FDA Approves Advanced Spinal Cord Stimulator

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a new spinal cord stimulator developed by Medtronic that can be managed, tracked and updated remotely on a Samsung Galaxy tablet.

The Intellis stimulator is designed for patients with chronic, intractable pain of the trunk and/or limbs.

The Intellis platform can track patient activity 24/7 on the Samsung Galaxy Tab S2 tablet, enabling physicians to personalize the settings for individual patients and monitor their progress using Medtronic’s Evolve software system. 

"The launch of the Intellis platform isn't just about a new device, but about combining cutting edge hardware with optimal therapy through the Evolve workflow to enable personalized, long-term pain relief," said Marshall Stanton, MD, president of Medtronic's Pain Therapies division.

“The Intellis platform was designed based on what is most important to patients and physicians. We considered the entire patient journey - starting with the primary goal of optimal pain relief and access to important diagnostic tools, like MRI, to ease of use with simplified programming, faster recharge and a smaller implant."

MEDTRONIC PHOTO

Spinal cord stimulators (SCS) are often considered the treatment of last resort for chronic back and 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.

Some patients find the stimulators ineffective and have them removed. According to one study, only about half of patients who received a traditional SCS device have a 50 percent reduction in their back and leg pain. New technologies are being developed to make the devices smaller, more effective and easier to recharge.

Medtronic says Intellis is the world's smallest fully implantable SCS neurostimulator. Its battery can be fully recharged from empty to full in about one hour and physicians can estimate recharge intervals based on therapy settings. Software upgrades are also easier to get through Samsung Galaxy tablets.

"We are excited to partner with Medtronic in their aim to simplify programming, and streamline therapy management with the Intellis platform," said Dr. Dave Rhew, chief medical officer and head of Healthcare and Fitness for Samsung Electronics America. "Samsung's Galaxy tablets-secured by the HIPAA-ready Samsung Knox mobile security platform-will support future Medtronic therapies and over the air (OTA) software upgrades to ensure clinicians using Intellis have access to the most up-to-date solutions."

One of the first implantation procedures using the Intellis platform was performed at Duke University Medical Center.

"Chronic pain is challenging to manage. Having real-time data can provide more information about patients' quality-of-life changes. This platform represents a welcome new option for managing some kinds of chronic pain," said Lance Roy, MD, a pain medicine specialist at Duke University Medical Center.

Chronic Pain Patient: ‘They Are Killing Us Off’

By Pat Anson, Editor

Rob Hale isn’t sure how much longer he’ll live. Which is why the 51-year old Missouri man wants to share his story one more time, so people can see the impact the CDC's opioid prescribing guideline -- what Rob calls the “new cruelty” – is having on pain patients like himself.   

“That's it, man. I quit. I am too weak to continue. I'm beat. I hope some of you can live long enough to see some change in this new cruelty,” Rob wrote to me in an email. “Thank you so much, Pat, for providing me a platform in which to vent my frustration, pain, and anger at the system. I'm not sure if it helped anyone or not, but I hope it did.”

Rob first shared his story with us in a PNN guest column last December. At the young age of 27, he was diagnosed with ankylosing spondylitis, a degenerative and incurable form of arthritis that causes severe inflammation in spinal joints.

As the decades passed, the joints in Rob’s spine and neck became fused, and he was disabled and bedridden by chronic pain.

Relief only came from relatively high doses of opioid pain medication – as much as 600 MEMs (morphine equivalent units) a day. It reduced the pain enough for Rob to start working again, do chores around the house, and take care of his elderly father. Rob felt like his life was worth living again.

ROB HALE

Then came the CDC guidelines in 2016. Although they are voluntary and only intended for primary care physicians, Rob’s pain management doctors reduced his daily morphine dose to 120 MEMs, with the ultimate goal of getting it down to 90 MEMs – what the CDC recommends as the ceiling for high doses.

With his pain no longer being treated properly, Rob’s health deteriorated and he started taking high doses of Motrin, a prescription form of ibuprofen. He took so much Motrin it built up to toxic levels in his kidneys.  

“I was hospitalized in May, when my father couldn’t revive me in the morning. I woke up intubated, with IV’s and wires connected everywhere.  I was unconscious for 4 days, and when I finally awoke, I thought I had died and come back,” Rob said. “I was told if my dad hadn’t found me, I would have died within hours."

The cost to Medicare and taxpayers for that one stay in the hospital was $91,000 -- one of the unintended consequences of weaning or tapering a patient off high doses of opioids. Their healthcare costs often go up.

"None of that would have been necessary if I hadn't been denied my meds in the first place," Rob adds.

Rob was hospitalized a second time in June. His pain now grows worse every day, his health is failing, and he feels his time is running out.

“I nearly died, all because of this ‘opiate crisis.’ I just wanted to tell you that I’m home, albeit on oxygen, because my lungs are still filled with fluid, and I’m not sure how long I have to live,” he said.  “My old palliative care doctor and my current GP doctor think all of this that I’m going through right now is because of the trauma of the pain that I’ve been feeling since they started cutting me back.”

Rob feels he and other pain patients are being held responsible for an overdose crisis they didn’t create. He’s written letters to the CDC, FDA, DEA and to President Trump -- and only gotten form letters in return.

