Pain

MILWAUKEE – More than 40% of white physician trainees demonstrated racial bias in medical decision making about treatment of low back pain, as did 31% of nonwhite trainees. However, just 6% of white residents and fellows, and 10% of the nonwhite residents and fellows, reported that patient race had factored into their treatment decisions in a virtual patient task.

The 444 medical residents and fellows who participated viewed video vignettes presenting 12 virtual patients who presented with low back pain, wrote Alexis Grant of Indiana University–Purdue University Indianapolis and her colleagues. In a poster presentation at the scientific meeting of the American Pain Society, Ms. Grant, a doctoral student in clinical psychology, and her collaborators explained that participants agreed to view a series of 12 videos of virtual patients.

The videos presented male and female virtual patients who were black or white and who had jobs associated with low or high socioeconomic status (SES). Information in text vignettes accompanying the videos included occupation, pain etiology, physical exam findings, and pain intensity by self-report.

After viewing the videos and reading the vignettes, participating clinicians were asked to use a 0-100 visual analog scale to report their likelihood of referring patients to a pain specialist or to physical therapy and of recommending opioid or nonopioid analgesia.

“Next, they rated the degree to which they considered different sources of patient information when making treatment decision,” Ms. Grant and her coauthors wrote. Statistical analysis “examined the extent to which providers demonstrated statistically reliable treatment differences across patient race and SES.” These findings were compared with how clinicians reported they used patient race and SES in decision making.

Demonstrated race-based decision making occurred for 41% of white and 31% of nonwhite clinicians. About two-thirds of providers (67.3%) were white, and of the remainder, 26.3% were Asian, 4.4% were classified as “other,” and 2.1% were black. The respondents were aged a mean 29.7 years, and were 42.3% female.

In addition, Ms. Grant and her coauthors estimated provider SES by asking about parental SES, dividing respondents into low (less than $38,000), medium ($38,000-$75,000), and high (greater than $75,000) SES categories.

Demonstrated bias based on socioeconomic status was common, and similar across levels of provider SES, at 41%, 43%, and 38% for low, medium, and high SES residents and fellows, respectively. However, the disconnect between reported and demonstrated bias that was seen with race was not seen with SES bias, with 43%-48% of providers in each SES group reporting that they had factored patient SES into their treatment decision making.

“These results suggest that providers have low awareness of making different pain treatment decisions” for black patients, compared with decision making for white patients, Ms. Grant and her colleagues wrote. “Decision-making awareness did not substantially differ across provider race or SES.” She and her collaborators called for more research into whether raising awareness about demonstrated racial bias in decision making can improve both racial and socioeconomic gaps in pain care.

The authors reported funding from the National Institutes of Health. They reported no conflicts of interest.

[email protected]

MILWAUKEE – More than 40% of white physician trainees demonstrated racial bias in medical decision making about treatment of low back pain, as did 31% of nonwhite trainees. However, just 6% of white residents and fellows, and 10% of the nonwhite residents and fellows, reported that patient race had factored into their treatment decisions in a virtual patient task.

The 444 medical residents and fellows who participated viewed video vignettes presenting 12 virtual patients who presented with low back pain, wrote Alexis Grant of Indiana University–Purdue University Indianapolis and her colleagues. In a poster presentation at the scientific meeting of the American Pain Society, Ms. Grant, a doctoral student in clinical psychology, and her collaborators explained that participants agreed to view a series of 12 videos of virtual patients.

The videos presented male and female virtual patients who were black or white and who had jobs associated with low or high socioeconomic status (SES). Information in text vignettes accompanying the videos included occupation, pain etiology, physical exam findings, and pain intensity by self-report.

After viewing the videos and reading the vignettes, participating clinicians were asked to use a 0-100 visual analog scale to report their likelihood of referring patients to a pain specialist or to physical therapy and of recommending opioid or nonopioid analgesia.

“Next, they rated the degree to which they considered different sources of patient information when making treatment decision,” Ms. Grant and her coauthors wrote. Statistical analysis “examined the extent to which providers demonstrated statistically reliable treatment differences across patient race and SES.” These findings were compared with how clinicians reported they used patient race and SES in decision making.

