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).

Sickle Cell Patients Make Difficult Choices About Fertility

By Farah Yousry, Kaiser Health News  

Teonna Woolford has always wanted six kids. Why six?

“I don’t know where that number came from. I just felt like four wasn’t enough,” said Woolford, a Baltimore resident. “Six is a good number.”

Woolford, 31, was born with sickle cell disease. The genetic disorder causes blood cells to become misshapen, which makes it harder for blood to carry oxygen and flow throughout the body. This can lead to strokes, organ damage, and frequent bouts of excruciating pain.

Sickle cell disease affects an estimated 100,000 people in the U.S., and the vast majority of them are Black. Federal and charitable dollars dedicated to fighting sickle cell disease pale in comparison to what is spent to combat other, less common diseases that mostly affect white patients.

Physicians and researchers said the disease is a stark example of the health inequities that pervade the U.S. health system. A poignant expression of this, patient advocates said, is the silence around the impact that sickle cell disease has on fertility and the lack of reproductive and sexual health care for the young people living with the complex disease.

Woolford’s sickle cell complications have run the gamut. By the time she was 15, her hip joints had become so damaged that she had to have both hips replaced. She depended on frequent blood transfusions to reduce pain episodes and vascular damage, and her liver was failing.

“So many complications, infections, hospitalizations, and so by the time I graduated high school, I just felt defeated [and] depressed,” said Woolford, speaking from a hospital bed in Baltimore.

She had experienced a sickle cell pain crisis a few days earlier and was receiving pain medication and intravenous fluids.

In her late teens, Woolford sought out a bone marrow transplant, a treatment that enables the sickle-shaped cells in the patient’s body to be replaced with healthy cells from a stem cell donor. The procedure comes with risks, and not everyone is eligible. It also relies on finding a compatible donor. But if it works, it can free a person from sickle cell disease forever.

Teonna Woolford

‘You’re Probably Already Infertile’

Woolford couldn’t find a perfect match, so she enrolled in a clinical trial in which doctors could use a “half-matched” donor. As part of the bone marrow transplant, patients first receive chemotherapy, which can impair or eliminate fertility. Woolford hesitated. After all, her ideal family included six children.

When she told her doctor about her worry, his response crushed her: “This doctor, he looked at me, and he was like, ‘Well, I’ll be honest, with all the complications you’ve already had from sickle cell, I don’t know why you’re even worried about this process making you infertile because you’re probably already infertile.’”

Even if patients don’t have the transplant, sickle cell disease can damage their bodies in ways that can affect their ability to have children, according to Dr. Leena Nahata, a pediatric endocrinologist at Nationwide Children’s Hospital in Ohio.

For women, chronic inflammation and the sickling of blood cells in the ovaries can make getting pregnant harder. For men, sickled blood can jam inside the blood vessels of the penis, causing painful, unwanted erections that last for hours. This condition, called priapism, can damage sexual function and decrease sperm count. And it’s not just the disease. Researchers are evaluating how some widely used treatments may affect fertility — for example, by decreasing sperm count.

“It remains unclear how that translates directly to fertility outcomes but at least raises the concern that this may be an issue,” Nahata said. Even more concerning to Nahata were the results of a small study, which she co-authored, that showed some patients were unaware of the many fertility risks related to sickle cell disease.

Woolford said she was 19 and shocked when her doctor told her she was probably already infertile. But no one could be sure, so she held out hope that she might still undergo a procedure to preserve her fertility before having the chemotherapy required for the bone marrow transplant.

From extensive research, she learned that egg freezing could cost more than $10,000 and that her insurance wouldn’t cover it. She couldn’t afford to do it on her own. Woolford wondered whether she could find another way to pay for egg freezing. “So I started looking into financial resources,” she said. “And I saw all these foundations [that] give away grants. But you had to have a diagnosis of cancer.”

In the end, Woolford had the transplant without freezing her eggs. She said she felt that being cured would “be a fair trade-off to give up my dream of biological children.”

Unfortunately, the partial-match transplant did not work. Woolford’s body rejected it.

“So, here I am,” she said. “I am 30, still have sickle cell disease, and I’m infertile.”

Fertility Preservation and Reproductive Justice

A grim thought sometimes pops into Woolford’s mind: If she had cancer instead of sickle cell disease, her dreams of having biological children might still come true.

The first description of sickle cell disease in medical literature was published over a century ago. Because most sickle cell patients in the U.S. were Black, it quickly became labeled as a “Black disease.” And with that came a legacy of systemic racism that still affects patients today.

Black patients tend to have less social capital and fewer resources, said Dr. Lydia Pecker, a sickle cell disease researcher and an assistant professor of medicine at Johns Hopkins University. For fertility treatment, the resources available to cancer patients differ starkly from those available to sickle cell patients.

“There are any number of foundations, large and small, that help support and pay for fertility preservation for people with cancer,” Pecker said. “Those foundations actually work with fertility preservation centers to negotiate lower rates for affected people.”

Clear clinical guidelines state that children who have cancer and are going through chemotherapy should be referred for fertility preservation. Children with sickle cell disease going through transplants are exposed to chemotherapy, too, “but we don’t really have guidelines like that yet for people with sickle cell disease,” Pecker said.

It’s not a perfect comparison, she added, because the kinds of chemotherapy drugs used in pediatric cancer are different from the chemotherapies used in sickle cell treatment. But fertility preservation can be crucial when there is any risk of treatment-associated fertility impairment, Pecker said. Without clear and widely adopted clinical guidelines, sickle cell patients may not be referred to appropriate care.

Pecker said current medical practice forces sickle cell patients to make a difficult choice. “You can have treatment or you can have fertility,” she said. But in cancer care, she said, the thought is: You can have treatment and you can have fertility.

In the U.S., health insurance coverage for fertility preservation and treatment is not guaranteed and varies from state to state. Only 12 states have laws that mandate fertility preservation coverage for patients who undergo treatments that could imperil their ability to have biological children — usually referred to as iatrogenic treatments — like chemotherapy or radiation.