“The simple truth is this: They are killing us off - all of us chronic pain patients. We are, quite simply, a drain on the system, and the whole system would function much better without us. They'll get what they want, too. Before long, we'll all be gone - whether by our own hands, or by complications from our untreated pain, like me,” Rob wrote.

"I sure hope something changes soon. I’m not ready to give up the ghost yet, but I’m so weak that I can hardly type.  Why are they doing this to us, man?"

Spouse Criticism Makes Back Pain Worse

By Pat Anson, Editor

Not one likes being criticized. But people with chronic back pain take it harder – physically and emotionally – when having an argument with a loved one.

Even a brief fight with a spouse can significantly worsen lower back pain, according to the findings of a small study published in the journal Pain.

Researchers at Rush University in Chicago – who have been studying the emotional, cognitive and social aspects of pain – enrolled 71 couples in a study to see how patients with degenerative discs, spinal stenosis or herniated discs coped with criticism from a spouse.

Researchers watched as the couples engaged in a 10 minute discussion that focused on how the partner with back pain could improve their ability to cope with pain. The patients were then put through a structured activity that included walking, bending, lifting and sitting while the spouse watched.

Pain levels and how the couple interacted were coded by researchers, who watched for signs of hostility or criticism.

Patients who felt they were criticized by a spouse not only experienced more anxiety, anger and sadness, but their pain levels increased for as long as three hours. Women and patients who were depressed seemed most sensitive to criticism.

“Results support the hypothesis that spouse criticism and hostility - actually expressed or perceived -- may worsen CLBP (chronic low back pain) patient symptoms. Further, women patients and patients high in depressive symptoms appeared most vulnerable to spouse criticism/hostility,” wrote lead author John Burns, PhD, principal investigator at the Acute and Chronic Pain Research Lab at Rush University.

Researchers were surprised to see that even when a partner was supportive – and expressed concern about a patient's pain or gave “helpful” suggestions – the interaction was still perceived as negative by patients.

“Because the study required both patient and spouse to cooperate enough to participate, they generally got along just fine,” Burns told Reuters Health. “Even with these fairly happy couples, spouses uttered enough critical and hostile comments to negatively affect patient pain and function.”

Previous research has also found that how couples interact with each other can play a significant role in pain levels. A recent study found that even just holding hands reduces pain intensity.    

Lyrica and Neurontin Face More Scrutiny

By Pat Anson, Editor

The safety and effectiveness of Lyrica (pregabalin) and Neurontin (gabapentin) – two non-opioid drugs widely used to treat chronic pain – are drawing new scrutiny from researchers and doctors who believe the medications are over-prescribed.

In a study published in PLOS Medicine, Canadian researchers say there is little evidence that gabapentinoids – a class of nerve medication that includes Neurontin and Lyrica – are effective in treating chronic low back pain. In their review of 8 clinical studies, the researchers also found the drugs have a “significant risk of adverse effects.”

Lyrica and Neurontin are commonly prescribed for fibromyalgia and neuropathic pain, but the researchers say the drugs are increasingly prescribed for chronic back pain, even though there is “no clear rationale” for it.

"Despite their widespread use, our systematic review with meta-analysis found that there are very few randomized controlled trials that have attempted to assess the benefit of using gabapentin or pregabalin in patients of chronic low back pain," wrote lead author Harsha Shanthanna, MD, an assistant professor at McMaster University in Hamilton, Ontario.

"They necessitate prolonged use and are associated with adverse effects and increased costs. Recent guidelines from the National Health Service (NHS), England, expressed concerns on their off-label use, in addition to the risk of misuse.”

Shanthanna and his colleagues found that gabapentin showed “minimal improvement” in back pain compared to a placebo and pregabalin was “inferior” compared to other analgesics. There were no deaths or hospitalizations reported in any of the studies, but both drugs were associated with increased risk of dizziness, fatigue, visual disturbances, and diminished mental activity.

Lyrica and Neurontin are both made by Pfizer and are two of the company’s top selling drugs, generating billions of dollars in sales annually. Lyrica is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles, and spinal cord injuries. It is also prescribed off-label to treat other chronic pain conditions, including lower back pain.

Neurontin is only approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, but is widely prescribed off label to treat depression, ADHD, migraine, fibromyalgia and bipolar disorder. According to one estimate, over 90% of Neurontin sales are for off-label uses. Pfizer has paid $945 million in fines to resolve criminal and civil charges that it marketed Neurontin off-label to treat conditions it was not approved for.

Sales of pregabalin and gabapentin have risen steadily in recent years, in part because of CDC prescribing guidelines that recommend the two drugs as alternatives to opioid pain medication. About 64 million prescriptions were written for gabapentin in the U.S. last year, a 49% increase since 2011.

“We believe… that gabapentinoids are being prescribed excessively — partly in response to the opioid epidemic,” Christopher Goodman, MD, and Allan Brett, MD, recently wrote in a commentary published in The New England Journal of Medicine. “We suspect that clinicians who are desperate for alternatives to opioids have lowered their threshold for prescribing gabapentinoids to patients with various types of acute, subacute, and chronic noncancer pain.

