’re almost all of acutely ill children, and quite a bit of it is on postoperative care,” Dr. Crego said. The current study captures early-life prescribing “for somebody who’s going to be on opioids for a lot of their life,” she noted.
The studies of opioids used for acute pain, she said, showed that parents would often “administer opioids for inappropriate indications.” She is now conducting a qualitative study investigating pharmacologic and non-pharmacologic pain interventions for children with sickle cell disease. She’s also investigating how parents decide to administer opioids: “What did they see in their child that would prompt them to give an opioid versus giving another type of analgesic?”
There are some limitations to working with a claims database, acknowledged Dr. Crego: “We don’t know about their actual use, because we don’t know how often they are taking it, but we know it’s a filled opioid prescription.”
Dr. Crego said that more work is needed to examine how parents administer opioids to their children with sickle cell disease, and to learn more about what parents are told – and what they understand – about how their child’s pain should be managed. Also, she added, more research is needed on non-pharmacologic pain management for pediatric patients with sickle cell disease.
The study was funded by the Agency for Healthcare Research and Quality. Dr. Crego and her coauthors reported no conflicts of interest.
SOURCE: Crego, N. et al. APS 2019.
MILWAUKEE – A new study of for them.
The Medicaid claims database analysis looked at a one-year snapshot of prescriptions filled for a variety of opioids among children and young adults in North Carolina, said Nancy Crego, PhD, in an interview at a poster session of the scientific meeting of the American Pain Society.
Dr. Crego and her colleagues at Duke University School of Nursing, Durham, N.C., studied 1,560 children and young adults aged 0-22 years with sickle cell disease who received Medicaid; in all, 586 (38%) had an opioid prescription filled during the year-long study period.
Among adolescents and young adults with sickle cell disease, outpatient opioid prescriptions were common, with increasing prescription fills seen through the middle years and young adulthood. “Opioid prescription claims were prevalent across all age groups,” wrote Dr. Crego and her associates.
Though 20% of preschoolers (87 of 428) had had a prescription filled for opioids, the rates of opioid prescribing increased with age. Of adolescents aged 15-18 years, 54% (154 of 284) had filled an opioid prescription, as had 50% (110 of 221) of those aged 19-22 years.
For the 366 school-aged children aged 6-10 years, 117 (32%) had an opioid prescription filled. The number of prescriptions filled per patient on an annual basis for this age group ranged from one to 10.
There was a wide variation in the number of prescriptions filled in all other age groups over the study period as well. For school-aged children, the range was 1 to 10, and 1 to 18 for middle schoolers aged 11-14 years. Adolescents filled from 1-30 prescriptions, and for young adults, the range was 1-24.
Though the rates of opioid prescribing increased with age, the number of doses per prescription actually fell throughout the adolescent and young adult years. In an interview at the poster presentation, Dr. Crego speculated that this decrease observed with increasing age might reflect provider concern about opioid misuse and diversion, though the study methodology didn’t allow them to examine this.
Dr. Crego said that she was surprised by the high numbers of children who were receiving opioid prescriptions in the preschool years. “I wonder what their parents are being taught about how to administer these medications” to this very young age group, she commented.
Opioids included in the claims database analysis included morphine, hydromorphone, hydrocodone, oxycodone, oxymorphone, methadone, fentanyl, codeine, and tramadol.
Children with sickle cell disease are exposed to opioids in early childhood,” Dr. Crego and her colleagues wrote in the poster, but they acknowledged that “it is unknown if this early exposure increases the risk of opioid misuse later in life in this population ... Prescribers should incorporate continuous assessments for potential misuse and abuse in all age groups.”
“Most of the data that we have on opioid prescription claims in children usually exclude chronically ill children; they’re almost all of acutely ill children, and quite a bit of it is on postoperative care,” Dr. Crego said. The current study captures early-life prescribing “for somebody who’s going to be on opioids for a lot of their life,” she noted.
The studies of opioids used for acute pain, she said, showed that parents would often “administer opioids for inappropriate indications.” She is now conducting a qualitative study investigating pharmacologic and non-pharmacologic pain interventions for children with sickle cell disease. She’s also investigating how parents decide to administer opioids: “What did they see in their child that would prompt them to give an opioid versus giving another type of analgesic?”
There are some limitations to working with a claims database, acknowledged Dr. Crego: “We don’t know about their actual use, because we don’t know how often they are taking it, but we know it’s a filled opioid prescription.”
Dr. Crego said that more work is needed to examine how parents administer opioids to their children with sickle cell disease, and to learn more about what parents are told – and what they understand – about how their child’s pain should be managed. Also, she added, more research is needed on non-pharmacologic pain management for pediatric patients with sickle cell disease.
The study was funded by the Agency for Healthcare Research and Quality. Dr. Crego and her coauthors reported no conflicts of interest.
SOURCE: Crego, N. et al. APS 2019.
MILWAUKEE – A new study of for them.
The Medicaid claims database analysis looked at a one-year snapshot of prescriptions filled for a variety of opioids among children and young adults in North Carolina, said Nancy Crego, PhD, in an interview at a poster session of the scientific meeting of the American Pain Society.
Dr. Crego and her colleagues at Duke University School of Nursing, Durham, N.C., studied 1,560 children and young adults aged 0-22 years with sickle cell disease who received Medicaid; in all, 586 (38%) had an opioid prescription filled during the year-long study period.
Among adolescents and young adults with sickle cell disease, outpatient opioid prescriptions were common, with increasing prescription fills seen through the middle years and young adulthood. “Opioid prescription claims were prevalent across all age groups,” wrote Dr. Crego and her associates.
Though 20% of preschoolers (87 of 428) had had a prescription filled for opioids, the rates of opioid prescribing increased with age. Of adolescents aged 15-18 years, 54% (154 of 284) had filled an opioid prescription, as had 50% (110 of 221) of those aged 19-22 years.
For the 366 school-aged children aged 6-10 years, 117 (32%) had an opioid prescription filled. The number of prescriptions filled per patient on an annual basis for this age group ranged from one to 10.
There was a wide variation in the number of prescriptions filled in all other age groups over the study period as well. For school-aged children, the range was 1 to 10, and 1 to 18 for middle schoolers aged 11-14 years. Adolescents filled from 1-30 prescriptions, and for young adults, the range was 1-24.
Though the rates of opioid prescribing increased with age, the number of doses per prescription actually fell throughout the adolescent and young adult years. In an interview at the poster presentation, Dr. Crego speculated that this decrease observed with increasing age might reflect provider concern about opioid misuse and diversion, though the study methodology didn’t allow them to examine this.
Dr. Crego said that she was surprised by the high numbers of children who were receiving opioid prescriptions in the preschool years. “I wonder what their parents are being taught about how to administer these medications” to this very young age group, she commented.
Opioids included in the claims database analysis included morphine, hydromorphone, hydrocodone, oxycodone, oxymorphone, methadone, fentanyl, codeine, and tramadol.
Children with sickle cell disease are exposed to opioids in early childhood,” Dr. Crego and her colleagues wrote in the poster, but they acknowledged that “it is unknown if this early exposure increases the risk of opioid misuse later in life in this population ... Prescribers should incorporate continuous assessments for potential misuse and abuse in all age groups.”
“Most of the data that we have on opioid prescription claims in children usually exclude chronically ill children; they’re almost all of acutely ill children, and quite a bit of it is on postoperative care,” Dr. Crego said. The current study captures early-life prescribing “for somebody who’s going to be on opioids for a lot of their life,” she noted.
The studies of opioids used for acute pain, she said, showed that parents would often “administer opioids for inappropriate indications.” She is now conducting a qualitative study investigating pharmacologic and non-pharmacologic pain interventions for children with sickle cell disease. She’s also investigating how parents decide to administer opioids: “What did they see in their child that would prompt them to give an opioid versus giving another type of analgesic?”
There are some limitations to working with a claims database, acknowledged Dr. Crego: “We don’t know about their actual use, because we don’t know how often they are taking it, but we know it’s a filled opioid prescription.”
Dr. Crego said that more work is needed to examine how parents administer opioids to their children with sickle cell disease, and to learn more about what parents are told – and what they understand – about how their child’s pain should be managed. Also, she added, more research is needed on non-pharmacologic pain management for pediatric patients with sickle cell disease.
The study was funded by the Agency for Healthcare Research and Quality. Dr. Crego and her coauthors reported no conflicts of interest.
SOURCE: Crego, N. et al. APS 2019.
REPORTING FROM APS 2019
Addressing anxiety helps youth with functional abdominal pain disorders
MILWAUKEE – A stepped-care approach to youth with functional abdominal pain disorders may be effective in targeting those with comorbid anxiety, according to ongoing research.
A study of 79 pediatric patients with a functional abdominal pain disorder (FAPD) and co-occurring anxiety found that those who received cognitive behavioral therapy (CBT) that included a component to address anxiety had less functional disability and anxiety than those who received treatment as usual. Pain scores also dropped, though the difference was not statistically significant.
The patients, aged 9-14 years and mostly white and female, were randomized to treatment allocation. Functional disability scores were significantly lower post-treatment for those who received the stepped therapy compared with the treatment as usual group (P less than .05, Cohen’s D = .49). This indicates a moderate effect size, said Natoshia Cunningham, PhD, speaking at the scientific meeting of the American Pain Society.
Mean scores on an anxiety rating scale also dropped below the threshold for clinical anxiety for those receiving the stepped therapy; on average, the treatment as usual group still scored above the clinical anxiety threshold after treatment (P for difference = .05).
The study, part of ongoing research, tests a hybrid online intervention, dubbed Aim to Decrease Anxiety and Pain Treatment, or ADAPT. The ADAPT program includes some common elements of CBT for anxiety that were not previously included in the pediatric pain CBT in use for the FAPD patients, she said.
The hybrid program began with two in-person sessions, each lasting one hour. These were followed by up to four web-based sessions. Patients viewed videos, read some material online, and complete activities with follow-up assessments. The web-based component was structured so that providers can see how patients fare on assessments – and even see which activities had been opened or completed. This, said Dr. Cunningham, allowed the treating provider to tailor what’s addressed in the associated weekly phone checks that accompany the online content.
Parents were also given practical, evidence-based advice to help manage their child’s FAPD. These include encouraging children to be independent in pain management, stopping “status checks,” encouraging normal school and social activities, and avoiding special privileges when pain interferes with activities.
Overall, up to 40% of pediatric functional abdominal pain patients may not respond to CBT, the most efficacious treatment known, said Dr. Cunningham, a pediatric psychologist at the University of Cincinnati. Her research indicates that comorbid anxiety may predict poor response, and that addressing anxiety improves pain and disability in this complex, common disorder.
With a brief psychosocial screening that identifies patients with anxiety, Dr. Cunningham and her colleagues can implement the targeted, partially web-based therapy strategy that tackles anxiety along with CBT for functional abdominal pain.
“Anxiety is common and related to poor outcomes,” noted Dr. Cunningham, She added that overall, half or more of individuals with chronic pain also have anxiety. Among children with FAPD, “Clinical anxiety predicts disability and poor treatment response.”
The first step, she said, was identifying the patients with FAPD who had anxiety, including those with subclinical anxiety.
At intake, children coming to the Cincinnati Children’s Hospital’s gastroenterology clinic complete anxiety screening via the Screen for Child Anxiety Related Emotional Disorders (SCARED) (Depress Anxiety. 2000;12[2]:85-91). Disability and pain are assessed by the Functional Disability Inventory and the Numeric Rating Scale (J Pediatr Psychol. 1991 Feb;16[1]:39-58).
In earlier research, Dr. Cunningham and her collaborators found a significant association between anxiety and both higher pain levels and more disability. And, clinically significant anxiety was more likely among the FAPD patients with persistent disability after six months of treatment.
A surprising finding from the screenings, said Dr. Cunningham, is that youth endorsed more anxiety symptoms in self-assessment than their parents observed. “Children are often their own best informants of their internalizing symptoms,” she said. “Not only do their parents not notice it, it may not be obvious to their providers, either.”
Since many children with FAPD have anxiety, the next question was “How do we better enhance their treatments?” she continued. To answer that question, she took one step back: “How do these youth respond to our current best practice?”
Looking at Cincinnati Children’s patients with FAPD who did – or did not – have anxiety, Dr. Cunningham found that “those who have clinical levels of anxiety don’t respond as well to CBT.” Pain-directed therapy alone, she said, “is insufficient to treat these patients.”
Together with brief screening, stepped therapy delivered via ADAPT offers promise to boost the efficacy of FAPD treatment, perhaps even in a primary care setting, said Dr. Cunningham. She and her collaborators are continuing to study comorbid anxiety and pain in youth; current work is using functional magnetic resonance imaging to examine cognitive and affective changes in patients receiving the ADAPT intervention.
The study was funded by the American Pain Society Sharon S. Keller Chronic Pain Research Grant, Cincinnati Children’s Hospital, and the National Institutes of Health. Dr. Cunningham reported no relevant conflicts of interest.
[email protected]
SOURCE: Cunningham N. et al. APS 2019.
MILWAUKEE – A stepped-care approach to youth with functional abdominal pain disorders may be effective in targeting those with comorbid anxiety, according to ongoing research.
A study of 79 pediatric patients with a functional abdominal pain disorder (FAPD) and co-occurring anxiety found that those who received cognitive behavioral therapy (CBT) that included a component to address anxiety had less functional disability and anxiety than those who received treatment as usual. Pain scores also dropped, though the difference was not statistically significant.
The patients, aged 9-14 years and mostly white and female, were randomized to treatment allocation. Functional disability scores were significantly lower post-treatment for those who received the stepped therapy compared with the treatment as usual group (P less than .05, Cohen’s D = .49). This indicates a moderate effect size, said Natoshia Cunningham, PhD, speaking at the scientific meeting of the American Pain Society.
Mean scores on an anxiety rating scale also dropped below the threshold for clinical anxiety for those receiving the stepped therapy; on average, the treatment as usual group still scored above the clinical anxiety threshold after treatment (P for difference = .05).
The study, part of ongoing research, tests a hybrid online intervention, dubbed Aim to Decrease Anxiety and Pain Treatment, or ADAPT. The ADAPT program includes some common elements of CBT for anxiety that were not previously included in the pediatric pain CBT in use for the FAPD patients, she said.
The hybrid program began with two in-person sessions, each lasting one hour. These were followed by up to four web-based sessions. Patients viewed videos, read some material online, and complete activities with follow-up assessments. The web-based component was structured so that providers can see how patients fare on assessments – and even see which activities had been opened or completed. This, said Dr. Cunningham, allowed the treating provider to tailor what’s addressed in the associated weekly phone checks that accompany the online content.
Parents were also given practical, evidence-based advice to help manage their child’s FAPD. These include encouraging children to be independent in pain management, stopping “status checks,” encouraging normal school and social activities, and avoiding special privileges when pain interferes with activities.
Overall, up to 40% of pediatric functional abdominal pain patients may not respond to CBT, the most efficacious treatment known, said Dr. Cunningham, a pediatric psychologist at the University of Cincinnati. Her research indicates that comorbid anxiety may predict poor response, and that addressing anxiety improves pain and disability in this complex, common disorder.
With a brief psychosocial screening that identifies patients with anxiety, Dr. Cunningham and her colleagues can implement the targeted, partially web-based therapy strategy that tackles anxiety along with CBT for functional abdominal pain.
“Anxiety is common and related to poor outcomes,” noted Dr. Cunningham, She added that overall, half or more of individuals with chronic pain also have anxiety. Among children with FAPD, “Clinical anxiety predicts disability and poor treatment response.”
The first step, she said, was identifying the patients with FAPD who had anxiety, including those with subclinical anxiety.
At intake, children coming to the Cincinnati Children’s Hospital’s gastroenterology clinic complete anxiety screening via the Screen for Child Anxiety Related Emotional Disorders (SCARED) (Depress Anxiety. 2000;12[2]:85-91). Disability and pain are assessed by the Functional Disability Inventory and the Numeric Rating Scale (J Pediatr Psychol. 1991 Feb;16[1]:39-58).
In earlier research, Dr. Cunningham and her collaborators found a significant association between anxiety and both higher pain levels and more disability. And, clinically significant anxiety was more likely among the FAPD patients with persistent disability after six months of treatment.
A surprising finding from the screenings, said Dr. Cunningham, is that youth endorsed more anxiety symptoms in self-assessment than their parents observed. “Children are often their own best informants of their internalizing symptoms,” she said. “Not only do their parents not notice it, it may not be obvious to their providers, either.”
Since many children with FAPD have anxiety, the next question was “How do we better enhance their treatments?” she continued. To answer that question, she took one step back: “How do these youth respond to our current best practice?”
Looking at Cincinnati Children’s patients with FAPD who did – or did not – have anxiety, Dr. Cunningham found that “those who have clinical levels of anxiety don’t respond as well to CBT.” Pain-directed therapy alone, she said, “is insufficient to treat these patients.”
Together with brief screening, stepped therapy delivered via ADAPT offers promise to boost the efficacy of FAPD treatment, perhaps even in a primary care setting, said Dr. Cunningham. She and her collaborators are continuing to study comorbid anxiety and pain in youth; current work is using functional magnetic resonance imaging to examine cognitive and affective changes in patients receiving the ADAPT intervention.
The study was funded by the American Pain Society Sharon S. Keller Chronic Pain Research Grant, Cincinnati Children’s Hospital, and the National Institutes of Health. Dr. Cunningham reported no relevant conflicts of interest.
[email protected]
SOURCE: Cunningham N. et al. APS 2019.
MILWAUKEE – A stepped-care approach to youth with functional abdominal pain disorders may be effective in targeting those with comorbid anxiety, according to ongoing research.
A study of 79 pediatric patients with a functional abdominal pain disorder (FAPD) and co-occurring anxiety found that those who received cognitive behavioral therapy (CBT) that included a component to address anxiety had less functional disability and anxiety than those who received treatment as usual. Pain scores also dropped, though the difference was not statistically significant.
The patients, aged 9-14 years and mostly white and female, were randomized to treatment allocation. Functional disability scores were significantly lower post-treatment for those who received the stepped therapy compared with the treatment as usual group (P less than .05, Cohen’s D = .49). This indicates a moderate effect size, said Natoshia Cunningham, PhD, speaking at the scientific meeting of the American Pain Society.
Mean scores on an anxiety rating scale also dropped below the threshold for clinical anxiety for those receiving the stepped therapy; on average, the treatment as usual group still scored above the clinical anxiety threshold after treatment (P for difference = .05).
The study, part of ongoing research, tests a hybrid online intervention, dubbed Aim to Decrease Anxiety and Pain Treatment, or ADAPT. The ADAPT program includes some common elements of CBT for anxiety that were not previously included in the pediatric pain CBT in use for the FAPD patients, she said.
The hybrid program began with two in-person sessions, each lasting one hour. These were followed by up to four web-based sessions. Patients viewed videos, read some material online, and complete activities with follow-up assessments. The web-based component was structured so that providers can see how patients fare on assessments – and even see which activities had been opened or completed. This, said Dr. Cunningham, allowed the treating provider to tailor what’s addressed in the associated weekly phone checks that accompany the online content.
Parents were also given practical, evidence-based advice to help manage their child’s FAPD. These include encouraging children to be independent in pain management, stopping “status checks,” encouraging normal school and social activities, and avoiding special privileges when pain interferes with activities.
Overall, up to 40% of pediatric functional abdominal pain patients may not respond to CBT, the most efficacious treatment known, said Dr. Cunningham, a pediatric psychologist at the University of Cincinnati. Her research indicates that comorbid anxiety may predict poor response, and that addressing anxiety improves pain and disability in this complex, common disorder.
With a brief psychosocial screening that identifies patients with anxiety, Dr. Cunningham and her colleagues can implement the targeted, partially web-based therapy strategy that tackles anxiety along with CBT for functional abdominal pain.
“Anxiety is common and related to poor outcomes,” noted Dr. Cunningham, She added that overall, half or more of individuals with chronic pain also have anxiety. Among children with FAPD, “Clinical anxiety predicts disability and poor treatment response.”
The first step, she said, was identifying the patients with FAPD who had anxiety, including those with subclinical anxiety.
At intake, children coming to the Cincinnati Children’s Hospital’s gastroenterology clinic complete anxiety screening via the Screen for Child Anxiety Related Emotional Disorders (SCARED) (Depress Anxiety. 2000;12[2]:85-91). Disability and pain are assessed by the Functional Disability Inventory and the Numeric Rating Scale (J Pediatr Psychol. 1991 Feb;16[1]:39-58).
In earlier research, Dr. Cunningham and her collaborators found a significant association between anxiety and both higher pain levels and more disability. And, clinically significant anxiety was more likely among the FAPD patients with persistent disability after six months of treatment.
A surprising finding from the screenings, said Dr. Cunningham, is that youth endorsed more anxiety symptoms in self-assessment than their parents observed. “Children are often their own best informants of their internalizing symptoms,” she said. “Not only do their parents not notice it, it may not be obvious to their providers, either.”
Since many children with FAPD have anxiety, the next question was “How do we better enhance their treatments?” she continued. To answer that question, she took one step back: “How do these youth respond to our current best practice?”
Looking at Cincinnati Children’s patients with FAPD who did – or did not – have anxiety, Dr. Cunningham found that “those who have clinical levels of anxiety don’t respond as well to CBT.” Pain-directed therapy alone, she said, “is insufficient to treat these patients.”
Together with brief screening, stepped therapy delivered via ADAPT offers promise to boost the efficacy of FAPD treatment, perhaps even in a primary care setting, said Dr. Cunningham. She and her collaborators are continuing to study comorbid anxiety and pain in youth; current work is using functional magnetic resonance imaging to examine cognitive and affective changes in patients receiving the ADAPT intervention.
The study was funded by the American Pain Society Sharon S. Keller Chronic Pain Research Grant, Cincinnati Children’s Hospital, and the National Institutes of Health. Dr. Cunningham reported no relevant conflicts of interest.
[email protected]
SOURCE: Cunningham N. et al. APS 2019.
REPORTING FROM APS 2019
High ankle sprains: Easy to miss, so follow these tips
CASE
A 19-year-old college football player presents to your outpatient family practice clinic after suffering a right ankle injury during a football game over the weekend. He reports having his right ankle planted on the turf with his foot externally rotated when an opponent fell onto his posterior right lower extremity. He reports having felt immediate pain in the area of the right ankle and requiring assistance off of the field, as he had difficulty walking. The patient was taken to the emergency department where x-rays of the right foot and ankle did not show any signs of acute fracture or dislocation. The patient was diagnosed with a lateral ankle sprain, placed in a pneumatic ankle walking brace, and given crutches.
