Muscle Relaxants Ineffective for Low Back Pain and Fibromyalgia

By Pat Anson

Muscle relaxants are increasingly prescribed “off label” as an alternative to opioid medication, but according to a new analysis they are no more effective than a placebo in treating fibromyalgia and low back pain. They may be beneficial, however, for patients suffering from muscle cramps, neck pain and trigeminal neuralgia.

Researchers reviewed 44 studies involving nearly 2,500 patients who were prescribed a muscle relaxant for various pain conditions. Nine skeletal muscle relaxants (SMRs) were assessed, drugs that were initially developed and then approved by the FDA as anti-spasticity and anti-spasmodic medications:

• Carisoprodol (Soma)

• Baclofen

• Tizanidine

• Cyclobenzaprine

• Eperisone

• Quinine

• Orphenadrine

• Chlormezanone

• Methocarbamol

Despite a lack of evidence on their effectiveness beyond 3 weeks, prescribing of SMRs doubled between 2005 and 2016, with office visits for refills of SMR prescriptions tripling over the same period, indicating they were increasingly being used long-term and off-label. According to a 2021 study, over a third of patients prescribed SMRs did not have a musculoskeletal disorder, a sign of “unnecessary or inappropriate use.”

Researchers involved in the current study, published in JAMA Network Open, reached a similar conclusion that muscle relaxants are overprescribed.

“Despite increasing prevalence and increasing risks of their use, our systematic review suggests only limited evidence of efficacy for long-term use of SMRs for a small subset of pain syndromes,” wrote lead author Benjamin Oldfield, MD, an Assistant Clinical Professor of Internal Medicine at Yale School of Medicine.

“Evidence for effectiveness was strongest for SMRs used for muscle spasms, painful cramps, and neck pain; in studies of SMRs for fibromyalgia, low back pain, headaches, and other syndromes, some showed small benefits and some did not, and on balance studies did not suggest a benefit.”

Oldfield and his colleagues say physicians should consider deprescribing SMRs to pain patients who have been using them long-term without apparent benefit.   

Adverse side effects from SMRs include sedation, somnolence, dizziness and dry mouth. The FDA also warns against taking the drugs with opioids, which could raise the risk of respiratory depression and overdose.

SMRs also increase the risk of falls, fractures, and vehicle crashes. Because of those risks, muscle relaxants should be avoided altogether in elderly patients, according to the American Geriatrics Society.

The Best Remedy for Low Back Pain? Go for a Walk

By Pat Anson, PNN Editor

Almost everyone experiences low back pain at some point in their lives. Repeated episodes of acute low back pain are also very common, with 70% of people who recover from one episode having another one within a year.

Is there any reliable way to end the cycle before low back pain turns chronic?

A new Australian study suggests the best and most cost-effective way to keep low back pain from returning is simple: Go for a walk.

Researchers at Macquarie University’s Spinal Pain Research Group enrolled 701 adults who recently recovered from low back pain in a clinical trial. Half were randomly assigned to an individualized walking and education program led by a physiotherapist for six months; while the other half served as a control group, receiving no treatment at all.

Participants in the walking group were encouraged to walk five times a week for at least 30 minutes, but were free to do more or less. Most gradually increased their walking, with the average amount of walking time doubling in the first 3 months.

Both groups were then followed for at least one year, with researchers tracking any recurrences of low back pain lasting at least 24 hours that were severe enough to limit daily activities.

The study findings, recently published in The Lancet, show that participants in the control group had a recurrence of low back pain after 112 days on average, while those in the walking group were pain free nearly twice as long, a median of 208 days. The overall risk of having a new episode of low back pain fell by 28% for the walkers.

“We don’t know exactly why walking is so good for preventing back pain, but it is likely to include the combination of the gentle oscillatory movements, loading and strengthening the spinal structures and muscles, relaxation and stress relief, and release of ‘feel-good’ endorphins,” said senior author Mark Hancock, PhD, a Professor of Physiotherapy at Macquarie University.

"And of course, we also know that walking comes with many other health benefits, including cardiovascular health, bone density, healthy weight, and improved mental health.”

Another benefit is cost. A significantly higher percentages of participants in the control group sought treatment from massage therapists, chiropractors, physiotherapists and other healthcare providers.

While it’s hard to assign a dollar number to quality of life, researchers estimate the total cost-effectiveness of walking vs. no treatment at AU$7,802. In U.S. dollars, that’s $5,190.    

“It not only improved people’s quality of life, but it reduced their need both to seek healthcare support and the amount of time taken off work by approximately half,” said lead author Natasha Pocovi, PhD, a Postdoctoral Fellow at Macquarie University.

In 2023, the World Health Organization (WHO) released its first guideline for managing low back pain, recommending treatments such as exercise, physical therapy, and patient education. Pocovi and her colleagues say a regular program of walking would be a cheaper alternative to joining a gym or hiring a trainer.

“The exercise-based interventions to prevent back pain that have been explored previously are typically group-based and need close clinical supervision and expensive equipment, so they are much less accessible to the majority of patients,” Pocovi said. “Our study has shown that this effective and accessible means of exercise has the potential to be successfully implemented at a much larger scale than other forms of exercise.”

Low back pain is the leading cause of disability worldwide. According to a 2022 Harris Poll, nearly 3 out of 10 U.S. adults live with chronic low back pain. On average, the typical back pain sufferer seeks relief from at least three healthcare providers, with many treatments proving ineffective.   

