FDA Approves Stem Cell Study for Degenerative Disc Disease

By Pat Anson

The Food and Drug Administration has given the go-ahead for a late-stage clinical trial of an injectable stem cell product that could give new hope to millions of patients suffering from lower back pain caused by degenerative disc disease (DDD).  Up to 400 patients with mild to moderate DDD are expected to enroll in the Phase 3 study later this year.

The trial is being conducted by DiscGenics, a Utah-based biopharmaceutical company that is developing new cell-based therapies for musculoskeletal conditions. It’s one of the first late-stage studies of a stem cell product to win approval from the FDA, which has been openly skeptical of cell-based therapies due to lack of evidence proving their safety and efficacy in clinical trials.

The only stem cell therapies currently approved by the FDA are used to treat sickle cell disease and some cancers. Approval of a stem cell product to treat degenerative discs would be a big step forward for regenerative medicine, and give patients an alternative to fusions and other more invasive spinal procedures.

“The FDA has been very familiar with our process, our product, and the chemistry, manufacturing and controls for quite some time,” says Flagg Flanagan, CEO and Chairman of DiscGenics. “We feel really good about where we are in terms of the patient reported outcomes. But most importantly about the safety. We feel like this cell is extremely safe to be used on human patients and we're feeling really, really good that we can help a lot of people.”

Discgenics’ injectable disc cell therapy (IDCT) is a single-injection biologic treatment designed to halt the progression of lumbar DDD by regenerating the disc “from the inside out.” The active ingredients in IDCT are enriched stem cells known as discogenic cells, which are derived from donated adult human disc tissue.

IDCT has been granted regenerative medicine advanced therapy and Fast Track designations by the FDA. Approval of the Phase 3 study came just weeks after Discgenics released positive results from a combined Phase 1/Phase 2 human trial of IDCT, published in the International Journal of Spine Surgery.

In that study, 60 patients with mild to moderate DDD were randomly assigned to receive an injection of either low-dose discogenic cells, high-dose cells, or a placebo. After one year, patients in the high-dose group had an average reduction in pain intensity of nearly 63 percent, along with significant improvements in their disability and quality of life. The regeneration of discs, which was monitored through MRIs and other imaging tests, was sustained two years after the injection.

“Things even came out a little better than we even expected,” Flanagan told PNN. “We showed very good durability, out to two years with the high dose patients. Anecdotally, we continue to follow some of those high dose patients and we have data in a pretty good cohort out to three years. We have a couple (patients) out to four years and the durability still seems to hold pretty well.”

The Phase 3 trial will consist of two parallel studies of IDCT that will also be randomized and placebo-controlled. Like the two earlier trials, each study will last for two years to assess the long-term safety and efficacy of IDCT. The first participants are expected to be enrolled in the final quarter of 2024.

“We'll start looking for patients and reviewing patient profiles that want to apply for the study shortly,” Flanagan said. “I think this is something where we can help many, many patients hopefully avoid a surgical intervention with an injection in a treatment room.”

People interested in getting updates on the Phase 3 IDCT trial or volunteering for it can submit their contact information to DiscGenics here.

Mesoblast, an Australian company specializing in regenerative medicine, recently began enrolling U.S. patients with chronic low back pain in a Phase 3 study of its proprietary mesenchymal stem cells, which are derived from young and healthy adult donors.

There’s Little Evidence That Massage Therapy Helps With Pain

By Crystal Lindell

It’s often touted as an alternative pain treatment, but it turns out there’s not much evidence showing that massage therapy actually helps with either chronic or acute pain. 

That’s according to new research published in JAMA Network Open that analyzed hundreds of clinical studies of massage therapy for pain. In a systematic review of those studies, the authors found little evidence that massage therapy actually helps relieve pain. In fact, most of the studies concluded that the certainty of evidence was low or very low. 

Notably, the researchers looked at studies involving many different types of pain, including cancer-related pain, chronic and acute back pain, chronic neck pain, fibromyalgia, labor pain, myofascial pain, plantar fasciitis, postpartum pain, postoperative pain, and pain experienced during palliative care. 

“There is a large literature of original randomized clinical trials and systematic reviews of randomized clinical trials of massage therapy as a treatment for pain,” wrote lead author Selene Mak, PhD, a researcher and program manager at the VA’s Greater Los Angeles Healthcare System. 

“Our systematic review found that despite this literature, there were only a few conditions for which authors of systematic reviews concluded that there was at least moderate-certainty evidence regarding health outcomes associated with massage therapy and pain. Most reviews reported low- or very low–certainty evidence.”

The results are especially concerning because massage therapy is often recommended as an nonopioid alternative for treating pain. In fact, in its revised 2022 opioid guideline, the CDC specifically mentions “massage” multiple times as a nonpharmacologic alternative. 

“Nonopioid therapies are preferred for subacute and chronic pain. Clinicians should maximize use of nonpharmacologic and nonopioid pharmacologic therapies as appropriate for the specific condition and patient,” the guideline says.

Researchers involved in the current study found that “massage therapy” was a poorly defined category of treatment, which made it more difficult to analyze. For example, in some studies, acupressure was considered massage therapy, but at other times it was classified as acupuncture. 

“Massage therapy is a broad term that is inclusive of many styles and techniques,” Mak wrote. “This highlights a fundamental issue with examining the evidence base of massage therapy for pain when there is ambiguity in defining what is considered massage therapy.”

Researchers also found that it was difficult to do placebo-controlled massage studies because it’s difficult to compare massage with a sham or placebo treatment. 

“Unlike a pharmaceutical placebo, sham massage therapy may not be truly inactive,” they wrote. “It is conceivable that even the light touch or touch with no clear criterion used in sham massage therapy may be associated with some positive outcomes.… Limitations of sham comparators raise the question of whether sham or placebo treatment is an appropriate comparison group in massage therapy trials.”

The researchers said it might be better to compare massage therapy with other treatments rather than a placebo. They also called for more high-quality research to look into exactly how helpful massage therapy is for pain. 

All of this doesn’t mean that massage therapy offers zero benefits, and patients who get something out of it should continue to use it.  However, medical professionals (and guideline authors) should be more cautious about recommending massage as a substitute for proven pain treatments, such as opioids. Because the last thing people in pain need is to be given ineffective treatments while being denied effective ones..

‘Misplaced and Dangerous’ Opioid Study Debunked by Critics

By Pat Anson, PNN Editor

Nearly a year after publishing a controversial study that questioned the effectiveness of opioid pain medication, The Lancet medical journal has published two rebuttal letters that challenge the study’s design and conclusions.

The blinded, placebo-controlled clinical trial – known as the OPAL study -- found that a 6-week course of low-dose oxycodone worked no better than a placebo in treating patients with recent mild-to-moderate back and neck pain. Based on that finding, Australian researchers recommended that opioids should not be used to treat acute back and neck pain, and that medical guidelines should be changed to reflect that view.

“Opioids should not be recommended for acute back and neck pain, full stop,” said lead investigator Christine Lin, PhD, a professor in the School of Public Health at University of Sydney.

