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.

Injection of Donor Cells Gives Long-Term Relief from Degenerative Disc Disease

By Pat Anson, PNN Editor

A single injection of cells and fluid derived from human donor tissue was successful long-term in relieving pain and restoring physical function in patients with degenerative disc disease, according to new research presented at the annual meeting of the Society of Interventional Radiology in Phoenix.

The injections, known as viable disc allograft supplementation, encourage cells in damaged discs to regenerate with healthy tissue. Degenerative disc disease is one of the leading causes of chronic lower back pain.

“The significant improvement in pain and function is promising for patients living with chronic low back pain – a condition that can greatly impact a person’s quality of life,” said lead author Douglas Beall, MD, chief of radiology at Clinical Radiology of Oklahoma. “Back pain is the leading cause of limited activity and workplace absenteeism. This treatment may help patients return to a normal activity level for a longer period time.”

Fifty patients participated in the VAST trial, with 46 patients receiving allograft treatment and four receiving saline injections as a placebo. VIVEX Biologics, a regenerative medicine company that processes donated cells and tissue to treat musculoskeletal injuries, wounds and burns, sponsored the study.

After three years, 60 percent of patients who received allograft treatment reported more than 50% improvement in pain and 70% had significant improvement in their function scores. No patients suffered adverse effects.

In healthy patients, discs cushion the spine’s vertebrae, facilitating movement and flexibility. But discs can wear out over time and cause the bones of the spine to rub together and pinch nerves, causing pain and disability. By age 60, most people have at least some disc degeneration.

“Existing treatment for chronic low back pain due to degenerative disc disease is often ineffective or the effects are short-lived,” said Beall, who is a medical consultant for VIVEX. “We need better treatments for this condition since conservative care is not providing the long-term outcomes that patients deserve. Injectable allograft treatment might be the answer for many people.”

Beall says allograft injections could decrease the use of pain medication by patients with chronic lower back pain. The treatment requires no incisions and patients are able to go home on the same day.

Other companies are also developing new injections to treat degenerative disc disease. In clinical trials, Australia-based Mesoblast says injections of its proprietary stem cell product provided long-term relief for people with lower back pain caused by disc disease. The company recently announced the FDA designated its stem cell injection as a Regenerative Medicine Advanced Therapy, which is designed to help speed up its development.   

Injections of an experimental gel developed by ReGelTec also show promise as a treatment for disc disease. The hydrogel is heated before injection to more easily fill cracks and tears in the affected discs. When the gel cools and hardens, it helps restore the disc’s structural integrity.   

7 Questions Seniors Should Ask Before Major Surgery

By Judith Graham, Kaiser Health News

Larry McMahon, who turns 80 this month, is weighing whether to undergo a major surgery. Over the past five years, his back pain has intensified. Physical therapy, muscle relaxants, and injections aren’t offering relief.

“It’s a pain that leaves me hardly able to do anything,” he said.

Should McMahon, a retired Virginia state trooper who now lives in Southport, North Carolina, try spinal fusion surgery, a procedure that can take up to six hours? (Eight years ago, he had a lumbar laminectomy, another arduous back surgery.)

“Will I recover in six months — or in a couple of years? Is it safe for a man of my age with various health issues to be put to sleep for a long period of time?” McMahon asked, relaying some of his concerns to me in a phone conversation.

Older adults contemplating major surgery often aren’t sure whether to proceed. In many cases, surgery can be lifesaving or improve a senior’s quality of life. But advanced age puts people at greater risk of unwanted outcomes, including difficulty with daily activities, extended hospitalizations, problems moving around, and the loss of independence.

I wrote in November about a new study that shed light on some risks seniors face when having invasive procedures. But readers wanted to know more. How does one determine if potential benefits from major surgery are worth the risks? And what questions should older adults ask as they try to figure this out? I asked several experts for their recommendations. Here’s some of what they suggested.

1) What’s the goal of this surgery?

Ask your surgeon, “How is this surgery going to make things better for me?” said Margaret “Gretchen” Schwarze, an associate professor of surgery at the University of Wisconsin School of Medicine and Public Health.

Will it extend your life by removing a fast-growing tumor? Will your quality of life improve by making it easier to walk? Will it prevent you from becoming disabled, akin to a hip replacement?

