New Device Makes Back Surgery Simpler (Video)

By Pat Anson, Editor

Human trials are set to begin in Australia on a new spinal fusion device that could change the way degenerative disc disease, stenosis and other types of severe back pain are surgically treated.

Traditional spinal fusions usually involve several metal rods, plates and screws to hold vertebrae in place, while a bone graft grows around them.

“Existing methods of spinal fusion use rod or cage systems that require screws to be drilled into the spine and a painful bone graft harvested,” said Professor Bill Walsh, Director of Surgical and Orthopaedic Laboratories at the University of New South Wales (UNSW). “These systems are very costly, difficult and time consuming to implant and they also have relatively variable rates of fusion success.”

Walsh and his colleagues at UNSW have invented a device they call the Thru-Fuze, which is designed to make spinal fusions much less invasive. Only a few inches long and made of titanium, Thru-Fuze has a porous design that allows the patient's own bone to grow through it, without the need for grafting or other metallic hardware.

Bone grafting – a transplant of bone from another part of the patient’s body – often fails to achieve a complete fusion. And it can take up to a year to find out if the surgery was a success.

In laboratory testing on animals, spinal fusion with Thru-Fuze began in as little as six weeks, with bone growing on and through the device in what it's developers call a rapid “biomechanical” fixation.

This video was produced by USNW to explain how Thru-Fuze works:

SUBSCRIBE to UNSWTV : http://www.youtube.com/user/unsw?sub_confirmation=1 Thru-Fuze, a new UNSW "spine-welding" invention for the treatment of chronic back pain will be tested in world-first human clinical trials, following a $1.59m grant from the NSW Government's Medical Device Fund. Professor Bill Walsh, Thru-Fuze inventor and Director of Surgical and Orthopaedic Labs at UNSW explains how it works.

Human trials of Thru-Fuze are expected to begin at Prince of Wales Hospital in Sydney next year with funding from a $1.5 million government grant. Intellectual Ventures, a private equity company, has also provided funding and has exclusive licensing of Thru-Fuze. Patents for the device have been filed in Australia, Europe, China and the United States.

Lower back pain is the world’s leading cause of disability, according to the Global Burden of Disease Study.

Patients ‘Treated Like Livestock’ in Kickback Scheme

By Pat Anson, Editor

Federal prosecutors have charged five people, including a former hospital executive and two orthopedic surgeons, with fraud in a $580 million kickback scheme involving thousands of spinal surgeries at two southern California hospitals.

The alleged scheme included tens of millions of dollars in illegal kickbacks paid to chiropractors, doctors and other health care providers over an eight year period.  As a result of the payments, thousands of patients were referred to Pacific Hospital in Long Beach for spinal surgeries that were paid for by Medicare or California worker’s compensation system.

“Medical referrals should be based on what’s best for the patient – not what’s best for the doctor’s bank account,” said IRS Special AgentErick Martinez. “In paying the kickbacks and submitting the resulting claims for spinal surgeries and medical services, the defendants acted with the intent to defraud workers’ compensation insurance carriers and to deprive the patients of their right to honest services.”

Two of the defendants have already pleaded guilty, and three others have agreed to plead guilty in the coming weeks. Prosecutors say all five have agreed to cooperate in the government’s ongoing investigation.

A second kickback scheme encouraged doctors to refer patients to the Tri-City Regional Medical Center in Hawaiian Gardens.

“Injured workers were treated like livestock by doctors and hospitals who paid or accepted kickbacks and bribes in exchange for referrals,” said California Insurance Commissioner Dave Jones. “Injured workers are put at risk when their medical treatment is based on kickbacks and bribes instead of their medical needs.”

The defendants include James Canedo, the former chief financial officer of Pacific Hospital. Canedo pleaded guilty in September to mail fraud, money laundering, paying or receiving kickbacks and other charges.

Orthopedic surgeons Philip Sobol and Mitchell Cohen, chiropractor Alan Ivar, and Paul Randall, a former health care marketer at the two hospitals, also agreed to plead guilty to charges stemming from the kickback scheme. Ivar admitted he was paid a monthly retainer by Pacific Hospital for over a decade to refer patients.  

Prosecutors say the conspirators typically paid a kickback of $15,000 for each lumbar fusion surgery and $10,000 for each cervical fusion surgery. Over 4,400 patients were referred to the hospitals, including some who lived hundreds of miles away.

Under the terms of their plea agreements, Sobol faces a federal prison term of up to 10 years; Canedo, Ivar and Randall could be sentenced to as much as five years; and Cohen faces up to three years in prison. All will be required to pay restitution to the victims of the scheme, which in Canedo’s case will be at least $20 million.

Opioids Saved My Life

By Rebecca “Becky” McCandless, Guest Columnist

My new life of chronic pain started in May of 2005. After being diagnosed with degenerative disc disease, I was given a series of 3 epidural steroid injections with a corticosteroid made by Pfizer called Depo-Medrol.

I had no relief from the first two injections, but my doctor insisted that I try a third one. He struggled to get the needle into the epidural space, probably because of scar tissue in my back caused by a prior back surgery, a laminectomy.

After the 3rd steroid injection, I had a severe, instant headache, which was relieved somewhat when I laid down. The doctor had punctured my dura, the outer lining of the spinal cord, which caused a spinal leak.

He was defensive when I told him about my headache pain, saying, “No way, there was no fluid in my syringe.”

After an unsuccessful blood patch, I ended up in the ER a week later with the worst, throbbing headache I ever suffered. Every time I lifted my head I vomited violently.

The doctor ordered numerous tests and he finally diagnosed me with too much STRESS! I knew something had gone wrong during the epidural steroid injection, yet my doctor blamed me for the harm he did to my spine. My pain worsened over time and it became so intense that I thought about suicide.

Luckily, I found a doctor who prescribed opioids for my intractable pain or I would not be here. Opioids saved my life.

rebecca roberts

I tried many other drugs, including Lyrica, which is much more expensive, made me tired and affected my thinking abilities.  Opioids allow me to do my grocery shopping and care for myself.  If I don't have access to my pain meds, I have no quality of life. Opioids keep my pain at tolerable levels. It does not get rid of my pain totally, nothing ever will.

Opioids are often blamed for accidental overdoses, but I know better as I have arachnoiditis friends who committed suicide because their pain was so bad.  Some families deny it was suicide because insurance companies will not pay if a family member commits suicide.

Eventually I found a doctor who diagnosed me with arachnoiditis. There is no cure for this pain condition. It is mainly iatrogenic, which means it is caused by a medical procedure.

I also found out arachnoiditis is caused by Depo-Medrol. Pfizer warns against the use of this drug in epidurals in Australia and New Zealand. The New Zealand datasheet states that Depo-Medrol must not be used in epidurals and on page 18 it says it can cause arachnoiditis.  Patients need to read the datasheet for themselves before they agree to allow a doctor to do an injection near their spinal cord.