Demonstrated race-based decision making occurred for 41% of white and 31% of nonwhite clinicians. About two-thirds of providers (67.3%) were white, and of the remainder, 26.3% were Asian, 4.4% were classified as “other,” and 2.1% were black. The respondents were aged a mean 29.7 years, and were 42.3% female.

In addition, Ms. Grant and her coauthors estimated provider SES by asking about parental SES, dividing respondents into low (less than $38,000), medium ($38,000-$75,000), and high (greater than $75,000) SES categories.

Demonstrated bias based on socioeconomic status was common, and similar across levels of provider SES, at 41%, 43%, and 38% for low, medium, and high SES residents and fellows, respectively. However, the disconnect between reported and demonstrated bias that was seen with race was not seen with SES bias, with 43%-48% of providers in each SES group reporting that they had factored patient SES into their treatment decision making.

“These results suggest that providers have low awareness of making different pain treatment decisions” for black patients, compared with decision making for white patients, Ms. Grant and her colleagues wrote. “Decision-making awareness did not substantially differ across provider race or SES.” She and her collaborators called for more research into whether raising awareness about demonstrated racial bias in decision making can improve both racial and socioeconomic gaps in pain care.

The authors reported funding from the National Institutes of Health. They reported no conflicts of interest.

[email protected]

MILWAUKEE – More than 40% of white physician trainees demonstrated racial bias in medical decision making about treatment of low back pain, as did 31% of nonwhite trainees. However, just 6% of white residents and fellows, and 10% of the nonwhite residents and fellows, reported that patient race had factored into their treatment decisions in a virtual patient task.

The 444 medical residents and fellows who participated viewed video vignettes presenting 12 virtual patients who presented with low back pain, wrote Alexis Grant of Indiana University–Purdue University Indianapolis and her colleagues. In a poster presentation at the scientific meeting of the American Pain Society, Ms. Grant, a doctoral student in clinical psychology, and her collaborators explained that participants agreed to view a series of 12 videos of virtual patients.

The videos presented male and female virtual patients who were black or white and who had jobs associated with low or high socioeconomic status (SES). Information in text vignettes accompanying the videos included occupation, pain etiology, physical exam findings, and pain intensity by self-report.

After viewing the videos and reading the vignettes, participating clinicians were asked to use a 0-100 visual analog scale to report their likelihood of referring patients to a pain specialist or to physical therapy and of recommending opioid or nonopioid analgesia.

“Next, they rated the degree to which they considered different sources of patient information when making treatment decision,” Ms. Grant and her coauthors wrote. Statistical analysis “examined the extent to which providers demonstrated statistically reliable treatment differences across patient race and SES.” These findings were compared with how clinicians reported they used patient race and SES in decision making.

Demonstrated race-based decision making occurred for 41% of white and 31% of nonwhite clinicians. About two-thirds of providers (67.3%) were white, and of the remainder, 26.3% were Asian, 4.4% were classified as “other,” and 2.1% were black. The respondents were aged a mean 29.7 years, and were 42.3% female.

In addition, Ms. Grant and her coauthors estimated provider SES by asking about parental SES, dividing respondents into low (less than $38,000), medium ($38,000-$75,000), and high (greater than $75,000) SES categories.

Demonstrated bias based on socioeconomic status was common, and similar across levels of provider SES, at 41%, 43%, and 38% for low, medium, and high SES residents and fellows, respectively. However, the disconnect between reported and demonstrated bias that was seen with race was not seen with SES bias, with 43%-48% of providers in each SES group reporting that they had factored patient SES into their treatment decision making.

“These results suggest that providers have low awareness of making different pain treatment decisions” for black patients, compared with decision making for white patients, Ms. Grant and her colleagues wrote. “Decision-making awareness did not substantially differ across provider race or SES.” She and her collaborators called for more research into whether raising awareness about demonstrated racial bias in decision making can improve both racial and socioeconomic gaps in pain care.

The authors reported funding from the National Institutes of Health. They reported no conflicts of interest.

[email protected]

Alvogen has issued a voluntary recall of two lots of its Fentanyl Transdermal System 12-mcg/h transdermal patches because of a product mislabeling, according to the Food and Drug Administration.