“Patients who are in pain deserve empathy, understanding, time, and attention. We believe some of them may benefit from a therapeutic trial of gabapentin or pregabalin for off-label indications, and we support robust efforts to limit opioid prescribing. Nevertheless, clinicians shouldn’t assume that gabapentinoids are an effective approach for most pain syndromes or a routinely appropriate substitute for opioids.”

FDA Seeks Public Comment on Abuse of Lyrica

The U.S. Food and Drug Administration announced last week that it was seeking public comment on reports that pregabalin is being abused. The FDA action was in response to a formal notification from the World Health Organization (WHO) that it may place international restrictions on pregabalin to reduce the risk of abuse and diversion. The FDA has until September 30 to respond to WHO.

“Reports indicate that patients are self-administering higher than recommended doses to achieve euphoria, especially patients who have a history of substance abuse, particularly opioids, and psychiatric illness. While effects of excessively high doses are generally non-lethal, gabapentinoids such as pregabalin are increasingly being identified in post-mortem toxicology analyses,” the FDA said in a notice published in the Federal Register.

Pregabalin is already classified as Schedule V controlled substance in the U.S. under the Controlled Substances Act, which means the DEA considers it to have a low potential for abuse.

The idea that Lyrica and Neurontin are being abused is surprising to many patients and doctors, but there are growing signs the drugs are being used recreationally.

Both Lyrica and Neurontin have been linked to heroin overdoses in England and Wales, where prescriptions for both drugs have soared in recent years.  Addicts have apparently found the medications enhance the effects of heroin and other opioids.

A small study of urine samples from patients being treated at U.S. pain clinics and addiction treatment centers found that one in five patients were taking gabapentin without a prescription.

Gabapentin and pregabalin are also being abused by prison inmates, according to Jeffrey Keller, MD, chief medical officer of Centurion, a private corrections company. 

“Gabapentin is the single biggest problem drug of abuse in many correctional systems,” Keller recently wrote in Corrections.com. “There is little difference (in my opinion) between Lyrica and gabapentin in both use for neuropathic pain or for abuse potential.”

Pfizer did not respond to a request for comment.

Study Finds Rain Not Linked to Joint Pain

By Pat Anson, Editor

The debate over weather’s influence on pain is heating up again, with the release of a new study that showed warmer temperatures -- not rainy conditions -- are associated with an increase in online searches about joint pain.

The apparent increase in knee and hip pain may be due to increased outdoor physical activity, according to researchers who reported their findings in PLOS ONE.

Investigators used Google Trends to analyze how often people used Google’s search engine to look up words and phrases associated with hip pain, knee pain and arthritis. Then they compared the results with local weather conditions at 45 U.S. cities. The weather data included temperature, precipitation, relative humidity and barometric pressure - conditions previously associated with increases in musculoskeletal pain.

Researchers found that as temperatures rose, Google searches about knee and hip pain rose steadily, too. But knee-pain searches peaked at 73 degrees Fahrenheit and became less frequent at higher temperatures. And searches for hip-pain peaked at 83 degrees and then tailed off.

Surprisingly, rain actually dampened search volumes for both knee and hip pain.

"We were surprised by how consistent the results were throughout the range of temperatures in cities across the country," said Scott Telfer, a researcher in orthopedics and sports medicine at the University of Washington School of Medicine.

Searches about arthritis, which was the study's main impetus, had no correlation with weather conditions.

"You hear people with arthritis say they can tell when the weather is changing," he said. "But with past studies there's only been vague associations, nothing very concrete, and our findings align with those."

What do the findings mean?

Because knee and hip-pain searches increased until it grew warm, and rainy days tended to slightly reduce searches for hip and knee pain, the researchers speculate that changes in outdoor physical activity may be primarily responsible for those searches.

"What we think is much more likely explanation is the fact that people are more active on nice days, so more prone to have overuse and acute injuries from that and to search online for relevant information,” Telfer said, adding that web searches are often the first response people have to health symptoms.

Researchers in Australia recently reported that cold, rainy weather has no impact on symptoms associated with back pain or osteoarthritis. Warmer temperatures did slightly increase the chances of lower back pain, but the amount of the increase was not considered clinically important. 

A previous study on back pain and weather by The George Institute for Global Health had similar findings, but received widespread criticism from the public, a sign of just how certain many people are that weather affects how much pain they feel.

“I know it is going to rain or have a thunderstorm before the weather person announces it on the news,” says Denee Hand, who suffers back pain from arachnoiditis, a chronic inflammation of the spinal membrane. She says the pain spreads down to her toes when the weather changes. 

“It is like my nervous system and muscles react to the coming weather and finally I get pain that feels like the tops of both my feet are being crushed,” she said in an email to PNN. “I have compression of the spinal cord with nerve damage to my nerves from the scar tissue and when the weather changes the scar tissue presses down against the damaged nerves.”

Researchers at the University of Manchester recently ended a study involving thousands of people who used smartphone apps to report their pain levels, giving investigators the ability to compare the pain data with real-time local weather. Researchers are now analyzing the database compiled over the last 15 months and will release their results next spring.

Smart Underwear May Prevent Back Pain

By Pat Anson, Editor

We have smartphones, smart cars, smart appliances and smart watches.

So perhaps it was inevitable that someone would invent smart underwear.

