Study Finds Many Treatments for Back Pain Ineffective

By Pat Anson, Editor

Lower back pain is the world’s leading cause of disability, affecting about 540 million people at any given time. With so many people suffering, you'd think there would be a consensus on the best way to treat or at least manage low back pain.

And you'd be wrong.

In a series of reviews appearing in The Lancet medical journal, an international team of researchers found that low back pain is usually treated with bad advice, inappropriate tests, risky surgeries and painkillers -- often against treatment guidelines.

“The majority of cases of low back pain respond to simple physical and psychological therapies that keep people active and enable them to stay at work,” says lead author Professor Rachelle Buchbinder of Monash University in Australia. “Often, however, it is more aggressive treatments of dubious benefit that are promoted and reimbursed.”

Buchbinder and her colleagues say low back pain is best managed in primary care, with the first line of treatment being education and advice to exercise, stay active and continue to work. Instead, a high number of low back pain patients are treated in emergency rooms, encouraged to rest and stop work, referred for scans or surgery, and prescribed painkillers.

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“In many countries, painkillers that have limited positive effect are routinely prescribed for low back pain, with very little emphasis on interventions that are evidence based such as exercises," adds co-author Professor Nadine Foster of Keele University in the UK.

"As lower-income countries respond to this rapidly rising cause of disability, it is critical that they avoid the waste that these misguided practices entail."

Low back pain mostly affects adults of working age in lower socioeconomic groups. People with physically demanding jobs, physical and mental comorbidities, smokers, and obese individuals are at greatest risk of reporting low back pain. 

Most people with new episodes of low back pain recover quickly, but recurrences are common. It’s also important to rule out more serious causes of back pain, such as cancer, arthritis and spinal fractures. In a small proportion of people, low back pain can become chronic and disabling.

The Lancet authors say patients should avoid harmful and useless treatments, and doctors need to address widespread misconceptions about their effectiveness. For example, there is limited evidence to support the use of opioids for low back pain, and epidural steroid injections and acetaminophen (paracetamol) are not recommended at all.

The authors recommend counseling, exercise and cognitive behavioral therapy as first-line treatments for short-term low back pain, followed by spinal manipulation, massage, acupuncture, meditation and yoga as second line treatments.

“Millions of people across the world are getting the wrong care for low back pain. Protection of the public from unproven or harmful approaches to managing low back pain requires that governments and health-care leaders tackle entrenched and counterproductive reimbursement strategies, vested interests, and financial and professional incentives that maintain the status quo,” said co-author Professor Jan Hartvigsen of University of Southern Denmark.

“Funders should pay only for high-value care, stop funding ineffective or harmful tests and treatments, and importantly intensify research into prevention, better tests and better treatments.”

The findings in The Lancet series are similar to those reported in other medical journals. A 2016 study published in JAMA Internal Medicine found that regular exercise and education reduce the risk of developing lower back pain by as much as 45 percent.

Another study in JAMA found that opioid medication provides only modest short-term relief for low back pain. Previous studies published in the British Medical Journal and The Lancet also found little evidence that acetaminophen was effective in treating low back pain.

My Arachnoiditis Family

By Elaine Ballard, Guest Columnist

I live in the rural county of Somerset in England, UK. At the age of 22, I had a sporting accident which eventually left me 80 percent disabled and unable to lead a normal life. 

The accident caused several crushed discs in my spine and a great deal of nerve damage. Over the years multi-level disc degeneration set in, as well as osteoarthritis. I am unable to use a wheelchair, as bulging discs prevent me from sitting without severe pain. I am now 73.

ELAINE BALLARD

ELAINE BALLARD

Since 1994, I have been confined to lying on a bed in my living room and only leave home to keep hospital appointments. I travel by stretcher ambulance.

Just over two years ago I had an MRI scan which showed I had Adhesive Arachnoiditis (AA) and my life changed drastically yet again. 

Arachnoiditis is listed as a rare neurological condition, but in fact many thousands of people all over the world have been diagnosed with it. There are also thousands of other people who have the same symptoms, but as yet, no diagnosis.

It is difficult for patients to get diagnosed as doctors are not trained to recognize this disease and often fail to even recognize the symptoms.

Arachnoiditis results from severe inflammation of the arachnoid membrane that surrounds the nerves of the spinal cord. It may cause stinging and burning pain, as well as muscle cramps, spasms, and uncontrollable twitching. The most common symptom is severe to unbearable neurological pain, especially to the nerves connecting to the lower back, legs and feet. This can lead to tingling, numbness, weakness and severe pain in the legs and feet.

Other symptoms include sensations that feel like insects crawling on the skin or water trickling down the legs. It can also affect the bladder, bowel and sexual function. Unfortunately for some, it may also result in paralysis.

