Exercise Best Prevention for Low Back Pain

By Pat Anson, Editor

Regular exercise significantly reduces the risk of developing low back pain, according to new research that found other therapies such as ergonomics, back belts and shoe inserts do little to prevent it. Lower back pain is the world’s leading cause of disability.

Researchers at the University of Sydney in Australia analyzed nearly two dozen back pain studies involving over 30,000 people to see which therapy works best in preventing low back pain. Their study, reported in JAMA Internal Medicine, found “moderate quality evidence” that exercise or a combination of exercise and education work best.

“For exercise to remain protective against future LBP (low back pain), it is likely that ongoing exercise is required. Prevention programs focusing on long-term behavior change in exercise habits seem to be important,” wrote lead author Daniel Steffens, PhD, of the University of Sydney. “The available evidence suggests that education alone, back belts, shoe insoles, and ergonomics do not prevent LBP.”

Over 80 percent of us suffer acute low back pain at least once in our lives, and about half will experience a recurrence within one year.  

The researchers estimate that exercise results in a 35 percent reduced risk of developing low back pain within a year; while exercise and education reduces the risk by 45 percent.

“If a medication or injection were available that reduced LBP recurrence by such an amount, we would be reading the marketing materials in our journals and viewing them on television. However, formal exercise instruction after an episode of LBP is uncommonly prescribed by physicians,” wrote Timothy Carey, MD, and Janet Freburger, PhD, of the University of North Carolina at Chapel Hill, in a commentary also published in JAMA Internal Medicine.

“This pattern is, unfortunately, similar to other musculoskeletal problems in which effective but lower-technology and often lower reimbursed activities are underused. In one study, fewer than half of the patients with chronic LBP or neck pain who were surveyed received exercise instruction despite a good evidence base for its effectiveness.”

Carey and Freburger said physicians and professional societies need to start working together to establish exercise guidelines for low back pain, and health insurance companies “will need to be convinced” about the benefits of exercise for them to start covering it. 

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

Are Chronic Fatigue Sufferers Afraid of Exercise?

By Pat Anson, Editor

Research published in a respected British medical journal is fueling a new debate over exercise and whether it helps or hurts people suffering from chronic fatigue syndrome.

Researchers at King’s College London reported in The Lancet Psychiatry that most chronic fatigue sufferers have “fear avoidance beliefs” that exercise will only make things worse.

Chronic Fatigue Syndrome (CFS) -- also known as Myalgic Encephalomyelitis (ME) –  is characterized by severe tiredness, disturbed sleep and a weakened immune system, along with muscle and joint pain. CFS is a comorbid condition often shared by fibromyalgia and other chronic pain sufferers.

The King’s College study followed 641 CFS patients who were given cognitive behavioral therapy (CBT) and graded exercise therapy that included light exercises such as walking. CBT encourages patients to think differently about their symptoms.

When used together, researchers say the two therapies helped about a third of the patients recover from CFS, primarily by reducing their fear that exercise and activity would only worsen their symptoms.

“Our results suggest that fearful beliefs can be changed by directly challenging such beliefs (as in CBT) or by simple behaviour change with a graded approach to the avoided activity,” said Professor Trudie Chalder of King’s College London. “Clinically, the results suggest that therapists delivering CBT could encourage more physical activities such as walking, which might enhance the effect of CBT and could be more acceptable to patients.”

Many CFS sufferers were outraged by the study and the way it was reported by the news media, feeling it added to a stereotype that they were lazy couch potatoes and malingerers.

“This article has made me so angry. This journalist should live my life for a few days and then maybe they’d reconsider what they wrote,” said one woman in an online comment to a Daily Mail story.

“Sometimes having a shower is like climbing a mountain,” wrote another CFS sufferer. “Until one of these ‘experts’ has had to literally crawl back to bed shaking and ill from just trying to clean their teeth I don’t think they’ll ever be able to understand what we go through.”

“Given the number of athletes and sportspeople diagnosed with this neurological disease, trying to pass it off as 'fear of exercise' is laughable. And lazy!” wrote another reader.

An American neuroscientist also weighed in, disputing the theory that exercise is an effective treatment for ME/CFS.

“Our studies clearly show that dynamic exercise like walking or jogging exacerbates symptoms associated with ME/CFS,” wrote Mark VanNess, PhD, a professor at the University of the Pacific in a letter published in the ME blog, Just ME. “Fear and avoidance of what worsens symptoms is a natural defense mechanism against a harmful stimulus. In fact, many researchers here in the U.S. utilize graded aerobic exercise as a tool to worsen and amplify ME/CFS symptoms – not as a treatment meant to be beneficial.

“For a patient with ME/CFS the fear of exercise is a reasonable, knowledgeable, and learned response to a noxious stimulus. If ME/CFS patients could exercise away their symptoms they most certainly would, regardless of the pain.”

Some skeptics in the medical community refuse to accept ME/CFS as a real disease, although it was classified as a neurological disease by the World Health Organization in 1969.

According to the National Alliance for Myalgic Encephalomyelitis, nearly 1 million people in the U.S. and 17 million worldwide have ME.

Supplements Help Relieve Pain of Osteoarthritis

By Pat Anson, Editor

Two natural dietary supplements are effective at relieving pain and stiffness caused by osteoarthritis, without the side effects caused by non-steroidal anti-inflammatory drugs (NSAIDs), according to two new research studies.

One study found that a combination of glucosamine and chondroitin was effective in treating knee osteoarthritis (OA), while the other study examined an herbal treatment used for thousands of years in Chinese medicine to treat joint pain.