After Woolford’s transplant failed, the disease continued its assault on her body. And Woolford has had to come to terms with the impossibility of ever having a biological child. She launched a nonprofit, the Sickle Cell Reproductive Health Education Directive, to raise awareness of fertility issues at medical conferences and among patients. A future goal is to provide financial grants to sickle cell patients struggling to pay for fertility preservation and treatments.

Most days, Woolford finds the work empowering. On other days, she admitted, it reminds her of the bleak reality that she will probably never conceive a child.

“It’s really hard because I don’t think a lot of people realize that I’m fighting for something that I didn’t have access to,” she said.

At this point, she said, it’s no longer a medical justice fight. It’s a reproductive justice one.

Reporting for this story was supported by the USC Annenberg Center for Health Journalism’s Impact Fund for Reporting on Health Equity and Health Systems. It was produced in partnership with Side Effects Public Media, WFYI, and Kaiser Health News.

Steroid Injections May Worsen Knee Arthritis

By Pat Anson, PNN Editor

Two new studies are raising doubts about a commonly used treatment for knee osteoarthritis, a progressive and painful condition found in many older adults. Corticosteroid injections in the knee are often used to relieve osteoarthritis pain by reducing inflammation in the joint, with the relief lasting for days, weeks or sometimes months.

But a new long-term study by researchers at the University of California, San Francisco (UCSF) found that corticosteroid injections appear to worsen the progression of knee osteoarthritis compared to patients who received injections of hyaluronic acid, a polymer gel that acts as a lubricant and shock absorber.

UCSF researchers followed 210 patients with knee osteoarthritis (OA). Seventy of the patients received injections of either corticosteroids or hyaluronic acid, while the rest received no injections and served as a control group. MRI scans were performed on all participants at the start of the study and again two years later, focusing on the meniscus, bone marrow lesions, cartilage, joint effusion and ligaments.

“This is the first direct comparison of corticosteroid and hyaluronic acid injections using the semi-quantitative, whole organ assessment of the knee with MRI,” said Upasana Upadhyay Bharadwaj, MD, a research fellow in the Department of Radiology at UCSF.

In findings presented this week at the annual meeting of the Radiological Society of North America (RSNA), Bharadwaj reported that corticosteroid injections were significantly associated with the progression of knee OA, specifically in the lateral meniscus, lateral cartilage and medial cartilage.

Hyaluronic injections were not associated with the progression of knee OA. Patients who received hyaluronic acid showed a decreased progression of osteoarthritis, specifically in bone marrow lesions, compared to the control group. 

The findings are important because osteoarthritis is the most common form of arthritis, causing progressive joint damage and thinning of cartilage.  Over 32 million U.S. adults have knee OA, and about 10% of them receive corticosteroid or hyaluronic injections.

“While both corticosteroid and hyaluronic acid injections are reported to help with symptomatic pain relief for knee osteoarthritis, our results conclusively show that corticosteroids are associated with significant progression of knee osteoarthritis up to two years post-injection and must be administered with caution,” Bharadwaj said. “Hyaluronic acid, on the other hand, may slow down progression of knee osteoarthritis and alleviate long term effects while offering symptomatic relief.

“Knowing the long-term effects of these injections will help osteoarthritis patients and clinicians make more informed decisions for managing the disease and the pain it causes.”

In a second study presented at the RSNA’s annual meeting, researchers at the Chicago Medical School compared X-ray images of 50 patients with knee OA who received injections of corticosteroids to 50 patients who received injections of hyaluronic acid. Another 50 patients who had no injections served as a control group. Like the UCSF study, X-rays of all patients were taken at the start of the study and again two years later.

The findings mirrored those found in the first study. Patients injected with corticosteroids had significantly more osteoarthritis progression, including medial joint space narrowing, a hallmark of the disease.

“Even though imaging findings for all patients were similar at baseline, the imaging hallmarks of osteoarthritis were worse two years later in patients who received corticosteroid injections compared to patients who received hyaluronic acid injections or no treatment at all,” said Azad Darbandi, a researcher and medical student.

“The results suggest that hyaluronic acid injections should be further explored for the management of knee osteoarthritis symptoms, and that steroid injections should be utilized with more caution.”

The Mayo Clinic recommends that corticosteroid injections be limited to once every six weeks, and that knee OA patients receive injections no more than three or four times a year.

There was a third long-term study presented at the RSNA meeting that debunked another common treatment for knee OA: non-steroidal anti-inflammatory drugs (NSAIDs). UCFS researchers found that NSAIDs worsen inflammation and weaken cartilage in patients with osteoarthritis, contributing to a painful joint condition called synovitis. MRI imaging at the start of the study found joint inflammation and cartilage quality were worse in patients taking NSAIDs, and their knee joints deteriorated even more after four years. 

Spinal Cord Stimulators Fail to Reduce Opioid Use

By Pat Anson, PNN Editor

A large new study is raising questions about the long-term effectiveness of spinal cord stimulators and whether they really help patients reduce their use of opioids and other pain treatments.

Researchers at the University of California San Francisco (UCSF) School of Medicine analyzed health data for 1,260 patients who received permanent stimulators and found that — when compared to a control group — the devices did not reduce their use of opioids, epidurals, corticosteroid injections or radiofrequency ablation after two years. About a fifth of the patients experienced complications so severe the devices had to be removed or revised.

Spinal cord stimulators (SCSs) are considered an invasive treatment of last resort for people with chronic back or leg pain, because the devices have to be surgically implanted near the spine and connected to batteries placed under the skin. The implants send electrical impulses into the spine to mask pain.

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.

But UCSF researchers found that SCS patients actually filled more opioid prescriptions after one year than a control group of pain patients (CMM) who did not get the devices. The use of other medications and procedures by SCS patients declined slightly after one year, but there were no significant differences between the two groups after two years.

“The lack of reduction in pharmacotherapy, epidural and facet corticosteroid injections, and radiofrequency ablations at 2 years among patients receiving SCS compared with those receiving CMM suggests that SCS was providing insufficient pain relief to forego other therapies or improve rates of depression or anxiety, as prescriptions for these drug classes did not decline,” lead author Sanket Dhruva, MD, an Assistant Professor of Medicine at UCSF, wrote in JAMA Neurology.