Three months after my epidurals, I could no longer work and had to leave my quality control job at a manufacturing plant, making transmission parts for Honda, which I had done successfully for four years. I loved my job and worked 60 to 70 hours per week.  Now I rely on Social Security disability. 

Luckily, my disability was quickly approved. Many of my arachnoiditis friends struggled for years to get their diagnosis.  Some never do.  According to one estimate, there are 11,000 new cases of arachnoiditis each year, but I think it is much more than that because doctors will not admit to harm.

My medical injury was 10 years ago.  I have been on a high stable dose of opioids with no increases. Now there is so much talk with the Centers for Disease Control Prevention creating guidelines to control opioid prescribing.

The CDC is clueless because they are recommending a cap on the daily dosages. How can they estimate a person’s pain levels? Everyone is different, and there are genetic differences and high metabolizers who need higher doses to control their pain. If that happens, my pain will be uncontrolled again, and I worry about my future. 

Is this fair to the thousands or even millions of pain patients who may suffer from arachnoiditis, who have been harmed by the medical community and incompetence of the Food and Drug Administration? Even though the FDA issued a warning on steroids used for back pain, doctors are ignoring it and not telling their patients. We were harmed and now we suffer because doctors are turning us away.

Thank you to producer Gerri Constant and KCBS-TV in Los Angeles for reporting on the dangers of epidural injections.  We agree with Dr. Forest Tennant that this pain condition is no longer rare.

Rebecca Roberts lives in Indiana. She is a member and supporter of the Arachnoiditis Society for Awareness and Prevention (ASAP)  and the Facebook group Arachnoiditis Together We Fight.

Pain News Network invites other readers to share their stories with us. 

Send them to:  editor@PainNewsNetwork.org.

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.

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.

How I Use Exercise to Manage Chronic Pain

By Fred Kaeser, Guest Columnist

My dilemma may not be yours. I can only speak for myself. But when my intermittent severe pain became everyday severe pain, I felt I had a choice to make. Find a doctor that would prescribe me enough opioids everyday so that my horrible pain could be reduced considerably… or…decide that the risks of using opioids on a regular, constant basis outweigh the benefits.

When making this risk-benefit analysis, I needed to explore as best I could the empirical evidence on both sides of the opioid debate. Just as important, I needed to look at the evidence concerning alternative pain management strategies such as exercise, physical therapy, nutrition, yoga, mindfulness visualizations, and the like.

I am 63 years old and am in severe pain on an everyday basis. I have severe cervical spinal stenosis, multiple osteophytes impinging on my thecal cord, severe spondylosis, and multiple discs that have been severely compromised. I have osteoarthritis throughout my body. My hips have been replaced and one will need revision surgery fairly soon. My knees are shot. My lumbar spine is not as bad as my cervical, but multiple discs are herniated, the stenosis is in the moderate range.

I have crawled around on the floor many times for days and even weeks at a time since I was 25. I also have intermittent, but infrequent bouts of intercostal neuralgia, where it feels like the left side of my ribs are on fire. But without question, my cervical spine is the worst of them all.

      fred kaeser

I was determined to be an educated consumer in my quest to relieve pain, but time was of the essence. It’s brutal being in constant severe pain. It not only hurts, it’s exhausting. Fighting the hurt, trying to stay positive, trying to do your daily stuff, trying to be friendly, just trying to smile becomes harder and harder. .

I had done enough periodic trials of opioids to know several things. They work. But then at a certain point they don’t work as well. Even upping the dosage works for only so long. I can take an opioid for breakthrough pain or an extended release opioid, but the weird haze I’d get, the strange cloudy, foggy feelings I have, I never felt normal doing them.

I mean, is that what I want to feel like for years to come? I hate the pain, but the opioid cloud from any extended use I hate also. And the risks: tolerance, dependence, respiratory distress, sexual disruption, and constipation. That last one can be a bitch. I didn’t want to live in pain. but I didn’t want the risks and that overall crap feeling that opioids presented me. So the search for alternative pain therapies was on.

Let me first say I had to have the right attitude. “Stinkin-thinkin” is out, or as my meditation expert friend says, “If you “awful-ize” regularly you will feel awful.” I cannot emphasize enough the benefit of staying upbeat. I’m not stupid, I get it. You feel horrible, you feel like crap, you want to crawl out of your skin. But I have a choice; get swallowed up in negative thoughts and that is where I’ll stay, or stay as positive as I can and that is where I’ll stay. Not easy by any means, but it is the only means for me.

I was always athletic but I smoked. Smoked from 24 years of age to 56. That had to stop. When I had my second hip replacement I said I would quit right as I entered the hospital. I did and I could write a book on that fun trip.

I knew my diet would have to change. Didn’t want anymore extra weight and I knew I needed to increase my intake of foods that reduce inflammation. I love hot peppers, love those oily fish, those greens like spinach, kale, collard greens, those whole grains, and those almonds (but gotta watch the calories).

It took hard work to stop smoking and change my diet. And there was still a whole bunch more to come. I wanted to exercise more, I wanted to do my physical therapy exercises and stretches regularly, I wanted to give basic yoga posturing a try, I wanted to do some sort of meditation/positive visualizing practice.

I had read about all the benefits these could offer and I also knew it wouldn’t come quick. THIS IS THE HARD PART. I knew I would have to stick with it. I know too many people who say they’re going to make changes in their health status and do not stick with it. They’re in abundance after all those New Year’s resolutions every January, right? I’ve been one of them any number of times! It’s much easier to stop all the hard work and a whole lot easier to just take the pills.

But not this time. I knew that if my chosen alternative pain strategies were to work, I would have to be loyal to them and I would have to give them time. A lot of time, like 3-6 months of everyday, regular time. I have a family, I was working, I had all the stuff that comes with life, and now I had to fit a bunch more things in. I had to get up earlier than before, I had to spend an hour and half to two hours at night after work doing things I hadn’t before, and I had to fit these things into my weekends as well.

My Exercise Regimen

I had a YMCA membership and it’s amazing how many free or very low cost add-ons they provide. Yoga was free. Fairly low cost trainer sessions. My insurance covered a certain amount of physical therapy. A colleague-friend at work was a meditation expert. I get a lot of free senior citizen exercise and healthy activity benefits from the town I live in.

I started an exercise regimen that included cardiopulmonary exercise, weight training, and core exercise. I do an hour and half a day, 6 days a week. The myriad PT exercises and stretches I learned had to be done every day, 7 days a week as well. I don’t do all I know every time, but I usually spend about 20 minutes to a half hour on these.

The meditation/visualization I do is a form of guided imagery. Real easy to learn and real calming to do. I conjure peaceful, beautiful images for a 15 minute period in the morning and before bed I do 15 minutes of a mindfulness type experience where I am aware of positive thoughts, feelings, and images. I try to put my pain into a corner and focus on just the other things.

The yoga may give me the most benefits. I just do poses and stretches. I incorporate most of them in my daily workout routine and at times combine them with my PT work. All nothing real fancy, or too in-depth, but just enough of the basics to really help.