A high ankle sprain, or distal tibiofibular syndesmotic injury, can be an elusive diagnosis and is often mistaken for the more common lateral ankle sprain. Syndesmotic injuries have been documented to occur in approximately 1% to 10% of all ankle sprains.1-3 The highest number of these injuries occurs between the ages of 18 and 34 years, and they are more frequently seen in athletes than in nonathletes, particularly those who play collision sports, such as football, ice hockey, rugby, wrestling, and lacrosse.1-9 In one study by Hunt et al,10 syndesmotic injuries accounted for 24.6% of all ankle injuries in National Collegiate Athletic Association (NCAA) football players. Incidence continues to grow as recognition of high ankle sprains increases among medical professionals.1,5 Identification of syndesmotic injury is critical, as lack of detection can lead to extensive time missed from athletic participation and chronic ankle dysfunction, including pain and instability.2,4,6,11
Back to basics: A brief anatomy review
Stability in the distal tibiofibular joint is maintained by the syndesmotic ligaments, which include the anterior inferior tibiofibular ligament (AITFL), the posterior inferior tibiofibular ligament (PITFL), the transverse ligament, and the interosseous ligament.3-6,8 This complex of ligaments stabilizes the fibula within the incisura of the tibia and maintains a stable ankle mortise.1,4,5,11 The deep portion of the deltoid ligament also adds stability to the syndesmosis and may be disrupted by a syndesmotic injury.2,5-7,11
Mechanisms of injury: From most common to less likely
The distal tibiofibular syndesmosis is disrupted when an injury forces apart the distal tibiofibular joint. The most commonly reported means of injury is external rotation with hyper-dorsiflexion of the ankle.1-3,5,6,11 With excessive external rotation of the forefoot, the talus is forced against the medial aspect of the fibula, resulting in separation of the distal tibia and fibula and injury to the syndesmotic ligaments.2,3,5,6 Injuries associated with external rotation are commonly seen in sports that immobilize the ankle within a rigid boot, such as skiing and ice hockey.1,2,5 Some authors have suggested that a planovalgus foot alignment may place athletes at inherent risk for an external rotation ankle injury.5,6
Syndesmotic injury may also occur with hyper-dorsiflexion, as the anterior, widest portion of the talus rotates into the ankle mortise, wedging the tibia and fibula apart.2,3,5 There have also been reports of syndesmotic injuries associated with internal rotation, plantar flexion, inversion, and eversion.3,5,11 Therefore, physicians should maintain a high index of suspicion for injury to the distal tibiofibular joint, regardless of the mechanism of injury.
Presentation and evaluation
Observation of the patient and visualization of the affected ankle can provide many clues. Many patients will have difficulty walking after suffering a syndesmotic injury and may require the use of an assistive device.5 The inability to bear weight after an ankle injury points to a more severe diagnosis, such as an ankle fracture or syndesmotic injury, as opposed to a simple lateral ankle sprain. Patients may report anterior ankle pain, a sensation of instability with weight bearing on the affected ankle, or have persistent symptoms despite a course of conservative treatment. Also, they can have a variable amount of edema and ecchymosis associated with their injury; a minimal extent of swelling or ecchymosis does not exclude syndesmotic injury.3
A large percentage of patients will present with a concomitant sprain of the lateral ligaments associated with lateral swelling and bruising. One study found that 91% of syndesmotic injuries involved at least 1 of the lateral collateral ligaments (anterior talofibular ligament [ATFL], calcaneofibular ligament [CFL], or posterior talofibular ligament [PTFL]).12 Patients may have pain or a sensation of instability when pushing off with the toes,5 and patients with syndesmotic injuries often have tenderness to palpation over the distal anterolateral ankle or syndesmotic ligaments.7
Continue to: A thorough examination...
A thorough examination of the ankle, including palpation of common fracture sites, is important. Employ the Ottawa Ankle Rules (see http://www.theottawarules.ca/ankle_rules) to investigate for: tenderness to palpation over the posterior 6 cm of the posterior aspects of the distal medial and lateral malleoli; tenderness over the navicular; tenderness over the base of the fifth metatarsal; and/or the inability to bear weight on the affected lower extremity immediately after injury or upon evaluation in the physician’s office. Any of these findings should raise concern for a possible fracture (see “Adult foot fractures: A guide”) and require an x-ray(s) for further evaluation.13
Perform range-of-motion and strength testing with regard to ankle dorsiflexion, plantar flexion, abduction, adduction, inversion, and eversion. Palpate the ATFL, CFL, and PTFL for tenderness, as these structures may be involved to varying degrees in lateral ankle sprains. An anterior drawer test (see https://www.youtube.com/watch?v=vAcBEYZKcto) may be positive with injury to the ATFL. This test is performed by stabilizing the distal tibia with one hand and using the other hand to grasp the posterior aspect of the calcaneus and apply an anterior force. The test is positive if the talus translates forward, which correlates with laxity or rupture of the ATFL.13 The examiner should also palpate the Achilles tendon, peroneal tendons just posterior to the lateral malleolus, and the tibialis posterior tendon just posterior to the medial malleolus to inspect for tenderness or defects that may be signs of injury to these tendons.
An associated Weber B or C fracture? Trauma causing ankle syndesmosis injuries may be associated with Weber B or Weber C distal fibula fractures.7 Weber B fractures occur in the distal fibula at the level of the ankle joint (see FIGURE 1). These types of fractures are typically associated with external rotation injuries and are usually not associated with disruption of the interosseous membrane.
Weber C fractures are distal fibular fractures occurring above the level of the ankle joint. These fractures are also typically associated with external ankle rotation injuries and include disruption of the syndesmosis and deltoid ligament.14
Also pay special attention to the proximal fibula, as syndesmotic injuries are commonly associated with a Maisonneuve fracture, which is a proximal fibula fracture associated with external rotation forces of the ankle (see FIGURE 1).1,2,4,11,14,15 Further workup should occur in any patient with the possibility of a Weber- or Maisonneuve-type fracture.
Continue to: Multiple tests...
Multiple tests are available to investigate the possibility of a syndesmotic injury and to assess return-to-sport readiness, including the External Rotation Test, the Squeeze Test, the Crossed-Leg Test, the Dorsiflexion Compression Test, the Cotton Test, the Stabilization Test, the Fibular Translation Test, and the Single Leg Hop Test (see TABLE1-3,5,6,16,17). The External Rotation Test is noted by some authors to have the highest interobserver reliability, and is our preferred test.2 The Squeeze Test also has moderate interobserver reliability.2 There is a significant degree of variation among the sensitivity and specificity of these diagnostic tests, and no single test is sufficiently reliable or accurate to diagnose a syndesmotic ankle injury. Therefore, it is recommended to use multiple physical exam maneuvers, the history and mechanism of injury, and findings on imaging studies in conjunction to make the diagnosis of a syndesmotic injury.1,16
Imaging: Which modes and when?
The initial workup should include ankle x-rays when evaluating for the possibility of a distal tibiofibular syndesmosis injury. While the Ottawa Ankle Rules are helpful in providing guidance with regard to x-rays, suspicion of a syndesmotic injury mandates x-rays to determine the stability of the joint and rule out fracture. The European Society of Sports Traumatology, Knee Surgery and Arthroscopy–European Foot and Ankle Associates (ESSKA-AFAS) recommend, at a minimum, obtaining anteroposterior (AP)- and mortise-view ankle x-rays to investigate the tibiofibular clear space, medial clear space, and tibiofibular overlap.7 Most physicians also include a lateral ankle x-ray.
If possible, images should be performed while the patient is bearing weight to further evaluate stability. Radiographic findings that support the diagnosis of syndesmotic injury include a tibiofibular clear space > 6 mm on AP view, medial clear space > 4 mm on mortise view, or tibiofibular overlap < 6 mm on AP view or < 1 mm on mortise view (see FIGURES 2 and 3).1,3,5,8 Additionally, if you suspect a proximal fibular fracture, obtain an x-ray series of the proximal tibia and fibula to investigate the possibility of a Maisonneuve injury.1,2,4,11
If you continue to suspect a syndesmotic injury despite normal x-rays, obtain stress x-rays, in addition to the AP and mortise views, to ensure stability. These x-rays include AP and mortise ankle views with manual external rotation of the ankle joint, which may demonstrate abnormalities not seen on standard x-rays. Bilateral imaging can also be useful to further assess when mild abnormalities vs symmetric anatomic variants are in question.1,7
If there is concern for an unstable injury, refer the patient to a foot and ankle surgeon, who may pursue magnetic resonance imaging (MRI) or standing computed tomography (CT).1,2,5,7 MRI is the recommended choice for further evaluation of a syndesmotic injury, as it is proven to be accurate in evaluating the integrity of the syndesmotic ligaments (see FIGURES 4 and 5).18 MRI has demonstrated 100% sensitivity for detecting AITFL and PITFL injuries, as well as 93% and 100% specificity for AITFL and PITFL tears, respectively.8 A weight-bearing CT scan, particularly axial views, can also be a useful adjunct, as it is more sensitive than standard x-rays for assessing for mild diastasis. Although CT can provide an assessment of bony structures, it is not able to evaluate soft tissue structures, limiting its utility in evaluation of syndesmotic injuries.1,7
Continue to: Although not the standard of care...
Although not the standard of care, ultrasonography (US) is gaining traction as a means of investigating the integrity of the syndesmotic ligaments. US is inexpensive, readily available in many clinics, allows for dynamic testing, and avoids radiation exposure.7 However, US requires a skilled sonographer with experience in the ankle joint for an accurate diagnosis. If the workup with advanced imaging is inconclusive, but a high degree of suspicion remains for an unstable syndesmotic injury, consider arthroscopy to directly visualize and assess the syndesmotic structures.1,2,5,7,8
Grading the severity of the injury and pursuing appropriate Tx
Typically, the severity of a syndesmotic injury is classified as fitting into 1 of 3 categories: Grade I and II injuries are the most common, each accounting for 40% of syndesmotic injuries, while 20% of high ankle sprains are classified as Grade III.12
A Grade I injury consists of a stable syndesmotic joint without abnormal radiographic findings. There may be associated tenderness to palpation over the distal tibiofibular joint, and provocative testing may be subtle or normal. These injuries are often minor and able to be treated conservatively.
A Grade II injury is associated with a partial syndesmotic disruption, typically with partial tearing of the AITFL and interosseous ligament. These injuries may be stable or accompanied by mild instability, and provocative testing is usually positive. X-rays are typically normal with Grade II injuries, but may display subtle radiographic findings suggestive of a syndesmotic injury. Treatment of Grade II injuries is somewhat controversial and should be an individualized decision based upon the patient’s age, activity level, clinical exam, and imaging findings. Therefore, treatment of Grade II syndesmotic injuries may include a trial of conservative management or surgical intervention.
A Grade III injury represents inherent instability of the distal tibiofibular joint with complete disruption of all syndesmotic ligaments, with or without involvement of the deltoid ligament. X-rays will be positive in Grade III syndesmotic injuries because of the complete disruption of syndesmotic ligaments. All Grade III injuries require surgical intervention with a syndesmotic screw or other stabilization procedure.1,6-8,15
Continue to: A 3-stage rehabilitation protocol
A 3-stage rehabilitation protocol
When conservative management is deemed appropriate for a stable syndesmotic sprain, a 3-stage rehabilitation protocol is typically utilized.
The acute phase focuses on protection, pain control, and decreasing inflammation. The patient’s ankle is often immobilized in a cast or controlled ankle movement (CAM) boot. The patient is typically allowed to bear weight in the immobilizer during this phase as long as he/she is pain-free. If pain is present with weight bearing despite immobilization, non-weight bearing is recommended. The patient is instructed to elevate the lower extremity, take anti-inflammatory medication, and ice the affected ankle. Additionally, physical therapy modalities may be utilized to help with edema and pain. Joint immobilization is typically employed for 1 to 3 weeks post-injury. In the acute phase, the patient may also work with a physical therapist or athletic trainer on passive range of motion (ROM), progressing to active ROM as tolerated.1,5,7,8,19
The patient can transition from the CAM boot to a lace-up ankle brace when he/she is able to bear full weight and can navigate stairs without pain, which typically occurs around 3 to 6 weeks post-injury.1,5,7 A pneumatic walking brace may also be used as a transition device to provide added stabilization.
In the sub-acute phase, rehabilitation may progress to increase ankle mobility, strengthening, neuromuscular control, and to allow the patient to perform activities of daily living.5-7
The advanced training phase includes continued neuromuscular control, increased strengthening, plyometrics, agility, and sports-specific drills.5 Athletes are allowed to return to full participation when they have regained full ROM, are able to perform sport-specific agility drills without pain or instability, and have near-normal strength.5-7 Some authors also advocate that a Single Leg Hop Test should be included in the physical exam, and that it should be pain free prior to allowing an athlete to return to competition.20 Both progression in physical rehabilitation and return to sport should be individualized based upon injury severity, patient functionality, and physical exam findings.
Continue to: Outcomes forecast
Outcomes forecast: Variable
The resolution of symptoms and return to competition after a syndesmotic injury is variable. In one cohort study of cadets (N = 614) at the United States Military Academy, the average time lost from a syndesmotic ankle sprain was 9.82 days (range 3-21 days).9 In a retrospective review of National Hockey League players, average time to return to competition after a syndesmotic ankle injury sprain (n = 14) was 45 days (range 6-137 days) vs 1.4 days (range 0-6 days) for lateral ankle sprains (n = 5).21 In another study, National Football League players with syndesmotic sprains (n = 36) had a mean time loss from play of 15.4 days (± 11.1 days) vs 6.5 days (± 6.5 days) of time loss from play in those with lateral ankle sprains (n = 53).22
Although there is a fair amount of variability among studies, most authors agree that the average athlete can expect to return to sport 4 to 8 weeks post-injury with conservative management.19 At least 1 study suggests that the average time to return to sport in patients with Grade III syndesmotic injuries who undergo surgical treatment with a syndesmotic screw is 41 days (range 32-48).23 The differences in return to sport may be related to severity of injury and/or type of activity.
Persistent symptoms are relatively common after conservative management of syndesmotic injuries. One case series found that 36% of patients treated conservatively had complaints of persistent mild-to-moderate ankle stiffness, 23% had mild-to-moderate pain, and 18% had mild-to-moderate ankle swelling.24 Despite these symptoms, 86% of the patients rated their ankle function as good after conservative treatment.24 In patients with persistent symptoms, other possible etiologies should be considered including neurologic injury, complex regional pain syndrome, osteochondral defect, loose body, or other sources that may be contributing to pain, swelling, or delayed recovery.
At least 1 randomized controlled trial (RCT) investigated the utility of platelet rich plasma (PRP) injections around the injured AITFL in the setting of an acute syndesmotic injury. The study showed promising results, including quicker return to play, restabilization of the syndesmotic joint, and less residual pain;25 however, the study population was relatively small (N = 16), and the authors believed that more research is required on the benefits of PRP therapy in syndesmotic injuries before recommendations can be made.
An ounce of preventionis worth a pound of cure
Although injury is not always avoidable, there are measures that can help prevent ankle sprains and facilitate return to play after injury. As previously mentioned, athletes should be able to demonstrate the ability to run, cut, jump, and perform sport-specific activities without limitations prior to being allowed to return to sport after injury.5-7,26 Additionally, issues with biomechanics and functional deficits should be analyzed and addressed. By targeting specific strength deficits, focusing on proprioceptive awareness, and working on neuromuscular control, injury rates and recurrent injuries can be minimized. One RCT showed a 35% reduction in the recurrence rate of lateral ankle sprains with the use of an unsupervised home-based proprioceptive training program.27
Continue to: Strength training...
Strength training, proprioceptive and neuromuscular control activities, and low-risk activities such as jogging, biking, and swimming do not necessarily require the use of prophylactic bracing. However, because syndesmotic injuries are associated with recurrent ankle injuries, prophylactic bracing should be used during high-risk activities that involve agility maneuvers and jumping. Substantial evidence demonstrates that the use of ankle taping or ankle bracing decreases the incidence of ankle injuries, particularly in those who have had previous ankle injuries.26 In one study (N = 450), only 3% of athletes with a history of prior ankle injuries suffered a recurrent ankle sprain when using an ankle orthosis compared with a 17% injury rate in the control group.28
More recently, 2 separate studies by McGuine et al demonstrated that the use of lace-up ankle braces led to a reduction in the incidence of acute ankle injuries by 61% among 2081 high-school football players, and resulted in a significant reduction in acute ankle injuries in a study of 1460 male and female high-school basketball players, compared with the control groups.29,30
CASE
Ten days after injuring himself, the patient returns for a follow-up exam. Despite using the walking brace and crutches, he is still having significant difficulty bearing weight. He reports a sensation of instability in the right ankle. On exam, you note visible edema of the right ankle and ecchymosis over the lateral ankle, as well as moderate tenderness to palpation over the area of the ATFL and deltoid ligament. Tenderness over the medial malleolus, lateral malleolus, fifth metatarsal, and navicular is absent. Pain is reproducible with external rotation, and a Squeeze Test is positive. There is no tenderness over the proximal tibia or fibula. The patient is neurovascularly intact.
You order stress x-rays, which show widening of the medial clear space. The patient is placed in a CAM boot, instructed to continue non–weight-bearing on the ankle, and referred to a local foot and ankle surgeon for consideration of surgical fixation.
CORRESPONDENCE
John T. Nickless, MD, Division of Primary Care Sports Medicine, Department of Orthopedic Surgery, Rush University Medical Center, 1611 W. Harrison Street, Suite 200, Chicago, IL, 60612; [email protected].
1. Switaj PJ, Mendoza M, Kadakia AR. Acute and chronic Injuries to the syndesmosis. Clin Sports Med. 2015;34:643-677.
2. Scheyerer MJ, Helfet DL, Wirth S, et al. Diagnostics in suspicion of ankle syndesmotic injury. Am J Orthop. 2011;40:192-197.
3. Smith KM, Kovacich-Smith KJ, Witt M. Evaluation and management of high ankle sprains. Clin Podiatr Med Surg. 2001;18:443-456.
4. Reissig J, Bitterman A, Lee S. Common foot and ankle injuries: what not to miss and how best to manage. J Am Osteopath Assoc. 2017;117:98-104.
5. Williams GN, Allen EJ. Rehabilitation of syndesmotic (high) ankle sprains. Sports Health. 2010;2:460-470.
6. Williams GN, Jones MH, Amendola A. Syndesmotic ankle sprains in athletes. Am J Sports Med. 2007;35:1197-1207.
7. Vopat ML, Vopat BG, Lubberts B, et al. Current trends in the diagnosis and management of syndesmotic injury. Curr Rev Musculoskelet Med. 2017;10:94-103.
8. Mak MF, Gartner L, Pearce CJ. Management of syndesmosis injuries in the elite athlete. Foot Ankle Clin. 2013;18:195-214.
9. Waterman BR, Belmont PJ, Cameron KL, et al. Epidemiology of ankle sprain at the United States Military Academy. Am J Sports Med. 2010;38:797-803.
10. Hunt KJ, George E, Harris AHS, et al. Epidemiology of syndesmosis injuries in intercollegiate football: incidence and risk factors from National Collegiate Athletic Association injury surveillance system data from 2004-2005 to 2008-2009. Clin J Sport Med. 2013;23:278-282.
11. Schnetzke M, Vetter SY, Beisemann N, et al. Management of syndesmotic injuries: what is the evidence? World J Orthop. 2016;7:718-725.
12. de César PC, Ávila EM, de Abreu MR. Comparison of magnetic resonance imaging to physical examination for syndesmotic injury after lateral ankle sprain. Foot Ankle Int. 2011;32:1110-1114.
13. Ivins D. Acute ankle sprain: an update. Am Fam Physician. 2006;74:1714-1720.
14. Porter D, Rund A, Barnes AF, et al. Optimal management of ankle syndesmosis injuries. Open Access J Sports Med. 2014;5:173-182.
15. Press CM, Gupta A, Hutchinson MR. Management of ankle syndesmosis injuries in the athlete. Curr Sports Med Rep. 2009;8:228-233.
16. Sman AD, Hiller CE, Rae K, et al. Diagnostic accuracy of clinical tests for ankle syndesmosis injury. Br J Sports Med. 2015;49:323-329.
17. Amendola A, Williams G, Foster D. Evidence-based approach to treatment of acute traumatic syndesmosis (high ankle) sprains. Sports Med Arthrosc. 2006;14:232-236.
18. Hunt KJ. Syndesmosis injuries. Curr Rev Musculoskelet Med. 2013;6:304-312.
19. Miller TL, Skalak T. Evaluation and treatment recommendations for acute injuries to the ankle syndesmosis without associated fracture. Sports Med. 2014;44:179-188.
20. Miller BS, Downie BK, Johnson PD, et al. Time to return to play after high ankle sprains in collegiate football players: a prediction model. Sports Health. 2012;4:504-509.
21. Wright RW, Barile RJ, Surprenant DA, et al. Ankle syndesmosis sprains in National Hockey League players. Am J Sports Med. 2016;32:1941-1945.
22. Osbahr DC, Drakos MC, O’Loughlin PF, et al. Syndesmosis and lateral ankle sprains in the National Football League. Orthopedics. 2013;36:e1378-e1384.
23. Taylor DC, Tenuta JJ, Uhorchak JM, et al. Aggressive surgical treatment and early return to sports in athletes with grade III syndesmosis sprains. Am J Sports Med. 2007;35:1133-1138.
24. Taylor DC, Englehardt DL, Bassett FH. Syndesmosis sprains of the ankle: the influence of heterotopic ossification. Am J Sports Med. 1992;20:146-150.
25. Laver L, Carmont MR, McConkey MO, et al. Plasma rich in growth factors (PRGF) as a treatment for high ankle sprain in elite athletes: a randomized control trial. Knee Surg Sports Traumatol Arthrosc. 2014;23:3383-3392.
26. Kaminski TW, Hertel J, Amendola N, et al. National Athletic Trainers’ Association position statement: conservative management and prevention of ankle sprains in athletes. J Athl Train. 2013;48:528-545.
27. Hupperets MDW, Verhagen EALM, van Mechelen W. Effect of unsupervised home based proprioceptive training on recurrences of ankle sprain: randomised controlled trial. BMJ. 2009;339:b2684.
28. Tropp H, Askling C, Gillquist J. Prevention of ankle sprains. Am J Sports Med. 1985;13:259-262.
29. McGuine TA, Brooks A, Hetzel S. The effect of lace-up ankle braces on injury rates in high school basketball players. Am J Sports Med. 2011;39:1840-1848.
30. McGuine TA, Hetzel S, Wilson J, et al. The effect of lace-up ankle braces on injury rates in high school football players. Am J Sports Med. 2012;40:49-57.
CASE
A 19-year-old college football player presents to your outpatient family practice clinic after suffering a right ankle injury during a football game over the weekend. He reports having his right ankle planted on the turf with his foot externally rotated when an opponent fell onto his posterior right lower extremity. He reports having felt immediate pain in the area of the right ankle and requiring assistance off of the field, as he had difficulty walking. The patient was taken to the emergency department where x-rays of the right foot and ankle did not show any signs of acute fracture or dislocation. The patient was diagnosed with a lateral ankle sprain, placed in a pneumatic ankle walking brace, and given crutches.