If your surgeon says, “We need to remove this growth or clear this blockage,” ask what impact that will have on your daily life. Just because an abnormality such as a hernia has been found doesn’t mean it has to be addressed, especially if you don’t have bothersome symptoms and the procedure comes with complications, said Drs. Robert Becher and Thomas Gill of Yale University, authors of that recent paper on major surgery in older adults.

2) If things go well, what can I expect?

Schwarze, a vascular surgeon, often cares for patients with abdominal aortic aneurysms, an enlargement in a major blood vessel that can be life-threatening if it bursts.

Here’s how she describes a “best case” surgical scenario for that condition: “Surgery will be about four to five hours. When it’s over, you’ll be in the ICU with a breathing tube overnight for a day or two. Then, you’ll be in the hospital for another week or so. Afterwards, you’ll probably have to go to rehab to get your strength back, but I think you can get back home in three to four weeks, and it’ll probably take you two to three months to feel like you did before surgery.”

Among other things people might ask their surgeon, according to a patient brochure Schwarze’s team has created: What will my daily life look like right after surgery? Three months later? One year later? Will I need help, and for how long? Will tubes or drains be inserted?

3) If things don’t go well, what can I expect?

A worst case scenario might look like this, according to Schwarze: “You have surgery, and you go to the ICU, and you have serious complications. You have a heart attack. Three weeks after surgery, you’re still in the ICU with a breathing tube, and you’ve lost most of your strength, and there’s no chance of ever getting home again. Or, the surgery didn’t work, and still you’ve gone through all this.”

“People often think I’ll just die on the operating table if things go wrong,” said Dr. Emily Finlayson, director of the UCSF Center for Surgery in Older Adults in San Francisco. “But we’re very good at rescuing people, and we can keep you alive for a long time. The reality is, there can be a lot of pain and suffering and interventions like feeding tubes and ventilators if things don’t go the way we hope.”

4) Given my health, age and functional status, what’s the most likely outcome?

Once your surgeon has walked you through various scenarios, ask, “Do I really need to have this surgery, in your opinion?” and “What outcomes do you think are most likely for me?” Finlayson advised.

Research suggests that older adults who are frail, have cognitive impairment, or other serious conditions such as heart disease have worse experiences with major surgery. Also, seniors in their 80s and 90s are at higher risk of things going wrong.

“It’s important to have family or friends in the room for these conversations with high-risk patients,” Finlayson said. Many seniors have some level of cognitive difficulties and may need assistance working through complex decisions.

5) What are the alternatives?

Make sure your physician tells you what the nonsurgical options are, Finlayson said. Older men with prostate cancer, for instance, might want to consider “watchful waiting,” ongoing monitoring of their symptoms, rather than risk invasive surgery. Women in their 80s who develop a small breast cancer may opt to leave it alone if removing it poses a risk, given other health factors.

Because of Larry McMahon’s age and underlying medical issues (a 2021 knee replacement that hasn’t healed, arthritis, high blood pressure), his neurosurgeon suggested he explore other interventions, including more injections and physical therapy, before surgery. “He told me, ‘I make my money from surgery, but that’s a last resort,” McMahon said.

6) What can I do to prepare myself?

“Preparing for surgery is really vital for older adults: If patients do a few things that doctors recommend — stop smoking, lose weight, walk more, eat better — they can decrease the likelihood of complications and the number of days spent in the hospital,” said Dr. Sandhya Lagoo-Deenadayalan, a leader in Duke University Medical Center’s Perioperative Optimization of Senior Health program.

When older patients are recommended to POSH, they receive a comprehensive evaluation of their medications, nutritional status, mobility, preexisting conditions, ability to perform daily activities, and support at home. They leave with a “to-do” list of recommended actions, usually starting several weeks before surgery.

If your hospital doesn’t have a program of this kind, ask your physician, “How can I get my body and mind ready” before having surgery, Finlayson said. Also ask: “How can I prepare my home in advance to anticipate what I’ll need during recovery?”

7) What will recovery look like?

There are three levels to consider: What will recovery in the hospital entail? Will you be transferred to a facility for rehabilitation? And what will recovery be like at home?

Ask how long you’re likely to stay in the hospital. Will you have pain, or aftereffects from the anesthesia? Preserving cognition is a concern, and you might want to ask your anesthesiologist what you can do to maintain cognitive functioning following surgery. If you go to a rehab center, you’ll want to know what kind of therapy you’ll need and whether you can expect to return to your baseline level of functioning.