“Because most patients still had their permanent SCS in place at 2 years, some may receive prolonged benefit from this modality, although we were not able to identify this through reductions in opioid use or nonpharmacologic pain interventions.”

Researchers also found that the total cost of care was about $39,000 higher for SCS patients in the first year, while health costs were similar for the two groups in the second year.

‘Sobering Insights’

"The findings appear to belie the popular belief that SCS may result in reduced opioid medication usage or overall fewer physician visits in the years immediately following device implant," wrote Prasad Shirvalkar, MD, and Lawrence Poree, MD, both from the UCSF Division of Pain Medicine, in an accompanying editorial.

“Using robust propensity matching, the present study provides sobering insights that SCS does not appear to reduce chronic opioid use or the utilization of health care resources compared with CMM in the first 2 years after implant. We believe this will help mitigate excessive enthusiasm of SCS as a panacea for chronic pain syndromes and illuminate biases of SCS hype cycle that can possibly be fueled by industry-related conflicts of interest.”

Stimulators are no longer limited to patients with chronic back, neck and leg pain. Last year the FDA expanded the use of SCSs to include pain from diabetic neuropathy. Stimulators are also now being used on patients with Complex Regional Pain Syndrome (CRPS).

A 2018 study by a team of 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. The review also identified nearly 500 deaths linked to the devices, along with nearly 78,000 injuries and 30,000 device malfunctions.

‘Promising Results’ for Low-Dose Naltrexone as Pain Reliever

By Pat Anson, PNN Editor

Low-dose naltrexone (LDN) continues to get more recognition from the medical community as a treatment for some types of chronic pain.

In a review of 47 studies on the off-label use of LDN, researchers at the University of Kansas Medical Center found “promising results” that naltrexone improves pain and function and reduces symptom severity in patients with chronic inflammatory or centralized pain. Most of the studies were small, however, and larger clinical trials are needed to demonstrate LDN’s efficacy.

“Though the results look promising, further, more well controlled studies are required before formal recommendations can be made,” said lead author Adam Rupp, DO, who will present his findings this week at the annual meeting of the American Society of Regional Anesthesia and Pain Medicine (ASRA) in Orlando, Florida.

Naltrexone is an inexpensive generic drug that is only approved by the Food and Drug Administration as a treatment for substance abuse. In 50mg doses, naltrexone blocks opioid receptors in the brain and decreases the desire to take opiates or alcohol.  

But in smaller doses of 5mg or less, patients with fibromyalgia, interstitial cystitis, intractable pain and other chronic conditions have found LDN to be an effective pain reliever. But because LDN is prescribed “off label” for pain, much of the evidence supporting LDN is anecdotal.

How naltrexone works is not entirely clear, but LDN supporters believe the drug helps modulate the immune system, reducing inflammation and stimulating the production of endorphins, the body's natural painkiller. LDN is not recommended for people currently taking opioid medication because it blocks opioid receptors and may cause withdrawal.

In their literature review, Rupp and his colleagues found that LDN improved physical function, sleep, mood, fatigue and quality of life in patients with Complex Regional Pain Syndrome (CRPS), fibromyalgia, diabetic neuropathy, Crohn’s disease, rheumatoid arthritis and low back pain. In patients with Crohn’s, improvements were also noted in the colon’s appearance during colonoscopies.

Side effects from LDN were minimal, consisting most commonly of vivid dreams, headaches, diarrhea and nausea. Most of the side effects resolved with continued use of LDN.

“The evidence in this review provides support for the off-label use of LDN for various chronic
inflammatory or centralized pain conditions. However, it is apparent that high-quality controlled studies focusing on administration, dosing and follow up time are needed before formal recommendations can be made,” Rupp said.

“Despite the current paucity of high-quality evidence in the literature, LDN continues to offer promising results in the management of symptoms in patients with chronic inflammatory or centralized pain conditions.”

Because LDN is not recommended as a pain treatment by the FDA or professional medical societies, patients interested in trying it often encounter doctors who refuse to prescribe it or don’t know anything about it. The LDN Research Trust includes a list of LDN-friendly doctors and pharmacies on its website.

FDA Warns Amazon and Walmart About Selling Misbranded Drugs

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has issued another warning to consumers not to purchase or use dietary supplements marketed for pain relief under the brand names “Artri” or “Ortiga” due to potentially dangerous pharmaceutical ingredients. Use of the products has led to liver toxicity and at least one death, according to the agency.

The FDA issued its first first warning about the supplements in January and followed up with a second warning  in April. The latest warning includes Amazon, Walmart and another retailer that continued to sell the supplements, which are marketed with claims that they treat arthritis and osteoarthritis, restore cartilage, and stop joint deterioration.

In a warning letter sent to Amazon last week, the FDA said it had purchased Artri and Ortiga supplements through its website and had them delivered through the company’s delivery service.

Laboratory testing confirmed the supplements purchased through Amazon contained diclofenac, a non-steroidal anti-inflammatory drug (NSAID), and dexamethasone, a corticosteroid used to treat inflammatory conditions.

Neither drug is mentioned on product labels, which list ingredients such as glucosamine and turmeric. The FDA warned Amazon that introducing or delivering a misbranded drug is a violation of federal law.  

“Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction. Please submit a written response to this letter within fifteen working days from the date of receipt, explaining the specific steps you have taken to address any violations,” the FDA letter states.

Similar warning letters were sent to Walmart and Latin Foods Market, which had previously issued voluntary recalls for the supplements, but still continued to sell them.

It appears the Artri and Ortiga supplements have now been removed from the websites of all three companies. The supplements were being marketed primarily to Spanish-speaking consumers, with claims they are “highly effective in restoring cartilage” and “fights arthritis.”  

Diclofenac raises the risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal bleeding and damage. When used long term or in high doses, dexamethasone and other corticosteroids can result in serious withdrawal symptoms if a consumer suddenly stops taking them. Both drugs can also interact with other medications.