“This recommendation is an extraordinary, misplaced, and dangerous conclusion, considering the authors studied the effects of only one type of slow-release opioid not indicated for acute pain and that guidelines should not be changed on the basis of a single randomized trial,” said Asaf Weisman, Dr. Youssef Masharawi and Dr. James Eubanks in their rebuttal letter. 

Weisman is a physiotherapist and spine researcher at Tel Aviv University, Masharawi is a professor of physical therapy at Tel Aviv University, and Eubanks is an assistant professor at the Medical University of South Carolina.    

“Relief of pain is one of the obligations of medical doctors. Despite the documented risks, which cannot be understated, opioids are indispensable for pain management, particularly in cases in which other forms of treatment are ineffective or inadequate,” they wrote. 

The second rebuttal letter noted that the OPAL study had an “extremely high” dropout rate and nearly a quarter of patients in the placebo group were taking opioids when the study began – two factors that confound and weaken the study’s findings. 

“We should be careful when drawing decisive conclusions based on this trial,” wrote Dr. Yu Toda, a palliative care specialist at Japan’s National Cancer Center Hospital. 

In reply to the letters, Lin and her co-authors defended the design of the OPAL study, but agreed the conclusions may have been too broad.

“We agree that we cannot generalize our results to all opioids. There are different opioid classes with different pharmacological profiles,” said Lin. “We agree that the OPAL results might not be generalizable to all patients with acute low back and neck pain, including those experiencing hyperacute pain requiring immediate pain relief in the emergency department.” 

Other critics found additional flaws in the OPAL study, pointing out that the daily dose of oxycodone was relatively low – ranging from 15 to 30 MME (morphine milligram equivalents) -- and that the oxycodone was combined with naloxone, a medication that blocks the effects of opioids. In clinical practice, a slow-release formulation of oxycodone is usually not prescribed for short-term pain and is never combined with naloxone,

Publishing rebuttal letters is a common practice for medical journals, but – until now -- The Lancet has not shared with its readers any counterpoints to the OPAL study

“The Lancet received submitted replies criticizing the OPAL Trial’s authors’ over-generalized conclusion within a month of the study’s online publication. Given evidence for patient harms from excessively rapid dose reductions or discontinuation of opioid therapy, waiting almost a year to publish these criticisms seems recklessly irresponsible,” said Dr. Chad Kollas, a palliative care physician and pain policy expert, whose rebuttal letter was rejected several months ago by The Lancet’s editors.

‘Many Patients Have Been Hurt’

The OPAL study received a fair amount of media attention when it came out and was even hailed as a “Landmark Trial” by some news outlets. But like many news stories dealing with opioids, they conveyed the simplistic message that all opioids are risky and ineffective, regardless of a patient’s condition, pain level or need.

“The Great Opioid Lie: Addictive painkillers do NOT reduce lower back or neck pain,” was the headline used by the Daily Mail. “Opioids might actually worsen pain in the long-run while increasing the odds of becoming addicted.”  

The OPAL study was even cited by U.S. Sens. Ed Markey (D-MA) and Joe Manchin (D-WV) in a letter to the FDA urging the agency not to conduct studies on the efficacy of opioids. Further studies are not needed, they claimed, and would only lead to the approval of new opioid medication.

“A recent randomized placebo-controlled study found that prolonged opioid use was ineffective for acute back and neck pain,” Sens. Markey and Manchin wrote. “For too long, drug manufacturers have been given the benefit of the doubt in developing and marketing a drug that unleashed a widespread, decades-long epidemic. Using a study model that risks continued bias in favor of approval is unacceptable.”

Weisman and his two colleagues say “opioid phobia” in the U.S. has led to pain patients around the world being denied appropriate treatment, causing unnecessary suffering.  

“Unfortunately, the opioid epidemic in the USA has led to many countries adopting strict umbrella policies and led to so-called opioid phobia among clinicians, and many patients worldwide have been hurt due to these processes,” they wrote.

Evidence Lacking for Spinal Cord Stimulators

By Drs. Ian Harris, Adrian Traeger and Caitlin Jones

In an episode of the Australian Broadcasting Corporation’s “Four Corners” this week, the use of spinal cord stimulators for chronic back pain was brought into question.

Spinal cord stimulators are devices implanted surgically which deliver electric impulses directly to the spinal cord. They’ve been used to treat people with chronic pain since the 1960s.

Their design has changed significantly over time. Early models required an external generator and invasive surgery to implant them. Current devices are fully implantable, rechargeable and can deliver a variety of electrical signals.

However, despite their long history, rigorous experimental research to test the effectiveness of spinal cord stimulators has only been conducted this century. The findings don’t support their use for treating chronic pain. In fact, data points to a significant risk of harm.

People with chronic pain are suffering infections, shocks and even more pain from a device advertised as safe and effective. There are now calls for them to be recalled following a Four Corners investigation. https://t.co/qb1i0A47Lv

— ABC News (@abcnews) April 9, 2024

What Does the Evidence Say?

One of the first studies used to support the effectiveness of spinal cord stimulators was published in 2005. This study looked at patients who didn’t get relief from initial spinal surgery and compared implantation of a spinal cord stimulator to a repeat of the spinal surgery.

Although it found spinal cord stimulation was the more effective intervention for chronic back pain, the fact this study compared the device to something that had already failed once is an obvious limitation.

Later studies provided more useful evidence. They compared spinal cord stimulation to non-surgical treatments or placebo devices (for example, deactivated spinal cord stimulators).

A 2023 Cochrane review of the published comparative studies found nearly all studies were restricted to short-term outcomes (weeks). And while some studies appeared to show better pain relief with active spinal cord stimulation, the benefits were small, and the evidence was uncertain.

Only one high-quality study compared spinal cord stimulation to placebo up to six months, and it showed no benefit. The review concluded the data doesn’t support the use of spinal cord stimulation for people with back pain.

The experimental studies often had small numbers of participants, making any estimate of the harms of spinal cord stimulation difficult. So we need to look to other sources.

A review of adverse events reported to Australia’s Therapeutic Goods Administration found the harms can be serious. Of the 520 events reported between 2012 and 2019, 79% were considered “severe” and 13% were “life threatening”

.We don’t know exactly how many spinal cord stimulators were implanted during this period, however this surgery is done reasonably widely in Australia, particularly in the private and workers compensation sectors. In 2023, health insurance data showed more than 1,300 spinal cord stimulator procedures were carried out around the country.

In the review, around half the reported harms were due to a malfunction of the device itself (for example, fracture of the electrical lead, or the lead moved to the wrong spot in the body). The other half involved declines in people’s health such as unexplained increased pain, infection, and tears in the lining around the spinal cord.

More than 80% of the harms required at least one surgery to correct the problem. The same study reported four out of every ten spinal cord stimulators implanted were being removed.

The cost here is considerable, with the devices alone costing tens of thousands of dollars. Adding associated hospital and medical costs, the total cost for a single procedure averages more than $A50,000 (US$ 32,542). With many patients undergoing multiple repeat procedures, it’s not unusual for costs to be measured in hundreds of thousands of dollars.

Rebates from Medicare, private health funds and other insurance schemes may go towards this total, along with out-of-pocket contributions.