During the covid-19 pandemic, “a lot of older adults have opted to go home instead of to rehab, and it’s really important to make sure they have appropriate support,” said Dr. Rachelle Bernacki, director of care transformation and postoperative services at the Center for Geriatric Surgery at Brigham and Women’s Hospital in Boston.

For some older adults, a loss of independence after surgery may be permanent. Be sure to inquire what your options are should that occur.

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

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.

FDA Approves Smallest Rechargeable Spinal Cord Stimulator

By Pat Anson, PNN Editor

The Food and Drug Administration has approved a new spinal cord stimulator that’s being touted as the smallest implantable neuromodulation device of its kind on the market. Abbott’s Eterna stimulator can also be recharged wirelessly as few as five times a year, unlike other stimulators that need recharging daily or weekly.

Spinal cord stimulators (SCSs) are an invasive treatment of last resort for people with chronic back or leg pain. The devices are surgically implanted near the spine and connected to batteries placed under the skin. The implants send low-level electrical impulses into the spine to block pain signals.

Abbott says it developed Eterna after extensive studies with pain patients and healthcare providers, who wanted a smaller implant with less need for recharging.

Eterna utilizes the company’s BurstDR stimulation, which mimics the natural firing patterns of nerves to provide pain relief without the tingling sensation of other simulators.

"Abbott's low-dose BurstDR stimulation is clinically proven to reduce pain, improve people's ability to perform everyday activities, and reduce emotional suffering associated with pain," Timothy Deer, MD, president and CEO of the Spine and Nerve Centers of the Virginias, said in a statement provided by Abbott.

ABBOTT IMAGE

"Until now, it wasn't available on a rechargeable device that was this small, and that only needs to be charged a few times a year. This makes a big difference in comfort for many patients who now can have access to the best of both worlds – a small, best-in-class rechargeable device with superior stimulation therapy."

Another advantage of the Eterna SCS system is that patients with the device can still have full-body MRI scans – a critical need for those who need access advanced imaging and diagnostics. The devices can also been monitored and programmed with a mobile app.

About 50,000 SCSs are implanted annually in the U.S. and their use is growing – in part because of the belief they’ll reduce the need for opioids and other pain therapies.

A recent study found that premise to be untrue. Researchers at the University of California San Francisco School of Medicine found that pain patients with stimulators did not reduce their use of opioids, epidurals, corticosteroid injections or radiofrequency ablation compared to a control group. About a fifth of the patients experienced complications so severe the devices had to be removed or revised.

A 2018 study found that SCSs have some of the worst safety records of medical devices tracked by the FDA. An FDA review of adverse events involving stimulators found that nearly a third were reports of poor pain relief. The review also identified nearly 500 deaths linked to the devices, along with nearly 78,000 injuries and 30,000 malfunctions.

SCS’s are no longer limited to patients with intractable back and neck pain. Last year the FDA expanded the use of stimulators to include lower limb pain from diabetic neuropathy.  Stimulators are also being used on patients with Complex Regional Pain Syndrome (CRPS).

4 Oldies But Goodies That Relieve Back Pain

By Dr. Forest Tennant, PNN Columnist 

In our studies, we routinely review persons with adhesive arachnoiditis (AA), Ehlers-Danlos Syndrome, Tarlov cysts and Epstein Barr autoimmunity. Our bulletins have, for the last two years, focused on new discoveries such as autoimmunity, medicinal agents, spinal fluid flow exercises, MRIs and laboratory testing.  

It’s a little embarrassing, but we haven’t sufficiently emphasized that some older treatments can still bring a lot of relief.  

AA causes considerable imbalance and unusual stretches to the muscles, tendons, nerves, and joints in the back, hips and pelvis. Consequently, these tissues become sprained, strained and inflamed. Many “old-time” measures can heal these tissues and enhance comfort and mobility. Here is a short summary of four that will be around for a long time since they simply provide comfort and relief. 

1. Ultrasound: Several years ago, we started using ultrasound for AA. The theory is that it may break up adhesions. While this may or may not happen, ultrasound often provides immediate relief that can last days or weeks. Medications such as cortisone cream can also be administered during ultrasound, which boosts their effectiveness. There are now hand-held ultrasound devices that can be purchased for use at home. 