I lost count how many times I would bitch and complain in the beginning. How many times did I feel all this stuff was a waste? How many times would I curse them? How many times my pain hurt when I did them? How many times was my pain worse right after them? How many times did I want to give up? How many times did I want to just take the opioids? The answers: MANY!

A month went by…two months…three months…and I started to actually feel better. My pain was being mitigated. Six months and they worked even better. And now, almost 7 years later, they work better than ever. And my opioids? I am prescribed oxycodone, but I only take it every other day or every two days. I try to allocate myself no more than 10 pills a week.

Do I still have pain? Yep. Do the opioids help? Yep. In fact, when I take them they work as effectively as the first day I started taking them. I know I could easily do more and, considering the level of pain I have, they are easily warranted. But my pain is mitigated by my alternative pain management and my opioid use is minimized.

Just as important, there has been another benefit. The cervical spine surgery that I should be eligible for I don’t have to do because my functioning is normal. You don’t do this surgery unless your functionality suffers considerably.  Removing 2-3 discs, shaving down multiple osteophytes, and fusing 3-4 vertebras pose considerable post-op risks and perhaps even more pain. I’ve been told that my function is so good because of all the exercises I do, so no surgery for now.

Like I said, I can only speak for myself. But I have found a very effective balance to mitigating my pain through alternative pain management and the limited use of opioids. I still have pain every day but I manage it with a lot of hard work.

I know there are many people out there that must take opioids every day. And they should be provided with them. But I felt that I would be cheating myself if I didn’t do my best to mitigate my pain through alternative means.

I always have to be honest with myself. Am I doing all I can to ease my pain other than by taking opioid medication?

Fred Kaeser, Ed.D, 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.

Pain News Network invites other readers to share their stories with us. 

Send them to:  editor@PainNewsNetwork.org.

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.

Study Finds Doctors Order Too Many Imaging Tests

By Pat Anson, Editor

Doctors are still ordering too many imaging tests for low back pain and headache, according to an early study of the effectiveness of the Choosing Wisely campaign, a national effort to reduce the number of unnecessary medical treatments and procedures.

In an analysis of seven clinical services with questionable benefit to patients, published in JAMA Internal Medicine, researchers found that the use of five procedures either increased or stayed the same; while there were only slight declines in the use of two others.

CT and MRI imaging tests for simple headache decreased from 14.9 percent to 13.4 percent, while cardiac imaging for patients with no history of heart problems dropped from 10.8 percent to 9.7 percent.

The prescribing of nonsteroidal anti-inflammatory drugs (NSAIDs) increased from 14.4% to 16.2% for hypertension, heart failure or chronic kidney disease. Testing for human papillomavirus (HPV) in young women also rose, from 4.8% to 6%.

Imaging tests for low back pain (53.7%), pre-operative chest x-rays (91.5%), and antibiotics for sinusitis (91.5%) remained stubbornly high.

The study was based on a database of insurance claims from 2013 for about 25 million members of Blue Cross and Blue Shield health plans.

“It remains an open question whether clinicians or consumers at large are aware of specific Choosing Wisely recommendations or have changed their attitude toward unnecessary tests and procedures,” wrote Ralph Gonzalez, MD, in a commentary published in JAMA Internal Medicine.

“In a fee-for services system, most delivery systems continue to get paid for tests and drugs. Payers are able to pass on these costs to employers and patients, creating a vicious cycle.”

The Choosing Wisely campaign was launched in 2012 by the ABIM Foundation (American Board of Internal Medicine) with the goal of reducing waste and unnecessary medical tests and treatments. It has grown to include a list of hundreds of frequently used procedures that have little value or may, in fact, be risky.

“Most people with lower-back pain feel better in about a month whether they get an imaging test or not. In fact, those tests can lead to additional procedures that complicate recovery,” Choosing Wisely states on its website.

“A study that looked at 1,800 people with back pain found that those who had imaging tests soon after reporting the problem fared no better and sometimes did worse than people who took simple steps like applying heat, staying active, and taking an OTC pain reliever. Another study found that back-pain sufferers who had an MRI in the first month were eight times more likely to have surgery, and had a five-fold increase in medical expenses.”

The Choosing Wisely campaign also discourages doctors from performing epidural steroid injections if a patient doesn’t show signs of improvement after one injection. A number of prominent pain doctors have told Pain News Network the shots are overused, with some patients getting dozens of injections.  

FDA Approves New Opioid Film Patch

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a new delivery system for the treatment of chronic pain – the first of its kind to use an oral film patch containing buprenorphine.

The film patch – which will be sold under the brand name Belbuca -- was jointly developed by Endo International (NASDAQ: ENDP) and BioDelivery Sciences (NASDAQ: BDSI). It’s expected to become available early next year.

image courtesy biodelivery sciences

Belbuca is designed to dissolve in the mouth, delivering buprenorphine through the inside lining of the cheek and into the bloodstream faster than conventional pills or skin patches. Buprenorphine is a weaker acting opioid that has long been used to treat both addiction and chronic pain.

“Belbuca provides a unique approach for chronic pain management, combining the proven efficacy and established safety of buprenorphine with a novel buccal film delivery system that adds convenience and flexibility," said Richard Rauck, MD, Director of Carolinas Pain Institute in Winston Salem, NC.

"For both opioid-naïve and opioid-experienced patients who require around-the-clock treatment and for whom alternative treatment options are inadequate, Belbuca offers appropriate, consistent pain relief and a low incidence of typical opioid-like side effects.”

Because the film delivers buprenorphine into the bloodstream faster than conventional methods, lower doses are needed to treat pain. Belbuca will be available in seven different dosage strengths, allowing for flexible dosing every 12 hours.

FDA approval of Belbuca was based on two Phase III studies involving over 1,500 patients with moderate to severe chronic low back pain. Patients who used Belbuca reported “statistically significant improvement” in pain relief over a 12-week period, compared to a placebo. The most common adverse reactions to Belbuca were nausea, constipation, headache, vomiting, fatigue, dizziness, somnolence, diarrhea, dry mouth, and upper respiratory tract infection.

Buprenorphine is a Schedule III controlled substance, which means it has a lower abuse potential than many other opioids. It may also be easier to get a prescription for than Schedule II drugs such as hydrocodone.

“If you’re going to use an opioid, I think based on its classification, Belbuca really does offer some significant benefits,” said Dr. Mark Sirgo, President and CEO of BioDeliversy Sciences.

“There are two areas this product will be used for. Those that are stepping up from a Motrin-like drug, a non-steroidal anti-inflammatory, that no longer controls their chronic pain. Those are good candidates for Belbuca. And in those that may already be on a Schedule II product such as Vicodon, one of the oxycodone products or morphine products, where a physician may feel more comfortable using a buprenorphine product than a Schedule II opioid."

Sirgo says Belbuca is also less likely to abused than a pill, because the film patches are difficult to grind or liquefy for snorting or injecting.