Osteoarthritis is a progressive joint disorder caused by painful inflammation of soft tissue, which leads to thinning of cartilage and joint damage in the knees, hips, fingers and spine.

The first study was a meta-analysis (a study of studies) involving over 16,000 patients with knee OA. Published in the journal Scientific Reports, it is the first study of its kind to compare glucosamine, chondroitin, and the two in combination, against the NSAID celecoxib or a placebo in the treatment of knee OA.

Researchers found that the combination of glucosamine and chondroitin was associated with significant improvement in pain relief and functional enhancement, compared to placebo, without the high rate of gastrointestinal side effects in patients who received celecoxib.

There was "no significant difference" in pain relief between celecoxib and the glucosamine/chondroitin combination.

"This comprehensive analysis provides us with a wealth of historical data supporting the safety and efficacy of glucosamine and chondroitin in the management of joint health. It is consistent with recent findings suggesting that the efficacy of this combination is comparable to celecoxib in terms of relieving pain and improving function," said lead author Chao Zeng, MD, of the Department of Orthopaedics at Xiangya Hospital at Central South University in Changsha, China.

"This is important news for patients requiring long-term treatment, as the potential side-effect associated with profiles of NSAIDs such as celecoxib warrant consideration of alternative treatment options that are safe and effective."

Glucosamine and chondroitin are both found in healthy cartilage, which acts as a cushion between the bones in a joint. In dietary supplements, glucosamine can be harvested from shells and shellfish or made synthetically. Chondroitin can also be made in a lab, or manufactured from cartilage found in cows, pigs, sharks and other animals.

Chondroitin and glucosamine are popular in supplements used to treat joint pain, but according to the Arthritis Foundation, “most studies assessing their effectiveness show modest to no improvement compared with placebo in either pain relief or joint damage.” The American Academy of Orthopaedic Surgeons also recommends against their use.

The second, smaller study examined the effectiveness of Arthrem, a dietary supplement made in New Zealand that contains an herbal extract from the plant Artemisia annua (Qinghaosu), which has been used in Chinese medicine for more than 2,000 years.

Forty-two people with osteoarthritis of the knee or hip were enrolled in the randomized, controlled study, which was published in the journal Clinical Rheumatology. Researchers say patients who took an Arthrem capsule twice a day for 12 weeks had a significant reduction in pain and stiffness and an increase in their physical function.

"The published results show that the natural product, Arthrem, has potential as an anti-inflammatory/analgesic in osteoarthritis," said Dr. Sheena Hunt, study co-author and principal scientist for Promisia Integrative, the company that makes Arthrem and conducted the study.

"Particularly positive results were observed in a subset of patients with mild to moderate osteoarthritis. In this subgroup, the average magnitude of pain after 12 weeks of taking Arthrem was less than half of the value at the start of the study. Arthrem at this dose was also well tolerated with no treatment-related side effects."

Arthrem recently became available in the United States. Those who qualify can sign up for a free, no obligation, two month trial online at www.Arthrem.com.

Compared to pharmaceuticals, the U.S. Food and Drug Administration loosely regulates the $35 billion dietary supplement industry and many manufacturers' claims about their products are unverified.  The agency recently announced plans to tighten enforcement of the industry by creating a dietary supplement office.

The World Health Organization estimates that about 10% of men and 18% of women over age 60 have osteoarthritis.

Vitamin D Lowers Inflammation from MS

By Pat Anson, Editor

A new study is adding to the growing body of evidence that Vitamin D supplements can be used to treat multiple sclerosis (MS) and other inflammatory chronic pain conditions.

The pilot study published by Johns Hopkins physicians in the journal Neurology found that taking a high dose of vitamin D3 is safe for people with MS and may help regulate the body’s hyperactive immune response.

“These results are exciting, as vitamin D has the potential to be an inexpensive, safe and convenient treatment for people with MS,” says study author Peter Calabresi, MD, director of the Johns Hopkins Multiple Sclerosis Center and professor of neurology at the Johns Hopkins University School of Medicine. “More research is needed to confirm these findings with larger groups of people and to help us understand the mechanisms for these effects, but the results are promising.”

MS is a chronic and incurable disease which attacks the body’s central nervous system, causing numbness in the limbs, difficulty walking, paralysis, loss of vision, fatigue and pain.

Low blood levels of vitamin D – known as the “sunshine vitamin”-- have been linked to an increased risk of developing MS.

People who have MS and low levels of vitamin D are also more likely to have greater disability and more disease activity.

In the Johns Hopkins study, 40 people with relapsing-remitting MS received either 10,400 international units or 800 international units (IU) of vitamin D3 supplements every day for six months. Patients with severe vitamin D deficiency were not included in the study. The current recommended daily allowance of vitamin D3 is 600 IU.

Blood tests at the start of the study, and after three and six months, measured the amount of vitamin D in the blood and the response in the immune system’s T cells, which play a key role in MS.

Participants taking the high dose of vitamin D reached optimal levels of Vitamin D in the blood (40 to 60 ng/ml), while the group taking the low dose did not reach that target. The people taking the high dose also had a reduction in the percentage of inflammatory T cells related to MS severity. The people taking the low dose did not have any noticeable changes in the percentages of their T cell subsets.

“We hope that these changes in inflammatory T cell responses translate to a reduced severity of disease,” says Calabresi. “Other clinical trials are underway to determine if that is the case.”

Another recent study in Neurology by Danish researchers found that MS patients who spent time in the sun every day during the summer as teenagers developed the disease later in life than those who spent their summers indoors. Ultraviolet rays in sunlight are a principal source of Vitamin D, which has a wide range of positive health effects, such as strengthening bones and inhibiting the growth of some cancers.