Insurers are uncertain of the effectiveness of spinal cord stimulators, but because their implantation is listed on the Medicare Benefits Schedule and the devices are approved for reimbursement by the government, insurers are forced to fund their use.

Industry Influence

If the evidence suggests no sustained benefit over placebo, the harms are significant and the cost is high, why are spinal cord stimulators being used so commonly in Australia? In New Zealand, for example, the devices are rarely used.

Doctors who implant spinal cord stimulators in Australia are well remunerated and funding arrangements are different in New Zealand. But the main reason behind the lack of use in New Zealand is because pain specialists there are not convinced of their effectiveness.

In Australia and elsewhere, the use of spinal cord stimulators is heavily promoted by the pain specialists who implant them, and the device manufacturers, often in unison. The tactics used by the spinal cord stimulator device industry to protect profits have been compared to tactics used by the tobacco industry.

A 2023 paper describes these tactics which include flooding the scientific literature with industry-funded research, undermining unfavourable independent research, and attacking the credibility of those who raise concerns about the devices.

More than three million Australians are living with chronic pain, and it's become a breeding ground for exploitation.

Watch Four Corners: Pain Factory, now on ABC iview.#4Cornershttps://t.co/cZ9Qrt0Lsk

— ABC News (@abcnews) April 8, 2024

Many who suffer from chronic pain may feel disillusioned after watching the Four Corners’ “Pain Factory” report. But it’s not all bad news. Australia happens to be home to some of the world’s top back pain researchers who are working on safe, effective therapies.

New approaches such as sensorimotor retraining, which includes reassurance and encouragement to increase patients’ activity levels, cognitive functional therapy, which targets unhelpful pain-related thinking and behaviour, and old approaches such as exercise, have recently shown benefits in robust clinical research.

If we were to remove funding for expensive, harmful and ineffective treatments, more funding could be directed towards effective ones.

Ian Harris, MD, is a Professor of Orthopedic Surgery at University of New South Wales.  He is a practicing orthopedic trauma surgeon and directs a research unit specializing in surgical outcomes and the evidence base for surgery.

Adrian Traeger, PhD, is a Research Fellow at the Institute for Musculoskeletal Health at The University of Sydney. He is a physiotherapist who specializes in treating low back pain and other musculoskeletal conditions.

Caitlin Jones, PhD, is a postdoctoral research associate at the University of Sydney. Her research evaluates the benefits and harms of treatments for musculoskeletal conditions.

This article originally appeared in The Conversation and is republished with permission.

New Imaging Allows Doctors to Watch Spinal Cord During Surgery

By Pat Anson, PNN Editor

A new type of imaging technology could improve the effectiveness of spinal surgeries by allowing doctors to view high resolution images of the spinal cord during surgery.

The technology, known as fUSI or functional ultrasound imaging, is currently used to track neural activity in the brain. Researchers at the University of California Riverside (UCR) and University of Southern California say fUSI could also be used during back surgery to help doctors “see” the spinal cord in real time and how it responds to electrical stimulation. That could improve the success rate of spinal cord stimulators and other devices that use neuromodulation to dull pain signals.

“The fUSI scanner is freely mobile across various settings and eliminates the requirement for the extensive infrastructure associated with classical neuroimaging techniques, such as functional magnetic resonance imaging (fMRI),” lead author Vasileios Christopoulos, PhD, an assistant professor of bioengineering at UCR, said in a press release. “Additionally, it offers ten times the sensitivity for detecting neuroactivation compared to fMRI.”

Christopoulos and his colleagues reported in the journal Neuron that fUSI imaging was used on six people with chronic back pain who had partial laminectomies, a surgery that eases pressure on spinal nerves through the removal of bone or tissue. During the surgeries, clinicians also stimulated the patients’ spinal cords with mild electric signals to test the viability of fUSI.

Until now, it’s been difficult to assess whether a surgery for back pain is working because patients are asleep under anesthesia and cannot provide feedback on their pain levels. The motion caused by a patient’s heart and breathing may also interfere with MRIs and other imaging methods.

“These movements introduce unwanted noise into the signal, making the spinal cord an unfavorable target for traditional neuroimaging techniques,” Christopoulos explained. “With ultrasound, we can monitor blood flow changes in the spinal cord induced by the electrical stimulation. This can be an indication that the treatment is working.”

Images produced by fUSI are clearer and less sensitive to motion. It uses ultrasound waves to track the flow of blood in specific areas. Christopoulos likens it to a submarine that uses sonar to detect objects in the water.

“We have big arteries and smaller branches, the capillaries. They are extremely thin, penetrating your brain and spinal cord, and bringing oxygen places so they can survive,” he said. “With fUSI, we can measure these tiny but critical changes in blood flow.”

Spinal cord stimulators (SCSs) are invasive and have poor success rates. That’s why it’s customary for patients to go through a short trial period before having the devices surgically implanted. With improved monitoring of blood flow during surgery, Christopoulos hopes the success rate of SCSs will improve dramatically.

“We needed to know how fast the blood is flowing, how strong, and how long it takes for blood flow to get back to baseline after spinal stimulation. Now, we will have these answers,” Christopoulos said. “With less risk of damage than older methods, fUSI will enable more effective pain treatments that are optimized for individual patients.”

About 50,000 spinal cord stimulators are implanted annually in the U.S. The devices are often touted as an alternative to opioid pain medication, although a growing number of studies have questioned their safety and efficacy.

Lack of Awareness Is Harming People with Scoliosis

By Drs. Sanja Schreiber and Emily Somers

Cael was a typical 15-year-old — until the discovery of an already advanced abnormal curvature of his spine.

“I felt like the Hunchback of Notre Dame,” Cael told CBC News, recalling the emotionally draining and gruesome two-year wait for spinal surgery during which his curve progressed to a whopping 108 degrees.

Scoliosis is an abnormal twisting and curving of the spine that can develop at any age, but mostly occurs during rapid growth spurts in children, and as part of spine aging in adults over the age of 60.

Of all types of scoliosis in children, adolescent idiopathic scoliosis is the most prevalent, accounting for as many as nine in 10 cases and impacting up to one in 20 adolescents globally. On the other end of the age spectrum, a staggering two-thirds of older adults are also affected.

In clinical care, research and education related to scoliosis, disparities persist worldwide. Despite its widespread prevalence, scoliosis often goes undiagnosed, or has delayed diagnosis as in Cael’s case. It also receives limited attention in clinical and public health education, leading to significant gaps in health care.

This general lack of awareness has serious implications for thousands of people like Cael.

Gaps in Scoliosis Care

In the United States, fewer than half of states legislate school-based scoliosis screening in children. Even worse, Canada discontinued screening back in 1979 because it was not considered cost-effective.

Pediatricians’ screening practices vary, and some cases of scoliosis in children are only discovered when an unrelated chest X-ray reveals a curved spine. With about 30 per cent of cases being hereditary, parents may not recognize the signs early on.

The recommended care in North America involves bracing for mild to moderate curves (25° to 45°) and surgery for curves exceeding 45°. Shockingly, 32 per cent of Canadian children, like Cael, face delayed referrals, discovering significant curves when they finally see specialists.

Despite documented success in managing scoliosis through early screening, exercise rehabilitation and brace treatment, global health-care education often neglects this condition.