That’s exactly what a team of engineering students at Vanderbilt University in Tennessee have done, although their underwear isn’t designed to park your car, count your steps or check your blood pressure.

They’ve invented a bio-mechanical undergarment that helps prevent back pain by reducing stress on back muscles. The device consists of two sections, one for the chest and the other for the legs, which are connected by straps across the middle back, with natural rubber pieces at the lower back and glutes. It looks like something Ben Affleck might wear in the latest Batman movie.

"I'm sick of Tony Stark and Bruce Wayne being the only ones with performance-boosting supersuits. We, the masses, want our own," jokes Erik Zelik, an assistant professor of mechanical engineering at Vanderbilt who led the design team.

"The difference is that I'm not fighting crime. I'm fighting the odds that I'll strain my back this week trying to lift my 2-year-old."

Zelik experienced back pain after repeatedly lifting his toddler son, which got him thinking about wearable tech solutions. Low tech belts and braces designed to give support to tired back muscles have been on the market for years, but many are bulky, uncomfortable or just plain unattractive.

VANDERBILT UNIVERSITY

"People are often trying to capitalize on a huge societal problem with devices that are unproven or unviable," said Dr. Aaron Yang, who specializes in nonsurgical treatment of the back and neck at Vanderbilt University Medical Center. "This smart clothing concept is different. I see a lot of health care workers or other professionals with jobs that require standing or leaning for long periods. Smart clothing may help offload some of those forces and reduce muscle fatigue."

The new, as yet unnamed device is designed so that users engage it only when they need it – like moving furniture or lifting 2-year old toddlers. A simple double tap to the shirt tightens the straps. When the task is done, another double tap releases the straps so the user can sit down comfortably and go about their business.  

The device can also be controlled by an app, with users tapping their phones to engage the smart clothing wirelessly via Bluetooth.

Eight people tested the undergarment by leaning forward and lifting 25 and 55-pound weights at a series of different angles. The device reduced activity in their lower back extensor muscles by an average of 15 to 45 percent for each task.

"The next idea is: Can we use sensors embedded in the clothing to monitor stress on the low back, and if it gets too high, can we automatically engage this smart clothing?" Zelik said.

The team unveiled the undergarment last week at the Congress of the International Society of Biomechanics in Brisbane, Australia, where it won a Young Investigator Award for engineering student Erik Lamers, one of the team members. The device makes its U.S. debut next week at the American Society of Biomechanics conference in Boulder, Colorado

The smart clothing project is funded by a Vanderbilt University Discovery Grant, a National Science Foundation Graduate Research Fellowship and a National Institutes of Health Career Development Award.

Insurance Claims Climb for Lyme Disease

By Pat Anson, Editor

Private insurance claims with a diagnosis of Lyme disease have soared in the U.S. over the past decade, according to a new report by FAIR Health, a nonprofit that tracks healthcare costs and insurance trends.

Lyme disease is a bacterial illness spread by ticks. It can also lead to other chronic pain conditions such as joint and back pain, chronic fatigue, fibromyalgia and neuropathy.

Fair Health analyzed a database of 23 billion private insurance claims from 2007 to 2016, and found that claims with a diagnosis of Lyme disease increased by 185 percent in rural areas and 40 percent in urban areas.

A recent CDC study also found the number of Lyme disease cases increasing, with nearly 40,000 confirmed and probable cases in 2015.

"Lyme disease is growing as a public health concern,” said FAIR Health President Robin Gelburd

Although Lyme disease historically has been concentrated in the Northeast and upper Midwest, the FAIR Health study suggests that it is spreading geographically. In 2007, insurance claims with diagnoses of Lyme disease were highest in New Jersey, Rhode Island, Connecticut, Massachusetts and New York.

By 2016, the top states were Rhode Island, New Jersey, Connecticut, North Carolina and New York -- with the emergence of North Carolina suggesting significant expansion to a new region.

Summer is the peak season for Lyme disease, with insurance claims more common in rural than in urban settings, according to the FAIR Health report. In the winter and early spring (December through April), claims involving Lyme disease were reported more often in urban than rural settings.

Age is also a differing factor in rural and urban environments. In rural settings, claims with Lyme disease diagnoses were more common for middle-aged and older people. Patients aged 41 years and older accounted for nearly two-thirds of the rural diagnoses. In urban populations, younger individuals with Lyme disease accounted for a higher percentage of claims.

Lyme disease is usually treated with antibiotics, but some patients experience complications that lead to Lyme disease syndrome (PTLDS), with long-term symptoms such as fatigue, muscle and joint pain and cognitive issues. Autoimmune diseases have also been associated with chronic Lyme disease.

Left untreated, Lyme disease can lead to serious chronic conditions, as Sarah Elizabeth Hirschle shared with us recently.

For patients with a Lyme disease diagnosis, FAIR Health reported the most common subsequent diagnoses were:

• Joint pain (dorsalgia, low back pain, hip and knee pain)
• Chronic fatigue  
• Soft tissue disorders (myalgia, neuralgia, fibromyalgia)
• Hypothyroidism

lyme disease rash

Early symptoms of Lyme disease include fever, chills, headaches, fatigue, muscle and joint aches, and swollen lymph nodes. A delayed rash often appears at the site of the tick bite. The rash grows in size and sometimes resembles a bulls-eye.