Seniors Surprisingly Eager To Try Virtual Reality Therapy for Pain

By Pat Anson, PNN Editor

When it comes to using new technology or acquiring new skills, older people have a reputation for being a little slow on the uptake. A Baby Boomer nearing 70, for example, might not rush out to buy the latest iPhone, while someone from GenZ or a Millennial would.

A new study of virtual reality (VR) therapy is proving how misguided that assumption is. Older people can indeed learn new things and benefit from them.

In a secondary analysis of a placebo controlled clinical trial, people over 65 were significantly more likely to use RelieVRx, a virtual reality program that distracts patients with back pain by immersing them in a “virtual” environment where they can swim with dolphins, play games or enjoy beautiful scenery.   

A demographically diverse group of over 1,000 patients with chronic low back pain participated in the 8-week trial, with the goal of spending a few minutes at home each day watching a RelieVRx program.

By the end of the study, pain scores were reduced by an average of 2 points on a zero to 10 pain scale.

The positive results were across the board, regardless of a person’s age, sex, ethnicity, income or education.

What stood out to researchers is that seniors were significantly more likely to use the devices daily – 47 times on average – compared to those under age 65 (37.6 times)

APPLIEDVR IMAGE

“We had the opportunity to do a deeper dive, and really see how the results were unfolding in younger adults versus older adults, and really found very good engagement with older adults 65 or older,” says Beth Darnall, PhD, Chief Science Advisor for AppliedVR, which makes the RelieVRx headset and programming. 

“What's important about this study and also interesting is that it challenges a very common misperception about older adults. That older people are low tech, disinterested in engaging with newer innovations. We actually saw great engagement among the older adults, as well as a great reduction in symptoms. It suggests that older adults are much more receptive to this type of an approach and that it's also very effective in this population.” 

There are a few caveats to the findings. Many older people are retired and have more time on their hands to participate in a home-based study like this. And since all the patients were recruited online, they may have already been tech savvy enough to wear the VR headset and make it work for them.

RelieVRx is currently being used in hundreds of hospitals and in the Veterans Affairs (VA) system. Patients who’ve tried VR seem to like it, regardless of their backgrounds.

“The VA patients are generally pretty different than the rest of the civilian populations,” says Josh Sackman, president and co-founder of AppliedVR. “The usage is fairly consistent, even with a VA patient prescribed by a doctor who has no exposure to what VR is ahead of time.” 

VR therapy is a form of mindfulness or cognitive behavioral therapy. It doesn’t cure or relieve physical pain, but distracts patients long enough that their symptoms seem less severe. A 2022 study found that VR therapy has long-lasting benefits up to six months after treatment stopped.

The FDA has authorized the marketing of EaseVRx for chronic low back pain in adults, the first medical device of its kind to receive that designation. EaseVRx is only available by prescription and can’t be purchased directly by consumers.

In the coming months, AppliedVR hopes to expand coverage of the device through Medicare, Medicaid, and at least one large commercial insurer.

New Physical Therapy Helps Older Adults with Chronic Low Back Pain

By Pat Anson, PNN Editor

Older adults suffering from chronic low back pain experienced faster pain relief after getting a new type of physical therapy focused on strengthening their hip muscles, according to a new study.

The study findings, recently reported in The Lancet Rheumatology, are notable given the limited research on back pain therapies for older adults.

“Unfortunately, the societal attitude is that older people don’t warrant the same level of care that younger people do when it comes to musculoskeletal problems,” lead author Gregory Hicks, PhD, Distinguished Professor of Health Sciences at the University of Delaware, said in a press release.

“When I started this work, there were a lot of naysayers. I’d tell them, ‘Read the literature — why are we excluding older adults from low back pain research?’ We all hope to get older. Why ignore a place in time where we all hope to end up?”

Hicks and his colleagues enrolled 184 people aged 60 or older who reported moderate low back pain, hip pain, and muscle weakness for at least 6 months. Patients were randomly assigned to a hip-focused physical therapy known as Manual Therapy and Strengthening the Hip (MASH) or a more traditional physical therapy for back pain that focused on the spine. Both groups received therapy for eight weeks at the University of Delaware, Duke University or the University of Pittsburgh.

Researchers found that participants who received the MASH therapy had more pain relief after eight weeks than those who had spine-focused therapy. They also showed more improvement in walking endurance and in their ability to rise from a seated position. However, after six months, both groups showed similar levels of improvement.

Previous research by Hicks, funded by the National Institutes of Health, has studied the impact of hip impairment, vitamin D deficiency, and trunk muscle composition in older patients with low back pain. He learned that there were distinct sub-groups of patients with back pain who had unique characteristics and treatment needs.

“It’s becoming quite clear, if you make the assumption that all low back pain is the same, you’re wrong,” said Hicks. “If you can identify sub-groups of low back pain patients with similar traits, you can develop matched treatments, which hopefully lead to better outcomes.”

Low back pain is the leading cause of disability worldwide. According to a recent Harris Poll, nearly 3 out of 10 U.S. adults currently suffer from chronic low back pain, surpassing the number of Americans who have arthritis, diabetes or heart disease. On average, the typical back pain sufferer has sought relief from at least three healthcare providers, with many treatments such as epidural steroid injections proving ineffective.   

Blacks and Hispanics More Likely to Develop Chronic Back Pain

By Pat Anson, PNN Editor

Chronic lower back pain is the leading cause of disability worldwide, with an estimated 72 million people suffering from it in the United States alone.   

New research suggests that Black and Hispanic Americans are significantly more likely to develop “high-impact” lower back pain than Whites. High impact pain is chronic pain that lasts at least six months and is severe enough to interfere with daily life or work activities.