As this disease progresses, the symptoms can become more severe or even permanent. Most people with Arachnoiditis are eventually unable to work and suffer significant disability because they are in constant pain. Pain is the most dominant factor and it is both chronic and acute. As the disease progresses, it can be relentless and unbearable and sadly suicide becomes an option.

Inflammation of the arachnoid membrane can lead to the formation of scar tissue, which may cause the spinal nerves to clump together and eventually adhere to the lining wall of the dura, the middle layer of the spine. The disease can then progress to Adhesive Arachnoiditis.

What Causes Arachnoiditis

There are a few different causes of Arachnoiditis. In the 1970's a dye used in myelograms was injected during spinal procedures directly into the area surrounding the spinal cord and nerves. The dye was too toxic for these delicate parts of the spine and was blamed for causing Arachnoiditis. This dye continues to be used in some parts of the world.

Bacterial infections and viruses in the spine can also lead to Arachnoiditis. So can complications from spinal surgery and invasive spinal procedures such as epidural steroid injections.

There is no cure for Arachnoiditis and there is little effective pain relief. This is a disease or condition for life. Opioids are offered by doctors, but are not specific to reducing neurological pain of this nature.

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It is very sad and cruel that opioids are being clamped down in America and that Arachnoiditis patients are being classed together with people who seek drugs for recreational purposes. We are not drug seekers but desperate victims crying out for something that will stop this relentless and overwhelming neurological pain.

The Facebook support group Arachnoiditis Together We Fight has been an important part of my education in understanding this disease. I am thankful to say it has become more of a family, where members can come in and gradually feel at home while we bring education, support and encouragement. This family atmosphere and great support has saved many lives, as people first arrive feeling suicidal and lost in a medical world that will not help them.

That is why I wrote this poem to show people how important support groups can be and to bring more attention to this rare but life changing disease.

"The Family"

By Elaine Ballard

Lonely, fearfully I knock at the door
Arac greets me, a smile, so kind
I want to die, eyes keep to the floor
"Welcome" she says, but what will I find?

"Welcome" repeated again and again
"Good to have you!" Are you kidding?  
"Family" really can it be true? 
Lost, lonely, rejected... what you too? 

I tell my story, they will never believe
"We understand, you're not alone"
Tears trickle down, I cannot believe
We are bound together by this dreaded disease

Files, inflammation, medication
Head's in a spin, where do I begin?  
Then a hand upon my shoulder
Guides me to those precious folders

Questions answered, hope is rising
Found some friends, pain subsiding
Flares still come but under control
No longer afraid nor out in the cold

We need each other, your pain is mine  
Strength in unity, love is the sign
Moving forward we are free
To Fight Together as one FAMILY

 

Elaine Ballard has written a book about Adhesive Arachnoiditis and how her Christian faith helped her through many difficult flares and times. It is called “The Furnace of Fire” and is available on Amazon. Click on the book's cover to see price and ordering information.

Pain News Network invites other readers to share their stories (and poems) 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.

What the JAMA Opioid Study Didn’t Find

By Roger Chriss, Columnist

A recent opioid study published in the Journal Of the American Medical Association (JAMA)  evaluated pain management in patients with hip and knee osteoarthritis and low back pain.

The study by VA researcher Erin Krebs, MD, and colleagues found that “treatment with opioids was not superior to treatment with nonopioid medications for improving pain-related function over 12 months.”  

That finding was widely and erroneously reported in the news media as meaning that opioids are ineffective for all types of chronic pain.

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But the most fascinating result of the study – the one not being reported -- is what wasn’t found. The 108 people in the study who took opioids for a year did not develop signs of opioid misuse, abuse or addiction, and did not develop opioid-induced hyperalgesia – a heightened sensitivity to pain.

And no one died of an overdose.

This is significant because it runs counter to commonly held beliefs in the medical profession about the risks of prescription opioids. Here are a few recent examples:

“Opioids are very addictive and their effectiveness wanes as people habituate to the medication,” Carl Noe, MD, director of a pain clinic at the University of Texas Medical Center wrote in an op/ed in The Texas Tribune.

Don Teater, MD, a family physician in North Carolina, also believes that people on long-term opioid therapy experience dose escalation, which leads to hyperalgesia. “Opioids cause permanent brain changes,” Teater told USA Today.

Krebs herself has made similar comments. "Within a few weeks or months of taking an opioid on a daily basis, your body gets used to that level of opioid, and you need more and more to get the same level of effect,” she told NPR.

But the Krebs study didn’t see any of that happen.

Krebs and colleagues closely monitored the 108 people in the opioid arm of the study, using “multiple approaches to evaluate for potential misuse, including medical record surveillance for evidence of ‘doctor-shopping’ (seeking medication from multiple physicians), diversion, substance use disorder, or death.” They also had participants complete the “Addiction Behavior Checklist” and assessed their alcohol and drug use with surveys and screening tools.