2. Epsom Salts: Foot baths with minerals are convenient and soothing. Epsom salt baths are generally believed to “pull out” or detoxify the body of excess electricity and toxins. They can be most helpful for burning feet sensations and stabbing pains in the legs. 

3. Heating Pad: Heat dilates blood vessels, which brings more oxygen to the treated area and promotes healing. Heat also relaxes muscles that may be in spasm. 

4. Transcutaneous Electrical Nerve Stimulation (TENS): Electrical currents act as an anesthetic on nerves and nerve roots. Pain in persons with AA may temporarily abate when an electric current is administered over the lower back. TENS can often break a flare.

The human body has remained unchanged for thousands of years. Remedies and treatments discovered long ago may still be applicable today. AA has many associated conditions including spinal fluid leaks, inflammation in tissues around the spine, muscle spasm, and radiating pain among others. Some “old-time” treatments may be a welcome adjunct to the 3-component medical protocols.

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. This column is adapted from an updated bulletin recently issued by the Arachnoiditis Research and Education Project. Readers interested in subscribing to the bulletins should click here.

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.  

Smoking Marijuana More Effective Than CBD Extracts for Back Pain

By Pat Anson, PNN Editor

One of the reasons many medical marijuana users prefer edibles over smoking is that they are perceived as healthier.  Marijuana smoke contains many of the same chemicals and carcinogens as cigarette smoke, and could have harmful effects on people with respiratory or cardiovascular problems.

But a small new study conducted in Israel found that smoking marijuana is better than ingesting it, at least when it comes to treating chronic lower back pain. Researchers enrolled 24 adults with MRI or CT scans that showed evidence of disc herniation or spinal stenosis, and had them try two different types of cannabis treatment.

The first was a cannabis extract rich in cannabidiol (CBD), which was taken sublingually under the tongue daily for 10 months. After a month of no treatment, the same group smoked cannabis flowers rich in tetrahydrocannabinol (THC) up to four times a day for 12 months. Participants were allowed to take pain medication as needed, including oxycodone and acetaminophen.

The study findings, published in the Rambam Maimonides Medical Journal, showed there was little to no improvement in back pain when participants took the extract, but significant improvement when they smoked cannabis. The use of analgesic drugs also dropped significantly while smoking.

Notably, three patients dropped out of the extract phase of the study because it wasn’t helping them, but then returned to participate in the smoking phase.

“The current study is the first, to our knowledge, to indicate that THC-rich smoked therapy is more advantageous in ameliorating LBP (lower back pain), than low THC CBD-rich sublingual extracts. Despite the small number of patients, our data indicate that THC-rich smoked therapy is helpful in mitigating LBP,” researchers reported.

The most commonly reported adverse events during the study were nausea, dizziness, drowsiness and fatigue during the extract phase; sore throat and drowsiness were reported during the smoking phase. All of the adverse symptoms disappeared after a dose tolerance was reached. Most of the adverse effects were in female patients.

A 2019 study of medical marijuana users also found that smoking cannabis provided more pain relief than ingesting it. Over 3,300 people logged their symptoms on a mobile app while using a variety of cannabis products, including dried flower, edibles, tinctures and ointments. Smoking the dried flower provided more pain relief than any other cannabis product, regardless of the amount of THC.

Another problem with CBD edibles is that they are frequently mislabeled. A recent study of 80 CBD oils found that only 43 had concentrations of cannabidiols that were within 10% of their label claims – an accuracy rate of just 54 percent.

FDA Approves Device That Uses Artificial Intelligence to Treat Chronic Pain

By Pat Anson, PNN Editor

The Nevro Corporation says it has won approval from the Food and Drug Administration for an advanced spinal cord stimulator (SCS) that uses artificial intelligence to individualize treatment for each patient.

Nevro says its Senza HFX iQ stimulator “learns from patients” as they use the device and develops customized algorithms for treating chronic back pain, leg pain and pain from diabetic neuropathy.

"HFX iQ is designed to improve the consistency of pain relief and is the only SCS system that truly personalizes care," D. Keith Grossman, Chair and CEO of Nevro, said in news release.