The general lack of global awareness leaves physicians, nurses and other practitioners unaware of effective treatments and referral processes, contributing to the misunderstanding and under-treatment of patients. Consequently, when children with scoliosis eventually reach specialists for care, they may encounter challenges navigating the health-care system as they transition into adulthood.

Sex Disparities

It is unclear why adolescent idiopathic scoliosis affects mainly girls. The more severe the curve, the more likely the patient is female.

Due to their specific biology, females also face a five-fold higher risk of progressive deformities and are 10 times more likely, compared to males, to require surgery.

Despite generally uncomplicated pregnancies and deliveries, women with scoliosis often face difficulties receiving pain control during labour, with higher epidural failure rates.

Moreover, they often suffer pregnancy-related back pain, and their spine curvature may worsen after pregnancy.

Healthcare Barriers

Healthcare access in the U.S. is influenced by a range of factors including race, income and health insurance coverage.

Patients with better insurance plans tend to seek pediatric orthopedic care at a younger age. Those with public insurance tend to have worse spine curvatures by the time they reach a scoliosis specialist; this is particularly striking among Black patients with public insurance, who are 67 per cent less likely to be diagnosed at a stage early enough for effective brace treatment compared to Black patients with private insurance.

While Canada’s health-care system covers spinal fusion for severe scoliosis, the lack of a national insurance program in the U.S. leads to varying out-of-pocket expenses for patients.

Those without insurance often cannot afford surgery at all.

But even with Canada’s universal coverage, patients typically wait an entire year for surgery due to a shortage of providers. Because of regional variability in resources such as access to spinal surgeons, funding and specialized facilities, some kids, like Cael, wait even longer, experiencing physical, emotional and psychological burdens, while their curves get progressively worse.

Delayed surgery in Canada cost the health-care system $44.6 million due to more complex surgeries, extended hospital stays, readmission and re-operation rates.

Lack of Research

Ongoing gender disparities in the healthcare workforce and lack of research funding for this female-predominant condition continue to hamper effective action.

Fewer than five per cent of spinal surgeons identify as women. Glass-ceiling effects surround women surgeons in this male-dominated culture, perpetuating gendered training environments, being held to higher standards and earning lower wages. The dearth of senior women role models and mentors is a further barrier for career advancement and retention.

Furthermore, research funding for diseases, such as scoliosis, that mainly affect females has historically lagged far behind funding for male-predominant diseases. Improving workforce diversity is an important facet of addressing health disparities and shaping research agendas.

Inequities abound in scoliosis care and research. The impact of lack of awareness and delayed care extends beyond physical challenges. The patient and their family suffer emotionally, incurring significant financial burden while fearing the future.

The message is clear, we must do better for this underserved population.

Sanja Schreiber, PhD, is an Adjunct Professor of Physical Therapy at the University of Alberta and the Owner/Director of Curvy Spine, a specialized clinic for treating structural spinal disorders and training physiotherapists in scoliosis rehabilitation.

Emily Somers, PhD, is an epidemiologist specializing in immune-mediated and musculoskeletal diseases. She also directs the Interdisciplinary Research & Team Science Program at the Michigan Institute for Clinical and Health Research.

This article originally appeared in The Conversation and is republished with permission.

WHO Releases First Guideline for Chronic Low Back Pain

By Pat Anson, PNN Editor

The World Health Organization (WHO) has released its first-ever guideline for managing chronic low back pain, recommending treatments such as exercise, physical therapy, chiropractic care and non-steroidal anti-inflammatory drugs (NSAIDs).

Chronic low back pain — also known as “non-specific low back pain” — is defined as pain that persists longer than three months, with symptoms that cannot be accounted for by a structural spinal problem or disease process such as arthritis.

Although lower back pain (LBP) is the leading cause of disability worldwide – affecting about 619 million people – there has been little certainty about how to treat it. Almost all of the clinical trial evidence reviewed by WHO’s guideline development group was considered low or very low quality, a persistent problem.in many medical guidelines dealing with pain.

The lengthy 274-page guideline takes a dim view of some commonly used therapies for LBP, such as muscle relaxants, anticonvulsants, steroids, opioids, transcutaneous electrical nerve stimulation (TENS), and injectable anesthetics – treatments that are primarily used in high-income countries. WHO recommends a more holistic approach to LBP, using therapies that are affordable and accessible to more people.

"Addressing chronic low back pain requires an integrated, person-centred approach. This means considering each person's unique situation and the factors that might influence their pain experience," Dr. Anshu Banerjee, WHO Director for Maternal, Newborn, Child, Adolescent Health and Ageing, said in a press release. "We are using this guideline as a tool to support a holistic approach to chronic low back pain care and to improve the quality, safety and availability of care."

WHO recommends that adults with chronic LBP start with treatments that are the least invasive and least potentially harmful. The values and preferences of patients should also be considered, as they are more likely to adhere to therapies they consider helpful.  

Recommended Treatments for Chronic LBP

• Patient education and counseling

• Exercise or physical therapy

• Acupuncture or dry needling

• Spinal manipulation (chiropractic care)

• Massage

• Cognitive behavioral therapy or mindfulness

• NSAIDs

• Topical cayenne pepper

The guideline states that opioid analgesics “should never be used as a stand-alone treatment” for chronic LBP. When opioids are used alongside other therapies, the lowest dose should be prescribed and only for a short duration, according to WHO.

Recommendations against routine use are also made about many other pharmaceuticals, including antidepressants, anticonvulsants, muscle relaxers, glucocorticoids (steroids), weight loss drugs, and injectable anesthetics such as lidocaine or bupivacaine.  

No recommendations are made about benzodiazepines, cannabis or acetaminophen (paracetamol), primarily due to lack of evidence, but also because of potentially harmful side effects. Cayenne pepper is the only herbal remedy recommended by WHO.

The guideline does not address surgical procedures such as spinal fusions and spinal cord stimulators, or invasive procedures such as epidural injections.

WHO’s 25-member guideline development group included a broad range of clinical experts from around the world. Among them is Roger Chou, MD, a researcher and longtime critic of opioid prescribing who heads the Pacific Northwest Evidence-based Practice Center. Chou is a co-author of the 2016 and 2022 CDC opioid guidelines, and has collaborated on several occasions with members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid advocacy group. Chou let his Oregon medical license lapse in 2022.

One of the clinical trials reviewed by WHO’s guideline group is a controversial Australian study – known as the OPAL study -- that found low dose opioids gave little relief to patients with short-term back and neck pain. The OPAL study has been panned by critics because the treatment period only lasted six weeks and used a formulation of oxycodone that would not normally be used in clinical practice. Nevertheless, it’s been cited as evidence that “prolonged opioid use” is ineffective.

In 2021, WHO updated its guideline on the treatment of chronic pain in children, recommending that prescription opioids only be used for children who are dying or seriously ill. An earlier WHO guideline that recommended more pediatric use of opioids was withdrawn in 2019, after two U.S. congressmen accused the United Nation’s health agency of being “corruptly influenced” by opioid manufactures.  

Will Thinking About Chronic Pain Differently Help Reduce It?

By Pat Anson, PNN Editor

Want to make your chronic back pain go away?