A high ankle sprain, or distal tibiofibular syndesmotic injury, can be an elusive diagnosis and is often mistaken for the more common lateral ankle sprain. Syndesmotic injuries have been documented to occur in approximately 1% to 10% of all ankle sprains.1-3 The highest number of these injuries occurs between the ages of 18 and 34 years, and they are more frequently seen in athletes than in nonathletes, particularly those who play collision sports, such as football, ice hockey, rugby, wrestling, and lacrosse.1-9 In one study by Hunt et al,10 syndesmotic injuries accounted for 24.6% of all ankle injuries in National Collegiate Athletic Association (NCAA) football players. Incidence continues to grow as recognition of high ankle sprains increases among medical professionals.1,5 Identification of syndesmotic injury is critical, as lack of detection can lead to extensive time missed from athletic participation and chronic ankle dysfunction, including pain and instability.2,4,6,11
Back to basics: A brief anatomy review
Stability in the distal tibiofibular joint is maintained by the syndesmotic ligaments, which include the anterior inferior tibiofibular ligament (AITFL), the posterior inferior tibiofibular ligament (PITFL), the transverse ligament, and the interosseous ligament.3-6,8 This complex of ligaments stabilizes the fibula within the incisura of the tibia and maintains a stable ankle mortise.1,4,5,11 The deep portion of the deltoid ligament also adds stability to the syndesmosis and may be disrupted by a syndesmotic injury.2,5-7,11
Mechanisms of injury: From most common to less likely
The distal tibiofibular syndesmosis is disrupted when an injury forces apart the distal tibiofibular joint. The most commonly reported means of injury is external rotation with hyper-dorsiflexion of the ankle.1-3,5,6,11 With excessive external rotation of the forefoot, the talus is forced against the medial aspect of the fibula, resulting in separation of the distal tibia and fibula and injury to the syndesmotic ligaments.2,3,5,6 Injuries associated with external rotation are commonly seen in sports that immobilize the ankle within a rigid boot, such as skiing and ice hockey.1,2,5 Some authors have suggested that a planovalgus foot alignment may place athletes at inherent risk for an external rotation ankle injury.5,6
Syndesmotic injury may also occur with hyper-dorsiflexion, as the anterior, widest portion of the talus rotates into the ankle mortise, wedging the tibia and fibula apart.2,3,5 There have also been reports of syndesmotic injuries associated with internal rotation, plantar flexion, inversion, and eversion.3,5,11 Therefore, physicians should maintain a high index of suspicion for injury to the distal tibiofibular joint, regardless of the mechanism of injury.
Presentation and evaluation
Observation of the patient and visualization of the affected ankle can provide many clues. Many patients will have difficulty walking after suffering a syndesmotic injury and may require the use of an assistive device.5 The inability to bear weight after an ankle injury points to a more severe diagnosis, such as an ankle fracture or syndesmotic injury, as opposed to a simple lateral ankle sprain. Patients may report anterior ankle pain, a sensation of instability with weight bearing on the affected ankle, or have persistent symptoms despite a course of conservative treatment. Also, they can have a variable amount of edema and ecchymosis associated with their injury; a minimal extent of swelling or ecchymosis does not exclude syndesmotic injury.3
A large percentage of patients will present with a concomitant sprain of the lateral ligaments associated with lateral swelling and bruising. One study found that 91% of syndesmotic injuries involved at least 1 of the lateral collateral ligaments (anterior talofibular ligament [ATFL], calcaneofibular ligament [CFL], or posterior talofibular ligament [PTFL]).12 Patients may have pain or a sensation of instability when pushing off with the toes,5 and patients with syndesmotic injuries often have tenderness to palpation over the distal anterolateral ankle or syndesmotic ligaments.7
Continue to: A thorough examination...
A thorough examination of the ankle, including palpation of common fracture sites, is important. Employ the Ottawa Ankle Rules (see http://www.theottawarules.ca/ankle_rules) to investigate for: tenderness to palpation over the posterior 6 cm of the posterior aspects of the distal medial and lateral malleoli; tenderness over the navicular; tenderness over the base of the fifth metatarsal; and/or the inability to bear weight on the affected lower extremity immediately after injury or upon evaluation in the physician’s office. Any of these findings should raise concern for a possible fracture (see “Adult foot fractures: A guide”) and require an x-ray(s) for further evaluation.13
Perform range-of-motion and strength testing with regard to ankle dorsiflexion, plantar flexion, abduction, adduction, inversion, and eversion. Palpate the ATFL, CFL, and PTFL for tenderness, as these structures may be involved to varying degrees in lateral ankle sprains. An anterior drawer test (see https://www.youtube.com/watch?v=vAcBEYZKcto) may be positive with injury to the ATFL. This test is performed by stabilizing the distal tibia with one hand and using the other hand to grasp the posterior aspect of the calcaneus and apply an anterior force. The test is positive if the talus translates forward, which correlates with laxity or rupture of the ATFL.13 The examiner should also palpate the Achilles tendon, peroneal tendons just posterior to the lateral malleolus, and the tibialis posterior tendon just posterior to the medial malleolus to inspect for tenderness or defects that may be signs of injury to these tendons.
An associated Weber B or C fracture? Trauma causing ankle syndesmosis injuries may be associated with Weber B or Weber C distal fibula fractures.7 Weber B fractures occur in the distal fibula at the level of the ankle joint (see FIGURE 1). These types of fractures are typically associated with external rotation injuries and are usually not associated with disruption of the interosseous membrane.
Weber C fractures are distal fibular fractures occurring above the level of the ankle joint. These fractures are also typically associated with external ankle rotation injuries and include disruption of the syndesmosis and deltoid ligament.14
Also pay special attention to the proximal fibula, as syndesmotic injuries are commonly associated with a Maisonneuve fracture, which is a proximal fibula fracture associated with external rotation forces of the ankle (see FIGURE 1).1,2,4,11,14,15 Further workup should occur in any patient with the possibility of a Weber- or Maisonneuve-type fracture.
Continue to: Multiple tests...
Multiple tests are available to investigate the possibility of a syndesmotic injury and to assess return-to-sport readiness, including the External Rotation Test, the Squeeze Test, the Crossed-Leg Test, the Dorsiflexion Compression Test, the Cotton Test, the Stabilization Test, the Fibular Translation Test, and the Single Leg Hop Test (see TABLE1-3,5,6,16,17). The External Rotation Test is noted by some authors to have the highest interobserver reliability, and is our preferred test.2 The Squeeze Test also has moderate interobserver reliability.2 There is a significant degree of variation among the sensitivity and specificity of these diagnostic tests, and no single test is sufficiently reliable or accurate to diagnose a syndesmotic ankle injury. Therefore, it is recommended to use multiple physical exam maneuvers, the history and mechanism of injury, and findings on imaging studies in conjunction to make the diagnosis of a syndesmotic injury.1,16
Imaging: Which modes and when?
The initial workup should include ankle x-rays when evaluating for the possibility of a distal tibiofibular syndesmosis injury. While the Ottawa Ankle Rules are helpful in providing guidance with regard to x-rays, suspicion of a syndesmotic injury mandates x-rays to determine the stability of the joint and rule out fracture. The European Society of Sports Traumatology, Knee Surgery and Arthroscopy–European Foot and Ankle Associates (ESSKA-AFAS) recommend, at a minimum, obtaining anteroposterior (AP)- and mortise-view ankle x-rays to investigate the tibiofibular clear space, medial clear space, and tibiofibular overlap.7 Most physicians also include a lateral ankle x-ray.
If possible, images should be performed while the patient is bearing weight to further evaluate stability. Radiographic findings that support the diagnosis of syndesmotic injury include a tibiofibular clear space > 6 mm on AP view, medial clear space > 4 mm on mortise view, or tibiofibular overlap < 6 mm on AP view or < 1 mm on mortise view (see FIGURES 2 and 3).1,3,5,8 Additionally, if you suspect a proximal fibular fracture, obtain an x-ray series of the proximal tibia and fibula to investigate the possibility of a Maisonneuve injury.1,2,4,11
If you continue to suspect a syndesmotic injury despite normal x-rays, obtain stress x-rays, in addition to the AP and mortise views, to ensure stability. These x-rays include AP and mortise ankle views with manual external rotation of the ankle joint, which may demonstrate abnormalities not seen on standard x-rays. Bilateral imaging can also be useful to further assess when mild abnormalities vs symmetric anatomic variants are in question.1,7
If there is concern for an unstable injury, refer the patient to a foot and ankle surgeon, who may pursue magnetic resonance imaging (MRI) or standing computed tomography (CT).1,2,5,7 MRI is the recommended choice for further evaluation of a syndesmotic injury, as it is proven to be accurate in evaluating the integrity of the syndesmotic ligaments (see FIGURES 4 and 5).18 MRI has demonstrated 100% sensitivity for detecting AITFL and PITFL injuries, as well as 93% and 100% specificity for AITFL and PITFL tears, respectively.8 A weight-bearing CT scan, particularly axial views, can also be a useful adjunct, as it is more sensitive than standard x-rays for assessing for mild diastasis. Although CT can provide an assessment of bony structures, it is not able to evaluate soft tissue structures, limiting its utility in evaluation of syndesmotic injuries.1,7
Continue to: Although not the standard of care...
Although not the standard of care, ultrasonography (US) is gaining traction as a means of investigating the integrity of the syndesmotic ligaments. US is inexpensive, readily available in many clinics, allows for dynamic testing, and avoids radiation exposure.7 However, US requires a skilled sonographer with experience in the ankle joint for an accurate diagnosis. If the workup with advanced imaging is inconclusive, but a high degree of suspicion remains for an unstable syndesmotic injury, consider arthroscopy to directly visualize and assess the syndesmotic structures.1,2,5,7,8
Grading the severity of the injury and pursuing appropriate Tx
Typically, the severity of a syndesmotic injury is classified as fitting into 1 of 3 categories: Grade I and II injuries are the most common, each accounting for 40% of syndesmotic injuries, while 20% of high ankle sprains are classified as Grade III.12
A Grade I injury consists of a stable syndesmotic joint without abnormal radiographic findings. There may be associated tenderness to palpation over the distal tibiofibular joint, and provocative testing may be subtle or normal. These injuries are often minor and able to be treated conservatively.
A Grade II injury is associated with a partial syndesmotic disruption, typically with partial tearing of the AITFL and interosseous ligament. These injuries may be stable or accompanied by mild instability, and provocative testing is usually positive. X-rays are typically normal with Grade II injuries, but may display subtle radiographic findings suggestive of a syndesmotic injury. Treatment of Grade II injuries is somewhat controversial and should be an individualized decision based upon the patient’s age, activity level, clinical exam, and imaging findings. Therefore, treatment of Grade II syndesmotic injuries may include a trial of conservative management or surgical intervention.
A Grade III injury represents inherent instability of the distal tibiofibular joint with complete disruption of all syndesmotic ligaments, with or without involvement of the deltoid ligament. X-rays will be positive in Grade III syndesmotic injuries because of the complete disruption of syndesmotic ligaments. All Grade III injuries require surgical intervention with a syndesmotic screw or other stabilization procedure.1,6-8,15
Continue to: A 3-stage rehabilitation protocol
A 3-stage rehabilitation protocol
When conservative management is deemed appropriate for a stable syndesmotic sprain, a 3-stage rehabilitation protocol is typically utilized.
The acute phase focuses on protection, pain control, and decreasing inflammation. The patient’s ankle is often immobilized in a cast or controlled ankle movement (CAM) boot. The patient is typically allowed to bear weight in the immobilizer during this phase as long as he/she is pain-free. If pain is present with weight bearing despite immobilization, non-weight bearing is recommended. The patient is instructed to elevate the lower extremity, take anti-inflammatory medication, and ice the affected ankle. Additionally, physical therapy modalities may be utilized to help with edema and pain. Joint immobilization is typically employed for 1 to 3 weeks post-injury. In the acute phase, the patient may also work with a physical therapist or athletic trainer on passive range of motion (ROM), progressing to active ROM as tolerated.1,5,7,8,19
The patient can transition from the CAM boot to a lace-up ankle brace when he/she is able to bear full weight and can navigate stairs without pain, which typically occurs around 3 to 6 weeks post-injury.1,5,7 A pneumatic walking brace may also be used as a transition device to provide added stabilization.
In the sub-acute phase, rehabilitation may progress to increase ankle mobility, strengthening, neuromuscular control, and to allow the patient to perform activities of daily living.5-7
The advanced training phase includes continued neuromuscular control, increased strengthening, plyometrics, agility, and sports-specific drills.5 Athletes are allowed to return to full participation when they have regained full ROM, are able to perform sport-specific agility drills without pain or instability, and have near-normal strength.5-7 Some authors also advocate that a Single Leg Hop Test should be included in the physical exam, and that it should be pain free prior to allowing an athlete to return to competition.20 Both progression in physical rehabilitation and return to sport should be individualized based upon injury severity, patient functionality, and physical exam findings.
Continue to: Outcomes forecast
Outcomes forecast: Variable
The resolution of symptoms and return to competition after a syndesmotic injury is variable. In one cohort study of cadets (N = 614) at the United States Military Academy, the average time lost from a syndesmotic ankle sprain was 9.82 days (range 3-21 days).9 In a retrospective review of National Hockey League players, average time to return to competition after a syndesmotic ankle injury sprain (n = 14) was 45 days (range 6-137 days) vs 1.4 days (range 0-6 days) for lateral ankle sprains (n = 5).21 In another study, National Football League players with syndesmotic sprains (n = 36) had a mean time loss from play of 15.4 days (± 11.1 days) vs 6.5 days (± 6.5 days) of time loss from play in those with lateral ankle sprains (n = 53).22
Although there is a fair amount of variability among studies, most authors agree that the average athlete can expect to return to sport 4 to 8 weeks post-injury with conservative management.19 At least 1 study suggests that the average time to return to sport in patients with Grade III syndesmotic injuries who undergo surgical treatment with a syndesmotic screw is 41 days (range 32-48).23 The differences in return to sport may be related to severity of injury and/or type of activity.
Persistent symptoms are relatively common after conservative management of syndesmotic injuries. One case series found that 36% of patients treated conservatively had complaints of persistent mild-to-moderate ankle stiffness, 23% had mild-to-moderate pain, and 18% had mild-to-moderate ankle swelling.24 Despite these symptoms, 86% of the patients rated their ankle function as good after conservative treatment.24 In patients with persistent symptoms, other possible etiologies should be considered including neurologic injury, complex regional pain syndrome, osteochondral defect, loose body, or other sources that may be contributing to pain, swelling, or delayed recovery.
At least 1 randomized controlled trial (RCT) investigated the utility of platelet rich plasma (PRP) injections around the injured AITFL in the setting of an acute syndesmotic injury. The study showed promising results, including quicker return to play, restabilization of the syndesmotic joint, and less residual pain;25 however, the study population was relatively small (N = 16), and the authors believed that more research is required on the benefits of PRP therapy in syndesmotic injuries before recommendations can be made.
An ounce of preventionis worth a pound of cure
Although injury is not always avoidable, there are measures that can help prevent ankle sprains and facilitate return to play after injury. As previously mentioned, athletes should be able to demonstrate the ability to run, cut, jump, and perform sport-specific activities without limitations prior to being allowed to return to sport after injury.5-7,26 Additionally, issues with biomechanics and functional deficits should be analyzed and addressed. By targeting specific strength deficits, focusing on proprioceptive awareness, and working on neuromuscular control, injury rates and recurrent injuries can be minimized. One RCT showed a 35% reduction in the recurrence rate of lateral ankle sprains with the use of an unsupervised home-based proprioceptive training program.27
Continue to: Strength training...
Strength training, proprioceptive and neuromuscular control activities, and low-risk activities such as jogging, biking, and swimming do not necessarily require the use of prophylactic bracing. However, because syndesmotic injuries are associated with recurrent ankle injuries, prophylactic bracing should be used during high-risk activities that involve agility maneuvers and jumping. Substantial evidence demonstrates that the use of ankle taping or ankle bracing decreases the incidence of ankle injuries, particularly in those who have had previous ankle injuries.26 In one study (N = 450), only 3% of athletes with a history of prior ankle injuries suffered a recurrent ankle sprain when using an ankle orthosis compared with a 17% injury rate in the control group.28
More recently, 2 separate studies by McGuine et al demonstrated that the use of lace-up ankle braces led to a reduction in the incidence of acute ankle injuries by 61% among 2081 high-school football players, and resulted in a significant reduction in acute ankle injuries in a study of 1460 male and female high-school basketball players, compared with the control groups.29,30
CASE
Ten days after injuring himself, the patient returns for a follow-up exam. Despite using the walking brace and crutches, he is still having significant difficulty bearing weight. He reports a sensation of instability in the right ankle. On exam, you note visible edema of the right ankle and ecchymosis over the lateral ankle, as well as moderate tenderness to palpation over the area of the ATFL and deltoid ligament. Tenderness over the medial malleolus, lateral malleolus, fifth metatarsal, and navicular is absent. Pain is reproducible with external rotation, and a Squeeze Test is positive. There is no tenderness over the proximal tibia or fibula. The patient is neurovascularly intact.
You order stress x-rays, which show widening of the medial clear space. The patient is placed in a CAM boot, instructed to continue non–weight-bearing on the ankle, and referred to a local foot and ankle surgeon for consideration of surgical fixation.
CORRESPONDENCE
John T. Nickless, MD, Division of Primary Care Sports Medicine, Department of Orthopedic Surgery, Rush University Medical Center, 1611 W. Harrison Street, Suite 200, Chicago, IL, 60612; [email protected].
CASE
A 19-year-old college football player presents to your outpatient family practice clinic after suffering a right ankle injury during a football game over the weekend. He reports having his right ankle planted on the turf with his foot externally rotated when an opponent fell onto his posterior right lower extremity. He reports having felt immediate pain in the area of the right ankle and requiring assistance off of the field, as he had difficulty walking. The patient was taken to the emergency department where x-rays of the right foot and ankle did not show any signs of acute fracture or dislocation. The patient was diagnosed with a lateral ankle sprain, placed in a pneumatic ankle walking brace, and given crutches.
A high ankle sprain, or distal tibiofibular syndesmotic injury, can be an elusive diagnosis and is often mistaken for the more common lateral ankle sprain. Syndesmotic injuries have been documented to occur in approximately 1% to 10% of all ankle sprains.1-3 The highest number of these injuries occurs between the ages of 18 and 34 years, and they are more frequently seen in athletes than in nonathletes, particularly those who play collision sports, such as football, ice hockey, rugby, wrestling, and lacrosse.1-9 In one study by Hunt et al,10 syndesmotic injuries accounted for 24.6% of all ankle injuries in National Collegiate Athletic Association (NCAA) football players. Incidence continues to grow as recognition of high ankle sprains increases among medical professionals.1,5 Identification of syndesmotic injury is critical, as lack of detection can lead to extensive time missed from athletic participation and chronic ankle dysfunction, including pain and instability.2,4,6,11
Back to basics: A brief anatomy review
Stability in the distal tibiofibular joint is maintained by the syndesmotic ligaments, which include the anterior inferior tibiofibular ligament (AITFL), the posterior inferior tibiofibular ligament (PITFL), the transverse ligament, and the interosseous ligament.3-6,8 This complex of ligaments stabilizes the fibula within the incisura of the tibia and maintains a stable ankle mortise.1,4,5,11 The deep portion of the deltoid ligament also adds stability to the syndesmosis and may be disrupted by a syndesmotic injury.2,5-7,11
Mechanisms of injury: From most common to less likely
The distal tibiofibular syndesmosis is disrupted when an injury forces apart the distal tibiofibular joint. The most commonly reported means of injury is external rotation with hyper-dorsiflexion of the ankle.1-3,5,6,11 With excessive external rotation of the forefoot, the talus is forced against the medial aspect of the fibula, resulting in separation of the distal tibia and fibula and injury to the syndesmotic ligaments.2,3,5,6 Injuries associated with external rotation are commonly seen in sports that immobilize the ankle within a rigid boot, such as skiing and ice hockey.1,2,5 Some authors have suggested that a planovalgus foot alignment may place athletes at inherent risk for an external rotation ankle injury.5,6
Syndesmotic injury may also occur with hyper-dorsiflexion, as the anterior, widest portion of the talus rotates into the ankle mortise, wedging the tibia and fibula apart.2,3,5 There have also been reports of syndesmotic injuries associated with internal rotation, plantar flexion, inversion, and eversion.3,5,11 Therefore, physicians should maintain a high index of suspicion for injury to the distal tibiofibular joint, regardless of the mechanism of injury.
Presentation and evaluation
Observation of the patient and visualization of the affected ankle can provide many clues. Many patients will have difficulty walking after suffering a syndesmotic injury and may require the use of an assistive device.5 The inability to bear weight after an ankle injury points to a more severe diagnosis, such as an ankle fracture or syndesmotic injury, as opposed to a simple lateral ankle sprain. Patients may report anterior ankle pain, a sensation of instability with weight bearing on the affected ankle, or have persistent symptoms despite a course of conservative treatment. Also, they can have a variable amount of edema and ecchymosis associated with their injury; a minimal extent of swelling or ecchymosis does not exclude syndesmotic injury.3
A large percentage of patients will present with a concomitant sprain of the lateral ligaments associated with lateral swelling and bruising. One study found that 91% of syndesmotic injuries involved at least 1 of the lateral collateral ligaments (anterior talofibular ligament [ATFL], calcaneofibular ligament [CFL], or posterior talofibular ligament [PTFL]).12 Patients may have pain or a sensation of instability when pushing off with the toes,5 and patients with syndesmotic injuries often have tenderness to palpation over the distal anterolateral ankle or syndesmotic ligaments.7
Continue to: A thorough examination...
A thorough examination of the ankle, including palpation of common fracture sites, is important. Employ the Ottawa Ankle Rules (see http://www.theottawarules.ca/ankle_rules) to investigate for: tenderness to palpation over the posterior 6 cm of the posterior aspects of the distal medial and lateral malleoli; tenderness over the navicular; tenderness over the base of the fifth metatarsal; and/or the inability to bear weight on the affected lower extremity immediately after injury or upon evaluation in the physician’s office. Any of these findings should raise concern for a possible fracture (see “Adult foot fractures: A guide”) and require an x-ray(s) for further evaluation.13
Perform range-of-motion and strength testing with regard to ankle dorsiflexion, plantar flexion, abduction, adduction, inversion, and eversion. Palpate the ATFL, CFL, and PTFL for tenderness, as these structures may be involved to varying degrees in lateral ankle sprains. An anterior drawer test (see https://www.youtube.com/watch?v=vAcBEYZKcto) may be positive with injury to the ATFL. This test is performed by stabilizing the distal tibia with one hand and using the other hand to grasp the posterior aspect of the calcaneus and apply an anterior force. The test is positive if the talus translates forward, which correlates with laxity or rupture of the ATFL.13 The examiner should also palpate the Achilles tendon, peroneal tendons just posterior to the lateral malleolus, and the tibialis posterior tendon just posterior to the medial malleolus to inspect for tenderness or defects that may be signs of injury to these tendons.
An associated Weber B or C fracture? Trauma causing ankle syndesmosis injuries may be associated with Weber B or Weber C distal fibula fractures.7 Weber B fractures occur in the distal fibula at the level of the ankle joint (see FIGURE 1). These types of fractures are typically associated with external rotation injuries and are usually not associated with disruption of the interosseous membrane.