Low levels of serum vitamin D have also been linked to fibromyalgia. In a study of over 1,800 fibromyalgia patients published in the journal Pain Physician, researchers at National Taiwan University Hospital found a “positive crude association” between chronic widespread pain and hypovitaminosis D, which is caused by poor nutritional intake of Vitamin D, inadequate sunlight or conditions that limit Vitamin D absorption.

Pain News Network columnist Crystal Lindell began taking Vitamin D supplements when her blood levels were found to be very low. Within a few months she was feeling better, exercising more, and losing weight. You can read Crystal’s story by clicking here.

Chronic Pain? There’s an App for That

By Pat Anson, Editor

Smartphones have revolutionized the way we communicate. And they are fast becoming a tool in the treatment of chronic pain.

Wearable medical devices linked to smartphones can not only do simple things like track your pulse and blood pressure, they can help relieve some types of chronic pain without the use of drugs. Several of these new medical devices are being showcased next month at the 2016 International Consumer Electronics Show (CES) January 6-9 in Las Vegas.

One device making its debut at the trade show is the iTens, the first FDA-cleared wireless TENS device that works via an iPhone or Android based app.

Transcutaneous Electrical Nerve Stimulation (TENS) has been used for decades to relieve pain by using electrical stimulation to block or mask pain signals. But the old TENS units typically come with many wires, are anything but portable, and could only be used for limited 30-minute periods.

images courtesy of itens

“The iTENS device was created for people who are in need of a portable, convenient method of pain management that doesn't involve taking prescription medication,” says iTENS CEO Joshua Lefkovitz. “We designed the iTENS to be thin, flexible, discreet, and easy to operate with the push of a button from the iTENS app.”

The iTens uses peel ‘n’ stick gel pads that can be directly applied to painful areas. The pads are powered by a lithium-ion rechargeable battery that can provides relief for up to 24 hours.  During that time, the iTENS app measures a user’s pain scale, tracks their results, and charts their progress.

“We’ve got the first clearance from the FDA that has a Bluetooth enabled app,” Lefkowitz told Pain News Network. “There are other wireless TENS devices out there, but none of them are app-enabled.

“It’s really cool, because with an app you can roll in new settings. We’ve got body part settings, condition-specific settings, and you’ve got manual settings so you can pre-program whatever settings you want.”

The iTens device will become commercially available in March for $89.95. No prescription is needed and the device is “FDA-cleared” – meaning the Food and Drug Administration has approved iTens’ safety, but not necessarily its efficacy.

Device makers have a huge advantage over pharmaceutical companies because they are held to a lower regulatory standard and often can get fast track approval from the FDA without any clinical studies – as long as the new device is substantially the same as an old device already on the market.

One disadvantage to that approach is that without full FDA approval, few insurance companies are likely to offer reimbursement for a wearable medical device and physicians are less likely to recommend them.

That conundrum will be addressed at the CES trade show in a panel discussion titled “Roadmap to FDA Approval.” One of the speakers is Shai Gozani, President and CEO of NeuroMetrix Inc., maker of the Quell pain relief device, a neurostimulator worn below the knee

“If wearable technology is going to achieve its tremendous potential it must move beyond wellness to tackling fundamental health problems such as chronic pain, diabetes, and heart disease. This necessarily implies regulation by the FDA,” said Gozani. “I hope this panel will start to demystify the regulatory process and encourage technology companies to embrace the opportunity of consumer medical technology.”

The FDA issued guidance earlier this year on the types of apps that would be subject to regulatory review. The agency said it was not trying to stifle innovation and the regulations would only apply to a  “small subset of mobile apps that are medical devices and present a greater risk to patients if they do not work as intended."

The goal is not to regulate “wellness” apps that keep track of things like fitness and nutrition, but apps that make specific claims about diseases and conditions.

According to industry estimates, by 2018 over half of the world’s 3.4 billion smartphone and tablet users will have downloaded mobile health applications

Give and Take Needed on CDC Guidelines

By Fred Kaeser, Guest Columnist

I wish we could all get along. Millions of people in chronic pain usually need opioids in adequate supply in order to manage their day and have some semblance of a quality of life. At the same time, tens of thousands of people's lives are destroyed, ruined, and ended each year from the very same drugs we pain sufferers find comfort from.

Looking objectively at the situation, there needs to be humane action on both sides of this conundrum. Whatever the result of the CDC's new prescribing guidelines, people in chronic pain must not be denied adequate access to opioids when absolutely needed, and yet some action needs to occur to reduce the outrageous rates of opioid addiction.

Think of what has happened in 15 very short years. We have gone from thinking that long term opioid use should only be provided for end-of-life care; to thinking that it is appropriate and acceptable to provide opioids on a regular basis for a myriad of pain causing illnesses and syndromes; back to thinking they are too dangerous and should be sharply limited. All within a 15-year period.

Yes, opioids reduce pain, just what all of us pain sufferers want. And yes, opioids destroy lives, something none of us want.

The truth is there have been no studies of long term opioid usage. And we know very little about just who is more prone to succumbing to the addictive aspects of these drugs once they are used for any length of time.

I do think there has got to be some give and take on both sides. The CDC has to understand that many, many chronic pain sufferers do indeed improve the quality of their lives by taking opioids. And I do think that we pain patients have to show a good faith effort that we are doing all we can to mitigate our pain through alternative pain treatments.
If you look at the CDC survey results attached to this website, you will see that almost 100% of pain respondents report little or no relief from alternative pain strategies. Over half of us say alternative strategies don't work and over a third of us say that they provide little relief.