The recall was issued because a small number of cartons labeled as containing 12-mcg/h patches contained 50-mcg/h patches. The 50-mcg/h patches were labeled as such within the package. The cartons were distributed to pharmacies nationwide.

Application of a 50-mcg/h patch instead of a 12-mcg/h patch could result in serious, life-threatening, or fatal respiratory depression. Groups at potential risk for such adverse events include first-time users of the patch, children, and the elderly. No reports of serious adverse events have yet been reported.

“Pharmacies are requested not to dispense any product subject to this recall,” the FDA said in a press release. Patients who “have product subject to this recall should immediately remove any patch currently in use and contact their health care provider. Patients with unused product should return it to point of purchase for replacement.”

Find more information on the recall at the FDA website.

[email protected]

Alvogen has issued a voluntary recall of two lots of its Fentanyl Transdermal System 12-mcg/h transdermal patches because of a product mislabeling, according to the Food and Drug Administration.

The recall was issued because a small number of cartons labeled as containing 12-mcg/h patches contained 50-mcg/h patches. The 50-mcg/h patches were labeled as such within the package. The cartons were distributed to pharmacies nationwide.

Application of a 50-mcg/h patch instead of a 12-mcg/h patch could result in serious, life-threatening, or fatal respiratory depression. Groups at potential risk for such adverse events include first-time users of the patch, children, and the elderly. No reports of serious adverse events have yet been reported.

“Pharmacies are requested not to dispense any product subject to this recall,” the FDA said in a press release. Patients who “have product subject to this recall should immediately remove any patch currently in use and contact their health care provider. Patients with unused product should return it to point of purchase for replacement.”

Find more information on the recall at the FDA website.

[email protected]

Alvogen has issued a voluntary recall of two lots of its Fentanyl Transdermal System 12-mcg/h transdermal patches because of a product mislabeling, according to the Food and Drug Administration.

The recall was issued because a small number of cartons labeled as containing 12-mcg/h patches contained 50-mcg/h patches. The 50-mcg/h patches were labeled as such within the package. The cartons were distributed to pharmacies nationwide.

Application of a 50-mcg/h patch instead of a 12-mcg/h patch could result in serious, life-threatening, or fatal respiratory depression. Groups at potential risk for such adverse events include first-time users of the patch, children, and the elderly. No reports of serious adverse events have yet been reported.

“Pharmacies are requested not to dispense any product subject to this recall,” the FDA said in a press release. Patients who “have product subject to this recall should immediately remove any patch currently in use and contact their health care provider. Patients with unused product should return it to point of purchase for replacement.”

Find more information on the recall at the FDA website.

[email protected]

PHILADELPHIA – Medical marijuana research to date provides some support for its use in neuropathic pain, nausea and vomiting, and spasticity, some insights into adverse effects, and “a lot of the Wild West,” Ellie Grossman, MD, MPH, said here at the annual meeting of the American College of Physicians.

Andrew Bowser/MDedge News

The opioid-sparing effects of medical marijuana have been highlighted in recent reports suggesting that cannabis users may use less opioids, and that states with medical marijuana laws have seen drops in opioid overdose mortality, Dr. Grossman said.

“That’s kind of a story on pain and cannabinoids, and that’s really the biggest story there is in terms of medical evidence and effectiveness for this agent,” said Dr. Grossman, an instructor at Harvard Medical School and Primary Care Lead for Behavioral Health Integration, Cambridge Health Alliance, Somerville, Mass.

However, being the top story in medical marijuana may not be a very high bar in 2019, given current issues with research in this area, including inconsistencies in medical marijuana formulations, relatively small numbers of patients enrolled in studies, and meta-analyses that have produced equivocal results.

“Unfortunately, this is an area where there’s a lot of, shall I say, ‘squishiness’ in the data, through no fault of the researchers involved – it’s just an area that’s really hard to study,” Dr. Goodman said in her update on medical marijuana use at the meeting.

Most studies of cannabinoids for chronic pain have compared these agents to placebo, rather than the long list of other medications that might be used to treat pain, Dr. Grossman said.

There are several meta-analyses available, including a recently published Cochrane review in which authors concluded that, for neuropathic pain, the potential benefits of cannabis-based medicines may outweigh their potential harms.