Then stop thinking about the physical cause of your pain with words like accident, bad posture or disc bulge.

Start attributing the cause of your pain to your own emotions. Use words like anxiety, stress and fear.

That’s the conclusion of a new analysis of an old study that found pain reprocessing therapy (PRT) beneficial in a small group of patients with chronic back pain. PRT is based on the theory that patients can reduce or even stop their pain simply by changing the way they think about it, without the use of drugs, injections or physical therapy.

“Millions of people are experiencing chronic pain and many haven’t found ways to help with the pain, making it clear that something is missing in the way we’re diagnosing and treating people,” says lead author Yoni Ashar, PhD, assistant professor of internal medicine at the University of Colorado Anschutz Medical Campus.

“Our study shows that discussing pain attributions with patients and helping them understand that pain is often ‘in the brain’ can help reduce it.”

Ashar and his colleagues were early proponents of PRT. In a 2021 clinical study, they recruited 151 people with moderate back pain, with an intensity of at least four on a pain scale of zero to 10. Participants assigned to PRT were encouraged to reappraise the severity of their pain and to think about it differently by engaging in movements they were afraid to do. About two-thirds found that helpful in reducing or even eliminating their pain.

In their new study, published in JAMA Network Open, researchers doubled down on their previous study by performing a “secondary analysis” of those same 151 people. Did they attribute their pain to a physical or emotional cause? What words did they use to describe it?

Before PRT treatment, only 10% of participants’ thought their back pain was mind or brain-related. After PRT, about half of them did. And the more they thought about their pain as a mind or brain process, the greater the reduction in pain they reported.

The graphic below demonstrates how participants thought about their pain differently before and after PRT. In a word cloud text analysis of their responses, PRT recipients were more likely to use words like stress and anxiety, and less likely to use words like muscles and injury.

Words Associated with Chronic Pain Before and After PRT

JAMA NETWORK OPEN

“These results show that shifting perspectives about the brain’s role in chronic pain can allow patients to experience better results and outcomes,” Ashar said.

“This study is critically important because patients’ pain attributions are often inaccurate. We found that very few people believed their brains had anything to do with their pain. This can be unhelpful and hurtful when it comes to planning for recovery since pain attributions guide major treatment decisions, such as whether to get surgery or psychological treatment.”

There are a number of caveats to this study. First is the small size. Second, participants had only low to moderate back pain, not the severe intractable pain caused by a spinal injury or disease. Thinking about your pain differently isn’t going to do much good for someone with arachnoiditis or Ehlers Danlos syndrome – and it is worrisome that studies like these are often used to deny patients with severe pain access to effective treatment such as opioid medication.

Third, pain reattribution was only modestly effective (about 9% on average) in relieving pain. Some participants who bought into the idea of thinking differently about their pain had no pain relief, leading the authors to admit that “reattribution alone is not sufficient for pain relief.”

Despite these weaknesses, researchers hope their study will encourage providers to talk to their patients more about the possible causes of their chronic pain.

“Often, discussions with patients focus on biomedical causes of pain. The role of the brain is rarely discussed,” said Ashar. “With this research, we want to provide patients as much relief as possible by exploring different treatments, including ones that address the brain drivers of chronic pain.”

You can learn more about PRT therapy by reading “The Way Out,” a book by psychotherapist Alan Gordon, who uses mindfulness and cognitive behavioral therapy to reduce the fear that many patients have about their pain and its triggers.

There Is Help Out There, But You Have Look For It

By Ann Marie Gaudon, PNN Columnist

As a patient, you strive to be heard. Nowhere is this truer than when your medical issues are chronic and complex. However, when your physicians dismiss, minimize, invalidate, and/or ignore what you say, this can lead to a misdiagnosis or lack of diagnosis – which can lead to your condition getting worse.

Physicians rely on test results, but what if the test is an epic failure? What if there is no test at all to diagnose you?

Medical providers can erroneously blame your suffering on your age, race, sexuality, gender, weight or other factors that have nothing to do with your complaint. It’s also not uncommon for a physician to tell a patient that there is nothing at all wrong with them and that it’s essentially “all in their head.”

Even if your symptoms do not resolve, further testing may not be offered. You may not be listened to or you may have your symptoms downplayed.

I learned that the hard way after experiencing a significant back injury in 2017. I thought I was going to be disabled forever. My own medical system could not help me. I was told I had to wait six weeks for an appointment and if I was still in pain then, an MRI would be ordered.

The MRI was ordered and the imaging showed a significant injury. But my general practitioner could offer no help aside from a mild muscle relaxant. I was referred to an orthopedic surgeon who could also offer no help. I never considered surgery – truth be told it terrified me – but I was looking for any treatment to help myself heal.

Fate brought me to a CBC radio interview with Stuart McGill, PhD, Professor Emeritus at the University of Waterloo. I immediately bought McGill’s book “Back Mechanic” and started my healing journey with one of his master clinicians.

I learned the medical system knows virtually nothing about the injury I had and had no way to help me heal from it.

Fast forward six years. Here I am “back” to back pain; limping and having significant pain in my upper right leg. I found out that I had been engaging in activity that I should not have been (weight lifting) and not doing enough to strengthen my core.

Now a loss of height and stiffness in my spinal joints are giving me much grief. My L4 and L5 have lost their strength due to injury, and the lower joint L3 is feeling the lack of support.

The entire point of this column is to show you the difference between seeing a physician who has no knowledge and relies on unreliable tests, and finding and seeing someone who has the essential knowledge to help you heal.

Take a look for yourself. Remember, my symptoms were lower back pain, upper right leg pain and a limp. Here is a copy of my recent MRI report, which is the only test my GP has ordered. Also, here is a copy of my personalized treatment recommendations from Professor McGill, which I use along with his book. Notice anything different between these two assessments?

This difference means everything! Why? Because one is antiseptic, hopeless and sounds like my pain was of my own doing. The other offers the reason for the pain, plus exercise and treatment options I can do to make it better.

My lapse in keeping up with the exercises necessary to protect my spine was slow and happened over time. I’m not sure that I even noticed. By the time I did, I had already irritated my compromised spine.

If I want to be free of back pain, I will always have to do protective exercises. I will always have to take care. This is of little consequence, considering that pain and disability are the alternative.

Thank you, Professor McGill for being the compassionate and skilled researcher that you are. There are so many of us in need of real help with our back injuries. I am so grateful for you and your life’s work.

Here is what I have learned. Often there is a practitioner who is knowledgeable and skilled in helping you with a complex and chronic condition. But the only way I have found these people is by accident or by word of mouth. I don’t see this changing anytime soon.

Don’t give up hope and be prepared to investigate your options!

Ann Marie Gaudon is a registered social worker and psychotherapist in the Waterloo region of Ontario, Canada with a specialty in chronic pain management.  She has been a chronic pain patient for over 30 years and works part-time as her health allows. For more information about Ann Marie's counseling services, visit her website. 

Virtual Reality Has Long-Term Benefits for Patients with Back Pain

By Pat Anson, PNN Editor

A novel treatment that combines virtual reality with cognitive behavioral therapy significantly reduced pain levels and other symptoms in patients with chronic back or neck pain, according to results of a new study presented at the annual meeting of the Congress of Neurological Surgeons.