Researchers at Boston Medical Center analyzed health data for over 9,000 patients experiencing acute lower back pain, who were being treated at primary care practices in the Baltimore, Boston, Pittsburgh and Salt Lake City areas.

After six months, patients who were Black (30%) or Hispanic (25%) were more likely than White patients (15%) to develop high impact chronic lower back pain. The Black and Hispanic patients were more likely to be younger, female, obese, have Medicaid insurance, and at higher risk of disability. They were also about half as likely to be prescribed opioids than Whites after their initial visit to a doctor.

“Our study has highlighted both a concern in the absolute number of patients with acute low back pain who develop chronic low back pain and concerns about racial and ethnic disparities in outcomes,” said lead author Eric Roseen, DC, director of the Program for Integrative Medicine and Health Disparities at Boston Medical Center.

“High-impact chronic pain has a negative impact on the lives of millions of Americans, particularly Black Americans, yet possible and significant causes of racial and ethnic disparities in long-term pain outcomes remain understudied and largely unaddressed. The disparities that emerged in this study shed light on the direct correlation among lived experiences, physical, and mental health, which must be addressed in order to improve patient outcomes.”

Roseen and his colleagues reported in the journal Pain Medicine that the risk of developing high-impact chronic pain was highest among Black women. They attribute that partially to socioeconomic reasons, suggesting that racial and ethnic differences in health insurance or neighborhood resources may impact the long-term outcomes of patients with new episodes of low back pain. 

Getting effective treatment for low back pain is problematic, regardless of race or ethnic group. A recent Harris Poll of over 5,000 U.S. adults found that over a third of those with chronic low back pain have never been told by a healthcare professional what causes their pain. Nearly half said they’ve experienced back pain for at least five years.

The survey found the typical back pain sufferer had sought relief from at least three different healthcare providers. About one in five had epidural steroid injections, which were rated as one of the least effective treatments for chronic low back pain. Opioid pain medication was rated as the most effective treatment, slightly ahead of physical therapy, chiropractic care and acupuncture.

Physical Therapy Reduces Healthcare Costs for Low Back Pain

By Pat Anson, PNN Editor

Almost everyone suffers from low back pain at some point in their lives. Most recover in a few days, but for some the pain lingers and become chronic, making low back pain the world’s leading cause of disability.  

Why are some people able to recover quickly from low back pain?

For many, the answer may be early treatment with physical therapy (PT), according to a new study by researchers at Johns Hopkins Medicine.   

“Our goal was to determine if early PT for patients with lower back pain had an impact on their overall health care resource utilization,” says senior author Richard Skolasky Jr., ScD, director of the Johns Hopkins Spine Outcomes Research Center. “We were especially curious about the 30 days after initial symptom onset, as this is when patients are most likely to seek care.” 

Skolasky and his colleagues analyzed healthcare data from 2010 to 2014 for nearly a million U.S. adults with acute low back pain, excluding those suffering from serious disorders such as arthritis or spinal cord injuries. About 10% of the patients received early treatment with physical therapy.

The study findings, recently published by BMC Health Services Research, showed that patients getting early PT were significantly less likely to see a chiropractor, orthopedic surgeon or pain specialist after 30 days than those who did not get physical therapy. They were also less likely to get advanced imaging, epidural steroid injections or to visit an emergency room.

Researchers estimate that healthcare costs for a typical patient getting early PT was about $500 less over 30 days than those not receiving physical therapy.

Another key finding from the study was significant geographical differences in the use of physical therapy. Patients in the West (16%) and Northeast (15%) were nearly twice as likely to get early PT than those in the Midwest (9.4%) and South (8.6%). The authors offered no explanation for why treatment patterns varied so much by region.

The study did not specifically examine whether physical therapy benefits patients with low back pain more than other forms of treatment, but the findings suggest that they did. Researchers say health outcomes should be examined more closely in future studies.

“As the U.S. population ages, the prevalence of lower back pain is expected to increase, along with the associated costs of treating it,” says Skolasky. “Furthermore, with advances in imaging and treatments, the cost of managing lower back pain has increased substantially. Our findings have important implications that may guide health care policy when examining downstream health care costs and resource utilization.” 

Previous studies have found that physical therapy and regular exercise significantly reduces low back pain. Other studies also found little evidence to support the use of opioids, spinal injections and acetaminophen for low back pain.  

Virtual Reality Shows Long Term Benefits for Chronic Low Back Pain

By Pat Anson, PNN Editor

Critics of virtual reality therapy often say it’s a poor treatment for chronic pain because it only distracts patients from their pain and that the effects are temporary, at best.

But new research suggests that the benefits of virtual reality (VR) can last six months after treatment has stopped – at least for patients with chronic low back pain.

The study, published in the Journal of Medical Internet Research, followed 188 people with chronic low back pain who had an average pain intensity score of 5 on a zero to 10 point scale.

Half the participants were given an EaseVRx headset to watch 3-D programs daily for 8 weeks, immersing themselves in a “virtual” environment where they can swim with dolphins, play games or enjoy beautiful scenery. The goal is help patients learn how to manage pain through cognitive behavioral therapy.  

The other patients also used the EaseVRx headset, but only watched routine nature scenes as a placebo or sham VR treatment.  

JOURNAL OF MEDICAL INTERNET RESEARCH

Patients were followed for six months after treatment was stopped. Participants in both groups reported improvement in their pain and other symptoms six months after treatment, but the improvements were more significant in those who received VR therapy. Pain intensity was 31% lower for patients in the VR group, compared to 16% in the sham group. Physical function, mood, sleep and pain-related interference in activity were also better in those who received VR therapy. No adverse side effects were reported in either group.