"Pain is variable from patient to patient and over time. Using the big data from our HFX Cloud patient database, our unique HFX Algorithm was developed to identify those programs where patients have been more likely to get relief in the real world.  HFX iQ takes direct input from each patient on their pain and quality of life measures to get smarter over time and recommend program changes.”

Nevro says patients will start with a program most likely to provide pain relief, and then adjusts it over time based on patient input and medical data, such as pain scores, activity levels and changes in use of pain medication. Patients can also adjust their pain relief programs through an app on their smartphones.

Spinal cord stimulators are usually considered the treatment of last resort for people with intractable or severe chronic pain that doesn’t respond to other therapies. The surgically implanted devices emit low levels of electricity that reduce the intensity of pain signals.

Unlike older stimulators, Senza stimulators use electric pulses of 10 kHz, a high frequency that doesn’t create an uncomfortable tingling sensation and delivers more pain relief. Last year the FDA approved Senza stimulators for the treatment of painful diabetic neuropathy, making it the first spinal cord stimulation system approved for that condition. Until then, most SCS devices were only approved for patients with severe back pain.

About 50,000 stimulators are implanted in the U.S. every year, with failure rates for the devices estimated at 25 to 30 percent. Most patients are required to undergo psychological testing and a trial treatment before getting a SCS.

The FDA has come under scrutiny for its regulation of stimulators and other medical devices.  A 2020 report by Public Citizen accused the FDA of “dangerously lax” oversight of stimulators, which were linked to 156,000 injuries and 931 deaths.  The agency responded to the report by sending a letter to healthcare providers reminding them to only implant stimulators after a trial period that demonstrates the device are effective. An FDA review of adverse events involving stimulators found that nearly a third were reports of unsatisfactory pain relief.

Nevro says it will begin a limited release of Senza HFX iQ later this year, with a full market launch in the U.S. in early 2023. Nevro is also seeking approval of HFX iQ in Europe.  

Time to Reject the Label ‘Failed Back Surgery Syndrome’

Dr. Forest Tennant, PNN Columnist

In our research studies on Adhesive Arachnoiditis (AA), a high percentage of patients tell us that their doctors have said the cause of their pain is “Failed Back Surgery Syndrome” (FBSS).

This misnomer and poor excuse for a diagnosis has fortunately been rejected “out-of-hand” as a cause of pain by most upscale physicians. After all, FBSS is neither a disease nor a symptom. We can do better in 2022.

Some three or four decades ago, FBSS became a popular moniker used by most physicians, including this author. Why? Patients who had back pain underwent surgery, which was technically and expertly done, but the pain didn’t go away. This situation was a mystery in times past, but the label FBSS should never be used or applied in this day and age.

Today, magnetic resonance imaging (MRI) has advanced so much since its invention in the late 1980’s that painful disorders and diseases of the spine can almost always be diagnosed. There is now a technique called “contrast MRI” that allows a clear distinction to be made between spinal fluid and solid tissues, including the spinal cord, discs, nerve roots and covering of the spinal canal.

In our recent research studies, we have reviewed contrast MRIs in well over 200 persons who have been labeled as having FBSS. Every person had one or more obvious reasons to have chronic pain, despite well-done, competent surgery. For example, our reviews have found discs that have protruded, adhesive arachnoiditis, epidural fibrosis, spondylolisthesis, Tarlov Cysts, arthritic vertebra or other good, solid reasons to have pain, regardless of surgery.

Let’s be clear. Spine surgery may be necessary for a number of reasons, the most common being significant herniation of a disc or collapse of vertebrae that may dangerously compress the spinal canal. It also may be fair to say that a lot of surgery can now be avoided, since eminent danger and need for surgery is pretty clear cut on modern, contrast MRI’s.    

In addition to contrast MRIs, we now have good diagnostic tests for inflammation, autoimmunity and genetic connective tissue disorders, which are emerging as legitimate causes of severe, chronic back pain that hasn’t responded to chiropractic, physical therapy, anti-inflammatory agents and corticosteroid injections.

Put simply, the diagnostic evaluation of severe chronic back pain needs a contrast MRI and specific diagnostic tests rather than a non-descript, “wastebasket” diagnosis like FBSS.

Perhaps the worst thing about the label FBSS, is that it is easy to apply and avoids the time, money and knowledge to make a specific diagnosis. These excuses to avoid a specific diagnosis must now be rejected because we have the diagnostic and treatment measures to better the lives and health of those who suffer from severe chronic back pain.