Unlike other therapies using virtual reality (VR) – which temporarily distract people from their pain – patients in this study had long term reductions in their pain, anxiety and depression. This suggests that combining VR with cognitive behavioral therapy (CBT) induces neuroplasticity, a “rewiring” of the brain and nervous system that reduces the impact of physical and emotional trauma.    

“What we found is it actually creates new neural pathways to form, what's called neuroplastic reprogramming or neuroplastic change, and that actually creates a more resilient patient,” said co-author Gerry Stanley, MD, Chief Medical Officer of Harvard MedTech, a medical device company that offers VR therapy.

“The patient who may be thinking about their pain 22 hours a day, and their pain (level) has always been eight or nine, now thinks about their pain one or two hours a day and their pain (level) is a three or four, because the brain is no longer fixating on it. So it allows for, I don't want to say permanent distraction, it’s really neuroplastic reprogramming.”

Stanley and his colleagues enrolled 145 patients with non-operative degenerative neck or back pain in Harvard MedTech’s Vx Therapy program, which included daily virtual reality sessions for 14 weeks and weekly telephone calls with a therapist trained in CBT.  

Unlike other VR therapies, which encourage physical activity, participants sat stationary in a chair while watching and listening to prerecorded programs with a headset and earphones. The VR programs come in four categories that emphasize education, meditation, distraction or entertainment, depending on the patient’s needs and goals.

HARVARD MEDTECH IMAGE

After 14 weeks, results showed that Vx Therapy reduced pain and anxiety during sessions by an average of 33% and 46%, respectively. The duration of pain relief also increased over time, from 2.5 hours in the first weeks of treatment to 4.5 hours in the final weeks.

The study has not been peer-reviewed or published yet, but Stanley says the findings mirror what his company has learned after treating about 4,000 patients. The benefits of Vx Therapy continue long after the treatment ends, with many patients still reporting improvement after two years.  

“They're often reporting the same level of resiliency. I think a lot of it is they start getting into better sleep patterns,” he told PNN.  “And they really get good at meditation. Most people fail in meditation because of distractions. But when they're doing it in the virtual reality, they get very good at it. So they really develop some nice, I'm going to say muscle memory, even though I know it's cognitive. But they do develop a little bit of muscle memory around the meditation.”

Because Vx Therapy is done remotely, it’s available to any patient regardless of location, as long as they have a prescription. Some worker compensation insurers cover the treatment.   

Previous studies have also suggested that virtual reality therapy has long-term benefits for people with chronic back pain. A 2022 study showed that people with moderate lower back pain reported improvements in pain, function, mood and sleep six months after treatment ended.  

My Story: Riding the Merry-Go-Round of Pain Care

By Christopher Matthews, Guest Columnist

About two and a half years ago, I began to feel a tight painful knot on the side of my neck. Any movement would trigger an intense shock up the back of my skull to the top of my head. Ultrasound, MRI and X-ray scans all came back negative, so we tried anti-inflammatory medications, ice, deep tissue message, chiropractic, and some lifestyle changes.

Over the next few months, the pain began radiating to my cervical spine and intensified. No OTC pain medication was touching this pain.  It felt like a hot steak knife was lodged in my back. The constant, unbearable pain and symptoms of neuropathy seemed to indicate that some minor disc bulging in my spine may be more severe than we thought.

It took 4 months to get an appointment with a specialist in neurosurgery at a prominent hospital in Massachusetts. The surgeon looked at me for 5 minutes and ordered more tests. They found some abnormalities in my arms and legs, but the imaging didn’t warrant surgery. They recommended that I see a neurologist, which meant waiting another 5 months for an appointment.

During the interim, my primary care doctor wanted to be proactive. She was the only one taking me seriously. I did physical therapy 3 days a week and about a dozen courses of oral steroids. I was hopped up on cortisone for months. I also had a series of injections into my spine. None of it seemed to help.

I finally saw the neurologist, who ordered another MRI, which showed the bulging discs in my back were getting worse. But I was still not a candidate for surgery.

I’ve now been hospitalized 4 times due to loss of function, pain flares or passing out from pain in public places. The pain is that bad. Some days I can’t even get out bed because my knees won’t work. Some days I have close to no use of my arms, because my elbows are on fire. I’ve been getting more and more bacterial infections.          

My primary care doctor is the only one who believes my pain is real. She showed mercy and set up a pain management contract with me. We started with 5mg hydrocodone/acetaminophen 3 times a day. I had never touched an opiate before in my life. What a relief! I was so happy I could cry, just for a few hours of pain relief.  

I got a second opinion from another neurologist, who ordered more imaging and blood tests. The images came back as they have in the past, but the blood tests also showed there was severe inflammation – a possible sign of autoimmune disease. So off to rheumatology I go. 

After another 5-month wait for an appointment, the rheumatologist orders more blood tests and an in-depth panel for autoimmune disease. Eight of those tests come back elevated and 4 of them are so high they’re alarming. I think to myself, “This may be terrible news or it may be good news. Either way, I’m finally getting a diagnosis.” 

Not even close. I get all these test results sent to me in an app, with a message from the doctor saying everything “looks fine.” He suggests aspirin and ibuprofen, and that I get off the hydrocodone.  

I lost my temper at that point. How dare you insinuate I’m drug seeking! Like I didn’t try every other option first. All those needles driven into my spine, the steroids, and off-label antidepressants. The months of physical therapy, chiropractic and emotional therapy, all before finally resorting to actual pain medication. 

Some of these doctors and pharmacists with their discriminatory attitudes and actions are disgusting. If it was about the drugs, I’d drive 10 minutes into town and buy them at a fraction of the price I pay at the pharmacy.  

This whole ordeal between deductibles and loss of wages has easily cost me over $100,000. I could have done so much with that money. My wife would have her student debt paid off by now. Instead, it all goes into the for-profit healthcare system. We’re not patients, we’re profits.  

Being on opioid medication now for 2 years, I cannot function without them. Without my pain medication, I feel like someone with industrial grade tools is trying to physically remove my head from my neck. 

CVS is a nightmare and the other pharmacies aren’t any better. They give you that look when you walk in or call to check on a prescription: “Oh, it’s you again. We spoke last month. You’re too early. We know why you people do that.” 

Excuse me, but I’m allowed to pick up my medication the day before I am out, so that I have medication available when I wake up the next day. So that I don’t have call you at 9am when you get in and then have to wait until 3 in the afternoon to pick it up. 

For a while, CVS was taking GoodRx coupons, which cut my insurance price in half. Recently, they told me there’s a new state law that prescription coupons were no longer valid for opioids. I checked with the state and no such law exists. The pharmacist does have the right to turn coupons away, but they flat out lied to me and said it was someone else making them do it.   

The number of days I’ve gone into withdrawal with brutal pain I wouldn’t wish on my worst enemy. All because CVS can’t find the prior authorization or they don’t tell me they are out of stock until I’m at the window to pick it up. Or some other excuse they can drum up. Just so they don’t have to give this “junkie” his drugs. It’s sickening.   