Yet, if one explores the rich empirical research that exists on exercise, yoga, mind-body techniques like meditation and guided imagery, and their various permutations, we see that they can have a profound effect on reducing pain and discomfort. There is a huge body of research that supports just how powerful of an effect these modalities can have on reducing pain. Yet, almost all of us say they have little if any effect.

So, how can this be? I can only speak for myself, but when my pain started to become constant and severe I too did not think any of these alternative techniques were worth it. The time, energy, and sometimes additional pain that went in practicing them just didn't seem worth it. After all, I could find significant relief in 20 minutes or so just by taking 10 milligrams or so of oxycodone.

So why go through all that other stuff when I could be feeling relief in less than a half hour? But as my pain became every day, all day, I decided that I wasn't going to walk hand-in-hand the rest of my life with a drug that could very easily do more harm to me than the medical condition I was taking it for.

Days, weeks, and months went by of every day hard work. Exercise, stretching, yoga techniques, learning different meditation strategies, etc. were not easy. Amazingly, none of it cost much in terms of money, but the cost in terms of energy and time that went into practicing them was considerable. BUT, there came a time when it all started to pay off.

The research is correct: alternative pain techniques do work. Maybe not for YOU, but enough so that many of us could be finding significantly more relief than just from our medication. And it doesn't necessarily mean that we still don't need pain medication to get through our pain, but it will likely mean we'll need less of it.

I do think this is what is needed. Some give and take from both sides of the equation.

Fred Kaeser, Ed.D, has suffered from back pain, osteoarthritis and other chronic conditions for most of his life. He recently wrote a column about how he uses exercise to manage his pain.

Fred is the former Director of Health for the NYC Public Schools. He taught at New York University and is the author of "What Your Child Needs to Know About Sex (and When): A Straight Talking Guide for Parents." Fred enjoys exercising, perennial gardens, and fishing.

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

Wear, Tear & Care: The ActiPatch

By Jennifer Kain Kilgore, Columnist

Loyal readers, I have returned.

It’s been a tumultuous month of bad days and flares, so while I was absent from my writing duties, I was trying out a hodgepodge of products designed to offer pain relief.

Naturally, none of them worked. Let’s discuss.

A while ago it was suggested that I try the ActiPatch. I was originally introduced to this new form of pain product by Lil’ Bub, the celebrity cat.

I should probably explain that.

Lil’ Bub, full name Lillian Bubbles, is a perma-kitten, meaning that she will retain her kitten-like characteristics for her entire lifespan.

She also has an extreme case of dwarfism and a rare bone condition called osteopetrosis (the only cat in recorded history to have it), which causes her bones to become incredibly dense as she grows older. This causes pain and difficulty when she tries to go from Point A to Point B.

Her person, called the Dude (like Jeff Bridges in “The Big Lebowski”), discovered the Assisi Loop, which is designed to treat pain and inflammation in pets. The device uses targeted PEMF technology (or pulsed electromagnetic fields) to induce healing within the area of the plastic “loop.”

IMAGE COURTESY LILBUB.COM

Before starting her treatment, Lil’ Bub was becoming stiffer and less mobile.  But two years of therapy later, she's running, jumping, and acting like any other cat.

Fast forward to the present day and the explanation as to why I am talking about a cat. ActiPatch is the version of this for humans. I received a letter and package from the president of BioElectronics that contained a thick wad of research and loops for my back, knees, and muscles/joints. I tossed the ones aimed for knees to my husband and kept the rest for myself. Because I’m selfish.

The ActiPatch loops manipulate the body by means of electrical signals, much like TENS devices. The field created within the loop “induces an electrical field in the target tissue,” as  Andrew Whelan stated in his letter to me. These fields affect nerve fibers and cellular function by increasing blood flow and decreasing inflammation, thereby reducing pain.

Additionally, as Mr. Whelan said, the field is “periodically amplified by the background energy within the target tissue, a process called stochastic resonance.” This is when unpredictable fluctuations, or “random energy,” cause an increase in the signal transmission.

During their “Try and Tell” rollout campaign in the U.K. and Ireland, more than 5,000 responded to a survey of trial devices that were sent to interested individuals for only the cost of postage. The company claims there was a “consistent response” of 52 percent reporting sustained pain relief.

Back in my world, I encountered a few problems when trying out the ActiPatch. My pain, as I have mentioned before, is both widespread and diffuse. There are specific areas of genesis, but the pain is by no means contained to just my spine. I have injuries to my cervical, thoracic, and lumbar spine, but the sections with the “loudest” pain tend to be my shoulders, the sides of my neck, my ribs, and my low back. These loops, which are only about the size of a small plate, could not possibly reach all these spots. I’d look like a rubber band ball.

During my trial run, I decided to place the loops both in the “genesis areas” (IE, over my spine directly) and on my shoulder blades. Getting the loop to fit over the curve of my trapezius muscles was difficult. The loops came with a box of Band-Aid-like stickers to hold the loops in place, and I made quite the mess attaching all of them to my skin. Once the loops are placed, however, you simply press a button on the little magnet, a green light comes on, and off you go.

I pulled my shirt on over everything and encountered another issue: the green lights of the loop batteries showed through my shirt, as did the loops themselves. I looked like an undercover informant with poorly-hidden wires. The mafia would surely figure me for a rat. The solution: many layers!

The day I chose for my test run was a normal weekend day. I hadn’t planned anything strenuous and no activities were going to be out of the ordinary. I didn’t wear my Quell, and I also left off the roll-on Stopain that I usually slather on every day. I wanted a day where I could control the variables in order to test the efficacy of the device. My husband and I ran our weekend errands and then decided to take a short walk out in nature. 