“The upshot here is that there may be some evidence for neuropathic pain, but the evidence is generally of poor quality and kind of mixed,” said Dr. Grossman.

State-level medical cannabis laws were linked to significantly lower opioid overdose mortality rates in a 2014 study (JAMA Intern Med. 2014;174[10]:1668-73). In more recent studies, states with medical cannabis laws were found to have lower Medicare Part D opioid-prescribing rates, and in another study, legalization of medical marijuana was linked to lower rates of chronic and high-risk opioid use.

“It certainly seems like maybe we as prescribers are prescribing [fewer] opioids if there’s medical cannabis around,” Dr. Grossman said. “What this means for our patients in the short term and long term, we don’t totally know. But clearly, fewer opioid overdoses is a way better thing than more, so there could be something here.”

The cannabinoids approved by the Food and Drug Administration include nabilone (Cesamet) and dronabinol (Marinol), both synthetic cannabinoids indicated for cancer chemotherapy–related nausea and vomiting, along with cannabidiol (Epidiolex), just approved in June 2018 for treatment of some rare pediatric refractory epilepsy syndromes, Dr. Grossman said.

For chemotherapy-induced nausea and vomiting, evidence suggests oral cannabinoids are more effective than placebo, but there’s mixed evidence as to whether they are better than other antiemetics, Dr. Grossman said, while in terms of spasticity related to multiple sclerosis, research has shown small improvements in patient-reported symptoms.

Long-term adverse event data specific to medical marijuana are scant, with much of the evidence coming from studies of recreational marijuana users, Dr. Grossman said.

Those long-term effects include increased risk of pulmonary effects such as cough, wheeze, and phlegm that improve with discontinuation; case reports of unintentional pediatric ingestions; and lower neonatal birth weight, which should be discussed with women of reproductive age who are using or considering medical marijuana, Dr. Grossman said.

Motor vehicle accidents, development of psychiatric symptoms, and psychosis relapse also have been linked to use, she said.

Some real-world adverse event data specific to medical marijuana data are available through the Minnesota medical cannabis program. They found 16% of surveyed users reported an adverse event within the first 4 months, including dry mouth, fatigue, mental clouding, and drowsiness, Dr. Grossman told attendees.

Dr. Grossman reported that she has no relationship with entities producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients.

SOURCE: Grossman E. ACP 2019, Presentation MTP 010.

PHILADELPHIA – Medical marijuana research to date provides some support for its use in neuropathic pain, nausea and vomiting, and spasticity, some insights into adverse effects, and “a lot of the Wild West,” Ellie Grossman, MD, MPH, said here at the annual meeting of the American College of Physicians.

Andrew Bowser/MDedge News

The opioid-sparing effects of medical marijuana have been highlighted in recent reports suggesting that cannabis users may use less opioids, and that states with medical marijuana laws have seen drops in opioid overdose mortality, Dr. Grossman said.

“That’s kind of a story on pain and cannabinoids, and that’s really the biggest story there is in terms of medical evidence and effectiveness for this agent,” said Dr. Grossman, an instructor at Harvard Medical School and Primary Care Lead for Behavioral Health Integration, Cambridge Health Alliance, Somerville, Mass.

However, being the top story in medical marijuana may not be a very high bar in 2019, given current issues with research in this area, including inconsistencies in medical marijuana formulations, relatively small numbers of patients enrolled in studies, and meta-analyses that have produced equivocal results.

“Unfortunately, this is an area where there’s a lot of, shall I say, ‘squishiness’ in the data, through no fault of the researchers involved – it’s just an area that’s really hard to study,” Dr. Goodman said in her update on medical marijuana use at the meeting.

Most studies of cannabinoids for chronic pain have compared these agents to placebo, rather than the long list of other medications that might be used to treat pain, Dr. Grossman said.

There are several meta-analyses available, including a recently published Cochrane review in which authors concluded that, for neuropathic pain, the potential benefits of cannabis-based medicines may outweigh their potential harms.

“The upshot here is that there may be some evidence for neuropathic pain, but the evidence is generally of poor quality and kind of mixed,” said Dr. Grossman.