What did Krebs find in the opioid group after 12 months of treatment?

“No deaths, ‘doctor-shopping,’ diversion, or opioid use disorder diagnoses were detected,” she reported. “There were no significant differences in adverse outcomes or potential misuse measures.”

Health-related quality of life and mental health in the opioid group did not significantly differ from the non-opioid group – and their anxiety levels actually improved.  

These are observational findings in the study. They were not a part of what Krebs and colleagues were specifically trying to measure. As the study notes: “This trial did not have sufficient statistical power to estimate rates of death, opioid use disorder, or other serious harms associated with prescribed opioids.”

ERIN KREBS, MD

ERIN KREBS, MD

But they are valuable observations. They note what didn’t happen in the study. Over 100 people were put on opioid therapy for a year, and none of them showed any signs of dose escalation or opioid-induced hyperalgesia, or any evidence of opioid misuse, abuse or addiction.

Krebs told the Minneapolis Star Tribune that this “could reflect the fact that the study did not enroll patients with addiction histories, and because the VA provided close supervision to all participants during the yearlong study.”

In other words, Krebs and colleagues used an opioid prescribing protocol that achieved an admirable level of patient safety. Their approach is similar to what many pain management practices currently pursue and what the CDC and various state guidelines recommend: Risk assessment before initial prescribing and careful monitoring over time.

The Krebs study provides rare and detailed observations of what happens when people are put on long-term opioid therapy. A lot of what is claimed about dose escalation, opioid-induced hyperalgesia, and misuse or abuse didn't happen at all.

This outcome demonstrates that long-term opioid therapy can be safe and effective, and may be useful in treating other chronic conditions, from intractable neuropathies to painful genetic disorders. That’s worth reporting too, isn’t it?

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Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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.

Is JAMA Opioid Study Based on Junk Science?

By Pat Anson, Editor

You may have read about a research study published this week in the Journal of the American Medical Association (JAMA), which compared the effectiveness of opioid and non-opioid medications in treating chronic pain. 

The yearlong study of 240 patients found that opioids were not superior to pain relievers like acetaminophen and ibuprofen in treating chronic back pain or hip and knee pain caused by osteoarthritis.  Pain improved for 41% of the patients who took opioids, compared to 54% in the non-opioid group.  

It’s an interesting study – one of the few to look at the effectiveness of any pain relievers long term – but some critics are questioning the study’s methodology and the alleged anti-opioid bias of its lead author, Erin Krebs, MD, a researcher for the Department of Veterans Affairs.

First let’s look at some of the news coverage the study is getting.

“Opioids Don’t Treat Chronic Pain Any Better Than Ibuprofen” reads the headline in Newsweek, an article that never mentions the JAMA study was limited to patients with back pain or osteoarthritis.

“Opioids Don’t Beat Other Medications for Chronic Pain” was the headline in NPR.com, while the Chicago Tribune went with “Opioids no better than common painkillers for treating chronic pain.”

The Tribune article included a quote from one of the co-authors of the CDC opioid guidelines. "The fact that opioids did worse is really pretty astounding," said Roger Chou, MD. "It calls into question our beliefs about the benefits of opioids."

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Notice the news coverage strongly suggests that opioids are ineffective for all types of chronic pain – not just back pain and osteoarthritis.  Patients living with chronic pain from arachnoiditis, trigeminal neuralgia or some other intractable pain condition would probably disagree about that. And they'd find the idea of taking ibuprofen laughable, if not infuriating. But no one asked for their opinion.

Also unmentioned is that opioids are usually not prescribed for osteoarthritis or simple back pain, which are often treated with NSAIDs and over-the-counter pain relievers.

So, what JAMA has published is a government funded study designed to look at a treatment (opioids) that most people with back pain and arthritis never actually get.

“You've been had by anti-opioid advocates disguising their advocacy as science.  Krebs is well known in professional circles for this kind of distorted advocacy junk science,” wrote patient advocate Red Lawhern, PhD, in a comment submitted to the Philadelphia Inquirer after it published a misleading headline of its own, “Prescription opioids fail rigorous new test for chronic pain.”

“I suggest that you retract your article.  In its present form, it is propaganda not fact,” said Lawhern, a co-founder of the Alliance for the Treatment of Intractable Pain (ATIP). “Opioids have never been the first-line medical treatment of choice in lower back pain or arthritis. That role is served by anti-inflammatory meds, some of them in the prescription cortico-steroid family.  NSAIDs have a role to play, recognizing that they are actively dangerous in many patients if taken at high doses for long periods.  Hundreds of people die every year of cardiac arrest or liver toxicity due to high-dose acetaminophen or ibuprofen.” 

Who is Erin Krebs?  

Dr. Krebs is an associate professor at the University of Minnesota Medical School and a prolific researcher at the VA Medical Center in Minneapolis.