Weber C fractures are distal fibular fractures occurring above the level of the ankle joint. These fractures are also typically associated with external ankle rotation injuries and include disruption of the syndesmosis and deltoid ligament.14
Also pay special attention to the proximal fibula, as syndesmotic injuries are commonly associated with a Maisonneuve fracture, which is a proximal fibula fracture associated with external rotation forces of the ankle (see FIGURE 1).1,2,4,11,14,15 Further workup should occur in any patient with the possibility of a Weber- or Maisonneuve-type fracture.
Continue to: Multiple tests...
Multiple tests are available to investigate the possibility of a syndesmotic injury and to assess return-to-sport readiness, including the External Rotation Test, the Squeeze Test, the Crossed-Leg Test, the Dorsiflexion Compression Test, the Cotton Test, the Stabilization Test, the Fibular Translation Test, and the Single Leg Hop Test (see TABLE1-3,5,6,16,17). The External Rotation Test is noted by some authors to have the highest interobserver reliability, and is our preferred test.2 The Squeeze Test also has moderate interobserver reliability.2 There is a significant degree of variation among the sensitivity and specificity of these diagnostic tests, and no single test is sufficiently reliable or accurate to diagnose a syndesmotic ankle injury. Therefore, it is recommended to use multiple physical exam maneuvers, the history and mechanism of injury, and findings on imaging studies in conjunction to make the diagnosis of a syndesmotic injury.1,16
Imaging: Which modes and when?
The initial workup should include ankle x-rays when evaluating for the possibility of a distal tibiofibular syndesmosis injury. While the Ottawa Ankle Rules are helpful in providing guidance with regard to x-rays, suspicion of a syndesmotic injury mandates x-rays to determine the stability of the joint and rule out fracture. The European Society of Sports Traumatology, Knee Surgery and Arthroscopy–European Foot and Ankle Associates (ESSKA-AFAS) recommend, at a minimum, obtaining anteroposterior (AP)- and mortise-view ankle x-rays to investigate the tibiofibular clear space, medial clear space, and tibiofibular overlap.7 Most physicians also include a lateral ankle x-ray.
If possible, images should be performed while the patient is bearing weight to further evaluate stability. Radiographic findings that support the diagnosis of syndesmotic injury include a tibiofibular clear space > 6 mm on AP view, medial clear space > 4 mm on mortise view, or tibiofibular overlap < 6 mm on AP view or < 1 mm on mortise view (see FIGURES 2 and 3).1,3,5,8 Additionally, if you suspect a proximal fibular fracture, obtain an x-ray series of the proximal tibia and fibula to investigate the possibility of a Maisonneuve injury.1,2,4,11
If you continue to suspect a syndesmotic injury despite normal x-rays, obtain stress x-rays, in addition to the AP and mortise views, to ensure stability. These x-rays include AP and mortise ankle views with manual external rotation of the ankle joint, which may demonstrate abnormalities not seen on standard x-rays. Bilateral imaging can also be useful to further assess when mild abnormalities vs symmetric anatomic variants are in question.1,7
If there is concern for an unstable injury, refer the patient to a foot and ankle surgeon, who may pursue magnetic resonance imaging (MRI) or standing computed tomography (CT).1,2,5,7 MRI is the recommended choice for further evaluation of a syndesmotic injury, as it is proven to be accurate in evaluating the integrity of the syndesmotic ligaments (see FIGURES 4 and 5).18 MRI has demonstrated 100% sensitivity for detecting AITFL and PITFL injuries, as well as 93% and 100% specificity for AITFL and PITFL tears, respectively.8 A weight-bearing CT scan, particularly axial views, can also be a useful adjunct, as it is more sensitive than standard x-rays for assessing for mild diastasis. Although CT can provide an assessment of bony structures, it is not able to evaluate soft tissue structures, limiting its utility in evaluation of syndesmotic injuries.1,7
Continue to: Although not the standard of care...
Although not the standard of care, ultrasonography (US) is gaining traction as a means of investigating the integrity of the syndesmotic ligaments. US is inexpensive, readily available in many clinics, allows for dynamic testing, and avoids radiation exposure.7 However, US requires a skilled sonographer with experience in the ankle joint for an accurate diagnosis. If the workup with advanced imaging is inconclusive, but a high degree of suspicion remains for an unstable syndesmotic injury, consider arthroscopy to directly visualize and assess the syndesmotic structures.1,2,5,7,8
Grading the severity of the injury and pursuing appropriate Tx
Typically, the severity of a syndesmotic injury is classified as fitting into 1 of 3 categories: Grade I and II injuries are the most common, each accounting for 40% of syndesmotic injuries, while 20% of high ankle sprains are classified as Grade III.12
A Grade I injury consists of a stable syndesmotic joint without abnormal radiographic findings. There may be associated tenderness to palpation over the distal tibiofibular joint, and provocative testing may be subtle or normal. These injuries are often minor and able to be treated conservatively.
A Grade II injury is associated with a partial syndesmotic disruption, typically with partial tearing of the AITFL and interosseous ligament. These injuries may be stable or accompanied by mild instability, and provocative testing is usually positive. X-rays are typically normal with Grade II injuries, but may display subtle radiographic findings suggestive of a syndesmotic injury. Treatment of Grade II injuries is somewhat controversial and should be an individualized decision based upon the patient’s age, activity level, clinical exam, and imaging findings. Therefore, treatment of Grade II syndesmotic injuries may include a trial of conservative management or surgical intervention.
A Grade III injury represents inherent instability of the distal tibiofibular joint with complete disruption of all syndesmotic ligaments, with or without involvement of the deltoid ligament. X-rays will be positive in Grade III syndesmotic injuries because of the complete disruption of syndesmotic ligaments. All Grade III injuries require surgical intervention with a syndesmotic screw or other stabilization procedure.1,6-8,15
Continue to: A 3-stage rehabilitation protocol
A 3-stage rehabilitation protocol
When conservative management is deemed appropriate for a stable syndesmotic sprain, a 3-stage rehabilitation protocol is typically utilized.
The acute phase focuses on protection, pain control, and decreasing inflammation. The patient’s ankle is often immobilized in a cast or controlled ankle movement (CAM) boot. The patient is typically allowed to bear weight in the immobilizer during this phase as long as he/she is pain-free. If pain is present with weight bearing despite immobilization, non-weight bearing is recommended. The patient is instructed to elevate the lower extremity, take anti-inflammatory medication, and ice the affected ankle. Additionally, physical therapy modalities may be utilized to help with edema and pain. Joint immobilization is typically employed for 1 to 3 weeks post-injury. In the acute phase, the patient may also work with a physical therapist or athletic trainer on passive range of motion (ROM), progressing to active ROM as tolerated.1,5,7,8,19
The patient can transition from the CAM boot to a lace-up ankle brace when he/she is able to bear full weight and can navigate stairs without pain, which typically occurs around 3 to 6 weeks post-injury.1,5,7 A pneumatic walking brace may also be used as a transition device to provide added stabilization.
In the sub-acute phase, rehabilitation may progress to increase ankle mobility, strengthening, neuromuscular control, and to allow the patient to perform activities of daily living.5-7
The advanced training phase includes continued neuromuscular control, increased strengthening, plyometrics, agility, and sports-specific drills.5 Athletes are allowed to return to full participation when they have regained full ROM, are able to perform sport-specific agility drills without pain or instability, and have near-normal strength.5-7 Some authors also advocate that a Single Leg Hop Test should be included in the physical exam, and that it should be pain free prior to allowing an athlete to return to competition.20 Both progression in physical rehabilitation and return to sport should be individualized based upon injury severity, patient functionality, and physical exam findings.
Continue to: Outcomes forecast
Outcomes forecast: Variable
The resolution of symptoms and return to competition after a syndesmotic injury is variable. In one cohort study of cadets (N = 614) at the United States Military Academy, the average time lost from a syndesmotic ankle sprain was 9.82 days (range 3-21 days).9 In a retrospective review of National Hockey League players, average time to return to competition after a syndesmotic ankle injury sprain (n = 14) was 45 days (range 6-137 days) vs 1.4 days (range 0-6 days) for lateral ankle sprains (n = 5).21 In another study, National Football League players with syndesmotic sprains (n = 36) had a mean time loss from play of 15.4 days (± 11.1 days) vs 6.5 days (± 6.5 days) of time loss from play in those with lateral ankle sprains (n = 53).22
Although there is a fair amount of variability among studies, most authors agree that the average athlete can expect to return to sport 4 to 8 weeks post-injury with conservative management.19 At least 1 study suggests that the average time to return to sport in patients with Grade III syndesmotic injuries who undergo surgical treatment with a syndesmotic screw is 41 days (range 32-48).23 The differences in return to sport may be related to severity of injury and/or type of activity.
Persistent symptoms are relatively common after conservative management of syndesmotic injuries. One case series found that 36% of patients treated conservatively had complaints of persistent mild-to-moderate ankle stiffness, 23% had mild-to-moderate pain, and 18% had mild-to-moderate ankle swelling.24 Despite these symptoms, 86% of the patients rated their ankle function as good after conservative treatment.24 In patients with persistent symptoms, other possible etiologies should be considered including neurologic injury, complex regional pain syndrome, osteochondral defect, loose body, or other sources that may be contributing to pain, swelling, or delayed recovery.
At least 1 randomized controlled trial (RCT) investigated the utility of platelet rich plasma (PRP) injections around the injured AITFL in the setting of an acute syndesmotic injury. The study showed promising results, including quicker return to play, restabilization of the syndesmotic joint, and less residual pain;25 however, the study population was relatively small (N = 16), and the authors believed that more research is required on the benefits of PRP therapy in syndesmotic injuries before recommendations can be made.
An ounce of preventionis worth a pound of cure
Although injury is not always avoidable, there are measures that can help prevent ankle sprains and facilitate return to play after injury. As previously mentioned, athletes should be able to demonstrate the ability to run, cut, jump, and perform sport-specific activities without limitations prior to being allowed to return to sport after injury.5-7,26 Additionally, issues with biomechanics and functional deficits should be analyzed and addressed. By targeting specific strength deficits, focusing on proprioceptive awareness, and working on neuromuscular control, injury rates and recurrent injuries can be minimized. One RCT showed a 35% reduction in the recurrence rate of lateral ankle sprains with the use of an unsupervised home-based proprioceptive training program.27
Continue to: Strength training...
Strength training, proprioceptive and neuromuscular control activities, and low-risk activities such as jogging, biking, and swimming do not necessarily require the use of prophylactic bracing. However, because syndesmotic injuries are associated with recurrent ankle injuries, prophylactic bracing should be used during high-risk activities that involve agility maneuvers and jumping. Substantial evidence demonstrates that the use of ankle taping or ankle bracing decreases the incidence of ankle injuries, particularly in those who have had previous ankle injuries.26 In one study (N = 450), only 3% of athletes with a history of prior ankle injuries suffered a recurrent ankle sprain when using an ankle orthosis compared with a 17% injury rate in the control group.28
More recently, 2 separate studies by McGuine et al demonstrated that the use of lace-up ankle braces led to a reduction in the incidence of acute ankle injuries by 61% among 2081 high-school football players, and resulted in a significant reduction in acute ankle injuries in a study of 1460 male and female high-school basketball players, compared with the control groups.29,30
CASE
Ten days after injuring himself, the patient returns for a follow-up exam. Despite using the walking brace and crutches, he is still having significant difficulty bearing weight. He reports a sensation of instability in the right ankle. On exam, you note visible edema of the right ankle and ecchymosis over the lateral ankle, as well as moderate tenderness to palpation over the area of the ATFL and deltoid ligament. Tenderness over the medial malleolus, lateral malleolus, fifth metatarsal, and navicular is absent. Pain is reproducible with external rotation, and a Squeeze Test is positive. There is no tenderness over the proximal tibia or fibula. The patient is neurovascularly intact.
You order stress x-rays, which show widening of the medial clear space. The patient is placed in a CAM boot, instructed to continue non–weight-bearing on the ankle, and referred to a local foot and ankle surgeon for consideration of surgical fixation.
CORRESPONDENCE
John T. Nickless, MD, Division of Primary Care Sports Medicine, Department of Orthopedic Surgery, Rush University Medical Center, 1611 W. Harrison Street, Suite 200, Chicago, IL, 60612; [email protected].
1. Switaj PJ, Mendoza M, Kadakia AR. Acute and chronic Injuries to the syndesmosis. Clin Sports Med. 2015;34:643-677.
2. Scheyerer MJ, Helfet DL, Wirth S, et al. Diagnostics in suspicion of ankle syndesmotic injury. Am J Orthop. 2011;40:192-197.
3. Smith KM, Kovacich-Smith KJ, Witt M. Evaluation and management of high ankle sprains. Clin Podiatr Med Surg. 2001;18:443-456.
4. Reissig J, Bitterman A, Lee S. Common foot and ankle injuries: what not to miss and how best to manage. J Am Osteopath Assoc. 2017;117:98-104.
5. Williams GN, Allen EJ. Rehabilitation of syndesmotic (high) ankle sprains. Sports Health. 2010;2:460-470.
6. Williams GN, Jones MH, Amendola A. Syndesmotic ankle sprains in athletes. Am J Sports Med. 2007;35:1197-1207.
7. Vopat ML, Vopat BG, Lubberts B, et al. Current trends in the diagnosis and management of syndesmotic injury. Curr Rev Musculoskelet Med. 2017;10:94-103.
8. Mak MF, Gartner L, Pearce CJ. Management of syndesmosis injuries in the elite athlete. Foot Ankle Clin. 2013;18:195-214.
9. Waterman BR, Belmont PJ, Cameron KL, et al. Epidemiology of ankle sprain at the United States Military Academy. Am J Sports Med. 2010;38:797-803.
10. Hunt KJ, George E, Harris AHS, et al. Epidemiology of syndesmosis injuries in intercollegiate football: incidence and risk factors from National Collegiate Athletic Association injury surveillance system data from 2004-2005 to 2008-2009. Clin J Sport Med. 2013;23:278-282.
11. Schnetzke M, Vetter SY, Beisemann N, et al. Management of syndesmotic injuries: what is the evidence? World J Orthop. 2016;7:718-725.
12. de César PC, Ávila EM, de Abreu MR. Comparison of magnetic resonance imaging to physical examination for syndesmotic injury after lateral ankle sprain. Foot Ankle Int. 2011;32:1110-1114.
13. Ivins D. Acute ankle sprain: an update. Am Fam Physician. 2006;74:1714-1720.
14. Porter D, Rund A, Barnes AF, et al. Optimal management of ankle syndesmosis injuries. Open Access J Sports Med. 2014;5:173-182.
15. Press CM, Gupta A, Hutchinson MR. Management of ankle syndesmosis injuries in the athlete. Curr Sports Med Rep. 2009;8:228-233.
16. Sman AD, Hiller CE, Rae K, et al. Diagnostic accuracy of clinical tests for ankle syndesmosis injury. Br J Sports Med. 2015;49:323-329.
17. Amendola A, Williams G, Foster D. Evidence-based approach to treatment of acute traumatic syndesmosis (high ankle) sprains. Sports Med Arthrosc. 2006;14:232-236.
18. Hunt KJ. Syndesmosis injuries. Curr Rev Musculoskelet Med. 2013;6:304-312.
19. Miller TL, Skalak T. Evaluation and treatment recommendations for acute injuries to the ankle syndesmosis without associated fracture. Sports Med. 2014;44:179-188.
20. Miller BS, Downie BK, Johnson PD, et al. Time to return to play after high ankle sprains in collegiate football players: a prediction model. Sports Health. 2012;4:504-509.
21. Wright RW, Barile RJ, Surprenant DA, et al. Ankle syndesmosis sprains in National Hockey League players. Am J Sports Med. 2016;32:1941-1945.
22. Osbahr DC, Drakos MC, O’Loughlin PF, et al. Syndesmosis and lateral ankle sprains in the National Football League. Orthopedics. 2013;36:e1378-e1384.
23. Taylor DC, Tenuta JJ, Uhorchak JM, et al. Aggressive surgical treatment and early return to sports in athletes with grade III syndesmosis sprains. Am J Sports Med. 2007;35:1133-1138.
24. Taylor DC, Englehardt DL, Bassett FH. Syndesmosis sprains of the ankle: the influence of heterotopic ossification. Am J Sports Med. 1992;20:146-150.
25. Laver L, Carmont MR, McConkey MO, et al. Plasma rich in growth factors (PRGF) as a treatment for high ankle sprain in elite athletes: a randomized control trial. Knee Surg Sports Traumatol Arthrosc. 2014;23:3383-3392.
26. Kaminski TW, Hertel J, Amendola N, et al. National Athletic Trainers’ Association position statement: conservative management and prevention of ankle sprains in athletes. J Athl Train. 2013;48:528-545.
27. Hupperets MDW, Verhagen EALM, van Mechelen W. Effect of unsupervised home based proprioceptive training on recurrences of ankle sprain: randomised controlled trial. BMJ. 2009;339:b2684.
28. Tropp H, Askling C, Gillquist J. Prevention of ankle sprains. Am J Sports Med. 1985;13:259-262.
29. McGuine TA, Brooks A, Hetzel S. The effect of lace-up ankle braces on injury rates in high school basketball players. Am J Sports Med. 2011;39:1840-1848.
30. McGuine TA, Hetzel S, Wilson J, et al. The effect of lace-up ankle braces on injury rates in high school football players. Am J Sports Med. 2012;40:49-57.
1. Switaj PJ, Mendoza M, Kadakia AR. Acute and chronic Injuries to the syndesmosis. Clin Sports Med. 2015;34:643-677.
2. Scheyerer MJ, Helfet DL, Wirth S, et al. Diagnostics in suspicion of ankle syndesmotic injury. Am J Orthop. 2011;40:192-197.
3. Smith KM, Kovacich-Smith KJ, Witt M. Evaluation and management of high ankle sprains. Clin Podiatr Med Surg. 2001;18:443-456.
4. Reissig J, Bitterman A, Lee S. Common foot and ankle injuries: what not to miss and how best to manage. J Am Osteopath Assoc. 2017;117:98-104.
5. Williams GN, Allen EJ. Rehabilitation of syndesmotic (high) ankle sprains. Sports Health. 2010;2:460-470.
6. Williams GN, Jones MH, Amendola A. Syndesmotic ankle sprains in athletes. Am J Sports Med. 2007;35:1197-1207.
7. Vopat ML, Vopat BG, Lubberts B, et al. Current trends in the diagnosis and management of syndesmotic injury. Curr Rev Musculoskelet Med. 2017;10:94-103.
8. Mak MF, Gartner L, Pearce CJ. Management of syndesmosis injuries in the elite athlete. Foot Ankle Clin. 2013;18:195-214.
9. Waterman BR, Belmont PJ, Cameron KL, et al. Epidemiology of ankle sprain at the United States Military Academy. Am J Sports Med. 2010;38:797-803.
10. Hunt KJ, George E, Harris AHS, et al. Epidemiology of syndesmosis injuries in intercollegiate football: incidence and risk factors from National Collegiate Athletic Association injury surveillance system data from 2004-2005 to 2008-2009. Clin J Sport Med. 2013;23:278-282.
11. Schnetzke M, Vetter SY, Beisemann N, et al. Management of syndesmotic injuries: what is the evidence? World J Orthop. 2016;7:718-725.
12. de César PC, Ávila EM, de Abreu MR. Comparison of magnetic resonance imaging to physical examination for syndesmotic injury after lateral ankle sprain. Foot Ankle Int. 2011;32:1110-1114.
13. Ivins D. Acute ankle sprain: an update. Am Fam Physician. 2006;74:1714-1720.
14. Porter D, Rund A, Barnes AF, et al. Optimal management of ankle syndesmosis injuries. Open Access J Sports Med. 2014;5:173-182.
15. Press CM, Gupta A, Hutchinson MR. Management of ankle syndesmosis injuries in the athlete. Curr Sports Med Rep. 2009;8:228-233.
16. Sman AD, Hiller CE, Rae K, et al. Diagnostic accuracy of clinical tests for ankle syndesmosis injury. Br J Sports Med. 2015;49:323-329.
17. Amendola A, Williams G, Foster D. Evidence-based approach to treatment of acute traumatic syndesmosis (high ankle) sprains. Sports Med Arthrosc. 2006;14:232-236.
18. Hunt KJ. Syndesmosis injuries. Curr Rev Musculoskelet Med. 2013;6:304-312.
19. Miller TL, Skalak T. Evaluation and treatment recommendations for acute injuries to the ankle syndesmosis without associated fracture. Sports Med. 2014;44:179-188.
20. Miller BS, Downie BK, Johnson PD, et al. Time to return to play after high ankle sprains in collegiate football players: a prediction model. Sports Health. 2012;4:504-509.
21. Wright RW, Barile RJ, Surprenant DA, et al. Ankle syndesmosis sprains in National Hockey League players. Am J Sports Med. 2016;32:1941-1945.
22. Osbahr DC, Drakos MC, O’Loughlin PF, et al. Syndesmosis and lateral ankle sprains in the National Football League. Orthopedics. 2013;36:e1378-e1384.
23. Taylor DC, Tenuta JJ, Uhorchak JM, et al. Aggressive surgical treatment and early return to sports in athletes with grade III syndesmosis sprains. Am J Sports Med. 2007;35:1133-1138.
24. Taylor DC, Englehardt DL, Bassett FH. Syndesmosis sprains of the ankle: the influence of heterotopic ossification. Am J Sports Med. 1992;20:146-150.
25. Laver L, Carmont MR, McConkey MO, et al. Plasma rich in growth factors (PRGF) as a treatment for high ankle sprain in elite athletes: a randomized control trial. Knee Surg Sports Traumatol Arthrosc. 2014;23:3383-3392.
26. Kaminski TW, Hertel J, Amendola N, et al. National Athletic Trainers’ Association position statement: conservative management and prevention of ankle sprains in athletes. J Athl Train. 2013;48:528-545.
27. Hupperets MDW, Verhagen EALM, van Mechelen W. Effect of unsupervised home based proprioceptive training on recurrences of ankle sprain: randomised controlled trial. BMJ. 2009;339:b2684.
28. Tropp H, Askling C, Gillquist J. Prevention of ankle sprains. Am J Sports Med. 1985;13:259-262.
29. McGuine TA, Brooks A, Hetzel S. The effect of lace-up ankle braces on injury rates in high school basketball players. Am J Sports Med. 2011;39:1840-1848.
30. McGuine TA, Hetzel S, Wilson J, et al. The effect of lace-up ankle braces on injury rates in high school football players. Am J Sports Med. 2012;40:49-57.