Jumping from Fire into Work Comp Nightmare

By Ron Angel, Guest Columnist

I was injured on July 1, 2001 while fighting fire for the U.S. Forest Service in Tok, Alaska.

At the end of a long day, we were setting up camp and I was carrying heavy packs which weighed about 100 pounds.  While walking I felt pain radiating from my neck and through my shoulders. After a restless night, I woke up the next day with a stiff neck and more pain. 

Every day for the next two weeks it got steadily worse and spread down my right arm. At the end of the first week I went into a local clinic where the doctor knew right away that I had blown out a disc in my neck. He prescribed Percocet for my pain.

After I returned home, the pain continued to worsen and I ran out of Percocet; so I went to the ER in Sandpoint, Idaho. They refused to give me narcotics for pain and gave me Neurontin instead, which did nothing for pain relief.

The pain continued to increase and it was more than I could handle. It was an 11 on a 10 scale so I walked into my doctor’s office in tears and showed him I was unable to lift my arm. He set me up for an MRI, which showed I had a herniated disc and two bulging discs.

Ron Angel

I had submitted a claim to the Department of Labor’s Office of Workers’ Compensation (OWCP) immediately after returning from Alaska. I tried to get OWCP to help me, but was mostly unable to contact them. When I did get a hold of someone, they had no sympathy and were extremely adversarial. 

I consulted with a neurosurgeon and he said I needed surgery immediately. I called my health insurance, but they said it was work related so they would not cover it. I still had no response from federal OWCP. 

After not being able to sleep for nine days due to the pain, I could no longer take it. I got my pistol and had it on my lap. I called Blue Cross Blue Shield and told them that if they didn't help me I was going to kill myself immediately. They begged me not to and said they would cover the costs and deal with Federal OWCP. I had my lifesaving neck surgery on August 9, 2001.

I finally received a letter from OWCP dated Oct. 16, 2001 telling me they decided to accept my claim. I would have been dead had I not had the surgery to relieve my neck and arm pain. 

Federal OWCP does not accept back injuries, brain injuries or heart injuries for a settlement, but if an injury of one of them affects an accepted body part they will pay a settlement for the loss of use. Due to the loss of strength, mobility and the continuing pain, they rated my right arm a 23% loss.

During a follow up with the surgeon in 2004 he noticed that I had some movement of an adjacent disc that was causing me some discomfort. He said this is common with fusion patients and that we should just monitor it. If it started to cause me more problems he would have to go back in and fuse the next segment. This is called adjacent segment disease and it occurs in about 25 percent of fusion patients.

I am now retired and a couple of months ago I began to lose strength in my right arm, which I can't raise above my shoulder.  Pain is now radiating from my shoulder down to my elbow. I would rate my pain at a level of 4 today.  I contacted OWCP for authorization to get a new MRI, but they informed me that due to the lack of activity they had closed my case in 2013.

I explained they should have provided notification because my surgeon had said that eventually I would need another fusion. They told me that since they closed it, I will have to file another work comp claim for a re-occurrence of the injury. 

In order to re-open my claim, OWCP requires a narrative from the doctor that states the new symptoms are connected to my original injury in 2001. They also require all of my medical records since 2001, five other requirements for the doctor, and three pages of questions that I have to answer. 

My surgeon says the bulge in my disc is severe and another fusion is necessary, but he won’t provide a statement to OWCP because he is tired of dealing with them. He said he has another patient who has been trying for approximately two years to get his claim reopened, unsuccessfully. He doesn't have time to play their games. 

Since my doctor will not give me a statement, the only way I can get it fixed is if my health insurance will cover it. I'll be responsible for 20% of the cost!  This could have been avoided if OWCP had contacted me before arbitrarily closing my case. 

Now it looks like I get to go through the same trials to fight for my next fusion, which OWCP claims was not caused by the original injury. It looks like my bureaucratic nightmare with federal work comp is starting all over again.    

Ron Angel lives in Idaho.

Pain News Network invites other readers to share their stories with us.

Send them to:  editor@PainNewsNetwork.org.

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.

FDA Won’t Change Warning Label for Steroid Injections

By Pat Anson, Editor

The U.S. Food and Drug Administration (FDA) has decided not to toughen its warning label on the use of epidural steroid injections – despite the risk of serious and sometimes fatal neurological problems caused by the procedure. The injections are commonly used to treat neck and back pain.

Last year, the FDA required all injectable glucocorticoid products to carry labels warning that “serious neurologic events, some resulting in death, have been reported with epidural injection” and that the “safety and effectiveness of epidural administration of corticosteroids have not been established.”

Since then, the agency has been lobbied by interventional pain physicians who perform the injections to weaken the warning label; while patient activists wanted even tougher language used. The FDA will do neither.

“The FDA has decided not to modify the warning about serious neurologic events. Without question, serious (sometimes fatal) neurologic events occur with epidural glucocorticoid injection. Given the large number of these procedures performed, these events appear to be rare; however, a population-based study would be needed to establish a valid estimate of their frequency,” wrote several FDA scientists in an article published in the New England Journal of Medicine.

The use of steroids in epidural injections (ESI’s) has never been approved by the FDA, but millions of the procedures are performed every year by doctors who use steroids “off label” – which the agency considers “part of the practice of medicine and not regulated by FDA.” 

As Pain News Network has reported, ESI’s can be a lucrative procedure for physicians, depending on insurance payments and where the epidurals are performed. Payments can vary widely, from a few hundred dollars to over $2,000 per injection.

Critics say the injections are risky, overused, and often a waste of money. While side effects appear to be rare, they can be very serious, including loss of vision, stroke, paralysis and a disabling condition known as arachnoiditis, a painful and chronic inflammation of the spinal cord.

“What do you think would happen if the FDA were to contraindicate Depo-Medrol, the steroid that gave me adhesive arachnoiditis?” asked Gary Snook, a Montana man who developed arachnoiditis after a series of epidurals for back pain.

“In a few days we would be seeing TV commercials asking, ‘Have you received an epidural steroid injection? Do you now have burning pain in your legs? Do you now have numbness, tingling or weakness?' The phones would be ringing off the hook!’” said Snook in an email to PNN. “Because of the sheer number of injections given, even at a disability rate of 1%, every pain clinic and hospital in the country would be facing multiple lawsuits. No. The FDA had to do nothing. They had to keep a lid on this degree of medical malpractice.”

Depo-Medrol is a steroid made by Pfizer that has been banned for epidural use in Australia and New Zealand. Another steroid commonly used in ESI's, Bristol-Myers Squibb's Kenalog, does come with a warning label against epidural use, but patients are rarely told by their doctors about the risks involved.

“Sadly, in the current marketplace that packages and merchandises epidural injections for the short term address of chronic pain, (the FDA’s) decision makes it more difficult to obtain a true patient centered solution focused on the problem of preventing and treating chronic and intractable pain,” said Terri Lewis, PhD, a patient advocate. “FDA turned the keys to the asylum over to the corporations who lobbied hard to preserve their bricks and mortar investments supported by Medicare, worker's compensation, Medicaid, and private insurance.”