She was also an original member of the “Core Expert Group” – an advisory panel that secretly drafted the CDC’s controversial opioid guidelines while getting a good deal of input from the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP). The guidelines recommend that opioids not be prescribed for chronic pain.

Krebs also appeared in a lecture series on opioid prescribing that was funded by the Steve Rummler Hope Foundation, which coincidentally is the fiscal sponsor of PROP. 

Some of her previous opioid research has been controversial. In a study published last year in the Annals of Internal Medicine, Krebs reviewed 67 studies on the safety and effectiveness of opioid tapering. Most of the studies were of poor quality, but nevertheless Krebs came to the conclusion that pain levels and the quality of life of patients “may improve during and after opioid dose reduction.”

ERIN KREBS, MD

ERIN KREBS, MD

“This review found insufficient evidence on adverse events related to opioid tapering, such as accidental overdose if patients resume use of high-dose opioids or switch to illicit opioid sources or onset of suicidality or other mental health symptoms,” wrote Krebs.

PROP founder Andrew Kolodny, MD, read the review and liked it, tweeting that “dangerously high doses should be reduced even if patient refuses.”

But forced opioid tapering is never a good idea, according to a top CDC official.

“Neither (Kreb’s) review nor CDC's guideline provides support for involuntary or precipitous tapering. Such practice could be associated with withdrawal symptoms, damage to the clinician–patient relationship, and patients obtaining opioids from other sources,” wrote Deborah Dowell, MD, a CDC Senior Medical Advisor, in an editorial also published in the Annals of Internal Medicine. 

As for Krebs’ contention that there is “insufficient evidence” of adverse events associated with opioid tapering, that notion may be put to rest next month when the VA releases a new study showing that tapering has led to a growing number of suicides by veterans.

In a summary of the findings, which will be presented at the Rx Drug Abuse & Heroin Summit, VA researchers report that “opioid discontinuation was not associated with overdose mortality, but was associated with increased suicide mortality.”  

Who and what should we believe in the neverending debate about opioids? PNN columnist Roger Chriss wrote about Krebs’ opioids vs. non-opioids study last year, when the initial reports of its findings came out. Roger said prescribing decisions are best left to physicians who know their patients’ medical conditions – not researchers, regulators or the news media.

“In reality, there is no ‘versus’ here. Opioids and NSAIDs are both valuable tools for chronic pain management. To pretend that one is inherently better than the other is to miss the essential point: Both work and should be available for use as medically appropriate,” Roger wrote. 

Oska Pulse Reduces Knee, Shoulder and Back Pain

By Pat Anson, Editor

A wearable device that stimulates the release of natural pain-relieving endorphins provides significant relief to patients with chronic knee, shoulder or back pain, according to the results of small clinical trial.

The Oska Pulse uses Pulsed Electromagnetic Field technology (PEMF) to dilate blood vessels, which increases blood flow, reduces inflammation, and releases the body’s endorphins to reduce joint and muscle pain.

The double blind, placebo-controlled study involved 30 patients who were recruited from two San Diego area pain clinics. Participants were given either an Oska Pulse or a placebo device and asked to wear them several times a day for two weeks, while completing a daily log to track their pain, stress and usage.

The study findings, first published in Practical Pain Management, found that the majority of participants who used the Oska Pulse had a significant decrease in pain levels. Some also reported a decrease in stress.

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“There was significantly more reduction in pain in the OSKA Pulse group after 14 days of use than placebo. These results suggested that the OSKA Pulse may be an effective tool in pain attenuation,” wrote lead author Joseph Shurman, MD, an anesthesiologist at Scripps Memorial Hospital in La Jolla, CA.

“Data analyses showed interesting trends in subjective pain scores, including a slight increase in pain in the placebo group after day 7, while the OSKA Pulse group, on average, reported a decline in pain intensity.”

Previous studies have found that PEMF therapy can be used to treat a variety of chronic pain conditions, not just simple muscle aches and joint pain. A recent survey of Oska Pulse users found that half had some type of pain for more than five years.

"I've had RSD/CRPS in my left leg for 21 years and tried many meds and treatments over the years, including 10 years of ketamine infusions," said Tracey M., an Oska customer quoted in a news release. "I started using Oska Pulse nine months ago and my pain was reduced more than ever before. I recently danced at my daughter's wedding. Before Oska, I wasn't even sure if I'd be able to attend."

PNN columnist Arlene Grau, who lives with rheumatoid arthritis and fibromyalgia, was at first skeptical about the Oska Pulse. But after trying it for several days, she found the device gave her some temporary pain relief.