To see some tips from the CDC on how to avoid tick bites, click here.

Do Depression and Back Pain Lead to More Opioids?

By Pat Anson, Editor

Depressed patients with low back pain were twice as likely to be prescribed an opioid medication and to receive higher doses, according to the results of a new study that looked at data from a decade ago.

Lower back pain is the world’s leading cause of disability and the most common condition for which opioids are prescribed. Nearly a quarter of the opioid prescriptions written in the U.S. are for low back pain.

"Our findings show that these drugs are more often prescribed to low back pain patients who also have symptoms of depression and there is strong evidence that depressed patients are at greater risk for misuse and overdose of opioids," said John Markman, MD, director of the Department of Neurosurgery's Translational Pain Research Program at the University of Rochester Medical Center and senior author of the study published in the journal PAIN Reports.

The researchers found that patients who screened positive for depression were more than twice as likely to be prescribed an opioid, and they received twice the cumulative dose of opioids per year.

This not only suggests that doctors were more likely to prescribe opioids to a patient suffering both physically and psychologically, but it also implies that analgesics are less effective in pain patients who are depressed.

One obvious weakness of the study is that it relied on prescription data from 2004 to 2009 that was compiled by the Medical Expenditure Panel Survey, a federal survey of patients, their families, healthcare providers and employers. That time frame coincides with a steep rise in opioidprescribing, but does not represent the current environment in which opioid medication is harder to obtain.

The researchers believe, however, that understanding prescribing patterns from a decade ago may help improve the effectiveness of clinical trials. Low back pain is the condition most often studied to approve new pain medications, and depressed patients are often excluded from trials because of incentives to get positive findings about a new analgesic.

“Because several pivotal clinical trials for opioid treatment of LBP (low back pain) have systematically excluded the most depressed patients, it is probable that clinicians and patients alike are drawing conclusions from a study group that may differ in important ways from likely opioid recipients. These clinical trial populations may underrepresent the patients most likely to receive opioids, especially those who are mostly likely to receive higher dosages for longer durations,” Markman said.

Lower back pain may be the world’s leading cause of disability, but there is surprisingly little evidence about the best ways to treat it.

A recent review of 20 clinical studies involving nearly 7,300 patients found that opioids provide only “modest” short-term relief from lower back pain. Opioids were also no more effective than non-steroidal anti-inflammatory drugs (NSAIDs). About half of the patients involved in the studies dropped out because they didn’t like the side-effects of opioids or because they found them to be ineffective.

FDA Gives Fast Track Designation to New Pain Med

By Pat Anson, Editor

The U.S. Food and Drug Administration has granted “fast track” designation to a new, non-opioid pain medication for patients with osteoarthritis and chronic low back pain -- even though the drug has a history of safety issues.

Tanezumab is an investigational humanized monoclonal antibody that targets nerve growth factor (NGF), a protein that increases in the body as a result of injury, inflammation or chronic pain. Tanezumab binds to NGF and inhibits pain signals from reaching the spinal cord and brain.

Tanezumab is the first NGF inhibitor to receive fast track designation from the FDA, a process that speeds up the development and review of new therapies to treat serious conditions with unmet medical needs.

“If approved, tanezumab would be the first in a new class of non-opioid chronic pain medications,” said Ken Verburg, Chief Development Officer, Neuroscience & Pain, Pfizer Global Product Development. “We believe it would represent an important medical advance in the treatment of debilitating osteoarthritis and chronic low back pain for patients who do not experience adequate pain relief or cannot tolerate currently available pain medications.”

Pfizer is jointly developing tanezumab with Eli Lilly. The two drug makers are currently recruiting patients for Phase 3 studies of tanezumab in 7,000 patients with osteoarthritis, low back pain or cancer pain. Participants will be injected with tanezumab once every eight weeks for treatment periods ranging from 16 to 56 weeks, followed by a 24-week safety follow-up period.  Results from the clinical trials are not expected until next year.

"It is estimated that there are more than 27 million Americans currently living with osteoarthritis and 23 million living with chronic low back pain, many of whom fail to achieve adequate pain relief despite treatment with various types of pain medications,” said Christi Shaw, Senior Vice President and President, Lilly Bio-Medicines.

“We are committed to offering innovative solutions to people suffering from chronic pain conditions, and look forward to working closely with the FDA to facilitate the development of tanezumab.”

Ironically, it was the FDA that slowed the development of NGF inhibitors in 2010 because of safety concerns. The agency ordered a partial halt to clinical studies after Pfizer said a small number of osteoarthritis patients receiving tanezumab experienced worsening of their disease and needed joint replacements. Another safety issue arose in 2012 because the drug caused “adverse changes in the sympathetic nervous system of mature animals.” 

Most clinical studies of tanezumab did not resume until 2015. Pfizer says the current Phase 3 studies include risk mitigation measures for joint safety and sympathetic nervous system safety.

A clinical study of fasinumab, another nerve growth factor drug being developed by Teva and  Regeneron Pharmaceuticals, was stopped by the FDA last year after a patient showed signs of severe joint disease. Regeneron and Teva said they would redesign the study of patients with chronic low back pain to exclude participants with advanced osteoarthritis.

Can Vitamin D and Good Sleep Reduce Pain?

