Why Smoking is a Pain in the Neck

By Pat Anson, Editor

Need another reason to stop smoking? What if you knew it was causing that pain in your neck?

That’s the conclusion of a new study being presented this week at the annual meeting of the Association of Academic Physiatrists. In a study of 182 patients who were given CT scans,  researchers found that smokers were more likely to have cervical degenerative disc disease.

“This is another example of the detrimental effects of smoking. Tobacco abuse is associated with a variety of diseases and death, and there are lifestyle factors associated with chronic neck pain,” says lead investigator Mitchel Leavitt, MD, resident physician at Emory University’s Department of Physical Medicine and Rehabilitation.

“Pain and spine clinics are filled with patients who suffer chronic neck and back pain, and this study provides the physician with more ammunition to use when educating them about their need to quit smoking.”

The cervical spine is located in the neck and is made up of bones called vertebrae. Between these bones are cervical discs that absorb shock to the spine. Through the normal aging process, these discs slowly degenerate, which means they become dehydrated and shrink.

In some cases, the drying of the disc may cause cracks and tears, through which some of the jelly-like central portion of the disc may spill out and irritate local nerves. That can result in pain in the shoulders, arms, hands and fingers.

It isn’t only wear and tear that can damage these discs. Some unhealthy habits, such as smoking, can add to cervical disc degeneration.

“Smoking is not healthy for a person’s intervertebral discs given the risk of developing microvascular disease – a disease of the small blood vessels – due to nicotine abuse,” says Leavitt. “Intervertebral discs receive their nourishment from the microvasculature that line the endplates on either side of each disc; when these blood vessels are damaged, the discs do not receive nourishment and this may speed up the degenerative process.”

While smoking has been associated with degeneration in the lumbar spine, this was one of the first studies to make the association with the cervical spine.  The patients evaluated by Leavitt and his colleagues were mostly female (57 percent), and about a third were smokers. A radiologist and a physiatrist – a physician who specializes in physical medicine and rehabilitation – reviewed their CT scans for signs of cervical degenerative disc disease. The amount of damage was rated on a scale of zero to 15.

Current smokers were found to have more cervical degenerative disc disease and were given a "damage score" that was about one point higher, on average. Not surprisingly, researchers also found that aging was associated with worsening cervical degenerative disc disease, but diabetes, hypertension, high cholesterol and high BMI were not.

Leavitt believes more research is needed on other lifestyle factors, such as high fat diets, alcohol use and obesity to see how they relate to chronic back and neck pain.

“Virtually everyone knows that moderate exercise somewhere around four to five times per week is beneficial, plus other lifestyle factors like avoidance of smoking and a proper diet are equally important. However, these topics are usually geared towards heart health, lowering blood pressure, managing diabetes, or controlling other medical conditions, and not specific to the spine,” Leavitt said. “It is one thing to live to the age of 95, and it is another to live to 95 while retaining one's mobility and being free of pain. Lifestyle medicine will likely play a large role in the future of healthcare, and having plenty of data to support lifestyle management is critical.”

Previous studies have found that smoking increases your chances of having several types of chronic pain conditions.

A study of over 6,000 Kentucky women found that those who smoked had a greater chance of having fibromyalgia, sciatica, chronic neck pain, chronic back pain and joint pain than non-smokers. Women in the study who smoked daily more than doubled their odds of having chronic pain.

A large study in Norway found that smokers and former smokers were more sensitive to pain than non-smokers. Smokers had the lowest tolerance to pain, while men and women who had never smoked had the highest pain tolerance.

In a recent study published in JAMA Neurology, Swedish researchers reported that continuing to smoke after a diagnosis of multiple sclerosis significantly accelerates progression of the disease.

Our Search for a New Pain Doctor

By Marlee Hanson, Guest Columnist

I am 31, and my husband Ray is 34.  Ray is disabled.  His biggest daily struggle is chronic pain from  a serious back injury. Adding to our troubles is that we live in Montana, a state where there is an acute shortage of doctors willing to treat chronic pain with pain medication.
 
Ray has undergone multiple surgeries to fuse his spine.  We went into these surgeries knowing he would lose some range of motion, but hopeful that they would lessen his pain, allowing Ray to be the husband and father he desperately wants to be.  Sadly, the surgeries were difficult, the recoveries were long, and his pain has only worsened postoperatively.  The disappointment has been crushing.
 