PRACTICE RECOMMENDATIONS
› Maintain a high level of suspicion for syndesmotic injury in any athlete describing an external rotation or hyper-dorsiflexion ankle injury. A
› Obtain weight-bearing anteroposterior- and mortise-view ankle x-rays in all cases of suspected syndesmotic injuries. A
› Consider stress x-rays of the affected ankle, contralateral ankle x-rays for comparison views, or advanced imaging with magnetic resonance imaging (MRI) or computed tomography if initial x-rays are unrevealing. A
› Treat stable syndesmotic injuries with conservative measures and rehabilitation. A
Strength of recommendation (SOR)
A Good-quality patient-oriented evidence
B Inconsistent or limited-quality patient-oriented evidence
C Consensus, usual practice, opinion, disease-oriented evidence, case series
It’s time to start asking all patients about intimate partner violence
Intimate partner violence (IPV) is a serious public health problem with considerable harmful health consequences. Decades of research have been dedicated to improving the identification of women in abusive heterosexual relationships and interventions that support healthier outcomes. A result of this work has been the recommendation of the US Preventive Services Task Force that all women of childbearing age be screened for IPV and provided with intervention or referral.1
The problem extends further, however: Epidemiologic studies and comprehensive reviews show: 1) a high rate of IPV victimization among heterosexual men and lesbian, gay, bisexual, and transsexual (LGBT) men and women2,3; 2) significant harmful effects on health and greater expectations of prejudice and discrimination among these populations4-6; and 3) evidence that screening and referral for IPV are likely to confer similar benefits for these populations.7 We argue that it is reasonable to ask all patients about abuse in their relationships while the research literature progresses.
We intend this article to serve a number of purposes:
- support national standards for IPV screening of female patients
- highlight the need for piloting universal IPV screening for all patients (ie, male and female, across the lifespan)
- offer recommendations for navigating the process from IPV screening to referral, using insights gained from the substance abuse literature.
We also provide supplemental materials that facilitate establishment of screening and referral protocols for physicians across practice settings.
What is intimate partner violence? How can you identify it?
Intimate partner violence includes physical and sexual violence and nonphysical forms of abuse, such as psychological aggression and emotional abuse, perpetrated by a current or former intimate partner.8 TABLE 19-14 provides definitions for each of these behavior categories and example behaviors. Nearly 25% of women and 20% of men report having experienced physical violence from a romantic partner and even higher rates of nonphysical IPV.15 Consequences of IPV victimization include acute and chronic medical illness, injury, and psychological problems, including depression, anxiety, and poor self-esteem.16
Intimate partner violence is heterogeneous, with differences in severity (eg, frequency and intensity of violence) and laterality (ie, is one partner violent? are both partners violent?). A recent comprehensive review of the literature revealed that, for 49.2%-69.7% of partner-violent couples across diverse samples, IPV is perpetrated by both partners.17 Furthermore, this bidirectionality is not due entirely to aggression perpetrated in self-defense; rather, across diverse patient samples, that is the case for fewer than one-quarter of males and no more than approximately one-third of females.18 In the remaining cases, bidirectionality may be attributed to other motivations, such as a maladaptive emotional expression or a means by which to get a partner’s attention.18
Women are disproportionately susceptible to harmful outcomes as a result of severe violence, including physical injury, psychological distress (eg, depression and anxiety), and substance abuse.16,19 Some patients in unidirectionally violent relationships experience severe physical violence that may be, or become, life-threatening (0.4%-2.4% of couples in community samples)20—victimization that is traditionally known as “battering.”21
Continue to: These tools can facilitate screening for IPV
These tools can facilitate screening for IPV
Physicians might have reservations asking about IPV because of 1) concern whether there is sufficient time during an office visit to interview, screen, and refer, 2) feelings of powerlessness to stop violence by or toward a patient, and 3) general discomfort with the topic.22 Additionally, mandated reporting laws regarding IPV vary by state, making it crucial to know one’s own state laws on this issue to protect the safety of the patient and those around them.
Research has shown that some patients prefer that their health care providers ask about relationship violence directly23; others are more willing to acknowledge IPV if asked using a paper-and-pencil measure, rather than face-to-face questions.24 Either way, screening increases the likelihood of engaging the patient in supportive services, thus decreasing the isolation that is typical of abuse.25 Based on this research, screening that utilizes face-valid items embedded within paperwork completed in the waiting room is recommended as an important first step toward identifying and helping patients who are experiencing IPV. Even under these conditions, however, heterosexual men and sexual minorities might be less willing than heterosexual women to admit experiencing IPV.26,27
A brief vignette that depicts how quickly the screening and referral process can be applied is presented in “IPV screening and referral: A real-world vignette." The vignette is a de-identified composite of heterosexual men experiencing IPV whom we have counseled.
SIDEBAR
IPV screening and referral: A real-world vignette
Physician: Before we wrap up: I noticed on your screening that you have been hurt and threatened a fair amount in the past year. Would it be OK if we spoke about that more?
Patient: My wife is emotional. Sometimes she gets really stressed out and just starts screaming and punching me. That’s just how she is.
Physician: Do you ever feel concerned for your safety?
Patient: Not really. She’s smaller than me and I can generally calm her down. I keep the guns locked up, so she can’t grab those any more. Mostly she just screams at me.
Physician: This may or may not fit with your perception but, based on what you are reporting, your relationship is what is called “at risk”—meaning you are at risk for having your physical or mental health negatively impacted. This actually happens to a lot of men, and there’s a brochure I can give you that has a lot more information about the risks and consequences of being hurt or threatened by a partner. Would you be willing to take a look at it?
Patient: I guess so.
Physician: OK. I’ll have the nurse bring you that brochure, and we can talk more about it next time you come in for an appointment. Would it be OK if we get you back in here 6 months from now?
Patient: Yeah, that could work.
Physician: Great. Let’s do that. Don’t hesitate to give me a call if your situation changes in any way in the meantime.
One model that provides a useful framework for IPV assessment is the Screening, Brief Intervention, and Referral to Treatment (SBIRT) model, which was developed to facilitate assessment of, and referral for, substance abuse—another heavily stigmatized health care problem. The SBIRT approach for substance abuse screening is associated with significant reduction in alcohol and drug abuse 6 months postintervention, as well as improvements in well-being, mental health, and functioning across gender, race and ethnicity, and age.28
IPASSPRT. Inspired by the SBIRT model for substance abuse, we created the Intimate Partner Aggression Screening, Safety Planning, and Referral to Treatment, or IPASSPRT (spoken as “i-passport”) project to provide tools that make IPV screening and referral accessible to a range of health care providers. These tools include a script and safety plan that guide providers through screening, safety planning, and referral in a manner that is collaborative and grounded in the spirit of motivational interviewing. We have made these tools available on the Web for ease of distribution (http://bit.ly/ipassprt; open by linking through “IPASSPRT-Script”).
Continue to: The IPASSPRT script appears lengthy...
The IPASSPRT script appears lengthy, but progress through its sections is directed by patient need; most patients will not require that all parts be completed. For example, a patient whose screen for IPV is negative and who feels safe in their relationship does not need assessment beyond page 2; on the other hand, the physician might need more information from a patient who is at greater risk for IPV. This response-based progression through the script makes the screening process dynamic, data-driven, and tailored to the patient’s needs—an approach that aids rapport and optimizes the physician’s limited time during the appointment.
In the sections that follow, we describe key components of this script.
What aggression, if any, is present? From whom? The Hurt, Insult, Threaten, and Scream inventory (HITS) (TABLE 2)29 is a widely used screen for IPV that has been validated for use in family medicine. A 4-item scale asks patients to report how often their partner physically hurts, insults, threatens, and screams at them using a 5-point scale (1 point, “never,” to 5 points, “frequently”). Although a score > 10 is indicative of IPV, item-level analysis is encouraged. Attending to which items the patient acknowledges and how often these behaviors occur yields a richer assessment than a summary score. In regard to simply asking a patient, “Do you feel safe at home?” (sensitivity of this question, 8.8%; specificity, 91.2%), the HITS better detects IPV with male and female patient populations in family practice and emergency care settings (sensitivity, 30%-100%; specificity, 86%-99%).27,30
What contextual factors and related concerns are present? It is important to understand proximal factors that might influence IPV risk to determine what kind of referral or treatment is appropriate—particularly for patients experiencing or engaging in infrequent, noninjurious, and bidirectional forms of IPV. Environmental and contextual stressors, such as financial hardship, unemployment, pregnancy, and discussion of divorce, can increase the risk for IPV.31,32 Situational influences, such as alcohol and drug intoxication, can also increase the risk for IPV. Victims of partner violence are at greater risk for mental health problems, including depression, anxiety, trauma- and stressor-related disorders, and substance use disorders. Risk goes both ways, however: Mental illness predicts subsequent IPV perpetration or victimization, and vice versa.31
Does the patient feel safe? Assessing the situation. Patient perception of safety in the relationship provides important information about the necessity of referral. Asking a patient if they feel unsafe because of the behavior of a current or former partner sheds light on the need for further safety assessment and immediate connection with appropriate resources.
Continue to: The Danger Assessment-5...
The Danger Assessment-5 (DA-5) (TABLE 333) is a useful 5-item tool for quickly assessing the risk for severe IPV.33 Patients respond to whether:
- the frequency or severity of violence has increased in the past year
- the partner has ever used, or threatened to use, a weapon
- the patient believes the partner is capable of killing her (him)
- the partner has ever tried to choke or strangle her (him)
- the partner is violently and constantly jealous.
Sensitivity and specificity analyses with a high-risk female sample suggested that 3 affirmative responses indicate a high risk for severe IPV and a need for adequate safety planning.
Brief motivational enhancement intervention. There are 3 components to this intervention.
- Assess interest in making changes or seeking help. IPV is paradoxical: Many factors complicate the decision to leave or stay, and patients across the spectrum of victimization might have some motivation to stay with their partner. It is important to assess the patient’s motivation to make changes in their relationship.4,34
- Provide feedback on screening. Sharing the results of screening with patients makes the assessment and referral process collaborative and transparent; collaborative engagement helps patients feel in control and invested in the follow-through.35 In the spirit of this endeavor, physicians are encouraged to refrain from providing raw or total scores from the measures; instead, share the interpretation of those scores, based on the participant’s responses to the screening items, in a matter-of-fact manner. At this point, elicit the patient’s response to this information, listen empathically, and answer questions before proceeding.
Consistent with screening for other serious health problems, we recommend that all patients be provided with information about abuse in romantic relationships. The National Center for Injury Prevention and Control Division of Violence Prevention has published a useful, easy-to-understand fact sheet (www.cdc.gov/violenceprevention/pdf/ipv-factsheet.pdf) that provides an overview of IPV-related behavior, how it influences health outcomes, who is at risk for IPV, and sources for support.
Continue to: Our IPASSPRT interview script...
Our IPASSPRT interview script (http://bit.ly/ipassprt) outlines how this information can be presented to patients as a typical part of the screening process. Providers are encouraged to share and review the information from the fact sheet with all patients and present it as part of the normal screening process to mitigate the potential for defensiveness on the part of the patient. For patients who screen positive for IPV, it might be important to brainstorm ideas for a safe, secure place to store this fact sheet and other resources from the brief intervention and referral process below (eg, a safety plan and specific referral information) so that the patient can access them quickly and easily, if needed.
For patients who screen negative for IPV, their screen and interview conclude at this point.
- Provide recommendations based on the screen. Evidence suggests that collaborating with the patient on safety planning and referral can increase the likelihood of their engagement.7 Furthermore, failure to tailor the referral to the needs of the patient can be detrimental36—ie, overshooting the level of intervention might decrease the patient’s future treatment-seeking behavior and undermine their internal coping strategies, increasing the likelihood of future victimization. For that reason, we provide the following guidance on navigating the referral process for patients who screen positive for IPV.
Screening-based referral: A delicate and collaborative process
Referral for IPV victimization. Individual counseling, with or without an IPV focus, might be appropriate for patients at lower levels of risk; immediate connection with local IPV resources is strongly encouraged for patients at higher risk. This is a delicate, collaborative process, in which the physician offers recommendations for referral commensurate to the patient’s risk but must, ultimately, respect the patient’s autonomy by identifying referrals that fit the patient’s goals. We encourage providers to provide risk-informed recommendations and to elicit the patient’s thoughts about that information.
Several online resources are available to help physicians locate and connect with IPV-related resources in their community, including the National Health Resource Center on Domestic Violence (http://ipvhealth.org/), which provides a step-by-step guide to making such connections. We encourage physicians to develop these collaborative partnerships early to facilitate warm handoffs and increase the likelihood that a patient will follow through with the referral after screening.37
Referral for related concerns. As we’ve noted, IPV has numerous physical and mental health consequences, including depression, low self-esteem, trauma- and non-trauma-related anxiety, and substance abuse. In general, cognitive behavioral therapies appear most efficacious for treating these IPV-related consequences, but evidence is limited that such interventions diminish the likelihood of re-victimization.38 Intervention programs that foster problem-solving, solution-seeking, and cognitive restructuring for self-critical thoughts and misconceptions seem to produce the best physical and mental health outcomes.39 For patients who have a substance use disorder, treatment programs that target substance use have demonstrated a reduction in the rate of IPV recidivism.40 These findings indicate that establishing multiple treatment targets might reduce the risk for future aggression in relationships.
Continue to: The Substance Abuse and Mental Health Services Administration...
The Substance Abuse and Mental Health Services Administration of the US Department of Health and Human Services provides a useful online tool (https://findtreatment.samhsa.gov/) for locating local referrals that address behavioral health and substance-related concerns. The agency also provides a hotline (1-800-662-HELP [4357]) as an alternative resource for information and treatment referrals.
Safety planning can improve outcomes
For a patient who screens above low risk, safety planning with the patient is an important part of improving outcomes and can take several forms. Online resources, such as the Path to Safety interactive Web page (www.thehotline.org/help/path-to-safety/) maintained by The National Domestic Violence Hotline ([800]799-SAFE [7233]), provide information regarding important considerations for safety planning when:
- living with an abusive partner
- children are in the home
- the patient is pregnant
- pets are involved.
The Web site also provides information regarding legal options and resources related to IPV (eg, an order of protection) and steps for improving safety when leaving an abusive relationship. Patients at risk for IPV can explore the online tool and call the hotline.
For physicians who want to engage in provider-assisted safety planning, we’ve provided further guidance in the IPASSPRT screening script and safety plan (http://bit.ly/ipassprt) (TABLE 4).
Goal: Affirm patients’ strengths and reinforce hope
Psychological aggression is the most common form of relationship aggression; repeated denigration might leave a person with little confidence in their ability to change their relationship or seek out identified resources. That’s why it’s useful to inquire—with genuine curiosity—about a time in the past when the patient accomplished something challenging. The physician’s enthusiastic reflection on this achievement can be a means of highlighting the patient’s ability to accomplish a meaningful goal; of reinforcing their hope; and of eliciting important resources within and around the patient that can facilitate action on their safety plan. (See “IPV-related resources for physicians and patients.”)
SIDEBAR
IPV-related resources for physicians and patients
Intimate Partner Aggression Screening, Safety Planning, and Referral to Treatment (IPASSPRT) Project
› http://bit.ly/ipassprt
Online resource with tools designed by the authors, including an SBIRT-inspired script and safety plan template for IPV screening, safety planning, and referral
National Center for Injury Prevention and Control Division of Violence Prevention
› www.cdc.gov/violenceprevention/pdf/ipv-factsheet.pdf
Overview of IPV-related behavior, influence on health outcomes, people at risk of IPV, and sources of support, all in a format easily understood by patients
National Health Resource Center on Domestic Violence
› http://ipvhealth.org/
Includes guidance on connecting with IPV-related community resources; establishing such connections can facilitate warm handoffs and improve the likelihood that patients will follow through
Path to Safety, a service of The National Domestic Violence Hotline
› www.thehotline.org/help/path-to-safety/
Extensive primer on safety plans for patients intending to stay in (or leave) an abusive relationship; includes important considerations for children, pets, and pregnancy, as well as emotional safety and legal options
The National Domestic Violence Hotline
› (800) 799-SAFE (7233)
Substance Abuse and Mental Health Services Administration
› www.samhsa.gov/sbirt
Learning resources for the SBIRT protocol for substance abuse
› https://findtreatment.samhsa.gov/
Search engine and resources for locating local referrals
› (800) 662-HELP (4357)
Hotline for information and assistance with locating local treatment referral
IPV, intimate partner violence; SBIRT, screening, brief intervention, and referral to treatment.
Continue to: Closing the screen and making a referral
Closing the screen and making a referral
The end of the interview should consist of a summary of topics discussed, including:
- changes that the patient wants to make (if any)
- their stated reasons for making those changes
- the patient’s plan for accomplishing changes.
Physicians should also include their own role in next steps—whether providing a warm handoff to a local IPV referral, agreeing to a follow-up schedule with the patient, or making a call as a mandated reporter. To close out the interview, it is important to affirm respect for the patient’s autonomy in executing the plan.
It’s important to screen all patients—here’s why
A major impetus for this article has been to raise awareness about the need for expanded IPV screening across primary care settings. As mentioned, much of the literature on IPV victimization has focused on women; however, the few epidemiological investigations of victimization rates among men and members of LGBT couples show a high rate of victimization and considerable harmful health outcomes. Driven by stigma surrounding IPV, sex, and sexual minority status, patients might have expectations that they will be judged by a provider or “outed.”
Such barriers can lead many to suffer in silence until the problem can no longer be hidden or the danger becomes more emergent. Compassionate, nonjudgmental screening and collaborative safety planning—such as the approach we describe in this article—help ease the concerns of LGBT victims of IPV and improve the likelihood that conversations you have with them will occur earlier, rather than later, in care.*
Underassessment of IPV (ie, underreporting as well as under-inquiry) because of stigma, misconception, and other factors obscures an accurate estimate of the rate of partner violence and its consequences for all couples. As a consequence, we know little about the dynamics of IPV, best practices for screening, and appropriate referral for couples from these populations. Furthermore, few resources are available to these understudied and underserved groups (eg, shelters for men and for transgender people).
Continue to: Although our immediate approach to IPV screening...
Although our immediate approach to IPV screening, safety planning, and referral with understudied patient populations might be informed by what we have learned from the experiences of heterosexual women in abusive relationships, such a practice is unsustainable. Unless we expand our scope of screening to all patients, it is unlikely that we will develop the evidence base necessary to 1) warrant stronger IPV screening recommendations for patient groups apart from women of childbearing age, let alone 2) demonstrate the need for additional community resources, and 3) provide comprehensive care in family practice of comparable quality.
The benefits of screening go beyond the individual patient
Screening for violence in the relationship does not take long; the value of asking about its presence in a relationship might offer benefits beyond the individual patient by raising awareness and providing the field of study with more data to increase attention and resources for under-researched and underserved populations. Screening might also combat the stigma that perpetuates the silence of many who deserve access to care.
CORRESPONDENCE
Joel G. Sprunger, PhD, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 260 Stetson St, Suite 3200, Cincinnati OH 45219; [email protected].
ACKNOWLEDGMENTS
The authors thank Jeffrey M. Girard, PhD, and Daniel C. Williams, PhD, for their input on the design and content, respectively, of the IPASSPRT screening materials; the authors of the DA-5 and the HITS screening tools, particularly Jacquelyn Campbell, PhD, RN, FAAN, and Kevin Sherin, MD, MPH, MBA, respectively, for permission to include these measures in this article and for their support of its goals; and The Journal of Family Practice’s peer reviewers for their thoughtful feedback throughout the prepublication process.
1. Campos-Outcalt D. USPSTF: What’s recommended, what’s not. J Fam Pract. 2014;63:265-269.
2. Black MC, Basile KC, Breiding MJ, et al. National Intimate Partner and Sexual Violence Survey: 2010 Summary Report. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2011:113. www.cdc.gov/violenceprevention/pdf/NISVS_Report2010-a.pdf. Accessed February 20, 2019.
3. West CM. Partner abuse in ethnic minority and gay, lesbian, bisexual, and transgender populations. Partner Abuse. 2012;3:336-357.
4. Hines DA, Malley-Morrison K. Psychological effects of partner abuse against men: a neglected research area. Psychology of Men & Masculinities. 2001;2:75-85.
5. Houston E, McKirnan DJ. Intimate partner abuse among gay and bisexual men: risk correlates and health outcomes. J Urban Health. 2007;84:681-690.
6. Carvalho AF, Lewis RJ, Derlega VJ, et al. Internalized sexual minority stressors and same-sex intimate partner violence. J Fam Violence. 2011;26:501-509.
7. Nicholls TL, Pritchard MM, Reeves KA, et al. Risk assessment in intimate partner violence: a systematic review of contemporary approaches. Partner Abuse. 2013;4:76-168.
8. Intimate partner violence: definitions. Atlanta, GA: National Center for Injury Prevention and Control, Division of Violence Prevention, Centers for Disease Control and Prevention, August 22, 2017. www.cdc.gov/violenceprevention/intimatepartnerviolence/definitions.html. Accessed February 20, 2019.
9. Archer J. Sex differences in aggression between heterosexual partners: a meta-analytic review. Psychol Bull. 2000;126:651-680.
10. Baron RA, Richardson DR. Human Aggression. New York, NY: Springer Science+Business Media; 2004.
11. Breiding MJ, Basile KC, Smith SG, et al. Intimate Partner Violence Surveillance: Uniform Definitions and Recommended Data Elements, Version 2.0. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2015.
12. Murphy CM, Eckhardt CI. Treating the Abusive Partner: An Individualized Cognitive-Behavioral Approach. New York, NY: Guilford Press; 2005.
13. Straus MA, Hamby SL, Boney-McCoy S, et al. The revised Conflict Tactics Scales (CTS2): development and preliminary psychometric data. J Fam Issues. 1996;17:283-316.
14. West CM. Partner abuse in ethnic minority and gay, lesbian, bisexual, and transgender populations. Partner Abuse. 2012;3:336-357.
15. Desmarais SL, Reeves KA, Nicholls TL, et al. Prevalence of physical violence in intimate relationships. Part 1: rates of male and female victimization. Partner Abuse. 2012;3:140-169.
16. Lawrence E, Orengo-Aguayo R, Langer A, et al. The impact and consequences of partner abuse on partners. Partner Abuse. 2012;3:406-428.
17. Langhinrichsen-Rohling J, Selwyn C, Rohling ML. Rates of bidirectional versus unidirectional intimate partner violence across samples, sexual orientations, and race/ethnicities: a comprehensive review. Partner Abuse. 2012;3:199-230.
18. Langhinrichsen-Rohling J, McCullars A, Misra TA. Motivations for men and women’s intimate partner violence perpetration: a comprehensive review. Partner Abuse. 2012;3:429-468.
19. Anderson CA, Bushman BJ. Human aggression. Annu Rev Psychol. 2002;53:27-51.
20. Straus MA, Gozjolko KL. “Intimate terrorism” and gender differences in injury of dating partners by male and female university students. J Fam Violence. 2014;29:51-65.
21. Ferraro KJ, Johnson JM. How women experience battering: the process of victimization. Soc Probl. 1983;30:325-339.
22. Sugg NK, Inui T. Primary care physicians’ response to domestic violence: opening Pandora’s box. JAMA. 1992;267:3157-3160.
23. Morgan KJ, Williamson E, Hester M, et al. Asking men about domestic violence and abuse in a family medicine context: help seeking and views on the general practitioner role. Aggress Violent Behav. 2014;19:637-642.