My first observation: I did not feel anything from the devices themselves. Others who have used the ActiPatch have told me they felt the sensation of heat within the area of the loops. I didn’t feel anything. I have decreased sensitivity in many areas of my body anyway, so that was not surprising. Additionally, the ActiPatch website states that there will be no sensations.

My second observation: The areas outside of the loops hurt more than normal. I don’t know how good the devices are at affecting areas other than what is in the confine of the loop. The space within those circles felt like a black hole, which is better than pain. While something was definitely going on in the loops -- when I took them off at the end of the day, those areas were red, appearing almost sunburned -- I don’t feel like it helped my widespread pain to any significant degree.

My third observation: I ended up crashing far earlier than normal. By early afternoon I was in my recliner and taking heavier medication.

My hypothesis: The ActiPatch device is probably great for somebody with an injury that is clearly restricted to a certain area. For instance, my husband hurt his knee while running. The loop would be able to focus on that since the pain does not radiate out all over the body.

For somebody like me (an anthropomorphic bruised banana), the loops are far too small. I would need a hula-hoop-sized device in order to make a dent in my daily pain.

J. W. Kain is an attorney in the Greater Boston area who also works as a writer and editor in her spare time.  She has chronic back and neck pain after two car accidents.

You can read more about J.W. 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.

New Skin Patch Delivers Pain Relief with Ibuprofen

By Pat Anson, Editor

There are many different types of skin patches already on the market to treat pain --- containing everything from lidocaine to capsaicin to powerful opioids like fentanyl. Now British researchers say they’re a step closer to developing the first transdermal patch containing ibuprofen.

Researchers at the University of Warwick have formed a company called Medherent to produce and patent an adhesive patch that can deliver a high dose of ibuprofen through the skin for as long as 12 hours to treat conditions such as back pain, arthritis and neuralgia.

Their patch differs from others already on the market because the medication is embedded into the polymer matrix that sticks the patch to the patient’s skin. The embedding technology allows the patch to contain 5 to 10 times the amount of analgesic currently used in medical patches.

"Many commercial patches surprisingly don't contain any pain relief agents at all, they simply soothe the body by a warming effect,” says University of Warwick research chemist Professor David Haddleton.

image courtesy of medherent

“Our technology now means that we can for the first time produce patches that contain effective doses of active ingredients such as ibuprofen for which no patches currently exist. Also, we can improve the drug loading and stickiness of patches containing other active ingredients to improve patient comfort and outcome."

The researchers are now testing other analgesics to see if they too can be embedded into the polymers. So far they’ve had good results with methyl salicylate – a wintergreen-scented chemical used in some topical liniments and gels.

“We believe that many other over the counter and prescription drugs can exploit our technology and we are seeking opportunities to test a much wider range of drugs and treatments within our patch," says Haddleton.

In an email to Pain News Network, Medherent’s CEO said the technology is compatible with a wide range of drugs, including opioids. The company is currently seeking partners to help develop the patches.

"Our first products will be over-the-counter pain relief patches and through partnering we would expect to have the first of those products on the market in around 2 years,” said Nigel Davis. “In addition to our pain relief products, our technology also works with drugs in many other therapeutic areas. We can see considerable opportunities in working with pharmaceutical companies to develop innovative products using our next generation transdermal drug-delivery platform."

Adding opioids to the mix is tricky business, because some opioid patches already on the market are being abused. According to CBCNews, transdermal patches containing fentanyl are blamed for over 600 deaths in Canada. Addicts have learned they can cut up fentanyl patches to smoke or ingest them  

Asked if Medherent’s patch technology would prevent similar abuse, Davis said, “We hope so but need to do more work on that before we make claims of that sort. “

Decision on Opioid Implant Nears

Meanwhile, Titan Pharmaceuticals (NASDAQ: TTNP) has announced that the Food and Drug Administration has scheduled a meeting with the company next month to discuss its new drug application for Probuphine, an implant containing buprenorphine, a weak acting opioid used to treat addiction.

Ironically, some addicts have learned they can get high by abusing buprenorphine and it is prized as a street drug that can ease withdrawal pains from heroin. Buprenorphine, which is more widely known under the brand name Suboxone, is currently only available in pills and oral films.

The Probuphine implant would be difficult to abuse. About the size of a matchstick, it is designed to be inserted subcutaneously under the skin of the upper arm, where it can release steady doses of buprenorphine for as long as six months.

Titan and its partner, Braeburn Pharmaceuticals, believe the implant technology could someday be used to deliver other medications, including opioids for pain relief.

image courtesy of titan pharmaceuticals

Probuphine’s path to the marketplace hasn’t been a smooth one. Braeburn and Titan were stunned in 2013 when the FDA denied approval of the implant and asked for a new clinical study of Probuphine’s effectiveness. Since then, the companies have conducted a study showing that the implant was more effective than buprenorphine tablets in treating addiction. The companies are hoping for FDA approval in 2016.

Tommie Copper Tarnished By Fed Charges

By Pat Anson, Editor

Some of the shine has come off athletic apparel company Tommie Copper, Inc.

The company has agreed to pay $1.35 million to settle federal charges that it deceptively advertised its copper-infused compression clothing would relieve pain and inflammation caused by arthritis, fibromyalgia and other chronic diseases.

Tommie Copper’s settlement with the Federal Trade Commission also requires the company and founder Thomas Kallish to have “competent and reliable” scientific evidence before making any future claims about pain relief, disease treatment, or the health benefits of their products.