Interventional pain procedures have sadly failed to help my husband as well.  He has endured diagnostic CT myelograms and developed post-procedure cerebrospinal fluid (CSF) leaks.  One was severe enough to require an epidural blood patch.  A CSF leak causes vomiting and a severe headache commonly known as a spinal headache.  These are not only painful, but can lead to meningitis.  The primary treatment is bed-rest.  When this fails, an epidural blood patch is performed.  Though it relieves the headache in most cases, it puts the patient at further risk of developing meningitis.

On many days my husband is not able to move, get out of bed, prepare food, or even take a simple shower because the pain is so severe.  Thankfully, Ray has found relief through opioids. Oxycodone allows him to function so he can be a husband and father.  It gives him enough relief that he is able to stretch and do physical therapy exercises. 

Exercise has also allowed him to rebuild muscle, improve stamina and helped decrease his pain.  None of this would be possible without the pain relief opioids provide him. Unfortunately, we fear my husband is weeks away from losing access to the one medication that truly gives him relief, as his physician’s license has been suspended.

Once we knew this was a possibility, Ray and I began seeking a new doctor to treat him. I believe my husband is a low risk patient.  He takes his medication as prescribed, does not abuse it, and has never been discharged by a doctor for misusing his medication. He has never overdosed. 

ray and marlee hanson

So far we have scheduled appointments with two doctors. The first one neither examined my husband nor reviewed the X-Rays and MRI’s we brought to the appointment. This physician made his treatment decision based on the prescription monitoring database and gave my disabled husband a prescription for one quarter of what he usually takes in a month, along with a pamphlet on vocational rehabilitation. 

We told the doctor Ray had already consulted vocational rehabilitation when it was suggested by his workers compensation caseworker.  We explained to the doctor how much opioids have reduced his pain and improved his ability to function.  The doctor said it was simply not worth the risk of his license being suspended.

Years ago, workers’ compensation and Social Security deemed that Ray was disabled, based on input from several physicians.  We felt this new doctor was not listening, and we were disappointed when he refused to provide the chronic pain management my husband needs. 
 
We were still hopeful that the second doctor, who was recommended by a friend, would assume responsibility for his care.  Ray waited five months for this appointment.  The day before the appointment, the doctor's office called to cancel, stating she would not see Ray for pain management. She also refused to fill his prescription.  He has taken these medications with good functional benefit for the past eight years.

We used to travel to Missoula for chronic pain management.  The trip was inconvenient and the long drive exacerbated his pain.  Eventually we were fortunate enough to find a physician in Helena near our home.  Unfortunately, we will now be forced to travel for appointments once again and deal with all that this entails.  Our next appointment will be in Great Falls.  If Ray does not receive care there, not only will we be forced to travel out of state, but my husband will also have exhausted his supply of medication. 

Ray is a law abiding citizen with a chronic pain condition that needs to be addressed.  Finding care is nearly impossible in the current regulatory climate.  I fear deeply that one day he will escape his pain by suicide.  Ray is not suicidal at all, but I fear if he is forced to go without medication, he will become bound to bed in pain, and I fear that suicide will be the outcome.

The government is looking at opioid pain relievers as harmful substances.  When these medications are illicitly used and abused there is a problem.  That problem does need to be addressed.  However, as harmful as those medications have been for some, they are just as helpful for others.  We do not need laws restricting or banning opioids; we need a nationwide effort to ease the suffering of those who are in pain.  We need doctors and practitioners who are trained in proper use & dosage of pain medication, as well as alternative pain treatment. 

Physicians need to look at chronic pain patients as individuals, just as they do with other patients.  Each condition varies in severity and everyone metabolizes drugs differently.  Please allow doctors to prescribe the medications Ray needs to survive so can be the husband and father he wants to be.  His children and I deserve that, as does he. 

Marlee and Ray Hanson live in Montana.

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.

My Life as a Teen with Chronic Pain

By Stacy Depew Ellis, Guest Columnist

School, sports, music, catching up on the latest gossip. That is what I wish I could say my teenage years were filled with.

Don’t get me wrong, I had a great life. However, I was more concerned with being at school, when my last dose of medicine was, and how I was going to get up the stairs.

When I was in eighth grade, I had a traumatic accident in my dance class. After being misdiagnosed and put in a cast for almost three months, I was diagnosed with a chronic pain syndrome called Reflex Sympathetic Disorder (RSD) or CRPS.