“We have been pleasantly pleased and surprised that patients are maintaining clinically meaningful changes in pain intensity and interference 6 months after returning the device. It appears people are actually acquiring skills in a relatively short period that they continue to retain/apply months after treatment,” said Josh Sackman, co-founder and president of AppliedVR, which makes the EaseVRx headset.

AppliedVR is planning more research to see how patients respond long-term to VR treatment. A brain imaging study is being conducted to measure brain activity before, during and after treatment. Patients are also being recruited for a large clinical trial to see how VR therapy impacts pharmacy and medical claims.  

“In order to drive real acceptance, we are committed to extensive research to address any skepticism people may have,” Sackman told PNN.

The EaseVRx headset was given a Breakthrough Device Designation by the FDA in 2020 for fibromyalgia and low back pain. Last year the agency authorized the marketing of the headset for chronic low back pain in adults, the first medical device of its kind to receive that designation.

EaseVRx headsets are currently being used for pain management in over 200 hospitals and healthcare systems. A full commercial launch for home-based use is not expected until next year.

Follow Treatment Guidelines for Low Back Pain and Get Back to Work Sooner

By Pat Anson, PNN Editor

Employees with acute low back pain miss fewer days of work if they exercise, take over-the-counter pain relievers and are not prescribed opioid medication, according to a large new study of worker compensation claims in California.

"The closer people's care follows evidence-based guidelines, the faster their back pain resolves, by quite a bit," said Kurt Hegmann, MD, director of the University of Utah Rocky Mountain Center for Occupational and Environmental Health.

Hegmann and his colleagues analyzed insurance data for nearly 60,000 people with low back pain from 2009 to 2018, comparing their treatment to guidelines created by the American College of Occupational and Environmental Medicine. Those guidelines recommend non-steroidal anti-inflammatory drugs (NSAIDs), muscle relaxants and physical therapy for low back pain, while frowning on the use of opioids or invasive procedures such as spinal injections.

The research findings, recently published in PLOS ONE, showed that people who didn’t follow treatment guidelines missed an average of 11 more days of work each year compared to those who only had recommended treatments.

Opioids were once commonly prescribed for low back pain, a practice that has fallen out of favor due to fears of addiction and overdose. In the nine years of the study, researchers found that opioid prescribing for low back pain declined by 86 percent, fueled in part by insurers who were unwilling to pay for the drugs.

"The reduction in opioids prescription is particularly impressive," Hegmann said. "In this case, the insurer is likely to not pay for opioids even if they are prescribed. It suggests what's possible when the 'carrot' of good health care is missed and instead the 'stick' of compliance with a guideline is in place."

Nearly two-thirds of the people included in the study received at least one non-recommended treatment, although adherence to treatment guidelines improved over time. In 2009, 10% were treated according to guidelines, but that rose to 18% by 2018.

Low back pain is the world’s leading cause of disability. It mostly affects adults of working age in lower socioeconomic groups, who often have physically demanding jobs.

Treatment guidelines for low back pain have changed considerably in the last 20 years. At one time, bed rest was commonly recommended, a treatment now seen as counterproductive. Moderate exercise and physical activity help people return to work sooner.

"Being out of work impacts many facets of your life," said first author Fraser Gaspar, PhD. "In addition to the physical disability that's causing the person to miss work, the worker is making less money, while they often incur additional costs and experience mental strain. Getting people back to their normal lives is really important, and our research shows that following guidelines makes that happen faster."

New European Guideline Says Opioids ‘Do Not Work’ for Many Types of Chronic Pain

By Pat Anson, PNN Editor

Calling opioid medication a “two edged sword,” the European Pain Federation (EFIC) has released new guidelines that strongly recommend against using opioids to treat fibromyalgia, low back pain, migraine, irritable bowel syndrome and other types of chronic non-cancer pain.

“The new recommendations advise that opioids should not be prescribed for people with chronic primary pain as they do not work for these patients,” the EFIC said in a statement.

However, the guideline states that low doses of opioids may be suitable for treating “secondary pain syndromes” caused by surgery, trauma, disease or nerve damage, but only after exercise, meditation and other non-pharmacological therapies are tried first.

“Opioids should neither be embraced as a cure‐all nor shunned as universally dangerous and inappropriate for chronic noncancer pain. They should only be used for some selected chronic noncancer pain syndromes if established non‐pharmacological and pharmacological treatment options have failed,” the guideline states. “In this context alone, opioid therapy can be a useful tool in achieving and maintaining an optimal level of pain control in some patients.”

Opioid pain relievers are not as widely used in Europe as they are in the United States or Canada. The EFIC said it was trying to “allay concerns over an opioid crisis” developing in Europe, as it has in North America.       

“As the leading pain science organisation in Europe, it is crucial that EFIC sets the agenda on issues such as opioids, where there are growing societal concerns. These recommendations clarify what role opioids should play in chronic pain management,” EFIC President Brona Fullen said in a statement.

The guideline’s lead author, Professor Winfried Häuser, said he and his colleagues tried to strike a middle ground on the use of opioids.

“The debate on opioid-prescribing for chronic non-cancer pain has become polarized: opioids are either seen as a dangerous risk for all patients, leading to addiction and deaths, or they are promoted as most potent pain killers for any type of pain,” said Häuser, who is an internal medicine specialist in Germany.