Now, all of a sudden, I can’t get hydrocodone of any dosage at any pharmacy within 50 miles of me. And none of them know when it’ll be back in stock. I found one pharmacy that had a three-week supply of hydrocodone, but by the time I got it called in and got there they said they only had two weeks supply for me because another patient needed a week.  

I’m officially up shirts creek without a paddle and don’t know what to do. I’m in the most pain I’ve ever felt in my life. It is 24/7 and unrelenting. It’s destroying my life, my marriage, my chance at children, my business, and my finances. I get sent from one specialist to another, and at each stop on the merry-go-round they extract $5 to $10 thousand from me in out-of-pocket tests.   

I’m not sure how much longer I can take it.  

Christopher Matthews is a pseudonym for the author, who asked that his full name not be used. He is 35 years old and played 3 years of professional soccer after graduating from college.

Do you have a “My Story” to share? Pain News Network invites other readers to share their experiences about living with pain and treating it.

Send your stories to editor@painnewsnetwork.org.

Low Dose Opioids Ineffective for Acute Lower Back and Neck Pain

By Pat Anson, PNN Editor

A low dose of prescription opioids works no better than a placebo in relieving acute lower back or neck pain, according to a new study in Australia.  

The blinded, placebo-controlled trial was relatively small – just 345 participants – but was unusual because patients were followed for up to a year, a rarity for a clinical trial that studies pain.  Half the participants received a combination of oxycodone and naloxone for six weeks at a low daily dose of 20mg or about 30 morphine milligram equivalents (MME). The other half received placebo tablets that looked similar to oxycodone.   

It's important to note that the study only included people with mild or moderate pain of less than 12 weeks duration -- not the severe, long-term back and neck pain caused by degenerative disc disease, spinal injuries, arthritis, and other chronic conditions. Participants were excluded if they had that type of pain.  

The study findings, published in The Lancet, showed no significant difference in pain severity between the opioid and placebo groups. On a scale of zero to 10, the average pain score was 2.8 in the opioid group after six weeks, compared to 2.3 in the placebo group. After a year, the average pain score was 2.4 in the opioid group, versus 1.8 in the placebo group. 

Pain Severity Over 52 Weeks

THE LANCET

Researchers say patients who received opioids had a slightly higher risk of opioid misuse at the end of the study, a finding based on a mental health survey that screens patients for drug related behavior.

“Our findings show that even judicious, short-term use of an opioid conferred no benefits in pain reduction and led to a small increase in pain at the medium-term and long-term compared with placebo. The opioid group had worse quality-of-life mental health scores than the placebo group,” researchers reported. “Although no difference was found in overall time to recovery, more people in the placebo group recovered in the first 14 days compared with those in the opioid group.”

Most medical guidelines recommend exercise and over-the-counter pain relievers for short-term back or neck pain, with opioids only used as a last resort. The authors of the Lancet study say even that limited use is inappropriate.

“Opioids should not be recommended for acute back and neck pain, full stop,” said lead investigator Christine Lin, PhD, a professor in the School of Public Health at University of Sydney. “Not even when other drug treatments are not able to be prescribed or have not been effective for a patient.”

The Lin study is somewhat similar to the 2018 Krebs study, which found that low doses of oxycodone were no more effective than over-the-counter pain relievers in treating chronic back and osteoarthritis pain. Critics say the Krebs study was biased from the start and this one is no better.

“They generalise enormously,” Michael Vagg, MD, Dean of Pain Medicine at the Australian and New Zealand College of Anaesthetists, told the Medical Republic. “They studied oxycodone and naloxone in a modified-release formulation. But modified-use opioids have never been on-label for use in acute pain and they are not recommended as such… to which I and everyone in pain medicine would say ‘We figured that out ages ago’. That’s not how you use opioids in acute pain.

“In layman’s terms, they’ve done a study where they tried to look at doing push-ups to help with back pain and then they’ve decided that all exercise is no good for the back pain.”

Lower back pain is the world’s leading cause of disability and neck pain is the fourth largest, but there is surprisingly little evidence about the best ways to treat them.

A previous study published in The Lancet by an international team of researchers found that lower back pain was often treated with bad advice, inappropriate tests, risky surgeries and painkillers. The authors said there was limited evidence to support the use of opioids for low back pain, and epidural steroid injections and acetaminophen (paracetamol) were not recommended at all. Most patients responded better to physical and psychological therapies that kept them active.

FDA Expands Use of Spinal Cord Stimulators to More Types of Back Pain

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration continues to expand the use of spinal cord stimulators, despite a growing body of research that questions the safety and effectiveness of the devices.

This month the FDA approved the use of Abbott’s spinal cord stimulators for the treatment of chronic back pain in people who are unable to get corrective surgery – known as non-surgical back pain -- because they are too medically frail or have numerous degenerative disc problems. Those patients are usually treated with pain medication, physical therapy or spinal injections.

FDA approval was granted after a clinical study showed that SCS devices equipped with Abbott's BurstDR technology provided significant pain relief, better physical function, and improved quality of life in 200 patients with non-surgical back pain. The devices are surgically placed near the spine and emit mild electrical impulses to disrupt pain signals before they reach the brain. 

Participants in the study had chronic and disabling back pain for an average of nearly 13 years before getting the devices.

"We have struggled with how to treat people who weren't considered a good surgical candidate because we didn't have clear, data-driven treatment options for non-surgical back pain," Timothy Deer, MD, CEO of the Spine and Nerve Centers of the Virginias, said in an Abbott press release. "This new indication for Abbott's SCS devices, together with BurstDR stimulation, allows physicians the ability to identify and treat a new group of people, providing them with relief from chronic back pain."

BurstDR stimulation uses mild electrical pulses — or bursts — without creating an uncomfortable tingling sensation in the spine known as paresthesia.  All of Abbott's SCS devices use BurstDR technology.

Nine out of ten patients who received BurstDR therapy experienced significantly better function or pain relief, with pain levels reduced an average of nearly 70 percent. The improvements were sustained 12 months after the devices were implanted.

"This FDA expanded indication approval for our SCS devices is a significant step forward in Abbott's goal to provide treatment access to those who suffer daily with chronic back pain but are not eligible for corrective surgery," said Pedro Malha, vice president of neuromodulation for Abbott.

SCS devices were long considered a treatment of last resort for people with severe back, neck and leg pain, but in recent years the FDA has expanded use of the devices for conditions such as painful diabetic neuropathy. The devices are often promoted as safer alternatives than opioid pain medication.

Recent research, however, has raised questions about the safety, efficacy and long-term benefits of the devices. A recent Cochrane review concluded the stimulators work no better than a placebo for treating chronic low back pain, and provide little or no improvement in quality of life.  In a review of 13 clinical trials, researchers found little clinical data on the long-term effectiveness of SCSs, and noted that most of the studies lasted less than a month, were poorly blinded, or funded by device makers.

A 2018 study by investigative journalists found that SCSs have some of the worst safety records of medical devices tracked by the FDA.

A 2020 FDA review of adverse events involving stimulators found that nearly a third were reports of unsatisfactory pain relief. Other common adverse events are nerve damage, infections, and device malfunctions that may lead to further surgeries.