I was sent to yet another doctor to see about treatment. It was decided that I would continue taking pain medication and start receiving lumbar injections. Little did I know that sleepless nights and several emergency room trips would also be included. I would be given more than the recommended amount of painkillers and would still be screaming in pain. Every trip back there offered more questions about a teenager being addicted to prescription drugs. Every doctor in town had seen me.

I started high school as a homebound student. I was going to school for my elective classes and seeing a teacher at my house for core classes. A lot of kids my age got hurt, most of them had a cast at some point. But my illness wasn’t visible; you couldn’t see anything wrong with me. I began losing friends and rumors spread like wildfire throughout my community and school. The worse my pain was, the worse the rumors were. It was tough, but I got through school.

STACY DEPEW ELLIS

After my 33rd spinal injection, I put a stop to the poking and prodding. The doctor hit a nerve and I was paralyzed from my shoulder to my finger tips for two days. Forty-eight hours of not moving an arm. Even more doctors came to see me and I started what would become the first of many steroid treatments.

Time went by and nothing got better. I had headaches, achiness, and started having trouble putting my thoughts into sentences. I saw a neurologist who once again started a smorgasbord of tests. Using my body as a human cushion was normal. What seemed like years of MRIs, spinal taps, and some things I have never heard of, led to the diagnosis of multiple sclerosis.

MS? Really? I was 21 years old.  My first round of treatment was a huge dose of steroids. I took 150 Prednisone pills followed by three days of IV steroids. My flare ups were bad, leaving me in the hospital for weeks at a time. I was a guinea pig for these pharmaceutical companies, injecting myself with a different medicine every month to see which worked best.

It was relieving to finally have a diagnosis and know what was wrong, but having MS is almost worse than not knowing. Heaven forbid I get sick and need to see a doctor. No one wants to treat someone with something like MS. Doctors immediately go to “it’s just the MS” and real problems get overlooked and never fixed. Honestly, the dentist even has trouble being your doctor.

I have been on medicine almost my whole life. I have been seen for depression and spent my paychecks on medical bills. There may never be a cure for multiple sclerosis and I may always be popping pills and injecting things into my stomach, but I am happy to say that I do my hardest to not let my disability hinder me. I try to not let it even be a part of me and I live my life to the fullest.

I will be on anti-anxiety medicine forever but I also believe that I can do anything that I desire. That is something that no doctor can ever take from me.

Stacy Depew Ellis lives in Alabama with her husband. Stacy proudly supports the Alabama-Mississippi National Multiple Sclerosis Society and the Ronald McDonald House Charity, which provided housing for Stacy and her mother when she was in a treatment program in Philadelphia.

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.

If I Had Cancer

By Vikki Towsey, Guest Columnist

I am not a junkie. I am not a pill seeker. I am not a doctor shopper. I am a chronic pain patient. I am a mother, a wife and a friend. I am a social worker. I work with offenders being released from prison who have HIV or AIDS. I am their advocate. I help navigate the healthcare system for my clients.

I find it odd that for my own healthcare needs I am often left on my own to mediate between my three treating physicians. No one advocates for me or helps me navigate through the labyrinth-like healthcare system. My doctors do not communicate nor do they collaborate with each other to make sure I am provided the best care possible.

I have Ankylosing Spondylitis (AS), a chronic autoimmune disorder that has wreaked havoc on my body. I went undiagnosed for 20 years, but it was not from a lack of trying to find answers to the severe back and hip pain that left me bedridden for months on end.

To say I have suffered is an understatement. My children suffer, my husband suffers, and my career suffers. This is largely due to the belief within the medical community that women do not contract AS or they have no idea what AS is.

My diagnosis came too late to prevent the damage done to my joints, which is not repairable. Ankylosing Spondylitis has also increased my chances of early mortality.

The treatment prescribed doesn't work well. I am on a biologic, sulfasalazine, and a commonly prescribed NSAID. While inflammation has decreased due to the joint damage, my pain is still severe. It disrupts my life and causes widespread fatigue.

VIKKI TOWSEY

People with disorders like mine are often fighting not only our conditions but a system that has become adversarial for many of us. Our pain has become a scarlet letter that identifies us as junkies, pill seekers, and criminals.  The CDC's proposed opioid guidelines will ensure that this continues. We are imprisoned by our suffering and endure a sentence of constantly fighting a system that is set up to deprive us of treatment that provides some quality of life.