“Opioids are still important in the management of chronic non-cancer pain – but only in some selected chronic pain syndromes and only if established non-pharmacological and non-opioids analgesics have failed or are not tolerated.”

PROP Consulted for European Guideline

The guideline was developed by a 17-member task force composed of European experts in pain management, including 9 delegates selected by EFIC’s board “who advocate and who are critical with the use of opioids.” Only one delegate from Pain Alliance Europe represented patients.

The recommendations developed by the task force were reviewed by five outside experts, including Drs. Jane Ballantyne and Mark Sullivan, who belong to Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group in the U.S.  Ballantyne is PROP’s President, while Sullivan is a PROP board member. Several changes suggested by the outside experts were adopted.

Coincidentally, Ballantyne, Sullivan and three other PROP board members were involved in the drafting of the opioid guideline released in 2016 by the U.S. Centers for Disease Control and Prevention. That controversial guideline is now being rewritten by the CDC after voluminous complaints from patients and doctors that the recommendations led to forced tapering, withdrawal, uncontrolled pain and suicides.

Sullivan and two other PROP board members were also involved in drafting Canada’s 2017 opioid guideline, which was modeled after the CDC’s and provoked similar complaints from Canadian pain patients.

90 MME Recommended Limit

The CDC and Canadian opioid guidelines appear to have been used as resources by the EFIC task force, which adopted many of the same recommendations, even while acknowledging the low quality of evidence used to support them.   

One recommendation is straight out of the CDC guideline, advising European doctors to “start low and go slow.” Prescribers are urged to start patients on low doses of 50 morphine milligram equivalents (MME) or less a day and to avoid increasing the dosage above 90 MME/day.

One significant difference with the North American guidelines is that the EFIC recommends that opioids not be prescribed for fibromyalgia, migraines and other chronic “primary pain” conditions for which there is no known cause – suggesting those disorders have an emotional or psychological element that will lead to opioid abuse.

“Prescription of high doses of opioids to patients with primary pain syndromes might have been a factor driving the opioid crisis in North America,” the EFIC guideline warns.

“This was further compounded by patient characteristics that included physical and psychological trauma, social disadvantage and hopelessness that served as a trigger for reports of pain intensity prompting prescriptions of more opioids.”

Secondary pain conditions for which opioids “can be considered“ include multiple sclerosis, stroke, restless leg syndrome, Parkinson’s disease, rheumatoid arthritis, phantom limb pain, non-diabetic neuropathy, spinal cord injuries and Complex Regional Pain Syndrome (CRPS). 

Unlike the North American guidelines, the EFIC acknowledges that there are physical and genetic differences between patients. Some patients who are rapid metabolizers “might require higher dosages of opioids than the ones recommended by the guidelines.“

EFIC GRAPHIC

The EFIC also warns that its guideline should not be used to justify abruptly tapering or discontinuing opioids for anyone already prescribed at higher dosages. The recommendations are also not intended for the management of short-term acute pain, sickle cell disease or end-of-life care.

Good Attitude Improves Effectiveness of Yoga and Physical Therapy

By Pat Anson, PNN Editor

Yoga is a four-letter word for a lot of chronic pain patients, who are often urged to try yoga or physical therapy to ease their pain. Many pain sufferers believe exercise will only make their pain worse.

But a new study by researchers at Boston Medical University found that people with chronic lower back pain are more likely to benefit from yoga and physical therapy if they have a positive attitude about exercise.

The study involved 299 mostly low-income patients with chronic lower back pain who took weekly yoga classes or had physical therapy for 12 weeks. They were compared to a control group who had “self-care” – which consisted of reading a handbook on self-management strategies for back pain, such as stretching and strengthening exercises.

Nearly half (42%) of those who had yoga or physical therapy responded to the treatment, while only 23% of those in the self-care group had improvement in their pain and physical function.

Interestingly, participants who continued taking pain medication during the study were more likely to benefit from yoga (42%) than those who had physical therapy (34%) or self-care (11%).

"Adults living with chronic low back pain could benefit from a multi-disciplinary approach to treatment including yoga or physical therapy, especially when they are already using pain medication,' said lead author Eric Roseen, DC, a chiropractic physician at Boston Medical Center.

Another important finding from the study, which was published in the journal Pain Medicine, is the effect that “fear avoidance” can have on patient outcomes.

Among the participants who had less fear of exercise, 53 percent responded to yoga, 42 percent responded to physical therapy and 13 percent responded to self-care. In contrast, participants who had a high fear of exercise usually had a poor response, regardless of what therapy group they were in.  

Other factors that appeared to improve patient response were a high school education, higher income, employment and being a non-smoker.

"Focusing on a diverse population with an average income well below the U.S. median, this research adds important data for an understudied and often underserved population," said Roseen. "Our findings of predictors are consistent with existing research, also showing that lower socioeconomic status, multiple comorbidities, depression, and smoking are all associated with poor response to treatment."

It doesn’t take a lot of time to benefit from exercise. A 2017 study found that just 45 minutes of moderate physical activity a week improved pain and function in patients with osteoarthritis.

A few weeks of yoga significantly improved the health and mental well-being of people suffering from arthritis, according to a 2015 study at Johns Hopkins University.

Study Finds Opioids and Imaging Tests Given Too Often for Low Back Pain

By Pat Anson, PNN Editor

Many Medicare patients with low back pain receive care that is contrary to clinical guidelines – including opioid medication and advanced imaging tests, according to a large new study.