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis through the Tennant Foundation’s Arachnoiditis Research and Education Project and the Intractable Pain Syndrome Research and Education Project.

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.   

Over 72 Million Americans Suffer Chronic Low Back Pain

By Pat Anson, PNN Editor

Nearly 3 out of 10 U.S. adults – 72.3 million people – currently suffer from chronic low back pain, surpassing the number of Americans who have arthritis, diabetes or heart disease, according to a large new Harris Poll. Over a third of those surveyed (36%) rate their back pain as “severe” or the “worst pain possible” and nearly half (44%) said they’ve experienced back pain for at least five years.

Over 5,000 adults participated in the online survey, which was sponsored by Vertos Medical, a company that makes medical devices to treat lumbar spinal stenosis (LSS).

One of the major findings in the survey is that over a third (37%) of adults with chronic low back pain (CLBP) have never been told by a healthcare professional what causes their pain. The vast majority (84%) say they wish there were better treatment options for CLBP.

"These survey results demonstrate that people with chronic low back pain are suffering greatly over long periods of time, and many have resigned themselves to living in a debilitated state," Kathy Steinberg, Vice President of Media and Communications Research at The Harris Poll, said in a statement. "The fact that more than a third are not being told what is causing their pain, such as LSS or an enlarged ligament, makes it more difficult to treat that pain.”

Lower back pain is the leading cause of disability, affecting about 540 million people worldwide. With so many people suffering, you'd think there would be a consensus on the best way to treat CLBP. But a 2018 review by The Lancet found that low back pain is usually treated with bad advice, inappropriate tests, risky surgeries and painkillers -- often against treatment guidelines.

The Harris Poll found that many Americans with CLBP are being treated with ineffective therapies, resulting in multiple visits to multiple doctors. On average, the typical back pain sufferer has sought relief from at least three healthcare providers, with an average of 4 office visits in the last year.  

Over one in five (21%) have had epidural steroid injections (ESIs), with 37% having 5 or more injections. ESI’s are not FDA-approved and the agency has warned that injections into the epidural space can result in rare but serious neurological problems, including loss of vision, stroke and paralysis. ESI’s were rated as one of the least effective treatments for CLBP in the Harris Poll.

Nearly a third of those surveyed (30%) said they have been prescribed opioids and 15% said they are currently taking them, even though medical guidelines caution that opioids are not appropriate for CLBP.

Opioids may not be recommended, but nearly 8 out of 10 (79%) said the medications were very or somewhat effective, making opioids the highest rated treatment for CLBP, slightly ahead of “conservative or eastern medicine” treatments such as physical therapy, chiropractic care and acupuncture.

Source: The Harris Poll

About half of those surveyed say CLBP has a major or moderate impact on their quality of life (53%), physical health (50%) and mental health (39%). Most strongly agree or somewhat agree (78%) that they have accepted CLBP as a part of their life.  

For more information about treatment options for CLBP, visit Know Your Back Story, a website hosted by Vertos Medical that promotes treatments for lumbar spinal stenosis.

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.  

Electromedical Treatments for Arachnoiditis

By Dr. Forest Tennant, PNN Columnist  

Adhesive Arachnoiditis (AA) is an inflammatory, nerve root entrapment disease in which cauda equina nerve roots are glued by adhesions to the arachnoid-dural covering of the spinal canal. An inflamed tumor-like mass is formed inside the spinal canal that blocks spinal fluid flow, allows seepage of fluid into tissue outside the spinal canal and shuts off electrical impulses that activate the legs, feet, bladder, intestine and sex organs. Autoimmunity is produced and/or magnified by AA. 

We highly recommend a three-component protocol for AA to reduce inflammation and autoimmunity, regenerate damaged tissue and to provide pain control. Recent advances in electromedical therapies can help achieve these three goals. 

There are two basic types of electromedical devices available for AA treatment: electric current therapy (EC) and electromagnetic therapy (EM). 

Electric Current Therapy 

Almost everyone is familiar with “TENS” units, which stands for “transcutaneous electrical nerve stimulation.” These devices were the first electromedical therapies to relieve pain and promote healing.

TENS units deliver a single electric current into tissues to produce an anesthetic, pain relieving effect.  