Tommie Cooper advertised its copper-infused garments in infomercials, brochures, social media, and print media such as Arthritis Today magazine. The ads claimed the clothing alleviated pain caused by multiple sclerosis, arthritis, and fibromyalgia; and could provide pain relief comparable to or better than drugs or surgery.

Some of the infomercials feature talk show host Montel Williams, who suffers from multiple sclerosis, declaring, “Tommie Copper truly is pain relief without a pill.”

 “It’s tempting to believe that wearing certain clothing will eliminate severe pain, but Tommie Copper didn’t have science to back its claims,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “If you see an ad for a product that promises to replace the need for drugs or surgery, talk to a healthcare professional before you spend your money.”

The company’s website now only claims its products “can be worn all day to provide relief from everyday aches and pains.” The clothing, including sleeves, braces, shirts and socks, range in price from $29.95 to $69.50.

The proposed federal court order imposes an $86.8 million judgment against Tommie Copper, which will be suspended upon payment of $1.35 million by the company within seven days . The company neither admitted or denied any of the allegations in the settlement.

The so-called “healing power” and pain relieving power of copper can be traced back thousands of years. But a 2013 study by British researchers found that copper does nothing to alleviate the pain, swelling, or disease progression of rheumatoid arthritis. The study, published in PLOS ONE, found that copper bracelets worn by 70 patients provide no more meaningful therapeutic effect than a placebo.

New Spinal Cord Stimulator Doesn’t Need Recharging

By Pat Anson, Editor

A new high-tech spinal cord stimulator is being launched in the U.S. and Europe, the first of its kind that doesn’t need recharging and can receive technology upgrades.

St. Jude Medical’s Proclaim Elite stimulator allows patients and clinicians to upload software upgrades to the device without surgery. Until now, most patients would require additional surgery to either update their devices or receive new ones. Unlike other spinal cord stimulators (SCS), the Proclaim Elite also doesn’t need recharging.

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

“We developed the Proclaim Elite SCS system to create a more patient-centric spinal cord stimulation therapy option,” said Allen Burton, MD, medical director of neuromodulation and vice president of medical affairs at St. Jude Medical.

“The Proclaim Elite SCS system offers patients a combination of advanced pain therapy options and the convenience of a device that doesn’t require recharging, while removing barriers for future therapy and diagnostic options.”

The U.S. Food and Drug Administration approved the Proclaim Elite system earlier this month.

The device uses "burst" stimulation -- intermittent pulses of electrical energy that are designed to mimic the body’s natural nerve firing patterns. St. Jude says burst stimulation significantly reduces or eliminates paresthesia, the tingling sensation commonly associated with traditional SCS devices.

image courtesy st. jude medical

Many design elements of Proclaim Elite are based on physician and patient feedback. In particular, the non-rechargeable system removes the burden of patients needing to regularly recharge their SCS system. By providing access to both traditional SCS and burst stimulation in one system, the device gives an option to patients who don't initially respond to traditional therapy

“We’re seeing a shift in the SCS treatment paradigm as we move to a device that’s capable of delivering effective therapy tailored to a patient’s pain condition but that requires no device recharging,” said Frank Huygen, MD, an anesthesiologist and pain specialist from Erasmus MC Hospital in the Netherlands. “By combining burst stimulation and upgradeability in a non-rechargeable device, this innovative technology ensures physicians are more empowered to deliver therapy that can appropriately address our patient’s pain.”

The device uses Bluetooth wireless technology and Apple mobile devices for the patient controller and clinician programmer to improve interaction and allow for more effective management of chronic pain. Proclaim Elite also has conditional magnetic resonance (MR) labeling, which will allow patients to safely undergo MRI scans.

Chronic back pain is usually treated with physical therapy, pain relievers, injections or surgery. When those treatments fail, SCS devices are usually considered the treatment of last resort.

MarketsandMarkets, a market research firm based in Dallas, estimates the global market for spinal cord stimulators and other neuromodulation devices could reach $6.8 billion by 2017.

Exercise Helps Reduce Chronic Pain of Fibromyalgia

By Pat Anson, Editor

This is the time of year when people start thinking of New Year’s resolutions – and losing weight and getting more exercise are two of the most common ones. New research suggests fibromyalgia sufferers should consider them both to relieve pain and improve their quality of life.

Exercise is known to relieve some types of chronic pain, but researchers at the University of Granada in Spain wanted to know what types of fitness are most effective in decreasing pain and improving mood in fibromyalgia patients. Fibromyalgia (FM) is a poorly understood disorder that is characterized by deep tissue pain, fatigue, depression and insomnia.

Researchers enrolled 468 female fibromyalgia patients in the study to assess their aerobic fitness, muscle strength, flexibility and motor ability. The study, published in the journal Arthritis Care & Research, also used a scale to quantify the women’s emotional response to chronic pain, such as catastrophizing (viewing something worse than it actually is) and self-efficacy (belief in the capacity to control things).

“Overall, higher physical fitness was consistently associated with lower levels of pain, lower pain-related catastrophizing, and higher chronic pain self-efficacy,” the researchers found.

Women with high muscle strength and high flexibility had the lowest levels of pain; and those with high flexibility and aerobic fitness had the best catastrophizing and self-efficacy profiles.

Another study, published in the Journal of Clinical Rheumatology, found that fibromyalgia patients were more likely to exercise less, be overweight, depressed, and take more medications.

Researchers at the Cleveland Clinic enrolled over 300 fibromyalgia patients in the study and collected detailed information about their demographic, socioeconomic, clinical, medical, surgical, and psychiatric history.