The FDA encourages healthcare providers and patients to report side effects involving use of the products to its Adverse Event Reporting System. .

Green Eyeglasses Improve Anxiety and Wellness in Fibromyalgia Patients

By Pat Anson, PNN Editor

Fibromyalgia is well known as one of the most difficult chronic pain conditions to treat. The Food and Drug Administration has approved a handful of medications for fibromyalgia, but many patients find them ineffective in treating the muscles aches, joint pain, fatigue, anxiety and other symptoms that are common in fibromyalgia.  

Researchers at Duke University may have found an easy way to reduce some of those symptoms without the use of drugs. In a small study of fibromyalgia patients being treated with opioids, those who wore eyeglasses with specially tinted green lenses reported a significant improvement in their anxiety and overall sense of wellness. And while their pain levels were unchanged, their use of opioids declined.

“My research has been focused heavily on finding alternatives to opioids for pain management,” says lead author Padma Gulur, MD, Executive Vice Chair of the Department of Anesthesiology at Duke University. “One of the things we discovered early on was that there were visually mediated triggers for pain. We definitely could see that with headaches, but also that it could actually impact pain itself, the pain pathways. While we still don’t fully understand the mechanism of how pathways for pain get activated with visual mediation, it definitely does happen.

“We narrowed it down over some years to the hypothesis that with green light, particularly in the green spectrum, there was an opportunity where it was influencing pain, both chronic pain and acute pain.”

Previous research has found that green light therapy has a calming effect on the brain and is useful in treating fibromyalgia and migraines. But in those studies, participants were confined to a room where they were immersed in green light and told to avoid activities like watching TV or using their cellphones.

Gulur thought there must be an easier way to experience the benefits of green light.

“People want pain relief, but they also want to live their lives. And spending hours and hours in a room or exposure takes away from that quality of life,” she told PNN. “On the other hand, wearing eyeglasses is something we’re all very comfortable doing and, thankfully these days, colored eyeglasses are all the thing.”

Gulur and her colleagues studied 34 fibromyalgia patients who were randomly selected to wear various shades of eyeglasses at least four hours a day for two weeks: 10 patients wore blue eyeglasses, 12 wore clear eyeglasses and 12 wore green eyeglasses.

DUKE UNIVERSITY

Their findings, presented this week at the annual meeting of the American Society of Anesthesiologists, showed that participants who wore green eyeglasses were four times more likely to have reduced anxiety than those in the other two groups, who reported no reduction in anxiety. They also reported feeling better.

“We found that although their pain scores remained the same, those who wore the green eyeglasses used fewer opioids, demonstrating that their pain was adequately controlled,” said Gulur, who noted that patients who wore the green eyeglasses asked if they could keep them at the end of the study.

“They didn’t want to give them back. We had no trouble getting the blue and the clear back, but none of them wanted to return the green glasses.”

Unfortunately, they had to give them back. The eyeglasses are specially formulated to filter a specific wavelength on the green light spectrum and were needed for further study. You can’t buy the glasses online or at your local drug store. At least not yet.

Gulur and her team are planning further studies with green eyeglasses on patients with diabetic neuropathy and chronic back pain.

Thinking Outside the Pill Box: Another Approach to Pain Management

By Alon Ironi, CEO, Theranica Bio-Electronics

Well into my adulthood, I struggled with chronic back pain. I took medication after medication, finding myself getting sucked into the habit of popping painkillers and wondering why my pain wasn’t healing. I eventually discovered the psychological and mental elements inherent in chronic pain, and shifted my approach to pain management, which rapidly cured my back pain.  

The holistic approach to healing pain has historically been ridiculed in the medical community, preventing many physicians from recognizing the legitimacy of alternative treatments. The time has come to evolve beyond just popping pills to treat pain, towards a biopsychosocial perspective.  

The discovery and introduction of penicillin in 1928, marked the very beginning of medication popularization in the West. The development of new medications – for a wide range of uses - has extended life span and improved quality of life.  Unfortunately, the benefits associated with medication have encouraged its frequent use for disorders it simply is not meant for, such as certain types of chronic pain.  

Medication overuse headache is one example where drugs intended to treat migraine and headache can, with excessive use, lead to the deterioration of the exact condition they are supposed to be treating. Medication is an incredible tool when used properly, but it’s not the only tool, and it can be seriously harmful when misapplied.

What is Pain and How Do We Treat It? 

Pain is a unique bodily experience that, unlike other disorders, indicates an underlying issue in one’s physiology. Pain is an alarm system. It tells us that something is wrong, and if we mask it without treating its underlying cause, we might cause a great disservice to our bodies.  

The use of medication to treat short-term acute pain, while a person simultaneously heals from the cause of that pain, like a pulled muscle or a tear in a tissue, makes sense. However, the use of medication in instances of chronic pain - pain that persists longer than three months - is problematic.  

Chronic pain is a debilitating condition that impacts an individual’s everyday life. From migraine to chronic knee pain to chronic back pain, the routine of normal life is disrupted. Often, this chronic pain had an initial cause, such as a surgery, fall or injury that has since healed, but the pain persists long after its source has disappeared. This type of pain, as Haider Warraich, a physician and clinical researcher at Harvard, so aptly puts it, is like “an overlearned traumatic memory that keeps ricocheting around in our brains, often long after the injury it rehearses has fully healed.” 

This perception of chronic pain has its roots in quite a controversial physician -the late Jon Sarno, MD, a professor of rehabilitation medicine in the 1980’s and 90’s. His theories, while not rigorously proven in formal clinical studies, were built upon anecdotal data from thousands of patients he treated during his lifetime and are still being explored today. They have jumpstarted a revolution in our understanding of pain.  

The biopsychosocial model focuses on illness as a complex interaction of chemical and electrical reactions that are induced by biological, psychological and social factors. Contemporary pain researchers, like Lorimer Mosely, a clinical scientist, have applied this model to pain, recognizing that pain is comprised of both physical sensation and emotional stimulus, such as the fear of pain itself.  