State-level medical cannabis laws were linked to significantly lower opioid overdose mortality rates in a 2014 study (JAMA Intern Med. 2014;174[10]:1668-73). In more recent studies, states with medical cannabis laws were found to have lower Medicare Part D opioid-prescribing rates, and in another study, legalization of medical marijuana was linked to lower rates of chronic and high-risk opioid use.

“It certainly seems like maybe we as prescribers are prescribing [fewer] opioids if there’s medical cannabis around,” Dr. Grossman said. “What this means for our patients in the short term and long term, we don’t totally know. But clearly, fewer opioid overdoses is a way better thing than more, so there could be something here.”

The cannabinoids approved by the Food and Drug Administration include nabilone (Cesamet) and dronabinol (Marinol), both synthetic cannabinoids indicated for cancer chemotherapy–related nausea and vomiting, along with cannabidiol (Epidiolex), just approved in June 2018 for treatment of some rare pediatric refractory epilepsy syndromes, Dr. Grossman said.

For chemotherapy-induced nausea and vomiting, evidence suggests oral cannabinoids are more effective than placebo, but there’s mixed evidence as to whether they are better than other antiemetics, Dr. Grossman said, while in terms of spasticity related to multiple sclerosis, research has shown small improvements in patient-reported symptoms.

Long-term adverse event data specific to medical marijuana are scant, with much of the evidence coming from studies of recreational marijuana users, Dr. Grossman said.

Those long-term effects include increased risk of pulmonary effects such as cough, wheeze, and phlegm that improve with discontinuation; case reports of unintentional pediatric ingestions; and lower neonatal birth weight, which should be discussed with women of reproductive age who are using or considering medical marijuana, Dr. Grossman said.

Motor vehicle accidents, development of psychiatric symptoms, and psychosis relapse also have been linked to use, she said.

Some real-world adverse event data specific to medical marijuana data are available through the Minnesota medical cannabis program. They found 16% of surveyed users reported an adverse event within the first 4 months, including dry mouth, fatigue, mental clouding, and drowsiness, Dr. Grossman told attendees.

Dr. Grossman reported that she has no relationship with entities producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients.

SOURCE: Grossman E. ACP 2019, Presentation MTP 010.

PHILADELPHIA – Medical marijuana research to date provides some support for its use in neuropathic pain, nausea and vomiting, and spasticity, some insights into adverse effects, and “a lot of the Wild West,” Ellie Grossman, MD, MPH, said here at the annual meeting of the American College of Physicians.

Andrew Bowser/MDedge News

The opioid-sparing effects of medical marijuana have been highlighted in recent reports suggesting that cannabis users may use less opioids, and that states with medical marijuana laws have seen drops in opioid overdose mortality, Dr. Grossman said.

“That’s kind of a story on pain and cannabinoids, and that’s really the biggest story there is in terms of medical evidence and effectiveness for this agent,” said Dr. Grossman, an instructor at Harvard Medical School and Primary Care Lead for Behavioral Health Integration, Cambridge Health Alliance, Somerville, Mass.

However, being the top story in medical marijuana may not be a very high bar in 2019, given current issues with research in this area, including inconsistencies in medical marijuana formulations, relatively small numbers of patients enrolled in studies, and meta-analyses that have produced equivocal results.

“Unfortunately, this is an area where there’s a lot of, shall I say, ‘squishiness’ in the data, through no fault of the researchers involved – it’s just an area that’s really hard to study,” Dr. Goodman said in her update on medical marijuana use at the meeting.

Most studies of cannabinoids for chronic pain have compared these agents to placebo, rather than the long list of other medications that might be used to treat pain, Dr. Grossman said.

There are several meta-analyses available, including a recently published Cochrane review in which authors concluded that, for neuropathic pain, the potential benefits of cannabis-based medicines may outweigh their potential harms.

“The upshot here is that there may be some evidence for neuropathic pain, but the evidence is generally of poor quality and kind of mixed,” said Dr. Grossman.

State-level medical cannabis laws were linked to significantly lower opioid overdose mortality rates in a 2014 study (JAMA Intern Med. 2014;174[10]:1668-73). In more recent studies, states with medical cannabis laws were found to have lower Medicare Part D opioid-prescribing rates, and in another study, legalization of medical marijuana was linked to lower rates of chronic and high-risk opioid use.