Nearly three quarters of the participants were either overweight or obese, as defined by the World Health Organization’s BMI (body mass index). Less than 10% of the obese patients said they performed regular aerobic exercise.

Obese patients were also significantly more likely to suffer from major depression and to be taking multiple medications.

“Compared with normal-weight patients, obese FM patients in our study were taking more medications for FM, including SSRIs, other antidepressants, and antipsychotic drugs, as well as gabapentinoids (Lyrica and Neurontin), all known to potentially cause weight gain,” the researchers found.

Interestingly, overweight and obese patients were also more likely to have a history of physical and sexual abuse than normal weight FM patients (48% vs. 34%).

The authors recommend that physicians treating overweight FM patients advise them to lose weight and exercise more.

‘Chili Pepper’ Patch Works Better Than Lyrica

By Pat Anson, Editor

A skin patch containing a synthetic substance found in chili peppers works better than pregabalin in treating patients with neuropathic pain, according to the results of a new study conducted in Europe.

Pregabalin is the generic name for Lyrica, a medication made by Pfizer that is widely prescribed for neuropathy, fibromyalgia and other chronic pain conditions.

Nearly 660 adults with moderate to serve peripheral neuropathic pain (PPN) caused by shingles were randomly assigned to groups receiving either a single treatment with the Qutenza patch or a daily dose of pregabalin.

The 8% capsaicin patch uses a synthetic form of capsaicin, the substance that gives chili peppers their heat, to dull pain-sensing nerves in the skin.

By the 8th week of the study, a little over half of the patients in both groups had achieved pain relief of at least 30 percent. However, the median time to pain relief in the capsaicin group was 7.5 days, compared to 36 days in the pregabalin group. Those who used the Qutenza patch were also more satisfied with their treatment and had fewer side effects.

The study, which is published in the European Journal of Pain, was funded by Astellas Pharma Europe Ltd., which makes the Qutenza patch.

"This is an important and well-conducted study that was designed to mimic everyday practice, allowing those patients randomised to the pregabalin arm to be individually titrated to the optimal tolerated dose,” said lead investigator Maija Haanpää, a professor in the Department of Neurosurgery at Helsinki University in Finland. “We found that topical treatment with the capsaicin 8% patch was non-inferior to the current standard of care. This means that there is now another treatment option for people with peripheral neuropathic pain, especially those patients who are very sensitive to the side effects of systemic medication or for those who do not wish to take tablets every day."

Until now, no head-to-head clinical trials have directly compared the capsaicin patch to pregabalin or other treatments for PNP.

"There is a need to tailor treatment to individual patients and these data show that the capsaicin 8% patch is an efficacious agent to manage patients with peripheral neuropathic pain," said Dr. Andreas Karas, Senior Director, Medical Affairs for Astellas Pharma.

In September of this year, the European Commission approved a label extension for Qutenza to include diabetic patients with neuropathic pain. In the United States, Qutenza has only been approved by the FDA for the management of neuropathic pain associated with postherpetic neuralgia.

Neuropathic pain is characterized by tingling pain that develops as a result of nerve damage caused by conditions such as shingles, diabetes, amputation, inflammation, and cancer. About 8% of adults worldwide suffer from neuropathy. Many drugs used to treat neuropathic pain, such as Neurontin and Lyrica, often don’t work or have unpleasant side effects. Common side effects of Lyrica are dizziness, nausea, headache, weight gain and fatigue.

In addition to neuropathic pain, Lyrica is approved by the FDA to treat chronic pain associated with fibromyalgia, epilepsy, shingles, diabetic peripheral neuropathy, and spinal cord injury. The drug is also prescribed “off label” to treat lumbar spinal stenosis, the most common type of lower back pain in older adults.

Lyrica is Pfizer’s top selling drug with annual worldwide sales of over $5 billion.

Meditation Changes Brain Activity to Reduce Pain

By Pat Anson, Editor

Mindfulness meditation significantly reduces both physical and emotional pain, according to a new placebo controlled study that used MRI imaging to document changes in the brain that occur during meditation.

"We were completely surprised by the findings. While we thought that there would be some overlap in brain regions between meditation and placebo, the findings from this study provide novel and objective evidence that mindfulness meditation reduces pain in a unique fashion," said Fadel Zeidan, PhD, assistant professor of neurobiology and anatomy at Wake Forest Baptist Medical Center in Winston-Salem, NC.

Zeidan and his colleagues enrolled 75 healthy volunteers in the study and used a thermal heat probe on their skin to test their reaction to pain. The probe was heated to 120 degrees Fahrenheit (49 degrees Centigrade) – a level most people find painful. Participants were then asked to rate the pain intensity (physical sensation) and pain unpleasantness (emotional response).

Those who had undergone mindfulness meditation reported their physical pain was reduced by 27 percent and the unpleasantness by 44 percent.

In contrast, volunteers who had used a placebo analgesic cream before the heat probe test said their physical pain was reduced by 11 percent and their emotional pain by 13 percent.

The participants' brains were also scanned with magnetic resonance imaging (MRI) before and after the heat probe experiment.  

"The MRI scans showed for the first time that mindfulness meditation produced patterns of brain activity that are different than those produced by the placebo cream," said Zeidan.

Mindfulness meditation activated brain regions (orbitofrontal and anterior cingulate cortex) associated with the self-control of pain; while the placebo cream lowered pain levels by reducing brain activity in pain-processing areas (secondary somatosensory cortex).