Pain is no longer perceived as entirely “physical” in nature. It is now understood to be exacerbated by the fear of tissue damage and the aversion to previously experienced pain. As clinical research develops and shifts its focus to a more biopsychosocial approach to illness and pain, doctors must re-evaluate their first-line treatment suggestions. 

Drug-Free Pain Management 

Based on this new perception of pain, several nonpharmacological treatment methods for pain management have been developed. One approach is a purely psychological treatment called cognitive behavioral therapy, a form of talk therapy that discourages negative thoughts associated with pain and trains people to adhere to thoughts that stimulate the body’s natural pain relief system. Another example of nonpharmacological pain treatment is massage therapy,  which addresses pain by releasing muscle tension.  

Neuromodulation is highly effective in treating certain pain disorders through the use of electrical stimulation to modulate pain pathways in the neural system.  Several forms of neuromodulation treatment exist today, with different mechanisms of action and efficacy.  

Spinal cord stimulation, for example, is used to treat back pain and leg pain. But it is highly invasive, with electrodes surgically placed near the spinal cord to send electrical currents to the spine.

Deep brain stimulation is being studied for the relief of chronic pain, but it is also quite invasive, as it involves implanting electrodes into the brain.  

Nerivio is a non-invasive, wearable neuromodulation device made by my company that is FDA-approved for the treatment of acute migraine. Nerivio is self-applied to the upper arm, where it uses remote electrical neuromodulation (REN) to stimulate analgesic neurotransmitters in the pain pathways of migraine. In clinical trials, Nerivio and other REN devices have been shown to be just as effective as pharmacological treatments.  

To be clear, medication is a necessary and beneficial tool for treating infections, reducing fever, managing sickness and much more. However, its use in chronic pain management is sometimes misplaced, especially at a time when newer non-drug therapies are emerging.  

The holistic approach to pain management is the future. It considers the balance and context of a patient’s life and combines multiple modalities for their treatment. People are multifaceted and their treatment should be multifaceted as well. It is my hope and vision that this field of research will continue to develop and will soon be widely embraced by most medical professionals.  

Having experienced the benefits of drug-free pain management first-hand, I truly hope that health care systems will support patients in accessing these much-needed alternative treatments to improve quality of care and life.  

Alon Ironi is the CEO and co-founder of Theranica Bio-Electronics, the developer of Nerivio.

Alon received a Master of Science in Electrical Engineering from Santa Clara University, and a Bachelor’s of Science in Electrical Engineering from the Technion- Israel Institute of Technology.

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.  

Justin Brown: A CRPS Story of Hope

By Miles Ryan Fisher

When Justin Brown took his first steps at the age of 40, his parents were overcome with joy. Only, it wasn’t the same joy that they’d experienced when he’d taken his first baby steps.  No, this joy came with great pain — the kind of pain that comes with watching one’s child lose nearly half his life to a debilitating condition called Complex Regional Pain Syndrome, also known as “the suicide disease.”

In 2006, just as Justin prepared to enter the working world as a Penn State graduate, he started losing weight. He began regurgitating his meals, vomiting most of whatever he ate. Over time, he grew gaunt. His face sunk and his cheekbones protruded. His skin wrapped around his body until he looked emaciated.

Doctors didn’t have answers. When Justin reached the point that he couldn’t hold down any food, they inserted a J-tube — a feeding tube — in him so that food could bypass his stomach. But it wasn’t his stomach that was the problem. It was the parasite they hadn’t tested for — the one dwelling in his intestine right where the tube was inserted. When they removed the J-tube, they accidentally left a part of it in him.

When Justin awoke from surgery, he awoke to something even more unbearable. Something hellish. The operation triggered a pain that spread through his entire body and left him incapacitated, even after the parasite and tube remnant were removed. At the age of 26, Justin no longer had the strength to walk, not even to the bathroom.

Since 2007, he lay in a hospital bed in the middle of his parents’ living room in Fort Washington, Pennsylvania, his arms at his sides, his head always facing the same direction. In order to subdue the pain that incapacitates him, Justin takes a daily mixture of heavy pain medication, including narcotics.

It took many years until Justin and his family found a doctor who offered an accurate diagnosis: Complex Regional Pain Syndrome or CRPS. Only, the doctor didn’t call it that. Back then, the condition was known as Reflex Sympathetic Dystrophy or RSD.  

CRPS/RSD happens when an injury — as minor as a broken finger or as major as surgery — triggers a pain so severe that it is, according to the McGill Pain Index, worse than than amputation. The pain typically remains in the region of the injury, usually involving a limb. But in Justin’s case, it spread through his entire body.

“A lot of people feel like their skin or their nerves are burning, but for me it feels like my bones are being crushed,” Justin says. “If I took my worst pain before CRPS, that would be like a 1 out of 10 compared to my pain now. You really can’t describe it.”

The pain that he’s bravely battled for 17 years has been excruciating and constant. With no end. And no cure.

“It’s there 24/7, and you don’t know when it’s going to go away or if it’s going to go away,” Justin says. “But I had two choices. One was to completely quit. And the other was to keep going and hope that it’ll get better.”

Finding Hope

But now, Justin is finally getting part of his life back through a form of non-allopathic (without drugs or surgery) treatment offered at the Spero Clinic in Fayetteville, Arkansas.

The clinic, which has over 40 employees and treats hundreds of patients every year, was founded in 2012 by Dr. Katinka van der Merwe. Born in South Africa, van der Merwe immigrated to the United States in 1994 and earned her Doctor of Chiropractic degree with the intent of using it to treat individuals who suffer from CRPS and other chronic pain conditions. .

Her clinic’s approach involves treating the vagus nerve, which is the longest and most complex of the body’s 12 cranial nerves. Individuals who suffer from chronic neurologic disorders often have an underactive vagus nerve, which causes inflammation that is either localized or, as in Justin’s case, envelops the entire body. It’s this inflammation that can cause excruciating pain.