“I originally thought the Oska Pulse was not going to work for me, since I'm used to the TENS unit shocking my body and actually feeling something happening. You don’t really ‘feel’ anything when the Oska Pulse is on, but I felt a difference after every use,” Arlene said. “I wouldn't necessarily compare it to the relief I get from opioids, but it was enough to make me feel like I didn't need to take prescription drugs every 4 hours. Which is a triumph.”  

Before using the Oska Pulse, it is recommended that cancer patients, or those who are pregnant, nursing, or have a pacemaker or defibrillator, should consult with their physician.

The Oska Pulse is available on Amazon for $399.

5 DIY Tips to Reduce Lower Back Pain

By Mark El-Hayek, Guest Columnist

Lower back pain is the world's leading cause of disability. Almost all of us will at some point in our lives have to deal with it.

Lower back pain is any form of pain or discomfort in the lower part of the spine, which is known as the lumbar spine. It can be brought about by things like muscle tension, stress, improper diet, lack of exercise, poor posture, excess body weight and pregnancy.

We put together five simple do-it-yourself tips to help reduce lower back pain.

1) Correct Posture

Poor posture is one of the leading causes of lower back pain. Good posture involves sitting, walking, standing and sleeping in ways that do not weaken or over activate your supporting muscles. There are several things you can do to improve posture.

When sitting, avoid sitting on the edge of a chair as this puts a lot of strain on your back. Sit with your back straight and shoulders back.

The same is true for walking. Avoid bending or slouching over while walking. This strains your back and causes lower back pain.

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When lying down, get into a position that is comfortable and one that does not compromise the curve in your back.

2) Ice and Heat

For many people, putting ice or something cold on an injured area provides relief from pain. Heat also works well in reducing lower back pain, but the two techniques work very differently.

When you put something cold on your lower back, the cold makes the blood vessels constrict, which reduces the pain caused by inflammation. Heat, on the other hand, relaxes blood vessels and increases blood flow, which helps heal the affected area.

It is advisable that when using ice and heat together, you start by doing the cold compress first and then the hot compress. You can use ice packs or frozen peas for the cold compress. For the hot compress, you can use a hot water bottle or a towel soaked in warm water.

Alternate between the cold and hot compresses for a few minutes and you will notice that your lower back pain has reduced.

3) Exercise

Regular exercise is a good way to prevent lower back pain. Make a point of exercising as often as you can. If you have a job that has you sitting for long hours, integrate exercises and movement into your everyday routine.

Walk to the bathroom or the water cooler a couple of times a day to keep your joints moving and lower back pain at bay. Take the stairs instead of the elevator or escalator to help stay fit.

4) Rest

Lower back pain is often caused by stress. The moment you start feeling back pain, take a couple of hours off to rest. You can start by taking a hot shower to help you relax. The shower will help your blood vessels relax and make oxygen flow freely to your lower back. After the hot shower, rest for a couple of hours and you will probably feel better.

5) Do not stay in bed too long

While resting is important, make sure you do not stay in bed too long. Lying down for an extended period of time, especially when your posture is poor or you do not have a good mattress, could increase your lower back pain. Instead of lying down, go for a slow walk to allow your joints and muscles to move and reduce inflammation.

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Mark El-Hayek graduated from Macquarie University in Sydney, Australia with a Masters of Chiropractic and a Bachelor of Medical Science.  He is the head chiropractor and owner of Spine and Posture Care in Sydney.

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.

An Open Letter to My Senator: CDC Has Killed Me

(Editor’s Note: Charles Malinowski is a 59-year old Paso Robles, California man who lives with Reflex Sympathetic Dystrophy (RSD), degenerative disc disease, ankylosing spondylitis, spinal stenosis and other chronic pain conditions.  He recently wrote this open letter to U.S. Senator Kamala Harris (D-CA). We thought his letter worth sharing with PNN readers.)

Dear Senator Harris,

The CDC has killed me!

Let me repeat that: The CDC has killed me!

I have a severe neurological condition that causes me unspeakable and crippling pain. Pain medication is literally the only thing keeping me alive. But with the issuance of the CDC’s short sighted, so-called voluntary opioid prescribing guidelines -- which are being rammed down the throats of medical providers -- my pain management doctor has cut me off of opiates.

For the last 10 years, I have been subjected to nearly every type of physical therapy, medical treatment and medication applicable to my affliction. The one and only thing that has ever had any demonstrable benefit in even temporarily suppressing my pain to a tolerable level has, unfortunately, been opiates.

In early October, I was told that I would have to stop taking either the oral opiates or the intrathecal opiates, as it was now illegal for a person to receive two different types of opiates via two different delivery methods concurrently. This was a major problem, as even with both oral and intrathecal opiates, my pain was severely under-managed to the point where I was almost completely bedridden. I left the house only to go to doctor's appointments.

When I was told that my pain management regimen - specifically the opiates - was going to be cut in half, even though my pain was already grossly under-managed, I spoke out about this.