A 2022 study found that patients who get the devices did not reduce their use of opioids, and continued getting medical procedures such as injections, epidurals and radiofrequency ablation.

Surgery for Sciatica Has No Long-Term Benefit

By Pat Anson, PNN Editor

A surgical procedure called a discectomy is usually considered the treatment of last resort for people with leg pain from sciatica. Most medical guidelines only recommend a discectomy when exercise, pain medication and epidural steroid injections don’t work or provide minimal relief.

But in a meta-analysis (a study of studies) published in The BMJ, an international team of researchers found little evidence that discectomies reduce leg pain and disability. And even when they do, researchers say the benefits are usually short-lived.

Sciatica is a common condition that occurs when a herniated or slipped disk puts pressure on the lumbar nerve, causing pain, numbness and inflammation. The pain is felt on the sciatic nerve, running from the lower back down to the legs. Sciatica usually responds to non-surgical treatment, but in about 20% of cases, the pain will persist for a year or more.

Researchers looked at 24 clinical trials that looked at the effectiveness of discectomy and found “very low to low certainty evidence” that the procedure was superior to steroid injections and non-surgical treatment. Pain relief was moderate at best over the short term, and negligible after 12 months. There was also little evidence that discectomies reduce disability.

Despite those findings, researchers concluded that a discectomy might still be an early option for people with severe sciatica pain who need rapid relief. A discectomy relieves pressure on the lumbar nerve by removing a portion of the damaged disk.

“These findings challenge the notion that non-surgical treatment should always be the first line treatment for sciatica. In people with sciatica who regard rapid pain relief as an important treatment goal, and who feel that the benefits of discectomy outweigh the risks and costs, discectomy could be an early management option,” wrote lead author Chang Liu, PhD, a Research Fellow at the University of New South Wales in Sydney, Australia.

“As a result of the treatment’s invasive nature and the substantial costs of surgery, we would encourage
clinicians to discuss with their patients that discectomy can provide rapid relief of leg pain, but that
non-surgical treatment can achieve similar results, although at a slower pace and with a potential chance
of requiring delayed surgery if they do not respond to non-surgical treatment.”

Liu and his colleagues found the risk of an adverse event from surgery, such as an infection, further disk herniation or post-operative pain, was similar between a discectomy and non-surgical treatment.

But in an editorial also published in The BMJ, researchers at the University of Oxford challenged Liu’s suggestion that an early discectomy might be appropriate for people who have not explored other treatment options. Most people with sciatica recover on their own, they said, without the risks of surgery.

“In primary care, about two thirds of people with sciatica recover within two to three months without the need or even an indication for invasive treatments. Therefore, extrapolation of Liu and colleagues’ findings to a primary care population would be misleading,” said lead author Annina Schmid, PhD, an Associate Professor at Oxford Neuroscience.

“Their conclusions should be limited to people with a specific diagnosis of radicular pain with or without radiculopathy, who have likely not responded adequately to non-surgical approaches, or to people with severe pain and a large enough impact on quality of life to warrant secondary care referral.”

Schmid and her co-authors say the new research highlights one of the problems in treating sciatica – it’s a complex condition influenced by individual factors, and no treatment will consistently have the same results for patients.

Study Finds Spinal Cord Stimulation Has No Benefit for Back Pain

By Pat Anson, PNN Editor

A scathing new Cochrane review is raising more questions about the safety, efficacy and long-term benefits of spinal cord stimulators, medical devices that are increasingly used to treat chronic back pain.  

Cochrane reviews are considered the gold standard in medical research because they use robust methodology to gather good quality evidence and reduce the impact of biased, poor-quality studies.

The review by Australian researchers concluded that spinal cord stimulation (SCS) works no better than a placebo for treating chronic low back pain, and provides little to no benefit in improving quality of life.

The devices are surgically placed near the spine and connected to batteries implanted under the skin, which send electrical impulses into the spine to mask pain.

“Spinal cord stimulation is invasive and has a great financial cost to people who choose surgery as a last resort to alleviate their pain. Our review found that the long-term benefits and harms are essentially unknown,” said lead author Adrian Traeger, PhD, a Research Fellow at the Institute for Musculoskeletal Health at the University of Sydney. “Our review of the clinical data suggests no sustained benefits to the surgery outweigh the costs and risks.”

Treager and his colleagues analyzed the results of 13 clinical trials of SCS devices, looking at data from almost 700 patients with low back pain. They found little to no clinical data on the long-term effectiveness of SCS because most of the studies lasted less than a month, were poorly blinded, or had selective reporting bias.

The researchers also found that side effects from SCS surgery were poorly documented, preventing them from assessing the level of risk involved. Serious adverse events include nerve damage, infection, and the devices’ electrical leads moving, all of which may lead to more surgeries.

“Data in this review do not support the use of SCS to manage low back pain outside a clinical trial. Current evidence suggests SCS probably does not have sustained clinical benefits that would outweigh the costs and risks of this surgical intervention,” they concluded. 

Findings from the Cochrane review have been submitted to Australia’s Department of Health and Aged Care, which is reviewing the effectiveness of spinal cord stimulators. The devices' long-term safety and performance are also being re-assessed by Australia's Therapeutic Goods Administration (TGA).

“Our review found that the clinical benefit of adding spinal cord stimulation to treat low back pain remains unknown. When coupled with the reality that these devices are very expensive and often break down there is clearly a problem here that should be of concern to regulators,” said Chris Maher, PhD, Co-Director of Sydney Musculoskeletal Health.

Increasing Use of Stimulators

About 50,000 spinal cord stimulators are implanted annually in the U.S. and their use is growing. The devices are no longer limited to patients with back, neck and leg pain. In 2021, the FDA expanded the use of SCS to treat chronic pain from diabetic neuropathy. Stimulators are also being used on patients with Complex Regional Pain Syndrome (CRPS).

A 2018 study by investigative journalists found that SCSs have some of the worst safety records of medical devices tracked by the FDA. A 2020 FDA review of adverse events involving stimulators found that nearly a third were reports of unsatisfactory pain relief. A more recent study found that patients with the devices did not reduce their use of opioids, and continued getting procedures such as epidurals, corticosteroid injections and radiofrequency ablation.

Although evidence is growing that questions the safety and effectiveness of SCS, medical device companies continue to roll out new stimulators with more advanced technology. This week Nevro said it would release the first SCS system in the U.S. that uses artificial intelligence to optimize pain relief for each patient. The HFX iQ SCS system is designed for patients with diabetic neuropathy or chronic back and leg pain.

"This is an exciting time in spinal cord stimulation -- better waveforms, more conditions we can treat, and a massive treasure trove of patient data," said Usman Latif, MD, an interventional pain specialist and consultant to Nevro.

“What if we could take all the programming experience and clinical outcomes of tens of thousands of patients across the country, including what programs worked and what didn't, and bring the power of all that knowledge into the palm of our patient's hand -- with them 24/7, monitoring them, and offering them the best program for their exact situation with a tap on the screen. HFX iQ is the future of medicine, where expanded data holds the promise of new capabilities and improved care."

In addition to the U.S. release of HFX iQ, Nevro has asked for approval from regulators in Europe and Australia.