“My philosophy and belief is that the body is incredibly intelligent and can heal from the inside out,” van der Merwe says. “People don’t come here to get a diagnosis and medication — they come here to have their bodies rehabilitated.”

The clinic approaches pain treatment in a holistic and noninvasive way, using a variety of therapies and tools involving electrical, physical and auditory/visual/sensory stimulation. It’s the clinic’s range of therapies that helps correct the nervous system and – hopefully -- puts the patient’s pain in remission.

“It’s a completely different approach to everything that I’ve tried so far,” Justin says. This has included the most radical of forms, such as being placed in a ketamine-induced coma in Mexico and brought out of it with the hope that his nerves would essentially reset. Some CRPS patients have found relief with ketamine infusions, but it didn’t work for Justin.

It was last March that Justin began treatment at the Spero Clinic. As soon as the first week ended, Justin experienced progress. It began with his ability to move his hands. Then the next week, he stood up. On the third week, he walked for the first time in 15 years.

Every week after that has brought similar victories — small to a healthy person, but momentous for Justin. Regaining his ability to drink a Gatorade. Regaining his ability to curl two-pound weights. Regaining his ability to wear clothing that fits him, rather than clothing so loose as to not press against his body and cause him a great deal of pain.

“Before I got here, the most I could take were fifteen steps,” Justin says. “And they weren’t good steps. I’d just drag my feet on the ground. Now I walk from my hotel room down a couple hallways, through the center of the hotel, and outside.”

Every incremental gain helps Justin continue to grind. Unlike most patients, who require two or three months of treatment, Justin will need at least half a year because of how severe his CRPS is.

Fundraising Help

The cost of every week of treatment — about $3,000 — is typically not covered by insurance, which does not make it any easier on Justin or his family. If anyone knows this, it’s Philip Robert, one of the Spero Clinic’s CRPS patients in 2016.

Robert spent ten weeks at the clinic and found his recovery so miraculous that he was inspired to form the Burning Limb Foundation, a non-profit whose mission is to raise funds to provide financial assistance to people with CRPS, primarily for treatment at the Spero Clinic. What makes the foundation different from most other non-profits is that 100% of the donations it receives are applied to treatment costs. And unlike other fundraising platforms like GoFundMe, donors are then able to write it off as a charitable gift on their tax returns.

“The idea is to get (CRPS patients) started — get them seed money — so that they can then do a fundraising campaign in the nonprofit world,” Robert says. “We provide a platform in which families can utilize their resources—their network of friends and family—who may be willing to give a little bit more.”

It’s through the Burning Limb Foundation that Justin has received much-needed financial support from family, friends and even people who have never met him but want to play a role in his recovery.

It’s that recovery that Justin realizes is so important, not only to live a life free of pain, but also to inspire others like him who suffer from CRPS. While not cured of the disease, he hopes his remission can bring hope to others.

“If it can work for me, it can work for anybody,” Justin says. “It’s not guaranteed to work for everybody, but it can work for anybody.” 

Miles Ryan Fisher is the Assistant Director of the Building Trades National Medical Screening Program and also serves on the advisory board for Columbia Lighthouse for the Blind. His articles have appeared in the Washington Post, Philadelphia Inquirer, Washingtonian Magazine, Motherly, and Go World Travel.

Virtual Reality Therapy Reduces Drug Use During Surgery

By Madora Pennington, PNN Columnist

Imagine going in for minor surgery, one where you don’t need to be totally unconscious, and being given a virtual reality headset for pain and anxiety relief instead of the usual dose of anesthesia.

The virtual reality (VR) device would distract you during surgery by immersing you in a nature scene, like a forest, mountain top or nighttime sky. And a guide meditation would reassure you with, “Surgery is going great! Try to stay still!”

Would this even work?

A small study led by researchers at the University of Colorado sought to find out by looking at 34 patients receiving hand surgery that could be done without general anesthesia. While virtual reality has been widely studied as a treatment for acute and chronic pain, researchers are just beginning to explore whether it can be used during surgery.

“In the field of anesthesia, we are constantly focused on improving patient safety and care quality,” said lead author Adeel Faruki, MD, an anesthesiologist at the University of Colorado Hospital. “There are many studies currently underway assessing if VR can be used for orthopedic joint surgeries.”

Faruki and his colleagues divided the patients into two groups. Half received the usual care and served as a control group, while the other half wore VR headsets and noise-cancelling headphones during surgery to promote relaxation and calmness. Both groups received local anesthesia and the sedative propofol, either upon patient request or at the discretion of an anesthesiologist.

Researchers found that patients in the VR group received significantly less propofol than those in the control group. Only four of the 17 patients in the VR group received any propofol during their surgery, while every patient in the control group received the sedative.

PLOS ONE

Not surprisingly, the VR patients tended to need more supplemental local anesthesia. Propofol can amplify the effectiveness of pain medication, so patients on propofol generally require less numbing and pain relief.

Patients in both groups reported their pain was well-controlled and they felt relaxed during surgery. There were no significant differences in their pain scores or surgery outcomes. In short, the VR group did just as well with the pleasant distraction of the device as those receiving more sedating medication.

There are advantages to using less propofol. The drug is commonly used as sedative during surgery, but poses risks because it tends to depress breathing, which is dangerous. “Acute propofol intoxication" was cited as the cause of pop star Michael Jackson’s overdose death in 2009.

Propofol is also hard on the brain and may cause lower cognition after surgery.  Being less drugged, patients who received VR were discharged from the postoperative recovery room an average of 22 minutes earlier than fully medicated patients. Getting patients released early frees hospital staff and resources for other patients and needs.

Some limitations the authors of the study acknowledge are that patients signing up for VR might be more likely to do well with less anesthesia if they volunteered for it. Neither the patients nor the healthcare providers were “blinded” in this study, meaning everyone knew which patients were getting VR and which ones weren’t. This scenario opens the possibility that providers participating in the study might inadvertently influence the results by giving the VR patients less propofol.

The bottom line for this study, which is being published in PLOS ONE, is that patients can have just as comfortable a surgery with less sedation when VR is used. The study does not prove that VR is better, just that it does as well as sedative medication.