24. MacMillan HL, Wathen CN, Jamieson E, et al; McMaster Violence Against Women Research Group. Approaches to screening for intimate partner violence in health care settings: a randomized trial. JAMA. 2006;296:530-536.
25. Thompson RS, Rivara FP, Thompson DC, et al. Identification and management of domestic violence: a randomized trial. Am J Prev Med. 2000;19:253-263.
26. Ard KL, Makadon HJ. Addressing intimate partner violence in lesbian, gay, bisexual, and transgender patients. J Gen Intern Med. 2011;26:930-933.
27. Rabin RF, Jennings JM, Campbell JC, et al. Intimate partner violence screening tools: a systematic review. Am J Prev Med. 2009;36:439-445.e4.
28. Madras BK, Compton WM, Avula D, et al. Screening, brief interventions, referral to treatment (SBIRT) for illicit drug and alcohol use at multiple healthcare sites: comparison at intake and 6 months later. Drug Alcohol Depend. 2009;99:280-295.
29. Sherin KM, Sinacore JM, Li XQ, et al. HITS: A short domestic violence screening tool for use in a family practice setting. Fam Med. 1998;30:508-512.
30. Peralta RL, Fleming MF. Screening for intimate partner violence in a primary care setting: the validity of “feeling safe at home” and prevalence results. J Am Board Fam Pract. 2003;16:525-532.
31. Capaldi DM, Knoble NB, Shortt JW, et al. A systematic review of risk factors for intimate partner violence. Partner Abuse. 2012;3:231-280.
32. Brownridge DA, Taillieu TL, Tyler KA, et al. Pregnancy and intimate partner violence: risk factors, severity, and health effects. Violence Against Women. 2011;17:858-881.
33. Messing JT, Campbell JC, Snider C. Validation and adaptation of the danger assessment-5: a brief intimate partner violence risk assessment. J Adv Nurs. 2017;73:3220-3230.
34. Grigsby N, Hartman BR. The Barriers Model: an integrated strategy for intervention with battered women. Psychotherapy: Theory, Research, Practice, Training. 1997;34:485-497.
35. Moyers TB, Rollnick S. A motivational interviewing perspective on resistance in psychotherapy. J Clin Psychol. 2002;58:185-193.
36. Belfrage H, Strand S, Storey JE, et al. Assessment and management of risk for intimate partner violence by police officers using the Spousal Assault Risk Assessment Guide. Law Hum Behav. 2012;36:60-67.
37. McCloskey LA, Lichter E, Williams C, et al. Assessing intimate partner violence in health care settings leads to women’s receipt of interventions and improved health. Publ Health Rep. 2006;121:435-444.
38. Eckhardt CI, Murphy CM, Whitaker DJ, et al. The effectiveness of intervention programs for perpetrators and victims of intimate partner violence. Partner Abuse. 2013;4:196-231.
39. Trabold N, McMahon J, Alsobrooks S, et al. A systematic review of intimate partner violence interventions: state of the field and implications for practitioners. Trauma Violence Abuse. January 2018:1524838018767934.
40. Kraanen FL, Vedel E, Scholing A, et al. The comparative effectiveness of Integrated treatment for Substance abuse and Partner violence (I-StoP) and substance abuse treatment alone: a randomized controlled trial. BMC Psychiatry. 2013;13:189.
Intimate partner violence (IPV) is a serious public health problem with considerable harmful health consequences. Decades of research have been dedicated to improving the identification of women in abusive heterosexual relationships and interventions that support healthier outcomes. A result of this work has been the recommendation of the US Preventive Services Task Force that all women of childbearing age be screened for IPV and provided with intervention or referral.1
The problem extends further, however: Epidemiologic studies and comprehensive reviews show: 1) a high rate of IPV victimization among heterosexual men and lesbian, gay, bisexual, and transsexual (LGBT) men and women2,3; 2) significant harmful effects on health and greater expectations of prejudice and discrimination among these populations4-6; and 3) evidence that screening and referral for IPV are likely to confer similar benefits for these populations.7 We argue that it is reasonable to ask all patients about abuse in their relationships while the research literature progresses.
We intend this article to serve a number of purposes:
- support national standards for IPV screening of female patients
- highlight the need for piloting universal IPV screening for all patients (ie, male and female, across the lifespan)
- offer recommendations for navigating the process from IPV screening to referral, using insights gained from the substance abuse literature.
We also provide supplemental materials that facilitate establishment of screening and referral protocols for physicians across practice settings.
What is intimate partner violence? How can you identify it?
Intimate partner violence includes physical and sexual violence and nonphysical forms of abuse, such as psychological aggression and emotional abuse, perpetrated by a current or former intimate partner.8 TABLE 19-14 provides definitions for each of these behavior categories and example behaviors. Nearly 25% of women and 20% of men report having experienced physical violence from a romantic partner and even higher rates of nonphysical IPV.15 Consequences of IPV victimization include acute and chronic medical illness, injury, and psychological problems, including depression, anxiety, and poor self-esteem.16
Intimate partner violence is heterogeneous, with differences in severity (eg, frequency and intensity of violence) and laterality (ie, is one partner violent? are both partners violent?). A recent comprehensive review of the literature revealed that, for 49.2%-69.7% of partner-violent couples across diverse samples, IPV is perpetrated by both partners.17 Furthermore, this bidirectionality is not due entirely to aggression perpetrated in self-defense; rather, across diverse patient samples, that is the case for fewer than one-quarter of males and no more than approximately one-third of females.18 In the remaining cases, bidirectionality may be attributed to other motivations, such as a maladaptive emotional expression or a means by which to get a partner’s attention.18
Women are disproportionately susceptible to harmful outcomes as a result of severe violence, including physical injury, psychological distress (eg, depression and anxiety), and substance abuse.16,19 Some patients in unidirectionally violent relationships experience severe physical violence that may be, or become, life-threatening (0.4%-2.4% of couples in community samples)20—victimization that is traditionally known as “battering.”21
Continue to: These tools can facilitate screening for IPV
These tools can facilitate screening for IPV
Physicians might have reservations asking about IPV because of 1) concern whether there is sufficient time during an office visit to interview, screen, and refer, 2) feelings of powerlessness to stop violence by or toward a patient, and 3) general discomfort with the topic.22 Additionally, mandated reporting laws regarding IPV vary by state, making it crucial to know one’s own state laws on this issue to protect the safety of the patient and those around them.
Research has shown that some patients prefer that their health care providers ask about relationship violence directly23; others are more willing to acknowledge IPV if asked using a paper-and-pencil measure, rather than face-to-face questions.24 Either way, screening increases the likelihood of engaging the patient in supportive services, thus decreasing the isolation that is typical of abuse.25 Based on this research, screening that utilizes face-valid items embedded within paperwork completed in the waiting room is recommended as an important first step toward identifying and helping patients who are experiencing IPV. Even under these conditions, however, heterosexual men and sexual minorities might be less willing than heterosexual women to admit experiencing IPV.26,27
A brief vignette that depicts how quickly the screening and referral process can be applied is presented in “IPV screening and referral: A real-world vignette." The vignette is a de-identified composite of heterosexual men experiencing IPV whom we have counseled.
SIDEBAR
IPV screening and referral: A real-world vignette
Physician: Before we wrap up: I noticed on your screening that you have been hurt and threatened a fair amount in the past year. Would it be OK if we spoke about that more?
Patient: My wife is emotional. Sometimes she gets really stressed out and just starts screaming and punching me. That’s just how she is.
Physician: Do you ever feel concerned for your safety?
Patient: Not really. She’s smaller than me and I can generally calm her down. I keep the guns locked up, so she can’t grab those any more. Mostly she just screams at me.
Physician: This may or may not fit with your perception but, based on what you are reporting, your relationship is what is called “at risk”—meaning you are at risk for having your physical or mental health negatively impacted. This actually happens to a lot of men, and there’s a brochure I can give you that has a lot more information about the risks and consequences of being hurt or threatened by a partner. Would you be willing to take a look at it?
Patient: I guess so.
Physician: OK. I’ll have the nurse bring you that brochure, and we can talk more about it next time you come in for an appointment. Would it be OK if we get you back in here 6 months from now?
Patient: Yeah, that could work.
Physician: Great. Let’s do that. Don’t hesitate to give me a call if your situation changes in any way in the meantime.
One model that provides a useful framework for IPV assessment is the Screening, Brief Intervention, and Referral to Treatment (SBIRT) model, which was developed to facilitate assessment of, and referral for, substance abuse—another heavily stigmatized health care problem. The SBIRT approach for substance abuse screening is associated with significant reduction in alcohol and drug abuse 6 months postintervention, as well as improvements in well-being, mental health, and functioning across gender, race and ethnicity, and age.28
IPASSPRT. Inspired by the SBIRT model for substance abuse, we created the Intimate Partner Aggression Screening, Safety Planning, and Referral to Treatment, or IPASSPRT (spoken as “i-passport”) project to provide tools that make IPV screening and referral accessible to a range of health care providers. These tools include a script and safety plan that guide providers through screening, safety planning, and referral in a manner that is collaborative and grounded in the spirit of motivational interviewing. We have made these tools available on the Web for ease of distribution (http://bit.ly/ipassprt; open by linking through “IPASSPRT-Script”).
Continue to: The IPASSPRT script appears lengthy...
The IPASSPRT script appears lengthy, but progress through its sections is directed by patient need; most patients will not require that all parts be completed. For example, a patient whose screen for IPV is negative and who feels safe in their relationship does not need assessment beyond page 2; on the other hand, the physician might need more information from a patient who is at greater risk for IPV. This response-based progression through the script makes the screening process dynamic, data-driven, and tailored to the patient’s needs—an approach that aids rapport and optimizes the physician’s limited time during the appointment.
In the sections that follow, we describe key components of this script.
What aggression, if any, is present? From whom? The Hurt, Insult, Threaten, and Scream inventory (HITS) (TABLE 2)29 is a widely used screen for IPV that has been validated for use in family medicine. A 4-item scale asks patients to report how often their partner physically hurts, insults, threatens, and screams at them using a 5-point scale (1 point, “never,” to 5 points, “frequently”). Although a score > 10 is indicative of IPV, item-level analysis is encouraged. Attending to which items the patient acknowledges and how often these behaviors occur yields a richer assessment than a summary score. In regard to simply asking a patient, “Do you feel safe at home?” (sensitivity of this question, 8.8%; specificity, 91.2%), the HITS better detects IPV with male and female patient populations in family practice and emergency care settings (sensitivity, 30%-100%; specificity, 86%-99%).27,30
What contextual factors and related concerns are present? It is important to understand proximal factors that might influence IPV risk to determine what kind of referral or treatment is appropriate—particularly for patients experiencing or engaging in infrequent, noninjurious, and bidirectional forms of IPV. Environmental and contextual stressors, such as financial hardship, unemployment, pregnancy, and discussion of divorce, can increase the risk for IPV.31,32 Situational influences, such as alcohol and drug intoxication, can also increase the risk for IPV. Victims of partner violence are at greater risk for mental health problems, including depression, anxiety, trauma- and stressor-related disorders, and substance use disorders. Risk goes both ways, however: Mental illness predicts subsequent IPV perpetration or victimization, and vice versa.31
Does the patient feel safe? Assessing the situation. Patient perception of safety in the relationship provides important information about the necessity of referral. Asking a patient if they feel unsafe because of the behavior of a current or former partner sheds light on the need for further safety assessment and immediate connection with appropriate resources.
Continue to: The Danger Assessment-5...
The Danger Assessment-5 (DA-5) (TABLE 333) is a useful 5-item tool for quickly assessing the risk for severe IPV.33 Patients respond to whether:
- the frequency or severity of violence has increased in the past year
- the partner has ever used, or threatened to use, a weapon
- the patient believes the partner is capable of killing her (him)
- the partner has ever tried to choke or strangle her (him)
- the partner is violently and constantly jealous.
Sensitivity and specificity analyses with a high-risk female sample suggested that 3 affirmative responses indicate a high risk for severe IPV and a need for adequate safety planning.
Brief motivational enhancement intervention. There are 3 components to this intervention.
- Assess interest in making changes or seeking help. IPV is paradoxical: Many factors complicate the decision to leave or stay, and patients across the spectrum of victimization might have some motivation to stay with their partner. It is important to assess the patient’s motivation to make changes in their relationship.4,34
- Provide feedback on screening. Sharing the results of screening with patients makes the assessment and referral process collaborative and transparent; collaborative engagement helps patients feel in control and invested in the follow-through.35 In the spirit of this endeavor, physicians are encouraged to refrain from providing raw or total scores from the measures; instead, share the interpretation of those scores, based on the participant’s responses to the screening items, in a matter-of-fact manner. At this point, elicit the patient’s response to this information, listen empathically, and answer questions before proceeding.
Consistent with screening for other serious health problems, we recommend that all patients be provided with information about abuse in romantic relationships. The National Center for Injury Prevention and Control Division of Violence Prevention has published a useful, easy-to-understand fact sheet (www.cdc.gov/violenceprevention/pdf/ipv-factsheet.pdf) that provides an overview of IPV-related behavior, how it influences health outcomes, who is at risk for IPV, and sources for support.
Continue to: Our IPASSPRT interview script...
Our IPASSPRT interview script (http://bit.ly/ipassprt) outlines how this information can be presented to patients as a typical part of the screening process. Providers are encouraged to share and review the information from the fact sheet with all patients and present it as part of the normal screening process to mitigate the potential for defensiveness on the part of the patient. For patients who screen positive for IPV, it might be important to brainstorm ideas for a safe, secure place to store this fact sheet and other resources from the brief intervention and referral process below (eg, a safety plan and specific referral information) so that the patient can access them quickly and easily, if needed.
For patients who screen negative for IPV, their screen and interview conclude at this point.
- Provide recommendations based on the screen. Evidence suggests that collaborating with the patient on safety planning and referral can increase the likelihood of their engagement.7 Furthermore, failure to tailor the referral to the needs of the patient can be detrimental36—ie, overshooting the level of intervention might decrease the patient’s future treatment-seeking behavior and undermine their internal coping strategies, increasing the likelihood of future victimization. For that reason, we provide the following guidance on navigating the referral process for patients who screen positive for IPV.
Screening-based referral: A delicate and collaborative process
Referral for IPV victimization. Individual counseling, with or without an IPV focus, might be appropriate for patients at lower levels of risk; immediate connection with local IPV resources is strongly encouraged for patients at higher risk. This is a delicate, collaborative process, in which the physician offers recommendations for referral commensurate to the patient’s risk but must, ultimately, respect the patient’s autonomy by identifying referrals that fit the patient’s goals. We encourage providers to provide risk-informed recommendations and to elicit the patient’s thoughts about that information.
Several online resources are available to help physicians locate and connect with IPV-related resources in their community, including the National Health Resource Center on Domestic Violence (http://ipvhealth.org/), which provides a step-by-step guide to making such connections. We encourage physicians to develop these collaborative partnerships early to facilitate warm handoffs and increase the likelihood that a patient will follow through with the referral after screening.37
Referral for related concerns. As we’ve noted, IPV has numerous physical and mental health consequences, including depression, low self-esteem, trauma- and non-trauma-related anxiety, and substance abuse. In general, cognitive behavioral therapies appear most efficacious for treating these IPV-related consequences, but evidence is limited that such interventions diminish the likelihood of re-victimization.38 Intervention programs that foster problem-solving, solution-seeking, and cognitive restructuring for self-critical thoughts and misconceptions seem to produce the best physical and mental health outcomes.39 For patients who have a substance use disorder, treatment programs that target substance use have demonstrated a reduction in the rate of IPV recidivism.40 These findings indicate that establishing multiple treatment targets might reduce the risk for future aggression in relationships.
Continue to: The Substance Abuse and Mental Health Services Administration...
The Substance Abuse and Mental Health Services Administration of the US Department of Health and Human Services provides a useful online tool (https://findtreatment.samhsa.gov/) for locating local referrals that address behavioral health and substance-related concerns. The agency also provides a hotline (1-800-662-HELP [4357]) as an alternative resource for information and treatment referrals.
Safety planning can improve outcomes
For a patient who screens above low risk, safety planning with the patient is an important part of improving outcomes and can take several forms. Online resources, such as the Path to Safety interactive Web page (www.thehotline.org/help/path-to-safety/) maintained by The National Domestic Violence Hotline ([800]799-SAFE [7233]), provide information regarding important considerations for safety planning when:
- living with an abusive partner
- children are in the home
- the patient is pregnant
- pets are involved.
The Web site also provides information regarding legal options and resources related to IPV (eg, an order of protection) and steps for improving safety when leaving an abusive relationship. Patients at risk for IPV can explore the online tool and call the hotline.
For physicians who want to engage in provider-assisted safety planning, we’ve provided further guidance in the IPASSPRT screening script and safety plan (http://bit.ly/ipassprt) (TABLE 4).
Goal: Affirm patients’ strengths and reinforce hope
Psychological aggression is the most common form of relationship aggression; repeated denigration might leave a person with little confidence in their ability to change their relationship or seek out identified resources. That’s why it’s useful to inquire—with genuine curiosity—about a time in the past when the patient accomplished something challenging. The physician’s enthusiastic reflection on this achievement can be a means of highlighting the patient’s ability to accomplish a meaningful goal; of reinforcing their hope; and of eliciting important resources within and around the patient that can facilitate action on their safety plan. (See “IPV-related resources for physicians and patients.”)
SIDEBAR
IPV-related resources for physicians and patients
Intimate Partner Aggression Screening, Safety Planning, and Referral to Treatment (IPASSPRT) Project
› http://bit.ly/ipassprt
Online resource with tools designed by the authors, including an SBIRT-inspired script and safety plan template for IPV screening, safety planning, and referral
National Center for Injury Prevention and Control Division of Violence Prevention
› www.cdc.gov/violenceprevention/pdf/ipv-factsheet.pdf
Overview of IPV-related behavior, influence on health outcomes, people at risk of IPV, and sources of support, all in a format easily understood by patients
National Health Resource Center on Domestic Violence
› http://ipvhealth.org/
Includes guidance on connecting with IPV-related community resources; establishing such connections can facilitate warm handoffs and improve the likelihood that patients will follow through
Path to Safety, a service of The National Domestic Violence Hotline
› www.thehotline.org/help/path-to-safety/
Extensive primer on safety plans for patients intending to stay in (or leave) an abusive relationship; includes important considerations for children, pets, and pregnancy, as well as emotional safety and legal options
The National Domestic Violence Hotline
› (800) 799-SAFE (7233)
Substance Abuse and Mental Health Services Administration
› www.samhsa.gov/sbirt
Learning resources for the SBIRT protocol for substance abuse
› https://findtreatment.samhsa.gov/
Search engine and resources for locating local referrals
› (800) 662-HELP (4357)
Hotline for information and assistance with locating local treatment referral
IPV, intimate partner violence; SBIRT, screening, brief intervention, and referral to treatment.
Continue to: Closing the screen and making a referral
Closing the screen and making a referral
The end of the interview should consist of a summary of topics discussed, including:
- changes that the patient wants to make (if any)
- their stated reasons for making those changes
- the patient’s plan for accomplishing changes.
Physicians should also include their own role in next steps—whether providing a warm handoff to a local IPV referral, agreeing to a follow-up schedule with the patient, or making a call as a mandated reporter. To close out the interview, it is important to affirm respect for the patient’s autonomy in executing the plan.
It’s important to screen all patients—here’s why
A major impetus for this article has been to raise awareness about the need for expanded IPV screening across primary care settings. As mentioned, much of the literature on IPV victimization has focused on women; however, the few epidemiological investigations of victimization rates among men and members of LGBT couples show a high rate of victimization and considerable harmful health outcomes. Driven by stigma surrounding IPV, sex, and sexual minority status, patients might have expectations that they will be judged by a provider or “outed.”
Such barriers can lead many to suffer in silence until the problem can no longer be hidden or the danger becomes more emergent. Compassionate, nonjudgmental screening and collaborative safety planning—such as the approach we describe in this article—help ease the concerns of LGBT victims of IPV and improve the likelihood that conversations you have with them will occur earlier, rather than later, in care.*
Underassessment of IPV (ie, underreporting as well as under-inquiry) because of stigma, misconception, and other factors obscures an accurate estimate of the rate of partner violence and its consequences for all couples. As a consequence, we know little about the dynamics of IPV, best practices for screening, and appropriate referral for couples from these populations. Furthermore, few resources are available to these understudied and underserved groups (eg, shelters for men and for transgender people).
Continue to: Although our immediate approach to IPV screening...
Although our immediate approach to IPV screening, safety planning, and referral with understudied patient populations might be informed by what we have learned from the experiences of heterosexual women in abusive relationships, such a practice is unsustainable. Unless we expand our scope of screening to all patients, it is unlikely that we will develop the evidence base necessary to 1) warrant stronger IPV screening recommendations for patient groups apart from women of childbearing age, let alone 2) demonstrate the need for additional community resources, and 3) provide comprehensive care in family practice of comparable quality.
The benefits of screening go beyond the individual patient
Screening for violence in the relationship does not take long; the value of asking about its presence in a relationship might offer benefits beyond the individual patient by raising awareness and providing the field of study with more data to increase attention and resources for under-researched and underserved populations. Screening might also combat the stigma that perpetuates the silence of many who deserve access to care.
CORRESPONDENCE
Joel G. Sprunger, PhD, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 260 Stetson St, Suite 3200, Cincinnati OH 45219; [email protected].
ACKNOWLEDGMENTS
The authors thank Jeffrey M. Girard, PhD, and Daniel C. Williams, PhD, for their input on the design and content, respectively, of the IPASSPRT screening materials; the authors of the DA-5 and the HITS screening tools, particularly Jacquelyn Campbell, PhD, RN, FAAN, and Kevin Sherin, MD, MPH, MBA, respectively, for permission to include these measures in this article and for their support of its goals; and The Journal of Family Practice’s peer reviewers for their thoughtful feedback throughout the prepublication process.
Intimate partner violence (IPV) is a serious public health problem with considerable harmful health consequences. Decades of research have been dedicated to improving the identification of women in abusive heterosexual relationships and interventions that support healthier outcomes. A result of this work has been the recommendation of the US Preventive Services Task Force that all women of childbearing age be screened for IPV and provided with intervention or referral.1
The problem extends further, however: Epidemiologic studies and comprehensive reviews show: 1) a high rate of IPV victimization among heterosexual men and lesbian, gay, bisexual, and transsexual (LGBT) men and women2,3; 2) significant harmful effects on health and greater expectations of prejudice and discrimination among these populations4-6; and 3) evidence that screening and referral for IPV are likely to confer similar benefits for these populations.7 We argue that it is reasonable to ask all patients about abuse in their relationships while the research literature progresses.
We intend this article to serve a number of purposes:
- support national standards for IPV screening of female patients
- highlight the need for piloting universal IPV screening for all patients (ie, male and female, across the lifespan)
- offer recommendations for navigating the process from IPV screening to referral, using insights gained from the substance abuse literature.
We also provide supplemental materials that facilitate establishment of screening and referral protocols for physicians across practice settings.
What is intimate partner violence? How can you identify it?