But the epidural injection industry didn’t get what it wanted, either. In a recent letter to the American Society of Interventional Pain Physicians, which petitioned the FDA to weaken or withdraw its warning label, FDA director Janet Woodcock said the label would not change.

“FDA has identified case reports of serious neurologic adverse events associated with all ESI approaches and all injection sites,” Woodcock wrote. “The totality of the available information provides evidence adequate to support the class safety warning.”

Woodcock also denied suggestions in the petition that an FDA advisory committee known as the "Working Group" met improperly with the Multisociety Pain Workgroup (MPW), a rival coalition of anesthesiologists, surgeons and pain management doctors, to discuss safety guidelines for ESI's.

"We do not agree with the unsupported characterizations of the Working Group, its activities, or its relationship to the MPW as asserted in your Petition," Woodock wrote.

Although 17 clinical guidelines were later issued by the Working Group, Woodock said the recommendations were for the "medical community" and were "neither binding on FDA nor endorsed by the FDA."

A federal study released earlier this year said there was little evidence that epidural steroid injections were effective in treating low back pain. The MPW called the report’s conclusions "flawed" and "absurd."

Wear, Tear & Care: Rating the Pain Creams

By Jennifer Kain Kilgore, Columnist

I am a connoisseur of pain creams. My idea of Christmas is when my friend’s mom mailed me a box filled with unopened packages of Bengay (true story). Every morning I slather on a layer of something containing menthol in order to numb my back. Then my cat decides to attack me. Why? Because cats love menthol (also a true story).

Anyway, I have tried many, many, many different topical anesthetics over the years. Here are my experiences with the common and unique brands:

Bengay: The gold standard. Whenever I use this brand, I generally gravitate toward the pain relief massage gel. However, my friend’s mom sent me the regular Bengay.

What, you thought I was kidding? Here’s a picture of my Bengay drawer.

There’s no doubt about it: Bengay is good. However, even the massage gel only contains 2.5 percent menthol, which is the active ingredient that transports your skin to the Arctic. It also has camphor, like what’s used in Vick’s VapoRub, to reduce pain and swelling.

While Bengay is good, it’s not great. Moving on!

Cryoderm has been my go-to for years, because it is, as they claim, “as cold as ice.” It has 10 percent menthol and also contains arnica and boswellia, the former of which has been used for centuries to control bruises and swelling. The latter is a solid anti-inflammatory agent. Cryoderm also makes a number of heat-producing products, one of which I own.

I use it on very cold winter days when the temperature makes me want to crawl back into bed. If I put it on during the rest of the year, I prematurely begin the process of menopause.

Anyway, just because I am a big fan of Cryoderm does not mean I haven’t tried other things, such as…

Emu oil: Last year I was at the Big E (only the greatest annual fair in the northeast, where all food is deep fried, even the Kool Aid) when, naturally, I gravitated toward a booth that was hawking pain relief products. They all centered around emus. Yes, that flightless bird from Australia. Apparently its oil can be used for anything, from cracked heels to unsightly patches on your skin. I used it for pain purposes, and I found it to be lacking. Not only was it difficult to apply, but it was ineffective. My search continued.

Arnica cream: This took the inactive ingredient in Cryoderm and went whole-hog by making it the active ingredient -- nay, the only ingredient. I think this would do a bang-up job of healing something acute, like bruises immediately following an injury. But for chronic, long-term pain, I was left wanting.

Lidocaine patches are available by prescription only, though there are some almost-as-powerful creams and patches online. I only get 10 at a time because they normally are not covered by my insurance.

These things are fantastic. If I could wrap myself in one like a big numb burrito, I would.

It contains 700 mg of lidocaine, which, based on the word’s suffix, you might recognize as a numbing agent similar to novocaine.

You can slap one on for 12 hours at a time; however, like any other sticky product, it can irritate the skin. These are perfect for very bad days, but what’s the next best thing if you can’t get your insurance to cover them?

Stopain. I have to admit, I was skeptical when my grandmother suggested this. Here is a close transcript our conversation:

“Honey, I saw this thing on TV that works on bad backs. You gotta get it.”

For reference, my grandmother is a Jew from Brooklyn in her upper eighties. She wears tracksuits with heels, always has makeup on, and has the best white Jewfro you could possibly imagine. Since friends and relatives are always suggesting pain relief products (which I do appreciate), I didn’t put much stock in what she said.

“Grandma, you can’t always believe that ‘As seen on TV’ stuff.'"

I didn’t actually say “stuff.” I said another word that starts with “S.”

“You watch your mouth with me, kiddo. Give it a try. C’mon, do it for me. The commercial said it really worked!”

So I bought it to humor her and let it sit in its packaging for about a week once it arrived. Then, when I ran low on my Cryoderm bottle, I gave it a whirl. I was prepared for it not to work, since the Cryoderm has 10 percent menthol and Stopain only has 8 percent, but... I was incredibly surprised.

I’ve been using it for a few weeks now, and I think it actually works better than the Cryoderm despite having less menthol. What it lacks in that ingredient, it makes up for in boswellia, arnica, eucalyptus oil, peppermint oil, and other things I can’t pronounce. It’s a veritable cornucopia of pain-relieving ointments.

So there you have it. Hopefully my experiences have saved you some time, and if not, at least you will smell delightful to any feline companions.

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.

Quell Device Relieves Variety of Pain Conditions

By Pat Anson, Editor

A new medical device that uses electrical nerve stimulation was effective in managing chronic pain in patients suffering from arthritis, neuropathy, fibromyalgia and other conditions, according to a small clinical study conducted by NeuroMetrix (NASDAQ: NURO), the device’s manufacturer.

Pain News Network recently featured the Quell Wearable Pain Relief device in a column by J.W. Kain, who reported that Quell “worked brilliantly” in relieving her chronic neck and back pain.

Eighty eight people were enrolled in a 60-day trial of Quell. All had chronic pain for at least year and nearly a quarter had more than 15 years of pain. Participants had “complex medical histories” with arthritis (61%), diabetic nerve pain (40%), sciatica (27%), and fibromyalgia (26%) as the most common conditions.

Over 80 percent of the participants said Quell relieved their chronic pain and improved their overall health. The largest measured changes were in pain relief, along with improved sleep, general activity, and walking ability.

Over two-thirds of the patients said Quell also reduced the amount of pain medication they were taking

image courtesy of neurometrix

"We are pleased with these results. They represent the first formal evaluation of self-administered wearable intensive nerve stimulation. Quell provided substantial pain relief and improvement in quality of life measures,” said Shai N. Gozani, MD, President and CEO of NeuroMetrix.

“We were not surprised that two-thirds of the subjects reduced their use of pain medications, as we have consistently received this anecdotal feedback from Quell users over the past several months.”

Quell is available over-the-counter and does not require a prescription. It relieves pain by using electric stimulation to “mask” pain signals before they reach brain, much like a TENS unit.  The device, which costs $249, is lightweight and designed to be worn over the upper calf during the day or night.