Researchers looked at Medicare claims for over 162,000 older adults with new low back pain (LBP) from 2011 to 2014. Over half (54%) made only one healthcare visit for LBP, which is consistent with evidence that many new cases of LBP "improve over time regardless of treatment."

It's what happened to the other patients that researchers found concerning.

Opioids were prescribed to about one-fourth of patients overall, and to about a third of those who made two or more visits to have their low back pain treated. Most clinical guidelines for LBP recommend that physical therapy and non-opioid pain relievers such as nonsteroidal anti-inflammatory drugs (NSAIDs) be tried before opioids.

Advanced imaging tests such as cat scans and magnetic resonance imaging (MRI) were ordered for about 15 percent of patients, which is contrary to advice from the American Academy of Family Physicians that most patients don't need advanced imaging for initial evaluation of low back pain.

Physical therapy (PT) was prescribed to only 11 percent of the Medicare patients. Most who were treated with opioids did not receive a prescription NSAID or physical therapy. Chronic opioid use developed in about one percent of patients overall, and nearly two percent of those with two or more visits.

"This study raises concerns about excessive use of low-value and potentially harmful treatments for the common problem of LBP in older adults," said Dan Pham, MD, of Harvard University, who published his findings in the journal Medical Care.

“Although prior research has suggested that PT may forestall the use of opioids in LBP, it is surprising that a high percentage of patients do not receive PT at all and many patients who eventually receive opioids did not first try PT. Similarly, it is surprising that when guidelines suggest that opioids should be a last resort for LBP, many patients on opioids have not yet tried prescription NSAIDs.”

It’s worth noting that Pham’s study only analyzed Medicare data compiled before the release of the 2016 CDC opioid guideline, which led to a widespread campaign to reduce opioid prescribing. Many physicians now refuse to prescribe opioids or only do it at low doses.  

Lower back pain is the world’s leading cause of disability. Over 80 percent of us suffer acute low back pain at least once in our lives.  

A guideline released by the American College of Physicians in 2017 strongly recommend that physicians treat acute low back pain with exercise and other non-pharmacological therapies. If medication is used, the guideline recommends NSAIDs or muscle relaxers. Opioids are only recommended for patients with chronic back pain who have failed at other treatments.

Some treatment guidelines also take a dim view of imaging for people with acute back pain. Early imaging for lower back pain is not recommended by the Choosing Wisely campaign, an initiative of the ABIM Foundation.

“Most people with lower-back pain feel better in about a month whether they get an imaging test or not. In fact, those tests can lead to additional procedures that complicate recovery,” Choosing Wisely states on its website.

The University of Michigan Center for Value-Based Insurance Design estimates there were 1.6 million unnecessary images for low-back pain in 2014, resulting $500 million in wasted spending. The Center recommends that imaging not be done in the first 6 weeks of low back pain.

A 2015 study found that physical therapy for low back pain significantly lowers healthcare costs by reducing the use of expensive treatments such as spinal surgery, injections and imaging.

Do You Really Need Spine Surgery?

By David Hanscom, MD, PNN Columnist

In today’s medical environment, big business is taking over in almost every realm. The focus is on productivity, instead of ensuring the highest quality of care. For spine surgeons like myself, the revenue generators are procedures and “interventions” – even though most of them have been shown to be ineffective.

New technology has made the situation worse instead of better. The interventions are larger, more expensive and much riskier. You, the patients, have become targets and opportunities.

The last five years of my practice became increasingly intolerable. I would see several patients a week who had surgery performed or recommended on spines that didn’t have a surgical problem. I hit a tipping point when I saw an athletic older gentleman who had his spine fused from his neck to his pelvis for muscular thoracic pain after lifting weights. He went from playing tennis and golf to being housebound, on high-dose opioids and had a psychotic break.

He was fused in a crooked position and could no longer see his feet.  He had to undergo a second 12-hour surgery just to stand him up straight again.

His case was a significant factor in my decision to retire from my practice as a complex spine surgeon in December of 2018 to pursue educating the public as to the nature and extent of the problem, as well as present viable solutions.

Fusions Have Low Success Rate

Spine surgery works wonderfully well when there is a distinct identifiable anatomical abnormality and pain is in the expected region of the body. However, surgery works poorly if the source of pain is unclear.

There is a widespread belief among patients and many physicians that when everything else has been tried and failed, then surgery is the next logical step. Nothing could be further from the truth.

Defining the correct anatomical problem to surgically treat is problematic. One of the most glaring examples of blindly proceeding with surgery in spite of the evidence is performing a fusion for low back pain (LBP).

It is well-documented that disc degeneration, bone spurs, arthritis, bulging discs, etc. are rarely the cause of LBP. Often, we really don’t know where the pain might be arising.

The success rate of fusions for LBP is less than 30%.  Most people expect a much better outcome and the resulting disappointment is problematic.

Another major problem is that when a surgical procedure is performed in a person with chronic pain in any part of the body, he or she may experience chronic pain at the new surgical site between 40 and 60% of the time. Five to ten percent of the time, the pain is permanent.

Many patients have told me undergoing spine surgery was one of the worst decisions of their life: “If I just knew how bad this could be, I never would have done it.”

Consider what happens when you go to the dentist with a painful cavity that may require a root canal, crown or extraction. There is a defined problem, and the pain will usually disappear once the problem is solved.

But what if you had gum disease or jaw pain, and a tooth doesn’t appear to be the source? Would you let your dentist randomly work on different teeth to see if it might help?

Making an accurate diagnosis of the problem is always the first step in solving it. 