If I had cancer, there would be widespread acceptance of any treatment that would provide improvement to my condition and quality of life. No one would think twice about writing me a prescription for opioids. In fact, not prescribing opiates would be considered malpractice. If I had cancer, I would also not be put in a federal database and I would not be looked at with suspicion by my pharmacist.

It almost creates a sense of envy for the chronic pain patient. Aside from the fact that cancer sucks, life might get a little easier for us. Before you argue that no one should wish for cancer, you are right! Cancer is horrible. So is living every day with pain so severe that it leaves a wake of victims in its path.

I didn't ask for this. I didn't choose this life. I didn't ask to be dependent on pain medications that give me the ability to take my children to a movie on a Saturday afternoon. My husband didn't ask to marry someone who cannot participate in household chores without the assistance of a pill.

I relate to the fear of asking for pain medication that will label me an addict, pill seeker, or junkie. We are let down every day by a system that is supposed to provide care for us. We are failed by doctors who took an oath to do no harm. All I want is a pain free day.  Is that too much to ask?

My life is worth more than haphazard and limited care. I demand better. We all should demand better. Our doctors should demand better. If we don't demand these things, then we just create more victims. Write to your doctor, write your representative, senators, and please write the CDC and tell them enough is enough!

Vikki Towsey lives in Virginia with her family. Vikki is a social worker, professional life coach, and co-administrator of the Ankylosing Spondylitis Project, an advocacy group for people with Ankylosing Spondylitis and other chronic illnesses.

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.

Pfizer’s Quiet Recall of Lyrica Capsules

By Pat Anson, Editor

Pfizer has quietly recalled three lots of its blockbuster drug Lyrica because of a manufacturing problem that could have left some capsules deformed or damaged.  The voluntary recall only involves 50 mg and 75 mg Lyrica capsules with a certain lot number and expiration date.

“Please note that use of, or exposure to, product from these lots is not likely to cause health consequences,” said Lou Dallago, Vice-President of Pfizer’s U.S. Trade Group, in a “Dear Customer” letter sent to retailers who may have received a shipment of the recalled Lyrica lots in September or October 2015.

The letter is dated January 11, 2016 and is stamped “Urgent: Drug Recall.”

Pfizer has not publicized or notified patients directly about the recall. The drug maker has issued no press releases about the recall and there is no mention of it on Pfizer’s Lyrica website or the Food and Drug Administration's website that lists recalled products. 

(An update to this story can be found by clicking here).

“The recall was initiated because some Lyrica capsules in the affected lots may be deformed or damaged,” GoodRx.com reported.  “This can affect the integrity of the medication in those capsules, which means they could lose some of the active ingredient—so you may or may not be getting the full dose with each capsule. If you don’t receive the correct dose, your prescription may not be as effective.”

Lyrica is the brand name of pregabalin, which was originally developed as an anti-seizure medication to treat epilepsy. Lyrica is also approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injury. Lyrica is prescribed “off label” to treat a variety of other conditions, including lumbar spinal stenosis, the most common type of lower back pain in older adults.

The recalled Lyrica includes 50 mg capsules in 90-count bottles, Lot #M07861 and with an expiration date of 5/31/2018.

Two lots of 75 mg capsules in 90-count bottles are also being recalled. Their lot numbers are #M07862 and #M07865, with expiration dates of 5/31/2018 and 6/30/2018.

Lyrica is Pfizer’s top selling drug, generates over $5 billion in annual sales, and is currently approved for use in over 130 countries. Last year Pfizer agreed to pay $400 million to settle a shareholder lawsuit over allegations it illegally marketed Lyrica and several other drugs off-label. The lawsuit stemmed from a $2.3 billion settlement with the federal government in 2009 for fraudulent marketing and illegal kickbacks paid to doctors who prescribed Lyrica and other Pfizer products.

Epidurals May Harm Newborn Babies

By Pat Anson, Editor

We’ve written before about the risks associated with epidural injections used to relieve back pain and pain during childbirth. Now comes word that epidural analgesia may also have adverse effects on newborns.

A large study by researchers at the University of Granada in Spain found that babies born after their mothers were given epidurals had a small decline in their overall health, were less likely to begin early breast feeding, and were significantly more likely to be admitted to neonatal intensive care. Resuscitation was also significantly more frequent in babies born after epidural analgesia.