The marketing of Quell for the treatment of chronic pain was approved by the Food and Drug Administration in 2014, but NeuroMatrix did not begin shipping the device to healthcare providers until this summer. It is also available through the company’s website.

A study abstract, “Treatment of Chronic Pain with a Novel Wearable Transcutaneous Electrical Nerve Stimulator,” has been accepted for poster presentation at the annual PAINWeek conference next month in Las Vegas.

Debate Grows over Spinal Injections

By Pat Anson, Editor

A controversial government funded study critical of epidural steroid injections has been republished in the Annals of Internal Medicine, fueling a growing debate over the effectiveness and safety of spinal injections.

A prominent pain specialist called the study’s publication in a peer-reviewed journal “an insult to thousands of physicians across the world."

In a systematic review of 30 placebo controlled trials, researchers found that epidural steroid injections (ESI’s) offer limited or no relief from radiculopathy and spinal stenosis, two conditions that cause low back pain. The study was funded by the Agency for Healthcare Research and Quality (AHRQ) and conducted at the request of the Centers for Medicare and Medicaid Services.

“Epidural corticosteroid injections for radiculopathy were associated with early improvements in some outcomes versus placebo interventions, but effects were small and unsustained, and epidural corticosteroid injections had no clear effects in patients with spinal stenosis,” wrote lead author Roger Chou, MD, a Professor at Oregon Health & Science University (OHSU) School of Medicine and a staff physician in the Internal Medicine Clinic at OHSU.

Epidural injections using analgesics have long been used to relieve pain during childbirth, but spinal injections with steroids are also widely used for back pain. Although the Food and Drug Administration has never approved the use of steroids to treat back pain, several million ESI’s are performed “off label” in the U.S. annually.

The shots have become a common and sometimes lucrative procedure at many hospitals and pain management clinics. Costs vary from a few hundred dollars to over $2,000 per injection.

“Evidence on the effects of using different approaches, corticosteroids, or doses on effectiveness of epidural corticosteroid injections was limited, but indicated no clear effects,” said Chou, who was the principal investigator and author of several other studies published in peer reviewed journals.

“It is a travesty that Chou et al continue to publish these types of manuscripts. It is an insult to thousands of physicians across the world who perform these procedures and millions of patients who have received relief from them,” said Laxmaiah Manchikanti, MD, chairman and CEO of the American Society of Interventional Pain Physicians.

Manchikanti, who is medical director of a pain clinic in Paducah, Kentucky, conducted several of the studies reviewed by Chou and his colleagues.

“Consumers need to understand that the design of their systematic review is flawed and that significant bias exists in the reporting of the results,” Manchikanti wrote in an email to Pain News Network. “It is like eating 2 bananas from different countries and saying both are equally sweet, so neither is sweet. They also are looking for the differences in improvement between both groups rather than how a patient has improved from before the treatment to after the treatment."

Chou’s study also came under fire when it was released by the AHRQ. The Multisociety Pain Workgroup (MPW), a coalition of 14 different societies representing anesthesiologists, surgeons and pain management doctors, sent a lengthy letter to the AHRQ, calling the report's analysis on the effectiveness of ESI's "flawed” and “absurd.”  .

"I don't think its surprising that people who do these injections might disagree or not be happy with the results. Some of the comments seem to demonstrate a poor understanding of how to look at interventions in scientific research," Chou told Pain News Network. "I think people are afraid that they're not going to get paid for doing these types of things. It's not surprising, when people's pocketbooks are threatened, this how they respond."

Chou and his colleagues found the only significant benefit of ESI’s was temporary relief from back pain that usually lasts for only a few days. He attributes much of the pain relief to a placebo effect.

"It's clear that interventions for back pain have a very high placebo effect. We've known that for decades and its been demonstrated over and over again," said Chou.

Manchikanti says most of his patients get pain relief that lasts for several weeks.

“Each patient should be selected individually. They should understand the risks and the off-label nature of these drugs in the epidural space,” he said. “Epidural corticosteroids have been shown to be risky, come with a warning from the FDA, and are an off-label use of these powerful anti-inflammatories.

“For a patient, if they choose to have the procedures done with local anesthetic alone, or with local anesthetic and steroids, they should measure their progress. If they do not improve with the first procedure, they should carefully think about the second procedure; however, there is no reason to have any more than 2 procedures if they do not improve.”

The Choosing Wisely campaign of the ABIM Foundation, which seeks to reduce or eliminate unnecessary medical procedures, also recommends that doctors do not to repeat the injection if a patient shows no sign of improvement.

A number of prominent pain doctors have told Pain News Network the shots are overused, with some patients getting dozens of injections.  

Terri Anderson says repeated shots gave her temporary pain relief from a bulging disc in her back.

“I did receive immediate and short-term benefits over a 3 year time frame. However, I am here to tell you that the injections did not save me from surgery as the disc ultimately failed,” she said.

Anderson now suffers from arachnoiditis, a chronic and painful inflammation of the spinal column that has left her permanently disabled. The Hamilton, Montana woman believes the condition was brought on by too many injections.

“If I had the opportunity to go back in time, I would have stayed away from intervention and lived with the pain I had which was chronic, but it was manageable,” Anderson said.

“The government and professional medical societies have been keeping chemically induced adhesive arachnoiditis hidden from public awareness. Why is that? There is too much profit at stake for hospitals and pain clinics throughout the country. If a physician were to provide their patients with true informed consent (and explain the horrors of arachnoiditis), then no one in their right mind would undergo an epidural steroid injection.”

Experts Say Epidural Steroid Injections Overused

By Pat Anson, Editor

Epidural steroid injections are being used too often to treat back pain, in part because of an insurance compensation system that encourages doctors to generate more income by using the procedure, several leading experts in pain management have told Pain News Network.

An estimated 9 million epidural steroid injections (ESI’s) are performed annually in the U.S. Epidural shots with an analgesic have long been used to relieve pain during child birth, but in recent years injections of a corticosteroid into the epidural space around the spinal cord have become an increasingly common procedure to treat back pain.

Critics say epidural injections are overused and patients risk permanent damage to their spinal cords if they get the shots too often.

“Have they been overused? Yes. And I’ve seen the complications. They happen when people have done far too many. I’ve seen people who’ve had two to three dozen epidurals in a given year,” said Forest Tennant, MD, a prominent pain management specialist in West Covina, California.

“It’s like a cumulative trauma. You just can’t keep doing epidurals on somebody or you’re going to get damage to the outer layer of the spinal cord. It’s amazing to me the number of people who’ve had epidurals and they can’t count how many they’ve had. I’ve had patients who say, ‘I’ve had a hundred.’ I mean, are you kidding me?”

One of Tennant’s patients compares epidurals to a game of Russian roulette.