CHARLES MALINOWSKI

CHARLES MALINOWSKI

As a result, not only was I cut off from the oral opiates, I got kicked out of the pain management practice where I have been a patient for more than seven years. The doctor said he didn't want to risk his license - but was perfectly willing to risk my life - over the CDC opioid guidelines.  These guidelines are supposed to be voluntary and are not supposed to take desperately needed pain medication away from legitimate chronic pain sufferers such as myself.

I expect that within 60 days, I will be dead from either heart failure or a stroke due to my body's inability to cope with the stress of the unrelenting pain. My neuropsychologist, who has been treating me for nearly 10 years, has consistently rated my level of pain as moderate to extreme, even while being medicated with both oral and intrathecal opiates, which I am now denied.

I'm not dead yet, but within 60 days I expect that the CDC will have effectively killed me. I honestly don't see myself being able to tolerate the pain any longer than that.

Congress, in going along with this blindly, will be explicitly complicit in this negligent homicide - or homicide by depraved indifference, take your pick - of one Charles James Malinowski, that being myself.

I would like to thank you, Senator, and all the rest of your colleagues for murdering me.

To help ease your conscience, it is not just me that Congress is complicit in murdering, but thousands, possibly tens of thousands of people in like positions.

Sincerely,

Charles Malinowski

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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.

A Promising Solution to Lower Back Pain

By A. Rahman Ford, Columnist

As many of us can attest to, lower back pain (LBP) is a debilitating and painful medical condition that severely impacts quality of life.  An analysis of the Global Burden of Disease in 2010 showed that LBP ranked as the greatest contributor to disability out of nearly 300 conditions studied. 

Lower back pain tends to peak in older age groups; thus, regions with higher life expectancies are disproportionately impacted.  The number of people with LBP is projected to increase in the coming decades, especially in low- and middle-income countries.  About 149 million work days are lost every year in the U.S. because of LBP, at an estimated cost of $100-200 billion.  

Of course, the costs to the patient – both financial and emotional – can never be adequately quantified.

Tough Questions, Few Answers

Although the causes of LBP generally are multifarious, the National Institutes of Health maintains that the majority of cases are mechanical in nature.   The gradual degeneration of the spine as a result of normal wear and tear – referred to as spondylosis – can result in a myriad of painful conditions that range from simple sprains, to herniated or ruptured discs, to injuries caused by trauma. 

While the causes of lower back pain are rarely addressed, analgesic medications are routinely prescribed to treat its symptoms.  Commonly prescribed medications include opioids, NSAIDS, anticonvulsants, antidepressants, counter-irritants and epidural steroid injections.

However, these analgesic treatments have shortcomings: potentially dangerous side-effects, adverse drug interactions, addiction, organ damage or only temporary relief.  Other treatment options include physical therapy, transcutaneous electrical nerve stimulation (TENS), acupuncture and in extreme cases, surgery. 

Sadly, neither the conservative management nor the more invasive surgical options consistently yield satisfactory results, because they fail to address the underlying disease processes.  In fact, some treatments may actually lead to a worsening of the condition in the long term.  Undoubtedly, new approaches are needed to solve the problem.

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Research Supports Stem Cells for LBP

Many cases of lower back pain involve structural damage to the intervertebral discs, either by way of a herniated disc or degenerative disc disease (DDD).  This condition is quite prevalent among older adults, with one study finding that 95% of older Americans exhibiting some degree of disc degeneration. 

In the search for treatments beyond analgesics and surgery, several researchers have demonstrated the effectiveness of stem cell therapy in treating disc injuries in both humans and animals. 

Leung et al. (2006) and Drazin et al. (2012) noted the potential for mesenchymal stem cells (MSC) to treat intravertebral disc degeneration in laboratory animals.  Orozco et al. (2011) used autologous bone marrow-derived MSCs to treat 10 patients with lumbar disc degeneration, who exhibited rapid improvement in pain and disability. 

Similarly, Pettine et al. (2015) reported significantly reduced pain scores in 26 patients who received autologous bone marrow-derived stem cells. 

Coming to a Clinic Near You?

Just this year, Centeno et al. successfully used an injection of autologous bone marrow derived MSCs to treat DDD in 33 patients with lower back pain.  The authors found “no safety issues, substantially reduced pain, increased function and reduced disc bulge size in most patients.”

That treatment utilized stem cell technology created by BioRestorative Therapies, which uses autologous bone marrow-derived MSCs to treat chronic lumbar disc disease.  According to the company’s website, “not only could this program potentially eliminate surgery in many cases, but it could also provide substantially more effective treatment than current non-invasive therapies with a design to be curative.”  The company has been cleared by the FDA for Phase 2 clinical trials to treat lower back pain due to DDD.