Intimate partner violence includes physical and sexual violence and nonphysical forms of abuse, such as psychological aggression and emotional abuse, perpetrated by a current or former intimate partner.8 TABLE 19-14 provides definitions for each of these behavior categories and example behaviors. Nearly 25% of women and 20% of men report having experienced physical violence from a romantic partner and even higher rates of nonphysical IPV.15 Consequences of IPV victimization include acute and chronic medical illness, injury, and psychological problems, including depression, anxiety, and poor self-esteem.16
Intimate partner violence is heterogeneous, with differences in severity (eg, frequency and intensity of violence) and laterality (ie, is one partner violent? are both partners violent?). A recent comprehensive review of the literature revealed that, for 49.2%-69.7% of partner-violent couples across diverse samples, IPV is perpetrated by both partners.17 Furthermore, this bidirectionality is not due entirely to aggression perpetrated in self-defense; rather, across diverse patient samples, that is the case for fewer than one-quarter of males and no more than approximately one-third of females.18 In the remaining cases, bidirectionality may be attributed to other motivations, such as a maladaptive emotional expression or a means by which to get a partner’s attention.18
Women are disproportionately susceptible to harmful outcomes as a result of severe violence, including physical injury, psychological distress (eg, depression and anxiety), and substance abuse.16,19 Some patients in unidirectionally violent relationships experience severe physical violence that may be, or become, life-threatening (0.4%-2.4% of couples in community samples)20—victimization that is traditionally known as “battering.”21
Continue to: These tools can facilitate screening for IPV
These tools can facilitate screening for IPV
Physicians might have reservations asking about IPV because of 1) concern whether there is sufficient time during an office visit to interview, screen, and refer, 2) feelings of powerlessness to stop violence by or toward a patient, and 3) general discomfort with the topic.22 Additionally, mandated reporting laws regarding IPV vary by state, making it crucial to know one’s own state laws on this issue to protect the safety of the patient and those around them.
Research has shown that some patients prefer that their health care providers ask about relationship violence directly23; others are more willing to acknowledge IPV if asked using a paper-and-pencil measure, rather than face-to-face questions.24 Either way, screening increases the likelihood of engaging the patient in supportive services, thus decreasing the isolation that is typical of abuse.25 Based on this research, screening that utilizes face-valid items embedded within paperwork completed in the waiting room is recommended as an important first step toward identifying and helping patients who are experiencing IPV. Even under these conditions, however, heterosexual men and sexual minorities might be less willing than heterosexual women to admit experiencing IPV.26,27
A brief vignette that depicts how quickly the screening and referral process can be applied is presented in “IPV screening and referral: A real-world vignette." The vignette is a de-identified composite of heterosexual men experiencing IPV whom we have counseled.
SIDEBAR
IPV screening and referral: A real-world vignette
Physician: Before we wrap up: I noticed on your screening that you have been hurt and threatened a fair amount in the past year. Would it be OK if we spoke about that more?
Patient: My wife is emotional. Sometimes she gets really stressed out and just starts screaming and punching me. That’s just how she is.
Physician: Do you ever feel concerned for your safety?
Patient: Not really. She’s smaller than me and I can generally calm her down. I keep the guns locked up, so she can’t grab those any more. Mostly she just screams at me.
Physician: This may or may not fit with your perception but, based on what you are reporting, your relationship is what is called “at risk”—meaning you are at risk for having your physical or mental health negatively impacted. This actually happens to a lot of men, and there’s a brochure I can give you that has a lot more information about the risks and consequences of being hurt or threatened by a partner. Would you be willing to take a look at it?
Patient: I guess so.
Physician: OK. I’ll have the nurse bring you that brochure, and we can talk more about it next time you come in for an appointment. Would it be OK if we get you back in here 6 months from now?
Patient: Yeah, that could work.
Physician: Great. Let’s do that. Don’t hesitate to give me a call if your situation changes in any way in the meantime.
One model that provides a useful framework for IPV assessment is the Screening, Brief Intervention, and Referral to Treatment (SBIRT) model, which was developed to facilitate assessment of, and referral for, substance abuse—another heavily stigmatized health care problem. The SBIRT approach for substance abuse screening is associated with significant reduction in alcohol and drug abuse 6 months postintervention, as well as improvements in well-being, mental health, and functioning across gender, race and ethnicity, and age.28
IPASSPRT. Inspired by the SBIRT model for substance abuse, we created the Intimate Partner Aggression Screening, Safety Planning, and Referral to Treatment, or IPASSPRT (spoken as “i-passport”) project to provide tools that make IPV screening and referral accessible to a range of health care providers. These tools include a script and safety plan that guide providers through screening, safety planning, and referral in a manner that is collaborative and grounded in the spirit of motivational interviewing. We have made these tools available on the Web for ease of distribution (http://bit.ly/ipassprt; open by linking through “IPASSPRT-Script”).
Continue to: The IPASSPRT script appears lengthy...
The IPASSPRT script appears lengthy, but progress through its sections is directed by patient need; most patients will not require that all parts be completed. For example, a patient whose screen for IPV is negative and who feels safe in their relationship does not need assessment beyond page 2; on the other hand, the physician might need more information from a patient who is at greater risk for IPV. This response-based progression through the script makes the screening process dynamic, data-driven, and tailored to the patient’s needs—an approach that aids rapport and optimizes the physician’s limited time during the appointment.
In the sections that follow, we describe key components of this script.
What aggression, if any, is present? From whom? The Hurt, Insult, Threaten, and Scream inventory (HITS) (TABLE 2)29 is a widely used screen for IPV that has been validated for use in family medicine. A 4-item scale asks patients to report how often their partner physically hurts, insults, threatens, and screams at them using a 5-point scale (1 point, “never,” to 5 points, “frequently”). Although a score > 10 is indicative of IPV, item-level analysis is encouraged. Attending to which items the patient acknowledges and how often these behaviors occur yields a richer assessment than a summary score. In regard to simply asking a patient, “Do you feel safe at home?” (sensitivity of this question, 8.8%; specificity, 91.2%), the HITS better detects IPV with male and female patient populations in family practice and emergency care settings (sensitivity, 30%-100%; specificity, 86%-99%).27,30
What contextual factors and related concerns are present? It is important to understand proximal factors that might influence IPV risk to determine what kind of referral or treatment is appropriate—particularly for patients experiencing or engaging in infrequent, noninjurious, and bidirectional forms of IPV. Environmental and contextual stressors, such as financial hardship, unemployment, pregnancy, and discussion of divorce, can increase the risk for IPV.31,32 Situational influences, such as alcohol and drug intoxication, can also increase the risk for IPV. Victims of partner violence are at greater risk for mental health problems, including depression, anxiety, trauma- and stressor-related disorders, and substance use disorders. Risk goes both ways, however: Mental illness predicts subsequent IPV perpetration or victimization, and vice versa.31
Does the patient feel safe? Assessing the situation. Patient perception of safety in the relationship provides important information about the necessity of referral. Asking a patient if they feel unsafe because of the behavior of a current or former partner sheds light on the need for further safety assessment and immediate connection with appropriate resources.
Continue to: The Danger Assessment-5...
The Danger Assessment-5 (DA-5) (TABLE 333) is a useful 5-item tool for quickly assessing the risk for severe IPV.33 Patients respond to whether:
- the frequency or severity of violence has increased in the past year
- the partner has ever used, or threatened to use, a weapon
- the patient believes the partner is capable of killing her (him)
- the partner has ever tried to choke or strangle her (him)
- the partner is violently and constantly jealous.
Sensitivity and specificity analyses with a high-risk female sample suggested that 3 affirmative responses indicate a high risk for severe IPV and a need for adequate safety planning.
Brief motivational enhancement intervention. There are 3 components to this intervention.
- Assess interest in making changes or seeking help. IPV is paradoxical: Many factors complicate the decision to leave or stay, and patients across the spectrum of victimization might have some motivation to stay with their partner. It is important to assess the patient’s motivation to make changes in their relationship.4,34
- Provide feedback on screening. Sharing the results of screening with patients makes the assessment and referral process collaborative and transparent; collaborative engagement helps patients feel in control and invested in the follow-through.35 In the spirit of this endeavor, physicians are encouraged to refrain from providing raw or total scores from the measures; instead, share the interpretation of those scores, based on the participant’s responses to the screening items, in a matter-of-fact manner. At this point, elicit the patient’s response to this information, listen empathically, and answer questions before proceeding.
Consistent with screening for other serious health problems, we recommend that all patients be provided with information about abuse in romantic relationships. The National Center for Injury Prevention and Control Division of Violence Prevention has published a useful, easy-to-understand fact sheet (www.cdc.gov/violenceprevention/pdf/ipv-factsheet.pdf) that provides an overview of IPV-related behavior, how it influences health outcomes, who is at risk for IPV, and sources for support.
Continue to: Our IPASSPRT interview script...
Our IPASSPRT interview script (http://bit.ly/ipassprt) outlines how this information can be presented to patients as a typical part of the screening process. Providers are encouraged to share and review the information from the fact sheet with all patients and present it as part of the normal screening process to mitigate the potential for defensiveness on the part of the patient. For patients who screen positive for IPV, it might be important to brainstorm ideas for a safe, secure place to store this fact sheet and other resources from the brief intervention and referral process below (eg, a safety plan and specific referral information) so that the patient can access them quickly and easily, if needed.
For patients who screen negative for IPV, their screen and interview conclude at this point.
- Provide recommendations based on the screen. Evidence suggests that collaborating with the patient on safety planning and referral can increase the likelihood of their engagement.7 Furthermore, failure to tailor the referral to the needs of the patient can be detrimental36—ie, overshooting the level of intervention might decrease the patient’s future treatment-seeking behavior and undermine their internal coping strategies, increasing the likelihood of future victimization. For that reason, we provide the following guidance on navigating the referral process for patients who screen positive for IPV.
Screening-based referral: A delicate and collaborative process
Referral for IPV victimization. Individual counseling, with or without an IPV focus, might be appropriate for patients at lower levels of risk; immediate connection with local IPV resources is strongly encouraged for patients at higher risk. This is a delicate, collaborative process, in which the physician offers recommendations for referral commensurate to the patient’s risk but must, ultimately, respect the patient’s autonomy by identifying referrals that fit the patient’s goals. We encourage providers to provide risk-informed recommendations and to elicit the patient’s thoughts about that information.
Several online resources are available to help physicians locate and connect with IPV-related resources in their community, including the National Health Resource Center on Domestic Violence (http://ipvhealth.org/), which provides a step-by-step guide to making such connections. We encourage physicians to develop these collaborative partnerships early to facilitate warm handoffs and increase the likelihood that a patient will follow through with the referral after screening.37
Referral for related concerns. As we’ve noted, IPV has numerous physical and mental health consequences, including depression, low self-esteem, trauma- and non-trauma-related anxiety, and substance abuse. In general, cognitive behavioral therapies appear most efficacious for treating these IPV-related consequences, but evidence is limited that such interventions diminish the likelihood of re-victimization.38 Intervention programs that foster problem-solving, solution-seeking, and cognitive restructuring for self-critical thoughts and misconceptions seem to produce the best physical and mental health outcomes.39 For patients who have a substance use disorder, treatment programs that target substance use have demonstrated a reduction in the rate of IPV recidivism.40 These findings indicate that establishing multiple treatment targets might reduce the risk for future aggression in relationships.
Continue to: The Substance Abuse and Mental Health Services Administration...
The Substance Abuse and Mental Health Services Administration of the US Department of Health and Human Services provides a useful online tool (https://findtreatment.samhsa.gov/) for locating local referrals that address behavioral health and substance-related concerns. The agency also provides a hotline (1-800-662-HELP [4357]) as an alternative resource for information and treatment referrals.
Safety planning can improve outcomes
For a patient who screens above low risk, safety planning with the patient is an important part of improving outcomes and can take several forms. Online resources, such as the Path to Safety interactive Web page (www.thehotline.org/help/path-to-safety/) maintained by The National Domestic Violence Hotline ([800]799-SAFE [7233]), provide information regarding important considerations for safety planning when:
- living with an abusive partner
- children are in the home
- the patient is pregnant
- pets are involved.
The Web site also provides information regarding legal options and resources related to IPV (eg, an order of protection) and steps for improving safety when leaving an abusive relationship. Patients at risk for IPV can explore the online tool and call the hotline.
For physicians who want to engage in provider-assisted safety planning, we’ve provided further guidance in the IPASSPRT screening script and safety plan (http://bit.ly/ipassprt) (TABLE 4).
Goal: Affirm patients’ strengths and reinforce hope
Psychological aggression is the most common form of relationship aggression; repeated denigration might leave a person with little confidence in their ability to change their relationship or seek out identified resources. That’s why it’s useful to inquire—with genuine curiosity—about a time in the past when the patient accomplished something challenging. The physician’s enthusiastic reflection on this achievement can be a means of highlighting the patient’s ability to accomplish a meaningful goal; of reinforcing their hope; and of eliciting important resources within and around the patient that can facilitate action on their safety plan. (See “IPV-related resources for physicians and patients.”)
SIDEBAR
IPV-related resources for physicians and patients
Intimate Partner Aggression Screening, Safety Planning, and Referral to Treatment (IPASSPRT) Project
› http://bit.ly/ipassprt
Online resource with tools designed by the authors, including an SBIRT-inspired script and safety plan template for IPV screening, safety planning, and referral
National Center for Injury Prevention and Control Division of Violence Prevention
› www.cdc.gov/violenceprevention/pdf/ipv-factsheet.pdf
Overview of IPV-related behavior, influence on health outcomes, people at risk of IPV, and sources of support, all in a format easily understood by patients
National Health Resource Center on Domestic Violence
› http://ipvhealth.org/
Includes guidance on connecting with IPV-related community resources; establishing such connections can facilitate warm handoffs and improve the likelihood that patients will follow through
Path to Safety, a service of The National Domestic Violence Hotline
› www.thehotline.org/help/path-to-safety/
Extensive primer on safety plans for patients intending to stay in (or leave) an abusive relationship; includes important considerations for children, pets, and pregnancy, as well as emotional safety and legal options
The National Domestic Violence Hotline
› (800) 799-SAFE (7233)
Substance Abuse and Mental Health Services Administration
› www.samhsa.gov/sbirt
Learning resources for the SBIRT protocol for substance abuse
› https://findtreatment.samhsa.gov/
Search engine and resources for locating local referrals
› (800) 662-HELP (4357)
Hotline for information and assistance with locating local treatment referral
IPV, intimate partner violence; SBIRT, screening, brief intervention, and referral to treatment.
Continue to: Closing the screen and making a referral
Closing the screen and making a referral
The end of the interview should consist of a summary of topics discussed, including:
- changes that the patient wants to make (if any)
- their stated reasons for making those changes
- the patient’s plan for accomplishing changes.
Physicians should also include their own role in next steps—whether providing a warm handoff to a local IPV referral, agreeing to a follow-up schedule with the patient, or making a call as a mandated reporter. To close out the interview, it is important to affirm respect for the patient’s autonomy in executing the plan.
It’s important to screen all patients—here’s why
A major impetus for this article has been to raise awareness about the need for expanded IPV screening across primary care settings. As mentioned, much of the literature on IPV victimization has focused on women; however, the few epidemiological investigations of victimization rates among men and members of LGBT couples show a high rate of victimization and considerable harmful health outcomes. Driven by stigma surrounding IPV, sex, and sexual minority status, patients might have expectations that they will be judged by a provider or “outed.”
Such barriers can lead many to suffer in silence until the problem can no longer be hidden or the danger becomes more emergent. Compassionate, nonjudgmental screening and collaborative safety planning—such as the approach we describe in this article—help ease the concerns of LGBT victims of IPV and improve the likelihood that conversations you have with them will occur earlier, rather than later, in care.*
Underassessment of IPV (ie, underreporting as well as under-inquiry) because of stigma, misconception, and other factors obscures an accurate estimate of the rate of partner violence and its consequences for all couples. As a consequence, we know little about the dynamics of IPV, best practices for screening, and appropriate referral for couples from these populations. Furthermore, few resources are available to these understudied and underserved groups (eg, shelters for men and for transgender people).
Continue to: Although our immediate approach to IPV screening...
Although our immediate approach to IPV screening, safety planning, and referral with understudied patient populations might be informed by what we have learned from the experiences of heterosexual women in abusive relationships, such a practice is unsustainable. Unless we expand our scope of screening to all patients, it is unlikely that we will develop the evidence base necessary to 1) warrant stronger IPV screening recommendations for patient groups apart from women of childbearing age, let alone 2) demonstrate the need for additional community resources, and 3) provide comprehensive care in family practice of comparable quality.
The benefits of screening go beyond the individual patient
Screening for violence in the relationship does not take long; the value of asking about its presence in a relationship might offer benefits beyond the individual patient by raising awareness and providing the field of study with more data to increase attention and resources for under-researched and underserved populations. Screening might also combat the stigma that perpetuates the silence of many who deserve access to care.
CORRESPONDENCE
Joel G. Sprunger, PhD, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 260 Stetson St, Suite 3200, Cincinnati OH 45219; [email protected].
ACKNOWLEDGMENTS
The authors thank Jeffrey M. Girard, PhD, and Daniel C. Williams, PhD, for their input on the design and content, respectively, of the IPASSPRT screening materials; the authors of the DA-5 and the HITS screening tools, particularly Jacquelyn Campbell, PhD, RN, FAAN, and Kevin Sherin, MD, MPH, MBA, respectively, for permission to include these measures in this article and for their support of its goals; and The Journal of Family Practice’s peer reviewers for their thoughtful feedback throughout the prepublication process.
1. Campos-Outcalt D. USPSTF: What’s recommended, what’s not. J Fam Pract. 2014;63:265-269.
2. Black MC, Basile KC, Breiding MJ, et al. National Intimate Partner and Sexual Violence Survey: 2010 Summary Report. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2011:113. www.cdc.gov/violenceprevention/pdf/NISVS_Report2010-a.pdf. Accessed February 20, 2019.
3. West CM. Partner abuse in ethnic minority and gay, lesbian, bisexual, and transgender populations. Partner Abuse. 2012;3:336-357.
4. Hines DA, Malley-Morrison K. Psychological effects of partner abuse against men: a neglected research area. Psychology of Men & Masculinities. 2001;2:75-85.
5. Houston E, McKirnan DJ. Intimate partner abuse among gay and bisexual men: risk correlates and health outcomes. J Urban Health. 2007;84:681-690.
6. Carvalho AF, Lewis RJ, Derlega VJ, et al. Internalized sexual minority stressors and same-sex intimate partner violence. J Fam Violence. 2011;26:501-509.
7. Nicholls TL, Pritchard MM, Reeves KA, et al. Risk assessment in intimate partner violence: a systematic review of contemporary approaches. Partner Abuse. 2013;4:76-168.
8. Intimate partner violence: definitions. Atlanta, GA: National Center for Injury Prevention and Control, Division of Violence Prevention, Centers for Disease Control and Prevention, August 22, 2017. www.cdc.gov/violenceprevention/intimatepartnerviolence/definitions.html. Accessed February 20, 2019.
9. Archer J. Sex differences in aggression between heterosexual partners: a meta-analytic review. Psychol Bull. 2000;126:651-680.
10. Baron RA, Richardson DR. Human Aggression. New York, NY: Springer Science+Business Media; 2004.
11. Breiding MJ, Basile KC, Smith SG, et al. Intimate Partner Violence Surveillance: Uniform Definitions and Recommended Data Elements, Version 2.0. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2015.
12. Murphy CM, Eckhardt CI. Treating the Abusive Partner: An Individualized Cognitive-Behavioral Approach. New York, NY: Guilford Press; 2005.
13. Straus MA, Hamby SL, Boney-McCoy S, et al. The revised Conflict Tactics Scales (CTS2): development and preliminary psychometric data. J Fam Issues. 1996;17:283-316.
14. West CM. Partner abuse in ethnic minority and gay, lesbian, bisexual, and transgender populations. Partner Abuse. 2012;3:336-357.
15. Desmarais SL, Reeves KA, Nicholls TL, et al. Prevalence of physical violence in intimate relationships. Part 1: rates of male and female victimization. Partner Abuse. 2012;3:140-169.
16. Lawrence E, Orengo-Aguayo R, Langer A, et al. The impact and consequences of partner abuse on partners. Partner Abuse. 2012;3:406-428.
17. Langhinrichsen-Rohling J, Selwyn C, Rohling ML. Rates of bidirectional versus unidirectional intimate partner violence across samples, sexual orientations, and race/ethnicities: a comprehensive review. Partner Abuse. 2012;3:199-230.
18. Langhinrichsen-Rohling J, McCullars A, Misra TA. Motivations for men and women’s intimate partner violence perpetration: a comprehensive review. Partner Abuse. 2012;3:429-468.
19. Anderson CA, Bushman BJ. Human aggression. Annu Rev Psychol. 2002;53:27-51.
20. Straus MA, Gozjolko KL. “Intimate terrorism” and gender differences in injury of dating partners by male and female university students. J Fam Violence. 2014;29:51-65.
21. Ferraro KJ, Johnson JM. How women experience battering: the process of victimization. Soc Probl. 1983;30:325-339.
22. Sugg NK, Inui T. Primary care physicians’ response to domestic violence: opening Pandora’s box. JAMA. 1992;267:3157-3160.
23. Morgan KJ, Williamson E, Hester M, et al. Asking men about domestic violence and abuse in a family medicine context: help seeking and views on the general practitioner role. Aggress Violent Behav. 2014;19:637-642.
24. MacMillan HL, Wathen CN, Jamieson E, et al; McMaster Violence Against Women Research Group. Approaches to screening for intimate partner violence in health care settings: a randomized trial. JAMA. 2006;296:530-536.
25. Thompson RS, Rivara FP, Thompson DC, et al. Identification and management of domestic violence: a randomized trial. Am J Prev Med. 2000;19:253-263.
26. Ard KL, Makadon HJ. Addressing intimate partner violence in lesbian, gay, bisexual, and transgender patients. J Gen Intern Med. 2011;26:930-933.
27. Rabin RF, Jennings JM, Campbell JC, et al. Intimate partner violence screening tools: a systematic review. Am J Prev Med. 2009;36:439-445.e4.
28. Madras BK, Compton WM, Avula D, et al. Screening, brief interventions, referral to treatment (SBIRT) for illicit drug and alcohol use at multiple healthcare sites: comparison at intake and 6 months later. Drug Alcohol Depend. 2009;99:280-295.
29. Sherin KM, Sinacore JM, Li XQ, et al. HITS: A short domestic violence screening tool for use in a family practice setting. Fam Med. 1998;30:508-512.
30. Peralta RL, Fleming MF. Screening for intimate partner violence in a primary care setting: the validity of “feeling safe at home” and prevalence results. J Am Board Fam Pract. 2003;16:525-532.
31. Capaldi DM, Knoble NB, Shortt JW, et al. A systematic review of risk factors for intimate partner violence. Partner Abuse. 2012;3:231-280.
32. Brownridge DA, Taillieu TL, Tyler KA, et al. Pregnancy and intimate partner violence: risk factors, severity, and health effects. Violence Against Women. 2011;17:858-881.