By Pat Anson, Editor

Vitamin D supplements, along with good sleeping habits, could help manage chronic pain from fibromyalgia, rheumatoid arthritis, back pain and other conditions, according to a new study.

The importance of vitamin D – the “sunshine vitamin” – in maintaining bone strength and overall health has long been known.  But recent research has focused on the role it plays in inflammation, musculoskeletal pain and sleep disorders.

“Vitamin D status seems to have an important role in the bidirectional relationship observed between sleep and pain,” said senior author Dr. Monica Levy Andersen in the Journal of Endocrinology. “We can hypothesize that suitable vitamin D supplementation combined with sleep hygiene may optimize the therapeutic management of pain-related diseases, such as fibromyalgia."

Andersen and her colleagues at Universidade Federal de Sao Paulo in Brazil reviewed 35 clinical studies of vitamin D, and concluded that vitamin D supplements could increase the effectiveness of pain treatments by stimulating an anti-inflammatory response.

"This research is very exciting and novel. We are unraveling the possible mechanisms of how vitamin D is involved in many complex processes, including what this review shows - that a good night's sleep and normal levels of vitamin D could be an effective way to manage pain," said Sof Andrikopoulos, assistant professor at the University of Melbourne and Editor of the Journal of Endocrinology.

Sources of Vitamin D include oily fish and eggs, but it can be difficult to get enough through diet alone. Ultraviolet rays in sunlight are a principal source of Vitamin D for most people.

Several recent studies have found an association between chronic pain and low levels of Vitamin D in the blood.  Researchers at National Taiwan University Hospital found low levels of serum vitamin D in over 1,800 fibromyalgia patients. Danish researchers have also found an association between lack of sunlight and multiple sclerosis.

But some question quality of the studies and whether Vitamin D supplements do any good.

“Evidence does not support vitamin D supplementation for the treatment of multiple sclerosis and rheumatoid arthritis or for improving depression/mental well-being,” wrote Michael Allan, a professor of Family Medicine and director of Evidence Based Medicine at the University of Alberta in the Journal of General Internal Medicine.

Allan says much of the research is of low quality. He doesn’t dispute the overall health benefits of Vitamin D – such as building strong bones and teeth -- but thinks taking supplements is unnecessary and could even be harmful in large doses.

"The 40 year old person is highly unlikely to benefit from vitamin D," said Allan. "And when I say highly unlikely, I mean it's not measurable in present science."

Study Finds ‘Nocebo Effect’ of Statins Cause Pain

By Pat Anson, Editor

An industry funded study is adding more fuel to a sometimes heated debate over statins – and whether the cholesterol-lowering drugs cause muscle pain and weakness.

Research involving nearly 10,000 patients published in The Lancet medical journal suggests that people taking Lipitor – the brand name for the statin atorvastatin -- are more likely to report muscle aches and other side effects, but only if they knew there were taking the drug.

This is what is called the “nocebo effect” – the opposite of the placebo effect – where people complain of side effects because they expect to have them.

"Just as the placebo effect can be very strong, so too can the nocebo effect. This is not a case of people making up symptoms, or that the symptoms are 'all in their heads'. Patients can experience very real pain as a result of the nocebo effect and the expectation that drugs will cause harm,” said lead author Peter Sever of the National Heart and Lung Institute at Imperial College London.

“What our study shows is that it's precisely the expectation of harm that is likely causing the increase in muscle pain and weakness, rather than the drugs themselves causing them."

Sever said complaints about the side effects overstate how common the problems are and discourage people from taking statins, resulting in "thousands of fatal and disabling heart attacks and strokes, which would otherwise have been avoided."

“These results will help assure both physicians and patients that most AEs (adverse effects) associated with statins are not causally related to use of the drug and should help counter the adverse effect on public health of exaggerated claims about statin-related side-effects,” he said.

The study was funded by Servier Research Group, Leo Laboratories and Pfizer – the maker of Lipitor. Five of the eight co-authors reported potential conflicts of interest, including payments from Pfizer and other drug makers that manufacture statins.  

Only about 2 percent of the patients taking Lipitor in The Lancet study reported having muscle pain, a finding that is substantially at odds with previous research.

For example, in a study at the Cleveland Clinic last year, 42 percent of patients taking Lipitor reported muscle pain and weakness. Other studies have found muscle pain in 5% to 29% of statin users.

The Food and Drug Administration considered the problem serious enough that in 2014 it required warning labels on statins, cautioning that some statins can cause a muscle injury called myopathy, which is characterized by muscle pain or weakness. In rare instances, the FDA says statins can also cause liver injury, diabetes and memory loss.

Another study this week, published in JAMA Internal Medicine, linked statin use to back pain conditions such as spondylosis and intervertebral disc disorders. The study involved over 13,000 military veterans and their families.

“To our knowledge, this study is the first to report greater odds of back disorders among statin users compared with the odds of nonusers in a population with equal access to and the same cost of health care,” said Una Makris, MD,  of the VA North Texas Health Care System in Dallas. “Our results provide additional motivation to further investigate the overall influence of statin therapy on musculoskeletal health, specifically if prescribed for primary prevention in physically active individuals.”