Understanding the Whole Picture

Chronic pain is a complex problem that requires time and a multi-pronged approach to treatment. Current neuroscience research has unlocked the puzzle of chronic pain and it’s a solvable problem using the correct paradigm. But in the current medical climate, surgeons are being asked (and pushed) to move too quickly, and not factor in all of the variables that affect pain and surgical outcomes.

One 2014 research paper reported that only 10% of orthopedic spine surgeons and neurosurgeons are addressing and treating the well-documented variables in patients that predict poor outcomes. For example, one common problem for patients is lack of sleep. A large four-year study out of Israel demonstrated that insomnia induces low back pain. If a patient is sleep-deprived for just one night, his or her pain tolerance drops dramatically.

There are two sets of variables to consider when deciding whether to undergo spine surgery.

1) Your anatomy:  Has your doctor used an MRI or diagnostic test to identify the anatomical problem? If there isn’t a clearly identifiable source of pain, then surgery isn’t an option, regardless of how much pain you are experiencing.

2) Your nervous system and body chemistry:  Are you calm? Or are you stressed and hyper-vigilant? If your nervous system is on “high alert” for any reason, the outcomes of surgery are predictably poor, especially if you can’t identify the anatomical problem.  

If you are stressed, there are simple, consistently effective measures that can calm your nervous system and help you become pain free, often without surgery.

We already have the knowledge and technology to offer superb care and much of the data is being ignored. Whatever you decide to do or what resources you might use, don’t jump into spine surgery until you understand the whole picture. It may be the biggest decision of your life. 

Dr. David Hanscom is a spinal surgeon who has helped hundreds of back pain sufferers by teaching them how to calm their central nervous systems without the use of drugs or surgery.

In his book Back in Control, Hanscom shares the latest developments in neuroscience research and his own personal history with pain.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

New Non-Opioid Drug Effective in Treating Low Back Pain

By Pat Anson, PNN Editor

Pfizer and Eli Lilly have announced positive results from a large Phase 3 study evaluating an experimental non-opioid pain reliever as a treatment for chronic low back pain.

Patients receiving 10 mg injections of tanezumab showed statistically significant improvement in back pain at 16 weeks compared to placebo. A lower dose of tanezumab 5 mg was not as effective. Over 1,800 people with chronic low back pain in North America, Europe and Asia participated in the study.

Tanezumab is a humanized monoclonal antibody that targets nerve growth factor (NGF), a protein that increases in the body because of injury, inflammation or chronic pain. Tanezumab binds to NGF and inhibits pain signals from muscles, skin and organs from reaching the brain.

"This study demonstrates the potential of tanezumab to treat individuals suffering from moderate-to-severe chronic low back pain who have been unable to achieve relief with currently available medicines," said Ken Verburg, Pfizer’s tanezumab development team leader.

“This is one of the longest studies conducted to date in chronic low back pain. We look forward to further analyzing these results, and believe the data from this study will support our planned future global regulatory submissions in chronic low back pain."

Pizer and Eli Lilly have also reported positive findings in evaluating tanezumab for the treatment of osteoarthritis. The Food and Drug Administration granted “fast track” designation to tanezumab in 2017 to help speed its development.

Tanezumab has a history of safety concerns. Clinical studies were halted in 2010 after Pfizer reported some osteoarthritis patients receiving the drug had worse symptoms and needed joint replacement surgery. Another safety issue arose in 2012 when tanezumab caused adverse changes in the nervous system of animals.  Most clinical studies of tanezumab did not resume until 2015.

In the current study, rapidly progressive osteoarthritis (RPOA) was observed in 1.4 percent of patients receiving tanezumab and 0.1 percent of patients in the other treatment groups. Joint fractures and total joint replacements were experienced in 0.4 percent and 0.7 percent of tanezumab-treated patients, respectively, while none were observed in the other treatment groups.

In addition to back pain, the ongoing Phase 3 program for tanezumab includes studies in osteoarthritis pain and cancer pain due to bone metastases.

Many Alternative Therapies for Back Pain Not Covered

By Pat Anson, PNN Editor

A new study by the Johns Hopkins Bloomberg School of Public Health has confirmed what many back pain sufferers already know: Public and private health insurance plans often do not cover non-drug alternative pain therapies.

Bloomberg researchers looked at dozens of Medicaid, Medicare and commercial insurance coverage policies for chronic lower back pain and found that while most plans covered physical therapy and chiropractic care, there was little or no coverage for acupuncture, massage or counseling.

"This study reveals an important opportunity for insurers to broaden and standardize their coverage of non-drug pain treatments to encourage their use as safer alternatives to opioids," says senior author Caleb Alexander, MD, a professor of epidemiology at the Bloomberg School.  

Alexander and his colleagues examined 15 Medicaid, 15 Medicare Advantage and 15 major commercial insurer plans that were available in 16 states in 2017.

Most payers covered physical therapy (98%), occupational therapy (96%), and chiropractic care (89%), but coverage was inconsistent for many of the other therapies.

Acupuncture was covered by only five of the 45 insurance plans and only one plan covered therapeutic massage.

Nine of the Medicaid plans covered steroid injections, but only three covered psychological counseling.

"We were perplexed by the absence of coverage language on psychological interventions," Alexander says. "It's hard to imagine that insurers wouldn't cover that."  

Even for physical therapy, a well-established method for relieving lower back pain, insurance coverage was inconsistent.

"Some plans covered two visits, some six, some 12; some allowed you to refer yourself for treatment, while others required referral by a doctor," Alexander says. "That variation indicates a lack of consensus among insurers regarding what model coverage should be, or a lack of willingness to pay for it.”  