Another brain region, the thalamus, was deactivated during mindfulness meditation. The thalamus serves as a gateway that determines if sensory information is allowed to reach other parts of the brain. By deactivating this area, researchers say, mindfulness meditation may cause signals about pain to simply fade away.

Mindfulness meditation also was significantly better at reducing pain intensity and pain unpleasantness than a placebo sham meditation. The placebo-meditation group had relatively small decreases in pain intensity (9%) and pain unpleasantness (24%).

"This study is the first to show that mindfulness meditation is mechanistically distinct and produces pain relief above and beyond the analgesic effects seen with either placebo cream or sham meditation," Zeidan said. "Based on our findings, we believe that as little as four 20-minute daily sessions of mindfulness meditation could enhance pain treatment in a clinical setting. However, given that the present study examined healthy, pain-free volunteers, we cannot generalize our findings to chronic pain patients at this time."

The Wake Forest study is published in the Journal of Neuroscience,

In addition to relieving pain, there is increasing evidence that meditation and mindfulness cognitive therapy are effective in treating a broad range of mental health issues, including anxiety, depression and stress.

One study, published in the British Medical Journal, found that online mindfulness courses were often just as effective as face-to-face meetings with a therapist.

You can sample a relaxing online pain management meditation at Meditainment.com (click here to see it). The initial course is free.

Miss Understood: Vibrant Trial

(Editor’s note:  Several weeks ago we were contacted by a sales representative for Neurovative Technologies, a Canadian manufacturer of medical devices that use vibration to relieve chronic pain. These “Vibrant” devices sell for about $300 each and, we were told, “have been able to decrease pain and stiffness and increase range of motion in 95% of our OA, RA and Fibromyalgia patients.” The company was invited and agreed to provide a Vibrant device for back pain at no cost to PNN columnist Arlene Grau for a test run. Arlene suffers from fibromylagia and rheumatoid arthritis.)

By Arlene Grau, Columnist

There are many people who suffer the same pain day in and day out with little to no relief from medication, acupuncture, medical devices, etc. My pain begins in my back and spreads throughout my body. Recently, I was asked to give a drug free and non-invasive device called Vibrant a try to see if it helped with some of the pain I was suffering from. I received the device that is designed for back pain management.

During my time using the device, which was about two weeks, I have found that there is no change in my pain level or relief for my back pain.

The device is recommended for use in 16 minute sessions.  It can be used as many times as you'd like during the day, however it is not recommended that anyone use it for an extended period of time all at once.

It is extremely easy to use. You just push the “on” button and it does all the work. It also comes with a charger and backpack for storing or carrying, which I thought was pretty neat.

The Vibrant device reminded me of a massage chair, but I kept wanting to raise the level of intensity and couldn't because it doesn't come with that feature.

It did however help relieve minor aches and pains related to everyday life. My husband even tried it and said that he found it to be relaxing.

I also have a TENS unit which was prescribed by my pain management doctor and I feel like I get a lot more relief from that than the Vibrant device. As far as being able to target my pain and getting deep down into the problem areas, I feel like the Vibrant device fell short.

It's possible that it's meant for smaller aches and pains, but as far as rheumatoid arthritis and fibromyalgia patients go, there really are no minor pains related to our diseases.

Arlene Grau lives in southern California. She suffers from rheumatoid arthritis, fibromyalgia, lupus, migraine, vasculitis, and Sjogren’s disease.

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

Wireless LED Device Could Block Pain Signals

By Pat Anson, Editor

Researchers say a new type of implantable wireless device could revolutionize the treatment of chronic pain by using light to block pain signals before they reach the brain.

In animal studies at Washington University School of Medicine and the University of Illinois at Urbana-Champaign, researchers used implanted microLED devices to “light up” peripheral nerve cells in mice. Their study is published online in the journal Nature Biotechnology.

"Our eventual goal is to use this technology to treat pain in very specific locations by providing a kind of 'switch' to turn off the pain signals long before they reach the brain," said co-senior investigator Robert Gereau IV, PhD, a Professor of Anesthesiology and director of the Washington University Pain Center.

Unlike spinal cord stimulators, which also mask pain signals to the brain, the new devices are  soft and stretchable, and can be implanted in parts of the body that move. Spinal cord stimulators have to be anchored to bone.

"When we're studying neurons in the spinal cord or in other areas outside of the central nervous system, we need stretchable implants that don't require anchoring," said Gereau.

image courtesy gereau lab/washington university

Gereau and his colleagues are experimenting with mice that are genetically engineered to have light-sensitive proteins on some of their nerve cells. The wireless implants contain microLED lights that use “optogenetics” to activate specific nerve cells. The devices are thin, flexible, and minimally invasive because they can be implanted in soft tissue.

Earlier versions of the device used remote lighting and fiber optic delivery systems that were tethered to power sources and could not be fully implanted.

Because the new devices are small, flexible and can be held in place with sutures, they have potential uses in or around the bladder, stomach, intestines, heart or other organs, according to John Rogers, PhD, a professor of materials science and engineering at the University of Illinois.

"They provide unique, biocompatible platforms for wireless delivery of light to virtually any targeted organ in the body," said Rogers.

Rogers and Gereau designed the implants with an eye toward mass production of the devices so they could be available to other researchers. They’ve formed a company called NeuroLux to aid in that goal.

According to iData Research, the spinal cord stimulator (SCS) market was valued at $1.3 billion in 2014. The company estimates that less than 10% of potential patients are being treated with an SCS device.

Stimulators are often considered the treatment of last resort after opioid pain medication, physical therapy, steroid shots and other types of treatment fail. Many patients are reluctant to get SCS devices because the surgery is so invasive.