“It certainly seems like maybe we as prescribers are prescribing [fewer] opioids if there’s medical cannabis around,” Dr. Grossman said. “What this means for our patients in the short term and long term, we don’t totally know. But clearly, fewer opioid overdoses is a way better thing than more, so there could be something here.”

The cannabinoids approved by the Food and Drug Administration include nabilone (Cesamet) and dronabinol (Marinol), both synthetic cannabinoids indicated for cancer chemotherapy–related nausea and vomiting, along with cannabidiol (Epidiolex), just approved in June 2018 for treatment of some rare pediatric refractory epilepsy syndromes, Dr. Grossman said.

For chemotherapy-induced nausea and vomiting, evidence suggests oral cannabinoids are more effective than placebo, but there’s mixed evidence as to whether they are better than other antiemetics, Dr. Grossman said, while in terms of spasticity related to multiple sclerosis, research has shown small improvements in patient-reported symptoms.

Long-term adverse event data specific to medical marijuana are scant, with much of the evidence coming from studies of recreational marijuana users, Dr. Grossman said.

Those long-term effects include increased risk of pulmonary effects such as cough, wheeze, and phlegm that improve with discontinuation; case reports of unintentional pediatric ingestions; and lower neonatal birth weight, which should be discussed with women of reproductive age who are using or considering medical marijuana, Dr. Grossman said.

Motor vehicle accidents, development of psychiatric symptoms, and psychosis relapse also have been linked to use, she said.

Some real-world adverse event data specific to medical marijuana data are available through the Minnesota medical cannabis program. They found 16% of surveyed users reported an adverse event within the first 4 months, including dry mouth, fatigue, mental clouding, and drowsiness, Dr. Grossman told attendees.

Dr. Grossman reported that she has no relationship with entities producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients.

SOURCE: Grossman E. ACP 2019, Presentation MTP 010.

PHILADELPHIA – Nearly 7%-10% of the general population experiences neuropathic pain, but studies on treatments have not found a clear winner for reducing this “burning or electriclike pain,” explained Raymond Price, MD, during a presentation.

Andrew Bowser/MDedge News

“It isn’t that exciting,” said Dr. Price, associate professor of neurology at the University of Pennsylvania, Philadelphia, in reference to his review of level 1-2 evidence for treatment of neuropathic pain that was presented in a study published in JAMA (2015 Nov 24;314[20]:2172-81). a few years ago. “On a scale of 1 to 10, you can reduce their pain scale by 1-2 points more than placebo,” he told his audience at the annual meeting of the American College of Physicians.

“In general, you can use any of these medicines [for neuropathic pain]. There are very limited head-to-head data as to which one is actually better,” he explained.

Given the absence of robust head-to-head trial data, Dr. Price tends to start a lot of patients on old, cheap medications like nortriptyline.

While there aren’t many head-to-head trials to guide treatment choice, the results of one prospective, randomized, open-label study of 333 patients with cryptogenic sensory polyneuropathy was presented by Barohn and colleagues at the 2018 annual meeting of the American Academy of Neurology, he said. In that study, somewhat higher efficacy rates were seen with duloxetine, a serotonin-noradrenaline reuptake inhibitor, and nortriptyline, a tricyclic antidepressant, compared with pregabalin, Dr. Price noted. Duloxetine and nortriptyline also had slightly better tolerability, as evidenced by a lower quit rate, compared with pregabalin, he added.

There was also a systematic review and meta-analysis (Lancet Neurol. 2015 Feb; 14[2]:162-73) conducted that determined the number needed to treat for neuropathic pain treatments, Dr. Price noted. In that paper, tricyclic antidepressants had a number needed to treat of 3.6, comparing favorably to 7.7 for pregabalin, 7.2 for gabapentin, and 6.4 for serotonin-noradrenaline reuptake inhibitors, mainly including duloxetine, said Dr. Price.

Regardless of the cause of neuropathic pain, the same general approach to treatment is taken, though most of the evidence comes from studies of patients with painful diabetic peripheral neuropathy or postherpetic neuralgia, he added.