DiscGenics, a biotech company based in Utah, has also received FDA approval for a study of stem cell therapy to treat patients with intervertebral disc disease. DiscGenics’ approach is different, because it uses patented technology to derive its proprietary “discogenic cells” directly from adult human disc tissue.

“We believe it has the potential to offer pain relief and restored function to millions of patients suffering from the debilitating effects of lower back pain,” DiscGenics CEO Flagg Flanagan told The Salt Lake Tribune. “Receiving the go-ahead from the agency to begin in-human trials is a critical step forward for our clinical program.”

DiscGenics plans to begin enrolling 60 patients in the study before the end of the year.  

Although both BioRestorative and DiscGenics have therapies that look promising, it will be some time – likely years – before either treatment is publicly available. But these studies could be a major step forward in finding an actual cure for back pain, not just another treatment that masks the pain.

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A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor in Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

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.

9 Holistic Approaches to Relieve Joint Pain

By Nicole Noel, Guest Columnist

Whatever your ailment may be, holistic medicine has an answer.

A therapeutic method that dates back to early civilizations, holistic medicine takes into account the mind, body, emotions and spirit -- with the aim of helping patients achieve or restore proper balance in life and prevent or heal a range of conditions, including musculoskeletal pain. Holistic treatments offer a ray of hope for many patients suffering from arthritis, osteoporosis, fibromyalgia and other conditions that cause joint pain.

Not all alternative medicine is created equal, and some natural healing methods will produce better and quicker results. If you want to treat arthritis and other joint aches with holistic treatments, here are a few natural pain relievers you can try.

1. Tai Chi

A low-impact activity that can increase range of motion and strengthen joints and surrounding muscle tissue, tai chi is an ancient physical and spiritual practice that can help arthritis patients soldier through their pain.

According to a 2013 study, tai chi can relieve pain, stiffness, and other side-effects of osteoarthritis. In addition to pain relief, tai chi can help improve range of motion and alleviate joint pain for people living with fibromyalgia and rheumatoid arthritis.

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2. Yoga

Another ancient technique which promotes natural healing, yoga is perfect for individuals suffering from lower back and joint pain. Gentle stretches and poses opening the joints can help prevent and alleviate chronic soreness in the shoulders, hips, and knees.

A form of yoga called mudras utilizes a series of hand gestures to increase energy, and improve mood and concentration.

3. Massage

An invigorating massage with warm essential oil can help many conditions, and joint pain is one of them.

By enhancing blood flow, relaxing the muscle tissue and soothing inflammation, a well-timed massage can ease joint stiffness and increase range of motion in individuals suffering from arthritis, fibromyalgia, and osteoporosis.

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4. Acupuncture

A 2013 review of medical studies has shown that acupuncture can help relieve musculoskeletal pain caused by fibromyalgia. By activating the body’s natural pain relief system and stimulating the nerves, muscles and connective tissue, acupuncture can relieve joint aches for people who are resistant to other holistic pain relief techniques.

A 2010 study found that acupuncture can also be a beneficial for peripheral joint osteoarthritis.

5. Diet Changes

An apple a day may or may not keep the doctor away, but a custom-tailored diet can help you with joint pain. Nutritional tweaks can begin with increased intake of chondroitin sulfate, glucosamine, and Omega 3 fatty acids, which can reduce joint pain in arthritis and osteoporosis patients.

To ease joint problems, your pantry should be stocked with foods that promote healing and reduce inflammation, such as onions, carrots, and flaxseed. Herbs and spices such as turmeric (curcumin) and cayenne pepper can also help with pain relief.

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6. Aromatherapy

If you think pain relief can’t smell good, you’re mistaken. Studies have shown that peppermint and eucalyptus oil can reduce swelling, pain and discomfort in patients with inflamed joints. For joint soreness and stiffness caused by arthritis, aromatherapy experts recommend regular application of myrrh, turmeric, orange, or frankincense oil to ease inflammation and pain, and to increase range of motion.

You can also combine aromatherapy with heat and cold treatments.  Be sure to keep the tender joints elevated during treatment to reduce swelling.

7. Spa Treatments

Few things can beat the appeal of a full-scale spa experience. If you’re suffering from knee, hip, shoulder or elbow pain and other holistic methods haven’t helped, try balneotherapy, which combines aqua massage with deep soaks in heated mineral water and medicinal mud baths.

One study found that balneotherapy significantly reduced knee and back pain in older adults.

8. Aquatic Sports

If you don’t want to immerse yourself in mud, you can supplement your holistic pain therapy with water aerobics, swimming, aqua jogging or aqua spinning. According to a 2014 study, water exercises can ease pain and improve joint function for osteoarthritis patients.

Additionally, a 2015 study found that aquatic circuit training can help relieve knee pain in cases of progressed osteoarthritis.