Warriors Coach in ‘Excruciating' Back Pain

By Pat Anson, Editor

Golden State Warriors coach Steve Kerr is in “excruciating pain” and may miss the rest of his team’s first round playoff series against the Portland Trail Blazers after his chronic back pain "took a turn for the worse." Kerr warned other back pain sufferers "to stay away from surgery."

Kerr was unable to attend Game 3 Saturday night and doesn't know when he’ll return. Sources told the San Jose Mercury News that Kerr was in so much pain he was barely able to walk, which “was scary because it wasn’t a feeling he’s had before.”

The team had only given vague reports that Kerr has an “illness” and is “not feeling well.”

"This past week, for whatever reason, things got worse and my symptoms got worse," Kerr said at a news conference Sunday.  "With things getting worse, I just made the decision that I couldn't coach. As of now, I'm consulting with my doctors. I'm hoping for some improvement. If I get some improvement, I'll get back on the sidelines. 

"I'm not going into details on the symptoms, it's just discomfort and pain. It's not fun. And I can tell you, if you're listening out there,  if you have a back problem, stay away from surgery. I can say that from the bottom of my heart."

In the past, Kerr has complained of headaches, nausea and neck pain.

Kerr missed the first 43 games of the 2015-16 NBA season due to complications from surgery for a ruptured spinal disk. The dura membrane that surrounds Kerr’s spinal cord was punctured during the operation, causing spinal fluid to leak. A second surgery was performed to stop the leak.

“It’s very rare, it does happen occasionally, but it happens when there’s an accidental nick of the dura that surrounds the spinal cord. But I lost spinal fluid, took about a month to figure out what was going on, a lot of headaches, some other symptoms,” Kerr said in October 2015.

Headaches, nausea, and burning, stinging or tingling pain in the back and legs are the classic symptoms of adhesive arachnoiditis, an inflammation that causes scar tissue to build around spinal nerves, causing them to adhere or stick together. The disease is progressive, incurable and difficult to treat.  Many patients developed arachnoiditis after surgeries or epidural steroid injections that permanently damaged their spines.

Neither Kerr or his doctors have said he has arachnoiditis.

There’s a great deal of debate in the medical community over the value of spinal injections, surgeries, spinal cord stimulators and other “interventional” procedures to treat back pain. About 9 million epidural steroid injections are performed annually in the United States, often as a substitute for opioid pain medication.

Chiropractic Therapy Gives ‘Modest’ Relief to Back Pain

By Pat Anson, Editor

When it comes to treating short-term back pain, spinal manipulation may not be all it’s cracked up to be.

In a review published in JAMA of over two dozen clinical trials involving over 1,700 patients, researchers said chiropractic adjustments provided only “modest” relief for acute low back pain – pain that lasts no more than 6 weeks.

The improvement in pain and function were considered “statistically significant,” but researchers said it was about the same as taking over-the-counter pain relievers. Over half of the patients also experienced side effects from having their spines manipulated, including increased pain, muscle stiffness and headache.

Although the study findings are mixed on the benefits of chiropractic treatment, the American Chiropractic Association (ACA) said it “adds to a growing body of recent research supporting the use of spinal manipulative therapy.”

“As the nation struggles to overcome the opioid crisis, research supporting non-drug treatments for pain should give patients and health care providers confidence that there are options that help avoid the risks and dependency associated with prescription medications,” said ACA President David Herd, DC.

Last month the ACA approved a resolution supporting new guidelines by the American College of Physicians (ACP), which recommend spinal manipulation, massage, heating pads and other non-drug therapies as first line treatments for chronic low back pain.

“By identifying and adopting guidelines that ACA believes reflect best practices based on the best available scientific evidence on low back pain, we hope not only to enhance outcomes but also to create greater consensus regarding patient care among chiropractors, other health care providers, payers and policy makers,” said Herd.

But the ACP guidelines are hardly a ringing endorsement of spinal manipulation. The overall evidence was considered low quality that chiropractic adjustments can “have a small effect on function” and that they provide “no difference in pain relief.”

In fact, the best treatment for acute low back pain may be none at all.

"Physicians should reassure their patients that acute and subacute low back pain usually improves over time regardless of treatment," said ACP President Nitin Damle, MD.

One in four adults will experience low back pain in the next three months, making it one of the most common reasons for Americans to visit a doctor. According to a 2016 Gallup survey, more than 35 million people visit a chiropractor annually.

Wear, Tear & Care: The SpineGym

By Jennifer Kilgore, Columnist

You’ve got to hand it to SpineGym’s marketing team -- when one of your device’s signature moves is visually hilarious, you could try to hide it... or you could own it.

They decided to own it.

The video was what intrigued me many months ago. I mean, it’s incredible.

I have Google Alerts set to notify me about new medical technology, and those are the types of emails sent to me by crowdfunding websites like Kickstarter and IndieGogo. The SpineGym device, which is designed to develop your back and abdominal muscles, was 928% funded nearly a year ago.

My core has as much strength as a trash bag filled with mashed potatoes. I’ve been desperate for something to help me focus on those important muscles, but I was concerned that it would be too intense for my spine at T-11 and T-12, as a facet joint in that area never healed correctly.

Upon watching the exercise video, however, it didn’t seem too physically strenuous. I reached out to SpineGym USA to ask for a test unit, and they were gracious enough to offer me one. I’ve been using the device for a couple months now. Each session is intended to be less than five minutes, a few times a week.