Today, more advanced EC devices administer micro-currents and/or a combination of multiple currents with different frequencies. 

Electromagnetic Therapy 

There is a form of energy that is half electricity and half magnetism, which can be divided into wave lengths. The very shortest wave of electromagnetic energy is “atomic” and the longest is “radio.” The shortest wave used in medicine is “laser.” Other electromagnetic energy waves used for medical purposes include infrared, light and microwave. 

EC and EM devices, when placed over the lower back, deliver electric current or electromagnetic energy to the lumbar-sacral spinal canal and the spine’s surrounding tissue.

Modern devices use intermittent pulsation of electric currents or electromagnetic energy to penetrate the skin and subcutaneous tissue to reach the AA site, which is usually about 2-3 inches below the skin.  

Some devices use the label PEMF, which stands for “pulsed electromagnetic frequency.” We believe that the newer EC and EM devices can deliver electric currents or electromagnetic energy that, when pulsed, penetrate deep enough to reach the AA disease site. 

Although not totally curative, these devices usually bring about pain reduction in the 20 to 30% range. Within an individual’s financial capability, we recommend that an EC and/or EM device be used 2 to 3 times a week (not daily). EC and EM therapy are not substitutes for a medical protocol. 

EM and EC devices often produce some initial healing, but later seem to stop working. In this situation the device may have done its maximal healing. The devices can still be used periodically to prevent relapses and treat flares. 

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. This column is adapted from a bulletin recently issued by the Arachnoiditis Research and Education Project. Readers interested in subscribing to the bulletins should click here.

Dr. Tennant’s new book, "Clinical Diagnosis and Treatment of Adhesive Arachnoiditis” is available on Amazon. 

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.   

Injectable Gel Shows Promise as Treatment for Back Pain

By Pat Anson, PNN Editor

An experimental gel shows promise as a treatment for low back pain caused by degenerative disc disease (DDD), according to the results of a small study being presented at the annual meeting of the Society of Interventional Radiology in Boston.

Hydrogels have been used for years to treat DDD, but this is the first time that Hydrafil – an injectable gel developed by ReGelTec – has been tested on humans.

Hydrafil was injected into the discs of 20 people in Colombia with chronic DDD, who had average pain levels of 7.1 on a 10-point pain scale. None of the participants had found more than temporary, mild relief from treatments such as rest, analgesics, physical therapy and back braces.

“We really have no good treatments for degenerative disc disease, aside from conservative care,” said lead investigator Douglas Beall, MD, a medical advisor to ReGelTec and chief of radiology services at Clinical Radiology of Oklahoma.

“Surgery is statistically no more effective than conservative care and can potentially make things worse; nerve ablation is appropriate for only a few patients; and existing hydrogels are inserted through an incision as a soft solid, which can pop out of place if you’re not highly skilled in placing it.”

Because Hydrafil is injectable, it requires no incision and is minimally invasive, although patients are sedated for the procedure. Researchers heat the gel to become a thick liquid and then use a 17-gauge needle to inject it directly into the affected discs, using fluoroscopic imaging to guide them. The gel fills in cracks and tears in the disc, and then hardens, restoring the disc’s structural integrity. The procedure takes about 30 minutes.

This promotional video by ReGelTec demonstrates how Hydrafil works:

Six months after the injection, all 20 participants in the study reported significantly less low back pain, with their pain levels declining to an average of 2.0 on the 10-point pain scale. They also reported significantly better physical function.

“If these findings are confirmed in further research, this procedure may be a very promising treatment for chronic low back pain in those who’ve found insufficient relief from conservative care,” said Beall. “The gel is easy to administer, requires no open surgery, and is an easy procedure for the patient.”

In 2020, Hydrafil received the FDA’s breakthrough device designation, which allows for an expedited review of an experimental product when there is evidence it provides more effective treatment than current options.

ReGelTec is currently recruiting 50 people with DDD in Canada for a new clinical trial of Hydrafil.

Degenerative disc disease is one of the leading causes of chronic low back pain. Healthy discs cushion the spine’s vertebrae, facilitating movement and flexibility. But with activity and normal aging, discs can wear out and cause the bones of the spine to rub together and pinch nerves, causing pain and numbness. By age 60, most people have at least some disc degeneration in their spines.