33. Messing JT, Campbell JC, Snider C. Validation and adaptation of the danger assessment-5: a brief intimate partner violence risk assessment. J Adv Nurs. 2017;73:3220-3230.
34. Grigsby N, Hartman BR. The Barriers Model: an integrated strategy for intervention with battered women. Psychotherapy: Theory, Research, Practice, Training. 1997;34:485-497.
35. Moyers TB, Rollnick S. A motivational interviewing perspective on resistance in psychotherapy. J Clin Psychol. 2002;58:185-193.
36. Belfrage H, Strand S, Storey JE, et al. Assessment and management of risk for intimate partner violence by police officers using the Spousal Assault Risk Assessment Guide. Law Hum Behav. 2012;36:60-67.
37. McCloskey LA, Lichter E, Williams C, et al. Assessing intimate partner violence in health care settings leads to women’s receipt of interventions and improved health. Publ Health Rep. 2006;121:435-444.
38. Eckhardt CI, Murphy CM, Whitaker DJ, et al. The effectiveness of intervention programs for perpetrators and victims of intimate partner violence. Partner Abuse. 2013;4:196-231.
39. Trabold N, McMahon J, Alsobrooks S, et al. A systematic review of intimate partner violence interventions: state of the field and implications for practitioners. Trauma Violence Abuse. January 2018:1524838018767934.
40. Kraanen FL, Vedel E, Scholing A, et al. The comparative effectiveness of Integrated treatment for Substance abuse and Partner violence (I-StoP) and substance abuse treatment alone: a randomized controlled trial. BMC Psychiatry. 2013;13:189.
1. Campos-Outcalt D. USPSTF: What’s recommended, what’s not. J Fam Pract. 2014;63:265-269.
2. Black MC, Basile KC, Breiding MJ, et al. National Intimate Partner and Sexual Violence Survey: 2010 Summary Report. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2011:113. www.cdc.gov/violenceprevention/pdf/NISVS_Report2010-a.pdf. Accessed February 20, 2019.
3. West CM. Partner abuse in ethnic minority and gay, lesbian, bisexual, and transgender populations. Partner Abuse. 2012;3:336-357.
4. Hines DA, Malley-Morrison K. Psychological effects of partner abuse against men: a neglected research area. Psychology of Men & Masculinities. 2001;2:75-85.
5. Houston E, McKirnan DJ. Intimate partner abuse among gay and bisexual men: risk correlates and health outcomes. J Urban Health. 2007;84:681-690.
6. Carvalho AF, Lewis RJ, Derlega VJ, et al. Internalized sexual minority stressors and same-sex intimate partner violence. J Fam Violence. 2011;26:501-509.
7. Nicholls TL, Pritchard MM, Reeves KA, et al. Risk assessment in intimate partner violence: a systematic review of contemporary approaches. Partner Abuse. 2013;4:76-168.
8. Intimate partner violence: definitions. Atlanta, GA: National Center for Injury Prevention and Control, Division of Violence Prevention, Centers for Disease Control and Prevention, August 22, 2017. www.cdc.gov/violenceprevention/intimatepartnerviolence/definitions.html. Accessed February 20, 2019.
9. Archer J. Sex differences in aggression between heterosexual partners: a meta-analytic review. Psychol Bull. 2000;126:651-680.
10. Baron RA, Richardson DR. Human Aggression. New York, NY: Springer Science+Business Media; 2004.
11. Breiding MJ, Basile KC, Smith SG, et al. Intimate Partner Violence Surveillance: Uniform Definitions and Recommended Data Elements, Version 2.0. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2015.
12. Murphy CM, Eckhardt CI. Treating the Abusive Partner: An Individualized Cognitive-Behavioral Approach. New York, NY: Guilford Press; 2005.
13. Straus MA, Hamby SL, Boney-McCoy S, et al. The revised Conflict Tactics Scales (CTS2): development and preliminary psychometric data. J Fam Issues. 1996;17:283-316.
14. West CM. Partner abuse in ethnic minority and gay, lesbian, bisexual, and transgender populations. Partner Abuse. 2012;3:336-357.
15. Desmarais SL, Reeves KA, Nicholls TL, et al. Prevalence of physical violence in intimate relationships. Part 1: rates of male and female victimization. Partner Abuse. 2012;3:140-169.
16. Lawrence E, Orengo-Aguayo R, Langer A, et al. The impact and consequences of partner abuse on partners. Partner Abuse. 2012;3:406-428.
17. Langhinrichsen-Rohling J, Selwyn C, Rohling ML. Rates of bidirectional versus unidirectional intimate partner violence across samples, sexual orientations, and race/ethnicities: a comprehensive review. Partner Abuse. 2012;3:199-230.
18. Langhinrichsen-Rohling J, McCullars A, Misra TA. Motivations for men and women’s intimate partner violence perpetration: a comprehensive review. Partner Abuse. 2012;3:429-468.
19. Anderson CA, Bushman BJ. Human aggression. Annu Rev Psychol. 2002;53:27-51.
20. Straus MA, Gozjolko KL. “Intimate terrorism” and gender differences in injury of dating partners by male and female university students. J Fam Violence. 2014;29:51-65.
21. Ferraro KJ, Johnson JM. How women experience battering: the process of victimization. Soc Probl. 1983;30:325-339.
22. Sugg NK, Inui T. Primary care physicians’ response to domestic violence: opening Pandora’s box. JAMA. 1992;267:3157-3160.
23. Morgan KJ, Williamson E, Hester M, et al. Asking men about domestic violence and abuse in a family medicine context: help seeking and views on the general practitioner role. Aggress Violent Behav. 2014;19:637-642.
24. MacMillan HL, Wathen CN, Jamieson E, et al; McMaster Violence Against Women Research Group. Approaches to screening for intimate partner violence in health care settings: a randomized trial. JAMA. 2006;296:530-536.
25. Thompson RS, Rivara FP, Thompson DC, et al. Identification and management of domestic violence: a randomized trial. Am J Prev Med. 2000;19:253-263.
26. Ard KL, Makadon HJ. Addressing intimate partner violence in lesbian, gay, bisexual, and transgender patients. J Gen Intern Med. 2011;26:930-933.
27. Rabin RF, Jennings JM, Campbell JC, et al. Intimate partner violence screening tools: a systematic review. Am J Prev Med. 2009;36:439-445.e4.
28. Madras BK, Compton WM, Avula D, et al. Screening, brief interventions, referral to treatment (SBIRT) for illicit drug and alcohol use at multiple healthcare sites: comparison at intake and 6 months later. Drug Alcohol Depend. 2009;99:280-295.
29. Sherin KM, Sinacore JM, Li XQ, et al. HITS: A short domestic violence screening tool for use in a family practice setting. Fam Med. 1998;30:508-512.
30. Peralta RL, Fleming MF. Screening for intimate partner violence in a primary care setting: the validity of “feeling safe at home” and prevalence results. J Am Board Fam Pract. 2003;16:525-532.
31. Capaldi DM, Knoble NB, Shortt JW, et al. A systematic review of risk factors for intimate partner violence. Partner Abuse. 2012;3:231-280.
32. Brownridge DA, Taillieu TL, Tyler KA, et al. Pregnancy and intimate partner violence: risk factors, severity, and health effects. Violence Against Women. 2011;17:858-881.
33. Messing JT, Campbell JC, Snider C. Validation and adaptation of the danger assessment-5: a brief intimate partner violence risk assessment. J Adv Nurs. 2017;73:3220-3230.
34. Grigsby N, Hartman BR. The Barriers Model: an integrated strategy for intervention with battered women. Psychotherapy: Theory, Research, Practice, Training. 1997;34:485-497.
35. Moyers TB, Rollnick S. A motivational interviewing perspective on resistance in psychotherapy. J Clin Psychol. 2002;58:185-193.
36. Belfrage H, Strand S, Storey JE, et al. Assessment and management of risk for intimate partner violence by police officers using the Spousal Assault Risk Assessment Guide. Law Hum Behav. 2012;36:60-67.
37. McCloskey LA, Lichter E, Williams C, et al. Assessing intimate partner violence in health care settings leads to women’s receipt of interventions and improved health. Publ Health Rep. 2006;121:435-444.
38. Eckhardt CI, Murphy CM, Whitaker DJ, et al. The effectiveness of intervention programs for perpetrators and victims of intimate partner violence. Partner Abuse. 2013;4:196-231.
39. Trabold N, McMahon J, Alsobrooks S, et al. A systematic review of intimate partner violence interventions: state of the field and implications for practitioners. Trauma Violence Abuse. January 2018:1524838018767934.
40. Kraanen FL, Vedel E, Scholing A, et al. The comparative effectiveness of Integrated treatment for Substance abuse and Partner violence (I-StoP) and substance abuse treatment alone: a randomized controlled trial. BMC Psychiatry. 2013;13:189.
PRACTICE RECOMMENDATIONS
› Perform annual screening for intimate partner violence of all female patients of childbearing age; strongly consider a pilot program of universal screening (all male and female patients, across the lifespan). B
› Establish a protocol for intimate partner violence screening and referral—possibly the most effective means of identifying intimate partner violence at early and severe stages. B
› Collaborate with the patient in the safety planning and referral process; benefits include improved likelihood that the patient will adhere to a safety plan and follow through with the referral. B
› Utilize online resources to 1) ease the process of establishing relationships with local intimate partner violence referrals and 2) facilitate warm handoffs to increase the likelihood of patient engagement. B
Strength of recommendation (SOR)
A Good-quality patient-oriented evidence
B Inconsistent or limited-quality patient-oriented evidence
C Consensus, usual practice, opinion, disease-oriented evidence, case series
Rituximab does not improve fatigue symptoms of ME/CFS
according to results from the phase 3 RituxME trial.
“The lack of clinical effect of B-cell depletion in this trial weakens the case for an important role of B lymphocytes in ME/CFS but does not exclude an immunologic basis,” Øystein Fluge, MD, PhD, of the department of oncology and medical physics at Haukeland University Hospital in Bergen, Norway, and his colleagues wrote April 1 in Annals of Internal Medicine.
The investigators noted that the basis for testing the effects of a B-cell–depleting intervention on clinical symptoms in patients with ME/CFS came from observations of its potential benefit in a subgroup of patients in previous studies. Dr. Fluge and his colleagues performed a three-patient case series in their own group that found benefit for patients who received rituximab for treatment of CFS (BMC Neurol. 2009 May 8;9:28. doi: 10.1186/1471-2377-9-28). A phase 2 trial of 30 patients with CFS also performed by his own group found improved fatigue scores in 66.7% of patients in the rituximab group, compared with placebo (PLOS One. 2011 Oct 19. doi: 10.1371/journal.pone.0026358).
In the double-blinded RituxME trial, 151 patients with ME/CFS from four university hospitals and one general hospital in Norway were recruited and randomized to receive infusions of rituximab (n = 77) or placebo (n = 74). The patients were aged 18-65 years old and had the disease ranging from 2 years to 15 years. Patients reported and rated their ME/CFS symptoms at baseline as well as completed forms for the SF-36, Hospital Anxiety and Depression Scale, Fatigue Severity Scale, and modified DePaul Symptom Questionnaire out to 24 months. The rituximab group received two infusions at 500 mg/m2 across body surface area at 2 weeks apart. They then received 500-mg maintenance infusions at 3 months, 6 months, 9 months, and 12 months where they also self-reported changes in ME/CFS symptoms.
There were no significant differences between groups regarding fatigue score at any follow-up period, with an average between-group difference of 0.02 at 24 months (95% confidence interval, –0.27 to 0.31). The overall response rate was 26% with rituximab and 35% with placebo. Dr. Fluge and his colleagues also noted no significant differences regarding SF-36 scores, function level, and fatigue severity between groups.
Adverse event rates were higher in the rituximab group (63 patients; 82%) than in the placebo group (48 patients; 65%), and these were more often attributed to treatment for those taking rituximab (26 patients [34%]) than for placebo (12 patients [16%]). Adverse events requiring hospitalization also occurred more often among those taking rituximab (31 events in 20 patients [26%]) than for those who took placebo (16 events in 14 patients [19%]).
Some of the weaknesses of the trial included its use of self-referral and self-reported symptom scores, which might have been subject to recall bias. In commenting on the difference in outcome between the phase 3 trial and others, Dr. Fluge and his associates said the discrepancy could potentially be high expectations in the placebo group, unknown factors surrounding symptom variation in ME/CFS patients, and unknown patient selection effects.
“[T]he negative outcome of RituxME should spur research to assess patient subgroups and further elucidate disease mechanisms, of which recently disclosed impairment of energy metabolism may be important,” Dr. Fluge and his coauthors wrote.
The trial was funded by grants to the researchers from the Norwegian Research Council, the Norwegian Regional Health Trusts, the MEandYou Foundation, the Norwegian ME Association, and the legacy of Torstein Hereid.
SOURCE: Fluge Ø et al. Ann Intern Med. 2019 Apr 1. doi: 10.7326/M18-1451
The RituxME trial’s results weaken the case for the use of rituximab to treat myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), but there are opportunities to test other treatments targeting immunologic abnormalities in ME/CFS, Peter C. Rowe, MD, of Johns Hopkins University, Baltimore, wrote in a related editorial.
“Persons with ME/CFS often meet criteria for several comorbid conditions, each of which could flare during a trial, possibly obscuring a true beneficial effect of an intervention,” Dr. Rowe wrote.
Trials with open treatment periods, in which ME/CFS patients all receive rituximab and then are grouped based on nontargeted conditions, could be warranted to “allow better control” of these conditions. Other trial designs could include randomizing patients to continue or discontinue therapy for responders, he added.
“The profound level of impaired function of affected individuals warrants a new commitment to hypothesis-driven clinical trials that incorporate and expand on the methodological sophistication of the rituximab trial,” Dr. Rowe wrote.
Dr. Rowe is with Johns Hopkins University, Baltimore. These comments summarize his editorial in response to Fluge et al. (Ann Intern Med. 2019 Apr 1. doi: 10.7326/M19-0643). Dr. Rowe reported receiving grants from the National Institutes of Health and is a scientific advisory board member for Solve ME/CFS, all outside the submitted work.
The RituxME trial’s results weaken the case for the use of rituximab to treat myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), but there are opportunities to test other treatments targeting immunologic abnormalities in ME/CFS, Peter C. Rowe, MD, of Johns Hopkins University, Baltimore, wrote in a related editorial.
“Persons with ME/CFS often meet criteria for several comorbid conditions, each of which could flare during a trial, possibly obscuring a true beneficial effect of an intervention,” Dr. Rowe wrote.
Trials with open treatment periods, in which ME/CFS patients all receive rituximab and then are grouped based on nontargeted conditions, could be warranted to “allow better control” of these conditions. Other trial designs could include randomizing patients to continue or discontinue therapy for responders, he added.
“The profound level of impaired function of affected individuals warrants a new commitment to hypothesis-driven clinical trials that incorporate and expand on the methodological sophistication of the rituximab trial,” Dr. Rowe wrote.
Dr. Rowe is with Johns Hopkins University, Baltimore. These comments summarize his editorial in response to Fluge et al. (Ann Intern Med. 2019 Apr 1. doi: 10.7326/M19-0643). Dr. Rowe reported receiving grants from the National Institutes of Health and is a scientific advisory board member for Solve ME/CFS, all outside the submitted work.
The RituxME trial’s results weaken the case for the use of rituximab to treat myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), but there are opportunities to test other treatments targeting immunologic abnormalities in ME/CFS, Peter C. Rowe, MD, of Johns Hopkins University, Baltimore, wrote in a related editorial.
“Persons with ME/CFS often meet criteria for several comorbid conditions, each of which could flare during a trial, possibly obscuring a true beneficial effect of an intervention,” Dr. Rowe wrote.
Trials with open treatment periods, in which ME/CFS patients all receive rituximab and then are grouped based on nontargeted conditions, could be warranted to “allow better control” of these conditions. Other trial designs could include randomizing patients to continue or discontinue therapy for responders, he added.
“The profound level of impaired function of affected individuals warrants a new commitment to hypothesis-driven clinical trials that incorporate and expand on the methodological sophistication of the rituximab trial,” Dr. Rowe wrote.
Dr. Rowe is with Johns Hopkins University, Baltimore. These comments summarize his editorial in response to Fluge et al. (Ann Intern Med. 2019 Apr 1. doi: 10.7326/M19-0643). Dr. Rowe reported receiving grants from the National Institutes of Health and is a scientific advisory board member for Solve ME/CFS, all outside the submitted work.
according to results from the phase 3 RituxME trial.
“The lack of clinical effect of B-cell depletion in this trial weakens the case for an important role of B lymphocytes in ME/CFS but does not exclude an immunologic basis,” Øystein Fluge, MD, PhD, of the department of oncology and medical physics at Haukeland University Hospital in Bergen, Norway, and his colleagues wrote April 1 in Annals of Internal Medicine.
The investigators noted that the basis for testing the effects of a B-cell–depleting intervention on clinical symptoms in patients with ME/CFS came from observations of its potential benefit in a subgroup of patients in previous studies. Dr. Fluge and his colleagues performed a three-patient case series in their own group that found benefit for patients who received rituximab for treatment of CFS (BMC Neurol. 2009 May 8;9:28. doi: 10.1186/1471-2377-9-28). A phase 2 trial of 30 patients with CFS also performed by his own group found improved fatigue scores in 66.7% of patients in the rituximab group, compared with placebo (PLOS One. 2011 Oct 19. doi: 10.1371/journal.pone.0026358).
In the double-blinded RituxME trial, 151 patients with ME/CFS from four university hospitals and one general hospital in Norway were recruited and randomized to receive infusions of rituximab (n = 77) or placebo (n = 74). The patients were aged 18-65 years old and had the disease ranging from 2 years to 15 years. Patients reported and rated their ME/CFS symptoms at baseline as well as completed forms for the SF-36, Hospital Anxiety and Depression Scale, Fatigue Severity Scale, and modified DePaul Symptom Questionnaire out to 24 months. The rituximab group received two infusions at 500 mg/m2 across body surface area at 2 weeks apart. They then received 500-mg maintenance infusions at 3 months, 6 months, 9 months, and 12 months where they also self-reported changes in ME/CFS symptoms.
There were no significant differences between groups regarding fatigue score at any follow-up period, with an average between-group difference of 0.02 at 24 months (95% confidence interval, –0.27 to 0.31). The overall response rate was 26% with rituximab and 35% with placebo. Dr. Fluge and his colleagues also noted no significant differences regarding SF-36 scores, function level, and fatigue severity between groups.
Adverse event rates were higher in the rituximab group (63 patients; 82%) than in the placebo group (48 patients; 65%), and these were more often attributed to treatment for those taking rituximab (26 patients [34%]) than for placebo (12 patients [16%]). Adverse events requiring hospitalization also occurred more often among those taking rituximab (31 events in 20 patients [26%]) than for those who took placebo (16 events in 14 patients [19%]).
Some of the weaknesses of the trial included its use of self-referral and self-reported symptom scores, which might have been subject to recall bias. In commenting on the difference in outcome between the phase 3 trial and others, Dr. Fluge and his associates said the discrepancy could potentially be high expectations in the placebo group, unknown factors surrounding symptom variation in ME/CFS patients, and unknown patient selection effects.
“[T]he negative outcome of RituxME should spur research to assess patient subgroups and further elucidate disease mechanisms, of which recently disclosed impairment of energy metabolism may be important,” Dr. Fluge and his coauthors wrote.
The trial was funded by grants to the researchers from the Norwegian Research Council, the Norwegian Regional Health Trusts, the MEandYou Foundation, the Norwegian ME Association, and the legacy of Torstein Hereid.
SOURCE: Fluge Ø et al. Ann Intern Med. 2019 Apr 1. doi: 10.7326/M18-1451
according to results from the phase 3 RituxME trial.
“The lack of clinical effect of B-cell depletion in this trial weakens the case for an important role of B lymphocytes in ME/CFS but does not exclude an immunologic basis,” Øystein Fluge, MD, PhD, of the department of oncology and medical physics at Haukeland University Hospital in Bergen, Norway, and his colleagues wrote April 1 in Annals of Internal Medicine.
The investigators noted that the basis for testing the effects of a B-cell–depleting intervention on clinical symptoms in patients with ME/CFS came from observations of its potential benefit in a subgroup of patients in previous studies. Dr. Fluge and his colleagues performed a three-patient case series in their own group that found benefit for patients who received rituximab for treatment of CFS (BMC Neurol. 2009 May 8;9:28. doi: 10.1186/1471-2377-9-28). A phase 2 trial of 30 patients with CFS also performed by his own group found improved fatigue scores in 66.7% of patients in the rituximab group, compared with placebo (PLOS One. 2011 Oct 19. doi: 10.1371/journal.pone.0026358).
In the double-blinded RituxME trial, 151 patients with ME/CFS from four university hospitals and one general hospital in Norway were recruited and randomized to receive infusions of rituximab (n = 77) or placebo (n = 74). The patients were aged 18-65 years old and had the disease ranging from 2 years to 15 years. Patients reported and rated their ME/CFS symptoms at baseline as well as completed forms for the SF-36, Hospital Anxiety and Depression Scale, Fatigue Severity Scale, and modified DePaul Symptom Questionnaire out to 24 months. The rituximab group received two infusions at 500 mg/m2 across body surface area at 2 weeks apart. They then received 500-mg maintenance infusions at 3 months, 6 months, 9 months, and 12 months where they also self-reported changes in ME/CFS symptoms.
There were no significant differences between groups regarding fatigue score at any follow-up period, with an average between-group difference of 0.02 at 24 months (95% confidence interval, –0.27 to 0.31). The overall response rate was 26% with rituximab and 35% with placebo. Dr. Fluge and his colleagues also noted no significant differences regarding SF-36 scores, function level, and fatigue severity between groups.
Adverse event rates were higher in the rituximab group (63 patients; 82%) than in the placebo group (48 patients; 65%), and these were more often attributed to treatment for those taking rituximab (26 patients [34%]) than for placebo (12 patients [16%]). Adverse events requiring hospitalization also occurred more often among those taking rituximab (31 events in 20 patients [26%]) than for those who took placebo (16 events in 14 patients [19%]).
Some of the weaknesses of the trial included its use of self-referral and self-reported symptom scores, which might have been subject to recall bias. In commenting on the difference in outcome between the phase 3 trial and others, Dr. Fluge and his associates said the discrepancy could potentially be high expectations in the placebo group, unknown factors surrounding symptom variation in ME/CFS patients, and unknown patient selection effects.
“[T]he negative outcome of RituxME should spur research to assess patient subgroups and further elucidate disease mechanisms, of which recently disclosed impairment of energy metabolism may be important,” Dr. Fluge and his coauthors wrote.
The trial was funded by grants to the researchers from the Norwegian Research Council, the Norwegian Regional Health Trusts, the MEandYou Foundation, the Norwegian ME Association, and the legacy of Torstein Hereid.
SOURCE: Fluge Ø et al. Ann Intern Med. 2019 Apr 1. doi: 10.7326/M18-1451
FROM ANNALS OF INTERNAL MEDICINE