“A doctor puts one bullet in the cylinder, gives it a spin, points it at your head, and pulls the trigger. Five of the six chambers are empty or ‘safe’ but the 6th chamber carries risk of a negative outcome that is so catastrophic that no one in his right mind would take the risks,” said Gary Snook, a Montana man who developed Arachnoiditis, a chronic and painful inflammation of the spinal cord, after getting a series of epidurals for back pain.

“These injections are expensive. Please take your limited health care dollars and spend them where they will do you some good. Join a gym, do pool exercises, swim, or learn and do Pilates. I know it is a lot of work, but you will not end up like me."

ESI’s can be a lucrative procedure for physicians, depending on insurance payments and where the epidurals are performed. Payments can vary widely, from a few hundred dollars to over $2,000 per injection.

The debate over the safety of ESI’s often pits surgeons and anesthesiologists, known as “interventionalists,” against traditional pain management doctors, who usually rely on opioids, physical therapy and other less invasive procedures to control pain.

“We have far too many interventionalists, compared to people who do medical management. I’m on the medical management side and I wish there were a lot more of us. I mean, I’m swamped,” Tennant told Pain News Network. “But on the other hand, you’ve got plenty of interventionalists who will do an epidural any day of the week. We have an imbalance of those people who want to do epidurals.

“Let’s face it. The money motive is there. And this money motive is not just the anesthesiologists. It’s the surgery centers, it’s the hospitals. And it has caused problems.”

Lobbying the Feds

Epidurals are drawing more scrutiny from federal agencies like the Food and Drug Administration, which has never approved the use of steroids in spinal injections. But steroids can still be used “off label” to treat back pain, which prompted the agency last year to warn that injectable steroids “may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.”

That prompted an outcry from the Multisociety Pain Workgroup (MPW), a coalition of 14 different societies representing anesthesiologists, surgeons and pain management doctors. The group sent a letter to the FDA defending the use of epidurals and asked the agency to revise its warning.

“While complications with epidural steroid injections have been reported, and are likely underreported, serious complications are limited to isolated case reports,” the MPW letter states.

The FDA hasn’t changed its warning, but the MPW has stepped up its lobbying campaign with the federal government, recently asking the Agency for Healthcare Research and Quality (AHRQ), which is part of the Department of Health and Human Services, to tone down another report which said there was little evidence that ESI’s were effective in treating low back pain.

“We are fully cognizant of the issues of overutilization and inappropriate utilization,” the MPW said in a lengthy letter to the AHRQ, which called the report's analysis on the effectiveness of epidurals "flawed” and “absurd.”  The letter makes no mention of how to address the overuse of epidurals.

The MPW’s lobbying campaign has drawn criticism from Laxmaiah Manchikanti, MD, chairman and CEO of the American Society of Interventional Pain Physicians, which is not part of the MPW coalition.

DR. LAXMAIAH MANCHIKANTI

“There is no question that epidural steroid injections are over-utilized,” said Manchikanti, who is medical director of a pain clinic in Paducah, Kentucky.  “Unfortunately, MPW has been contributing to over-utilization of transforaminal epidural injections because of their own interest in this.”

Instead of addressing the overuse of epidurals, Manchikanti says the MPW is actually making the problem worse.

“They may be even promoting them. Multiple MPW signatories have numerous conflicts of interest of their own and each one is looking out for themselves,” he wrote in an email to Pain News Network.

Manchikanti has done some lobbying of his own, and is heading an effort to get the Centers for Medicare and Medicaid Services (CMS) to change its compensation system for epidural procedures.

Medicare currently pays about $132 to doctors who perform epidurals in their own offices, while physicians who do the same injections in a hospital, pain clinic or surgical center will get about $670. That “remarkable discrepancy,” according to Manchikanti, contributes to over-utilization by encouraging hospitals and other large facilities to do more epidurals.

“Office-based practices are increasingly being purchased by hospitals and in this well-documented circumstance, the ownership has the potential to change the payment dramatically,” Manchikanti wrote in a letter to the journal Pain Physician. “These patterns increase expenses by paying a much higher rate for HOPDs  (hospital outpatient services), even though they are just physician offices. This issue also favors inappropriate performance of the procedures with bundling." 

Repeated requests to the CMS for comment on this story went unanswered.

Solutions to Overuse

What can be done to reduce or eliminate the overuse of epidurals? One approach is to stop paying high reimbursement rates for the procedure.

“Site-neutral payment is the solution,” says Manchikanti. “We have been working on this issue where a hospital’s pay should be reduced to the level of ambulatory surgery centers (ASCs) or about 10% higher, and office reimbursement should be at least 60% of ASC payment.” 

“Probably everything that gets compensated well is over-utilized because it’s the compensation system. It’s a reimbursement system that pays more for treatment procedures than outcomes,” said Lynn Webster, MD, a prominent pain physician and past president of the American Academy of Pain Medicine, which is a part of the MPW coalition.

“I think our healthcare system is perverted and doesn’t really help us deliver better outcomes; but more procedures, more visits, and none of that’s tied to improving the quality of care.”

Like Manchikanti, Tennant and other physicians Pain News Network interviewed for this story, Webster says epidurals can be effective in managing back pain when used sparingly.

“I’ve performed many epidural steroids and as a result I was able to I think provide a great deal of relief for thousands of individuals and they didn’t have to be on any other medicines,” Webster said. “Because the epidural steroids could work for several months sometimes, I would do an epidural steroid injection once every year for some people.”

Tennant thinks the solution is limiting the number of epidurals, regardless of where they are performed.

“There’s got to be a balance here. Epidurals have a place," Tennant said. "But I do think there needs to be some standards set based on the number of epidurals one can endure, in let’s say a year’s period of time.”

Wear, Tear & Care: The Biomat

By Jennifer Kain Kilgore, Columnist

Some pain relief modalities are unusual to the point that they’re out in the stratosphere. It’s also true that some products only work for some people. Just because a device doesn’t offer visible results the first, second, or even third time doesn’t mean it isn’t working.

That is why I have to keep an open mind and not make snap judgments based on concepts, websites, or promotional material.

Like, for instance, today’s topic: thermotherapy and the Amethyst Richway Biomat.

Amethysts?

Yes, amethysts -- February’s birthstone -- can also be beneficial in thermotherapy.

When speaking specifically about the Biomat, I should warn you that Richway’s website isn’t slick. The idea of amethysts being associated with anything health-related is out of most people’s comfort zone.

But hey, I’ve used the Biomat for upward of five years and fall onto it whenever I have sore muscles, which is constantly. It’s such a fixture in my life that at first I didn’t even think to discuss it. So here we go!

The Biomat. Behold:

This version is the full-body mat covered with a sheet. Underneath my head is the Biomat pillow. Each session can last for five minutes or twelve hours, depending on how much time you have available. The heat can reach temperatures of 158 F° degrees. Read on to find out why that number means absolutely nothing when it comes to treating pain.

The FDA has approved the marketing of the Biomat for a whole host of things: relaxation of muscles, improvement of circulation, temporary relief of muscle pain and/or spasms, and much more. There are specific range settings for certain medical conditions, though it is generally safe.