For these patients, an adequate trial of a neuropathic pain treatment should be 6-12 weeks, reflecting the length of the intervention needed to demonstrate the efficacy of these agents, he said.

If that first drug doesn’t work, another can be tried, or multiple drugs can be tried together to see if the patient’s condition improves, he said.

Dr. Price reported no conflicts of interest.
 

SOURCE: Price R Internal Medicine 2019, Presentation MSFM 002.

PHILADELPHIA – Nearly 7%-10% of the general population experiences neuropathic pain, but studies on treatments have not found a clear winner for reducing this “burning or electriclike pain,” explained Raymond Price, MD, during a presentation.

Andrew Bowser/MDedge News

“It isn’t that exciting,” said Dr. Price, associate professor of neurology at the University of Pennsylvania, Philadelphia, in reference to his review of level 1-2 evidence for treatment of neuropathic pain that was presented in a study published in JAMA (2015 Nov 24;314[20]:2172-81). a few years ago. “On a scale of 1 to 10, you can reduce their pain scale by 1-2 points more than placebo,” he told his audience at the annual meeting of the American College of Physicians.

“In general, you can use any of these medicines [for neuropathic pain]. There are very limited head-to-head data as to which one is actually better,” he explained.

Given the absence of robust head-to-head trial data, Dr. Price tends to start a lot of patients on old, cheap medications like nortriptyline.

While there aren’t many head-to-head trials to guide treatment choice, the results of one prospective, randomized, open-label study of 333 patients with cryptogenic sensory polyneuropathy was presented by Barohn and colleagues at the 2018 annual meeting of the American Academy of Neurology, he said. In that study, somewhat higher efficacy rates were seen with duloxetine, a serotonin-noradrenaline reuptake inhibitor, and nortriptyline, a tricyclic antidepressant, compared with pregabalin, Dr. Price noted. Duloxetine and nortriptyline also had slightly better tolerability, as evidenced by a lower quit rate, compared with pregabalin, he added.

There was also a systematic review and meta-analysis (Lancet Neurol. 2015 Feb; 14[2]:162-73) conducted that determined the number needed to treat for neuropathic pain treatments, Dr. Price noted. In that paper, tricyclic antidepressants had a number needed to treat of 3.6, comparing favorably to 7.7 for pregabalin, 7.2 for gabapentin, and 6.4 for serotonin-noradrenaline reuptake inhibitors, mainly including duloxetine, said Dr. Price.

Regardless of the cause of neuropathic pain, the same general approach to treatment is taken, though most of the evidence comes from studies of patients with painful diabetic peripheral neuropathy or postherpetic neuralgia, he added.

For these patients, an adequate trial of a neuropathic pain treatment should be 6-12 weeks, reflecting the length of the intervention needed to demonstrate the efficacy of these agents, he said.

If that first drug doesn’t work, another can be tried, or multiple drugs can be tried together to see if the patient’s condition improves, he said.

Dr. Price reported no conflicts of interest.
 

SOURCE: Price R Internal Medicine 2019, Presentation MSFM 002.

PHILADELPHIA – Nearly 7%-10% of the general population experiences neuropathic pain, but studies on treatments have not found a clear winner for reducing this “burning or electriclike pain,” explained Raymond Price, MD, during a presentation.

Andrew Bowser/MDedge News

“It isn’t that exciting,” said Dr. Price, associate professor of neurology at the University of Pennsylvania, Philadelphia, in reference to his review of level 1-2 evidence for treatment of neuropathic pain that was presented in a study published in JAMA (2015 Nov 24;314[20]:2172-81). a few years ago. “On a scale of 1 to 10, you can reduce their pain scale by 1-2 points more than placebo,” he told his audience at the annual meeting of the American College of Physicians.

“In general, you can use any of these medicines [for neuropathic pain]. There are very limited head-to-head data as to which one is actually better,” he explained.

Given the absence of robust head-to-head trial data, Dr. Price tends to start a lot of patients on old, cheap medications like nortriptyline.