The study, published in Midwifery magazine, involved over 2,600 babies born between 2010 and 2013 at San Juan de la Cruz hospital in Úbeda, a province of Jaén, Spain

"A series of adverse effects have been observed both on the mother and on the baby,” said lead author Concepción Ruiz Rodríguez, a professor in the Department of Nursing of the University of Granada.

“Adverse effects observed on the baby are attributed to a direct pharmacological effect, due to a placental transmission of the drug administered to the mother, or due to an indirect secondary effect as a consequence to the physiological changes the drug causes in the mother, such as hormonal changes."

Researchers measured the overall health of the babies by using Apgar index values, a quick test applied to newborn babies to assess their general health. They found the Apgar values were “slightly but significantly lower” in newborns whose mothers had epidurals.

“Epidural analgesia may have adverse effects on newborns, although the risks are low, and further research is required to elucidate the causal nature of this relationship,” said Ruiz Rodriguez. "For that, we consider that it's important that both mothers and health professionals (obstetricians and midwives) know and have in mind those risks when the time for taking a decision comes.”

Epidurals involve the injection of steroids, opioids or other analgesic drugs through a catheter. The injection blocks the transmission of pain signals through nerves in the spinal cord.

Epidurals are commonly used to relieve pain during childbirth and, while the risks are low, they can result in complications for the mother such as headaches, difficulty breathing, seizures, or damage to the spinal cord. Drugs used during epidurals also pass through the placenta to the baby.

Epidurals injections are given to millions of Americans each year for back pain and there is growing controversy over their use. A study by federal researchers last year found that steroid injections provide limited or no relief  from radiculopathy and spinal stenosis, two conditions that cause low back pain.

A number of prominent physicians have told Pain News Network the shots are overused, with some patients getting dozens of injections, which raises their risk of complications.  

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.

Imaging Identified as Most Wasteful Medical Test

By Pat Anson, Editor

Should you get an MRI for your headache?

What about a CT scan for low back pain?

Or a bone-density scan for someone under the age of 65?

In most cases, the answer to all of those questions is no, according to the Choosing Wisely campaign of the ABIM Foundation, which seeks to reduce the use of hundreds of unnecessary and costly medical tests. Experts say an MRI or CT scan of the lower back can cost over $1,200 and does nothing to relieve your back pain.

Since Choosing Wisely was launched in 2012, over 370 wasteful procedures have been identified by over 70 medical societies, such as the American Academy of Sleep Medicine and the American Academy of Neurological Surgeons. Each organization was asked to identify an initial list of five medical services that may be unnecessary. Many societies went far beyond that, returning with two or even three lists.

A neurologist at the University of Michigan says the list of recommendations from the American Academy of Neurology (AAN) only scratches the surface. Brian Callaghan, MD, has identified 74 tests and procedures related to neurology that are often unnecessary. Many involve the use of imaging.

“The two biggest areas that might be done more than they should are imaging for low back pain and imaging for headaches,” Callaghan said. “It’s a big problem and it costs a lot of money – we’re talking a billion dollars a year on just headache imaging.”

According to a recent study at the University of Michigan, one in eight visits to a doctor for a headache or migraine end up with the patient going for a brain scan. Often a doctor will order a CT or MRI scan to ease a patient’s fear that they may have a brain tumor or some other serious issue causing their pain. Physicians could also order a scan to protect themselves legally in case of a future lawsuit.

In most cases, however, the brain scan will be useless. Previous research found that only 1 to 3 percent of brain scans of patients with repeated headaches identify a cancerous growth or aneurysm that's causing the problem. Many of the issues that a scan might identify don’t pose a serious threat or may not require treatment right away. There is also the risk of a false positive that could generate unnecessary fear and alarm.

“These are all areas where lots of physicians agree that you’re more likely to get harmed by doing the procedures,” said Callaghan, whose study was recently published in the journal Neurology.

Callaghan isn’t encouraging you to say no if your doctor wants to image your brain or lower back, but he hopes his research will inspire a thoughtful discussion between doctors and patients about the purpose of the test and its value

“Ordering an MRI for a headache is very quick, and it actually takes longer to describe to the patient why that’s not the best route,” Callaghan said. “These guidelines are meant for physicians and patients both, to trigger a conversation.”

Besides imaging, another treatment that is widely questioned is the use of opioid pain medication to treat headaches and migraine. The Choosing Wisely campaign recommends that opioids only be used as a last resort for severe headaches, including migraine. Overuse of any pain reliever – even over-the-counter medications -- are known to make headaches worse.

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.

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.

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.