The science involved came to being when Drs. Erwin Neher and Bert Sakmann discovered how ions flow in and out of cells, which they called the “ion channel theory.” The two scientists revolutionized the field of cell biology and won the Nobel Prize in 1991 for their shared research.

If you’re like me, you have no idea what this means. However, this ion channel theory is put into play by the Biomat’s use of negative ions, which is then complemented by far infrared spectrum therapy (or thermotherapy, like what is found in saunas) and the amethysts embedded in the outer layer of the mat. These stones have been used for thousands of years for everything from fighting the evils of drunkenness to helping with meditation.

In modern times, researchers discovered that amethysts can carry an electrical charge. (Readers, are you still with me? Hang on, we’re almost there!) So, the infrared rays pass through the amethyst layer of the mat and then become “long wavelengths capable of safely penetrating the body as deeply as seven inches.” This heats up your core body temperature, encouraging your body to detoxify.

To put all of this in English: The Biomat creates an environment in which the patient can safely enjoy negative ion therapy and infrared therapy.

What does this mean for the person actually flopped onto the mat? It means a yummy, delicious, low-grade heat. And low-grade does mean low-grade, even if it can reach 158 F° degrees.

One time, my husband wanted to use a heating pad on a strained muscle and cranked it all the way up to eleven: “Honey, I don’t think this is working. I’ve maxed it out and it’s still not warm enough.”

That’s because it doesn’t generate heat the same way a traditional heating pad does. It gets toasty, sure, but you couldn’t cook meat on top of it. At its price point, you certainly wouldn’t want to cook any sort of food on it.

I mean, look at the controls. It’s like the cockpit of an airplane.

For me, the Biomat doesn’t present a dramatic “Before and After” picture. It’s not like Tiny Tim could throw away his crutches after using this product. I can’t think of things I couldn’t do before that, with the Biomat, I can do afterward. Even so, I would never stop using it.

This product is just better than a heating pad. When you hurt all over, you want something that reaches all over. Those of us with chronic pain, we use a plethora of heating devices and creams and patches in order to soothe sore muscles. The Biomat, while extremely expensive, is a full-body restoration and relaxation device. Even the mini mat fits into a chair and covers a lot of real estate.

At the end of a long day, I look forward to sitting on the Biomat. I sleep better when I use it; in the summer, for instance, even a low-grade heat is too much for me, and I go to bed feeling stiffer and more rickety, like a broken marionette. Those are the days I truly notice a difference. Studies have been conducted regarding thermotherapy and resulted in pain decreasing significantly (concurrently with anger and depression). It has even been used to treat cancer.

So does one recline upon the Biomat and come forth as a new person? No, not after one session, two sessions, twelve sessions, or fifty sessions, but you absolutely do feel better. Your muscles are soothed. Your knots unwind, even just a little bit. Your pain is quieted for a time. And that’s enough for me.

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.

Fed Report Sparks New Debate over Steroid Injections

By Pat Anson, Editor

A government report on epidural steroid injections is sparking a new debate on the safety and effectiveness of the procedure, which is used to treat back pain in millions of people.

A coalition of spine and pain management doctors is calling the report’s conclusion that steroid injections have little value  “fundamentally false.”

But critics of the procedure say the injections are risky, overused, and often a waste of money.

The report by the Agency for Healthcare Research and Quality (AHRQ), which is part of the Department of Health and Human Services, said there is little evidence that epidural steroid injections were effective in treating low back pain.

“Epidural corticosteroid injections for radiculopathy were associated with immediate improvements in pain and might be associated with immediate improvements in function, but benefits were small and not sustained, and there was no effect on long-term risk of surgery,” the report states.

Epidural injections have been used for many years to relieve pain during childbirth, but they are increasingly being used to treat back pain.

An estimated 9 million epidural steroid injections are performed in the U.S. annually, and the shots have become a common procedure at many pain management clinics. Costs vary from as little as $445 to $2,000 per injection.

A coalition of 14 different societies representing anesthesiologists, surgeons and pain management doctors is lobbying the AHRQ to tone down its report, saying it has raised “significant concerns for physicians who utilize injection procedures.”

“We are fully cognizant of the issues of overutilization and inappropriate utilization, and therefore also wish to bring into focus which interventions are effective when treating the various causes of back pain,” wrote Belinda Duszynski, senior director of Policy and Practice for the International Spine Society, in a lengthy letter to the AHRQ on behalf of the Multisociety Pain Workgroup.

Duszynski’s letter, which is also being sent to a number of medical journals, claims the authors of the AHRQ report used “flawed” and “absurd” analysis on the effectiveness of the injections. She warned the report “may lead to egregious denial of access to these procedures for many patients suffering from low back pain.”

But critics say "interventionalist" doctors are simply trying to preserve a lucrative part of their practice.

“These professional medical societies are worked up because this study basically states that epidural steroid injections have small benefit, the improvements in function are not sustained, and they do not prevent surgery,” said Terri Anderson, a Montana woman whose spine was permanently damaged after receiving about 20 steroid injections for a ruptured disc in her back.

Anderson now suffers from arachnoiditis, an inflammation in the spinal membrane that causes severe chronic pain and disability.

“From my personal perspective, these spinal injections are wasting billions of dollars on the front end, plus there is no estimate high enough to account for the human suffering that this industry has brought upon the American public,” Anderson wrote in an email to Pain News Network.  “When the injections go south and the steroids are misplaced in the spinal cord, this results in life-long disabilities and suffering that cannot be described.” 

The AHRQ report is not the first to raise questions about the safety and effectiveness of epidural steroid injections. Several recent studies have found the injections raise the risk of spinal fractures and do little to control back pain. Questions about their safety also led to an order from the Food and Drug Administration last year that requires drug makers to put warning labels on injectable steroids.

“Injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death,” the FDA said in a statement.

The agency has never formally approved the use of steroid injections to treat back pain. However, the procedure can still be used “off label” to treat back pain.

Many patients who were injured by spinal injections say they were never warned about the risks involved.

“The fact of the matter remains that there is no solid evidence that these injections are of any lasting benefit,” said Dawn Gonzalez, who developed arachnoiditis after a botched epidural during childbirth. “There is just no sound supporting evidence of the efficacy of corticosteroid injections in the spine, and more evidence of the contrary. Epidural steroid injections are bad science.”

A study funded by the AHRQ and published last year in the New England Journal of Medicine found that epidural steroid injections do not relieve pain in patients with lumbar spinal stenosis, a common cause of lower back and leg pain.

The Choosing Wisely campaign of the ABIM Foundation, which seeks to reduce or eliminate unnecessary medical procedures, does not oppose the use of steroid injections for back pain. But it does urge doctors not to repeat the procedure if a patient shows no improvement from a previous injection. 

Lower back pain is the world's leading cause of disability, causing more health loss than diabetes, chronic obstructive pulmonary disease, and asthma combined. Over 80 percent of adults have low back pain at some point in their lives.