Madora Pennington is the author of the blog LessFlexible.com about her life with Ehlers-Danlos Syndrome. Madora has tried virtual reality therapy and found it useful in reducing both pain and anxiety.  

Ketamine and Oxytocin Provide Pain Relief for Arachnoiditis

By Dr. Forest Tennant, PNN Columnist

Nearly every day we receive an email from someone who is having trouble getting enough pain medication to give them a good quality of life.  In this age of opioid restrictions, there is hope. 

In the past, opioids and gamma amino butyric acid (GABA) substitutes such as diazepam (Valium) and gabapentin (Neurontin) have been the mainstays for pain control of adhesive arachnoiditis (AA). Today, there are alternatives that can enhance your current program to give you better pain control.

Low dose naltrexone is the initial pain reliever recommended to newly diagnosed AA cases. There are two other potent pain relievers that can be used with both naltrexone and opioids to achieve better pain relief: ketamine and oxytocin. Either agent is a good opioid substitute.

Ketamine provides pain relief primarily by suppressing a nerve receptor called N-methyl-d-aspartate. It can be taken by several non-oral routes of administration: nasal, injectable, sublingual or troche (dissolvable tablet).

Oxytocin (not to be confused with oxycodone or OxyContin) is a hormone that is a natural pain reliever. It surges in a woman’s body at the time of delivery to provide pain relief. It acts by activating the endorphin (opioid) receptors and by blocking nerve impulses between the brain and spinal cord.

Every community now has one or more pharmacies that will compound or “make” formulations of ketamine or oxytocin. We favor under-the-tongue (sublingual) or buccal (cheek) formulations.

Ketamine and/or oxytocin can be taken between opioid dosages or within 5 to 10 minutes before or after an opioid dosage to make the opioid stronger and last longer.

Ketamine and oxytocin can be used separately or used as combination therapy. Starting dosages of ketamine are 10-15 mg and oxytocin 10-20 units, which are administered within 10 minutes of each other. Dosages can later be raised above the starting dose.

We find the combination of ketamine and oxytocin to provide equal or better pain relief that most prescription opioids. Neither ketamine nor oxytocin are opioids, so there is no bias or resistance to their use. Also, overdoses are essentially not known to occur with regular dosages.

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.

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

‘Cognitive Rehab’ May Help Clear Brain Fog

By Judith Graham, Kaiser Health News

Eight months after falling ill with covid-19, the 73-year-old woman couldn’t remember what her husband had told her a few hours before. She would forget to remove laundry from the dryer at the end of the cycle. She would turn on the tap at a sink and walk away.

Before covid, the woman had been doing bookkeeping for a local business. Now, she couldn’t add single-digit numbers in her head. Was it the earliest stage of dementia, unmasked by covid? No. When a therapist assessed the woman’s cognition, her scores were normal.

What was going on? Like many people who’ve contracted covid, this woman was having difficulty sustaining attention, organizing activities, and multitasking. She complained of brain fog. She didn’t feel like herself.

But this patient was lucky. Jill Jonas, an occupational therapist associated with the Washington University School of Medicine in St. Louis who described her to me, has been providing cognitive rehabilitation to the patient, and she is getting better.

Cognitive rehabilitation is therapy for people whose brains have been injured by concussions, traumatic accidents, strokes, or neurodegenerative conditions such as Parkinson’s disease. It’s a suite of interventions designed to help people recover from brain injuries, if possible, and adapt to ongoing cognitive impairment. Services are typically provided by speech and occupational therapists, neuropsychologists and neurorehabilitation experts.

In a recent development, some medical centers are offering cognitive rehabilitation to patients with long covid, who have symptoms that persist several months or longer after the initial infection. According to the Centers for Disease Control and Prevention, about 1 in 4 older adults who survive covid have at least one persistent symptom.

“Anecdotally, we’re seeing a good number of people make significant gains with the right kinds of interventions,” said Monique Tremaine, director of neuropsychology and cognitive rehabilitation at Hackensack Meridian Health’s JFK Johnson Rehabilitation Institute in New Jersey.

Among the post-covid cognitive complaints being addressed are problems with attention, language, information processing, memory, and visual-spatial orientation. A recent review in JAMA Psychiatry found that up to 47% of patients hospitalized in intensive care with covid developed problems of this sort.

Seniors More Vulnerable

There’s emerging evidence that seniors are more likely to experience cognitive challenges post-covid than younger people — a vulnerability attributed, in part, to older adults’ propensity to have other medical conditions. Cognitive challenges arise because of small blood clots, chronic inflammation, abnormal immune responses, brain injuries such as strokes and hemorrhages, viral persistence, and neurodegeneration triggered by covid.

Getting help starts with an assessment by a rehabilitation professional to pinpoint cognitive tasks that need attention and determine the severity of a person’s difficulties. One person may need help finding words while speaking, for instance, while another may need help with planning and yet another may not be processing information efficiently. Several deficits may be present at the same time.

Next comes an effort to understand how patients’ cognitive issues affect their daily lives. Among the questions that therapists will ask, according to Jason Smith, a rehabilitation psychologist at the University of Texas Southwestern Medical Center in Dallas: “Is this showing up at work? At home? Somewhere else? Which activities are being affected? What’s most important to you and what do you want to work on?”

To try to restore brain circuits that have been damaged, patients may be prescribed a series of repetitive exercises. If attention is the issue, for instance, a therapist might tap a finger on the table once or twice and ask a patient to do the same, repeating it multiple times. This type of intervention is known as restorative cognitive rehabilitation.

“It isn’t easy because it’s so monotonous and someone can easily lose attentional focus,” said Joe Giacino, a professor of physical medicine and rehabilitation at Harvard Medical School. “But it’s a kind of muscle building for the brain.”

A therapist might then ask the patient to do two things at once: repeat the tapping task while answering questions about their personal background, for instance.

“Now the brain has to split attention — a much more demanding task — and you’re building connections where they can be built,” Giacino explained.