While there aren’t many head-to-head trials to guide treatment choice, the results of one prospective, randomized, open-label study of 333 patients with cryptogenic sensory polyneuropathy was presented by Barohn and colleagues at the 2018 annual meeting of the American Academy of Neurology, he said. In that study, somewhat higher efficacy rates were seen with duloxetine, a serotonin-noradrenaline reuptake inhibitor, and nortriptyline, a tricyclic antidepressant, compared with pregabalin, Dr. Price noted. Duloxetine and nortriptyline also had slightly better tolerability, as evidenced by a lower quit rate, compared with pregabalin, he added.

There was also a systematic review and meta-analysis (Lancet Neurol. 2015 Feb; 14[2]:162-73) conducted that determined the number needed to treat for neuropathic pain treatments, Dr. Price noted. In that paper, tricyclic antidepressants had a number needed to treat of 3.6, comparing favorably to 7.7 for pregabalin, 7.2 for gabapentin, and 6.4 for serotonin-noradrenaline reuptake inhibitors, mainly including duloxetine, said Dr. Price.

Regardless of the cause of neuropathic pain, the same general approach to treatment is taken, though most of the evidence comes from studies of patients with painful diabetic peripheral neuropathy or postherpetic neuralgia, he added.

For these patients, an adequate trial of a neuropathic pain treatment should be 6-12 weeks, reflecting the length of the intervention needed to demonstrate the efficacy of these agents, he said.

If that first drug doesn’t work, another can be tried, or multiple drugs can be tried together to see if the patient’s condition improves, he said.

Dr. Price reported no conflicts of interest.
 

SOURCE: Price R Internal Medicine 2019, Presentation MSFM 002.

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. The study, they explained, extends laboratory-based work on cognitive dysfunction in fibromyalgia to a real-world setting 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.

[email protected]

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. The study, they explained, extends laboratory-based work on cognitive dysfunction in fibromyalgia to a real-world setting 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.

[email protected]

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. The study, they explained, extends laboratory-based work on cognitive dysfunction in fibromyalgia to a real-world setting 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.

[email protected]

SOURCE: Kratz A et al. APS 2019, Poster 117.

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.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA has recently received reports that patients physically dependent on opioid pain medicines who are taken off their medication too quickly have experienced serious adverse events, 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.

[email protected]

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.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA has recently received reports that patients physically dependent on opioid pain medicines who are taken off their medication too quickly have experienced serious adverse events, 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.

[email protected]

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.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA has recently received reports that patients physically dependent on opioid pain medicines who are taken off their medication too quickly have experienced serious adverse events, 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.

[email protected]

The Food and Drug Administration approved romosozumab-aqqg (Evenity) for treating osteoporosis in postmenopausal women who are at high risk for fracture.

“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.

[email protected]

The Food and Drug Administration approved romosozumab-aqqg (Evenity) for treating osteoporosis in postmenopausal women who are at high risk for fracture.

“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.

[email protected]

The Food and Drug Administration approved romosozumab-aqqg (Evenity) for treating osteoporosis in postmenopausal women who are at high risk for fracture.

“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.

[email protected]

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 Helping to End Addiction Long-term (HEAL) initiative has over $850 million in total obligated for fiscal year 2019, 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.

[email protected]

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 Helping to End Addiction Long-term (HEAL) initiative has over $850 million in total obligated for fiscal year 2019, 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.

[email protected]

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 Helping to End Addiction Long-term (HEAL) initiative has over $850 million in total obligated for fiscal year 2019, 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.

[email protected]

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

Electrical and Cold Laser Modalities

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

Electrical and Cold Laser Modalities

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

Electrical and Cold Laser Modalities

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.

MILWAUKEE – A new study of children with sickle cell disease found prevalent opioid use, with one in five preschoolers having had an opioid prescribed and filled for them.

Kari Oakes/MDedge News

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.

[email protected]

SOURCE: Crego, N. et al. APS 2019.

MILWAUKEE – A new study of children with sickle cell disease found prevalent opioid use, with one in five preschoolers having had an opioid prescribed and filled for them.

Kari Oakes/MDedge News

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.

[email protected]

SOURCE: Crego, N. et al. APS 2019.

MILWAUKEE – A new study of children with sickle cell disease found prevalent opioid use, with one in five preschoolers having had an opioid prescribed and filled for them.

Kari Oakes/MDedge News

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.

[email protected]

SOURCE: Crego, N. et al. APS 2019.