Surprisingly, that’s all I can physically manage.

What is the SpineGym?

The SpineGym has two parallel poles set into a floorplate that go back and forth. There is a black band between the poles that you lean back or forward on. There are also loops on the base plate where you can hook plastic bands as an alternative workout for your arms.

The machine bases a workout’s pace on the user’s strength and capabilities, because the force working against the machine is what sets the tone. The moves themselves range from simple isometrics to a variation of crunches that work the abdominal and back stabilizer muscles.

With the positioning of the machine’s arms, it changes the moves entirely. I felt my muscles in a way I never had on a yoga mat, and they engaged from my low back all the way up to the base of my neck. When you watch the video it doesn’t look hard, but it’s surprisingly difficult when you actually try it.

SPINEGYM PHOTO

I wondered if this was because I have absolutely no core strength, so I asked my husband to try it. Here are a few key demographic differences between the two of us: He’s 6’, an ultra-marathon runner and exercises for approximately three hours a day. (Yes, I am aware of the irony.) He did agree with my assessment, however, and said that the SpineGym engaged his midsection in a way that crunches definitely do not.

SpineGym’s Data

When 20 sedentary workers aged 35-60 were given SpineGyms to use for two weeks, they were instructed to exercise for only five minutes a day. The following results were based on EMG measurements after two weeks:

• an average 80% improvement in activation of back muscles
• an average 141% improvement in activation of abdominal muscles
• significant postural improvements
• significant improvements in abdominal muscle strength
• approximately 90% of users found the training method to be efficient or very efficient.

A second test was performed on users aged 70-90 and included three SpineGym sessions a week for two months. Each session lasted four to five minutes.

• Standing balance improvement of 74%
• Muscle strength and coordination: improvement of 58%
• Walking speed improvement of 41%

Most of this improvement was reached by participants already after the first month of exercise.

How It Worked for Me

My lower back has been hurting much more recently in that “coming-back-from-the-dead” way. If I overdo it with the SpineGym -- meaning if I use it more often than once every few days -- I go into spasm and have a flare. This is when a session lasts about five minutes. It targets that specific area that needs the most work, so I am very excited about this unit.

People larger than 6’ might find it a bit flimsy for their size, as the poles are quite tall, set into a base plate that fits your shoes side by side, and is made of carbon fiber. It’s a bit of a balancing act. However, as long as your feet are firmly planted and your core is engaged, the platform should not move. Plus, there’s an anti-slip pad underneath.

The other great things? It’s relatively small and light for medical equipment (11.2 pounds or 5.1 kg). It sets up and breaks down easily and stores flat in a T-shirt-shaped bag, though I don’t ever put it away. It doesn’t take up much space, so why bother?

When I’ve been working all day and desperately need to stretch my lower and mid back, the SpineGym hits the muscles that need releasing the most. The unit targets the discomfort better than an upward-facing dog pose on the yoga mat. I just have to remind myself not to use the SpineGym too often, or I’ll be my own worst enemy in terms of progress.

You can purchase the SpineGym for $198 through Indiegogo.

Jennifer Kain Kilgore is an attorney editor for both Enjuris.com and the Association of International Law Firm Networks. She has chronic back and neck pain after two car accidents.

You can read more about Jennifer on her blog, Wear, Tear, & Care.  

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

Study Finds Opioids Reduce Effectiveness of Massage

By Pat Anson, Editor

Massage therapy significantly improves chronic low back pain, but is not as effective when patients are taking opioid pain medication, according to a new study.

Nearly 100 patients with low back pain were given a series of 10 massages designed and provided by a massage therapist. Over half experienced clinically meaningful improvements in their low back pain.

"The study can give primary care providers the confidence to tell patients with chronic low back pain to try massage, if the patients can afford to do so," said lead author Niki Munk, an assistant professor of health sciences in the School of Health and Rehabilitation Sciences at Indiana University-Purdue University Indianapolis.

Most patients showed improvement in their pain and disability after 12 weeks, but the effectiveness of massage appeared to diminish after 24 weeks of therapy.

The study also identified several characteristics in patients that made them more or less likely to experience relief from massage:

• Adults older than 49 had better pain and disability outcomes than younger adults.
• Patients who were taking opioids were two times less likely to experience clinically meaningful change compared to those who were not taking opioids.
• Obese patients experienced significant improvements, but those improvements were not sustained over time.

"The fact of the matter is that chronic lower back pain is very complex and often requires a maintenance-type approach versus a short-term intervention option," said Munk.

Another inhibiting factor is cost. Patients in the study were given free massages, but in the real world massage therapy is often not covered by insurance, Medicaid and Medicare. Researchers say more studies are needed to determine just how cost-effective massage is compared to other treatments,

"Massage is an out-of-pocket cost," Munk said. "Generally, people wonder if it is worth it. Will it pay to provide massage to people for an extended period of time? Will it help avoid back surgeries, for example, that may or may not have great outcomes? These are the types of analyses that we hope will result from this study."

The study was published in the journal Pain Medicine. 

Lower back pain is the world's leading cause of disability. Over 80 percent of adults have low back pain at some point in their lives.