To address impairments that interfere with people’s daily lives, a therapist will work on practical strategies with patients. Examples include making lists, setting alarms or reminders, breaking down tasks into steps, balancing activity with rest, figuring out how to conserve energy, and learning how to slow down and assess what needs to be done before taking action.

A growing body of evidence shows that “older adults can learn to use these strategies and that it does, in fact, enhance their everyday life,” said Alyssa Lanzi, a research assistant professor who studies cognitive rehabilitation at the University of Delaware.

Along the way, patients and therapists discuss what worked well and what didn’t, and practice useful skills, such as using calendars or notebooks as memory aids.

“As patients become more aware of where difficulties occur and why, they can prepare for them and they start seeing improvement,” said Lyana Kardanova Frantz, a speech therapist at Johns Hopkins University. “A lot of my patients say, ‘I had no idea this could be so helpful.’”

Johns Hopkins has been conducting neuropsychiatric exams on patients who come to its post-covid clinic. About 67% have mild to moderate cognitive dysfunction at least three months after being infected, said Dr. Alba Miranda Azola, co-director of Johns Hopkins’ Post-Acute COVID-19 Team. When cognitive rehabilitation is recommended, patients usually meet with therapists once or twice a week for two to three months.

Before this kind of therapy can be tried, other problems may need to be addressed. “We want to make sure that people are sleeping enough, maintaining their nutrition and hydration, and getting physical exercise that maintains blood flow and oxygenation to the brain,” Frantz said. “All of those impact our cognitive function and communication.”

Depression and anxiety — common companions for people who are seriously ill or disabled — also need attention. “A lot of times when people are struggling to manage deficits, they’re focusing on what they were able to do in the past and really mourning that loss of efficiency,” Tremaine said. “There’s a large psychological component as well that needs to be managed.”

Medicare usually covers cognitive rehabilitation, but Medicare Advantage plans may differ in the type and length of therapy they’ll approve and how much they’ll reimburse providers — an issue that can affect access to care.

Still, Tremaine noted, “not a lot of people know about cognitive rehabilitation or understand what it does, and it remains underutilized.” She and other experts don’t recommend digital brain-training programs marketed to consumers as a substitute for practitioner-led cognitive rehabilitation because of the lack of individualized assessment, feedback, and coaching.

Also, experts warn, while cognitive rehabilitation can help people with mild cognitive impairment, it’s not appropriate for people who have advanced dementia.

If you’re noticing cognitive changes of concern, ask for a referral from your primary care physician to an occupational or speech therapist, said Erin Foster, an associate professor of occupational therapy, neurology, and psychiatry at Washington University School of Medicine in St. Louis. Be sure to ask therapists if they have experience addressing memory and thinking issues in daily life, she recommended.

“If there’s a medical center in your area with a rehabilitation department, get in touch with them and ask for a referral to cognitive rehabilitation,” said Smith, of UT Southwestern Medical Center. “The professional discipline that helps the most with cognitive rehabilitation is going to be rehabilitation medicine.”

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

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.  

‘No Pain, No Gain’ Approach Helps People With Peripheral Artery Disease

By Pat Anson, PNN Editor

“No pain, no gain” is a phrase that caught on in the 1980’s when fitness videos promoting aerobic exercise became popular. Most doctors today will say that’s bad advice, because physical pain during exercise could be a sign of a serious injury or health problem. Pain is your body’s way of warning you that something is wrong.  

But it turns out that pain and discomfort while walking for exercise may actually be a good thing for people with peripheral artery disease – PAD for short – a condition that occurs when arteries become narrow or clogged, reducing the flow of blood and oxygen throughout the body.

In a new study published in the Journal of the American Heart Association, researchers reported that people with PAD who experienced cramping, soreness, fatigue and other ischemic leg symptoms while walking may actually benefit from the pain.

“We were surprised by the results because walking for exercise at a pace that induces pain in the legs among people with PAD has been thought to be associated with damage to leg muscles,” said senior author Mary McDermott, MD, an Internal Medicine and Geriatric Professor at Northwestern University’s Feinberg School of Medicine. “Based on these results, clinicians should advise patients to walk for exercise at a pace that induces leg discomfort, instead of at a comfortable pace without pain.”

McDermott and her colleagues followed 264 mostly elderly people with PAD for 12 months, randomly assigning them to one of three groups. The first group walked at home at a comfortable pace; the second group walked at a faster pace that induced ischemic leg symptoms; and the third group did not walk for exercise.

Participants who walked were asked to exercise 5 days per week for up to 50 minutes, while wearing an ActiGraph, a device that monitored the intensity and duration of their walking.

After six months, researchers found that people who walked at a pace that induced ischemic leg symptoms walked significantly faster in daily life than those who did not exercise or walked at a comfortable pace without leg symptoms. They also performed better on a physical performance test that assessed their speed, strength and balance. The findings were similar after 12 months.

“This finding is consistent with ‘no pain, no gain’ with regard to walking exercise in PAD,” McDermott said in a press release. “Exercise that induces leg pain is beneficial, though difficult.

“We now are working to identify interventions that can make the higher intensity exercise easier -- and still beneficial -- for people with PAD.”

Between 8 and 10 million people in the United States have PAD. The condition disproportionately affects African-Americans, Native Americans and those with low socioeconomic status.

Previous research found that walking for exercise improves walking ability and walking distance for people with PAD. What remained unclear, until now, were the potential effects of walking at a pace that induced symptoms such as leg pain.

The American Heart Association and 24 other organizations recently launched the PAD National Action Plan, a guide to assist in the prevention of PAD complications, reduce cardiovascular risk, and improve quality of life for those living with the disease.

“PAD is a lifelong medical condition, but people with PAD can lead active and long lives,” said Joshua Beckman, MD, professor of medicine at Vanderbilt University. “If you notice walking is becoming more difficult, keeping up with others is hard, or you have pain when you walk, talk with a doctor and describe when it happens and how it feels.” 

A recent study found that walking for exercise is also beneficial for people with osteoarthritis, who experienced 40% less knee pain than non-walkers.