The Bloomberg study is being published online in the journal JAMA Network Open.  It was funded by the U.S. Department of Health and Human Services, National Institutes of Health and the Centers for Disease Control and Prevention.  

Lower back pain is the world’s leading cause of disability, but there is surprisingly little consensus on the best way to treat it. A recent series of reviews by an international team of experts in The Lancet medical journal found that low back pain is usually treated with bad advice, inappropriate tests, risky surgeries and painkillers.

“The majority of cases of low back pain respond to simple physical and psychological therapies that keep people active and enable them to stay at work,” said lead author Rachelle Buchbinder, PhD, a professor at Monash University in Australia. “Often, however, it is more aggressive treatments of dubious benefit that are promoted and reimbursed.”

The authors recommend counseling, exercise and cognitive behavioral therapy as first-line treatments for short-term low back pain, followed by spinal manipulation, massage, acupuncture, meditation and yoga as second line treatments. They found limited evidence to support the use of opioids for low back pain, and epidural steroid injections and acetaminophen (paracetamol) are not recommended at all.

What Back Pain Sufferers Should Know

By Doug Beall, MD, Guest Columnist

Allow me to describe a common patient referred to my office. Their back pain has been around long enough to be chronic and anti-inflammatory pills no longer dilute the pain.  Good days are when the patient is able to leave the house and painfully make it through eight hours at work; bad days are when the only endurable position is to lay flat at home all day.

Learning to live with the pain is no longer an option, so his physician refers him to my office. Let's pause the story here.

This sequence has been the experience of countless patients suffering from back pain. After months — sometimes years — of what feels like a 10 on the pain scale, these patients are willing to do almost anything to make the pain go away.

By the time they come to the doctor, most have done their research and have already written their own prescription, concluding that invasive surgeries and painkillers are the only options strong enough to alleviate their pain. But how did we get to the point where the all-out attack option seems like the only option?

As a doctor who specializes in treating patients for back pain, here’s what I wish more patients suffering from chronic pain knew.

When it comes to strong painkillers and increasingly invasive surgeries, bigger is not better. While surgery is the right option for some, the culture of pain management in the United States has produced the myth that the more invasive and aggressive the technique, the more effective it is. This over-reliance on aggressive techniques, especially opioids and invasive surgeries, puts last resorts at the front of the line while ignoring a range of safer and frequently more effective treatments — injections, vertebral augmentation, stem cell therapy or radiofrequency ablation, to name a few.

Simply put, the more aggressive and invasive techniques have not demonstrated that they produce better results. People aren’t automobiles. Our bodies can’t be put back together quickly or without some downside from surgery. While the more invasive repair may be better for your car, when it comes to people, the less invasive the technique, the better the patient recovery will be.

The primary consequence of the bigger is better mentally has produced a dangerous dependence on opioids for treating non-cancer pain and post-surgical pain. Opioids may be necessary for a relatively comfortable recovery after surgery, but normally not for more than four to six weeks. Recent research published in the Journal of the American Medical Association (JAMA) estimates that six percent of patients prescribed opioids after surgery become persistent opioid users. Chronic opioid use has ruined countless lives, so any treatment relying on opioids should only be considered a last resort.

Furthermore, it’s not clear that invasive surgeries are effective for patients. As an example, one of the most common pain management procedures is lumbar spinal fusion surgery, which is often used to treat chronic lower back pain. A new study from the medical journal Spine indicates 20 percent of patients undergo another operation within four years of an initial spinal fusion. Patients can only hope they’re not the unlucky one out of five sitting in the doctor’s waiting room who will be back for a second operation.

Pain sufferers should know that the vast majority of their chronic pain could be helped with simple, less invasive procedures without having to make an incision. When patients are referred to my office, I start with the least invasive options before moving on to surgery and more definitive techniques.

Instead of having patients go under the knife and prescribing them opioids, many of my patients suffering from chronic lower back pain have experienced tremendous results with radiofrequency ablation, which uses radiofrequency energy to deactivate a nerve that transmits pain from a patient’s lumbar disc.  This procedure can be done with a needle during an outpatient visit, and it often provides instant relief that can last for years.

Other procedures include epidural steroid injections (ESIs) and vertebral augmentation surgery. Both are minimally invasive options that help relieve acute and chronic pain.

Epidural injections relieve a variety of conditions, including sciatica, herniated discs and spinal stenosis. During an ESI, a surgeon or interventional pain physician injects a local anesthetic and a steroid into the epidural space, providing swift pain relief for the region. While this relief only lasts for a few weeks or months, it provides patients with enough time to continue working on their physical therapy and for the underlying pathology to heal.

Vertebral augmentation is an injection of a cementing agent into a vertebra in order to stabilize a vertical compression fracture (VCF). VCFs can result in severe deformity and extreme pain, and vertebral augmentation can help fix this injury with minimal complication or risk.

For patients suffering the disabling effects of chronic back pain, it’s important to know there are alternatives to opioids and invasive surgeries; not only radiofrequency ablation, but a whole range of minimally-invasive techniques. In the end, surgery may be necessary — but for many, these other options will prove to be not only safer, but also more effective.

(Editor’s note: For another view on ESI’s and their risks, see Dr. Margaret Aranda’s column, “5 Things to Know About Epidural Steroid Injections.”)

Dr. Doug Beall is a Fellow of Interventional Pain Practice, a Diplomate of the American Academy of Pain Management and is the Chief of Services at Clinical Radiology of Oklahoma, specializing in interventional musculoskeletal care.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.