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9. Capsaicin cream

Another natural treatment for joint pain and stiffness is homemade capsaicin cream, which can help reduce swelling and increase range of motion. To stay on the safe side, you should be careful when handling hot peppers when preparing the cream, and avoid using it on sensitive and damaged skin.

As our bodies age, joint pain can become a chronic. If you don’t want to take your chances with conventional pharmaceuticals, you can always turn to holistic medicine for answers and help. When musculoskeletal pain hits home, one or more of these holistic treatments can help.

Nicole Noel is a lifestyle blogger who is passionate about yoga and healthy living. She enjoys sharing her experiences and ideas on how to lead a happy and healthy life. If you want to read more from Nicole, you can find her on Twitter and Facebook.

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.

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5 Things to Know About Epidural Steroid Injections

By Margaret Aranda, MD, Columnist

Some patients with neck and back pain report that their doctor requires them to get epidural steroid injections (ESI's) before they are prescribed opioid pain medication. Many do not realize that the procedure or any use of drugs for spinal injection is not FDA approved and is considered "off label."

Some patients benefit from ESI’s, while others gain no pain relief or suffer serious complications. In 2014, the FDA warned that injection of corticosteroids into the epidural space of the spine may result in rare but serious neurological events, including "loss of vision, stroke, paralysis, and death."  

A 2015 commentary by FDA scientists in The New England Journal of Medicine urged doctors to carefully select patients to identify those who might benefit from spinal injections and to minimize serious risks.

Probably the worst epidural steroid catastrophe was the 2012-13 outbreak of fungal meningitis, caused by contaminated steroids produced at the New England Compounding Center. As many as 13,000 patients nationwide were exposed to the fungus, mostly through epidural injection, resulting in 751 meningitis infections and at least 64 deaths.

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Let's take a step back to assess why epidural steroids may or may not be a good idea. The rationale behind the procedure comes from the anti-inflammatory effect of steroids on the nerves.

Chronic inflammation in nerves can lead to pain, numbness, and muscle weakness. Nerve injury causes microscopic changes in nerve anatomy, including tissue swelling or edema, an increase in fibrous tissue and, in the worst case, nerve death through something called Wallerian degeneration. In cases like traumatic brain injury or stroke, the nerve damage can be permanent.

There are now about 9 million epidural steroid injections performed annually in the U.S and the number of procedures appears to be growing.

During a standard epidural injection, the doctor may inject into the epidural space a contrast dye using x-ray guidance (fluoroscopy) to make sure the dye is going into the correct location.  Others may use a more blind approach, called the "loss of resistance" technique, with a syringe of air that injects itself into the epidural space as it enters. There is a "pop" when the needle penetrates the epidural space.

After the air or dye is injected and the needle located, a second syringe containing  the steroid is injected. Afterward, the patient is observed for signs of pain relief and complications.

Many studies show that about 50% of patients feel better. If there is no pain relief after one ESI, a second attempt is usually in order. If partial relief is exhibited, a series of three injections in two weeks may be performed.

There is controversy over the rate and frequency of epidurals for pain. Typically, a “cycle” of epidurals is done, but if there is no pain relief after two injections, some doctors recommend that a different treatment be used. Some patients report getting as many as two or three dozen epidurals in a single year.  Critics say that raises the risk of a misplaced needle causing “cumulative trauma” and serious complications such as adhesive arachnoiditis.

If you doctor recommends that you get an epidural steroid injection, here are five things you need to know:

1. Drugs Used: The two most common drugs for ESI are a local anesthetic (lidocaine or bupivacaine) and/or a corticosteroid (betamethasone, dexamethasone, hydrocortisone, methyl-prednisolone, triamcinolone). 

The local anesthetic offers immediate numbing and pain relief. It also verifies whether the injection was done in the right place and gives an idea of how the steroid may act to decrease inflammation. After the anesthetic wears off, the steroid kicks in for an effect that may last varying times, sometimes for a short period and sometimes forever.

Patients and doctors need to know whether there was immediate pain relief from the local anesthetic. The doctor should ask, "Does the pain feel better?" to assess the temporary anesthetic effect.

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If the answer is yes, then the steroid should provide more pain relief. If the answer is no, the steroid is much less likely to have any clinical effect. There is no indication to repeat the procedure if there is no decrease in pain. Doing so would unnecessarily expose a patient to serious complications or death.

2. Injection Sites: The most common injections are into the neck (cervical) and into the lower back (lumbar). Less commonly, epidural injections are placed into the upper back (thoracic) or to the bottom tip of the spine in the sacral area (caudal). The needle can go either straight into the middle of the spine (interlaminar), or enter from the left or right side (transforaminal). 

In general, the closer the injection is placed to the head, the greater the risk of serious complications if the needle accidentally hits a nerve or artery, an air bubble causes an embolism, or if the injection goes into the spinal fluid.

3. Minor complications: Adverse events can occur within minutes or up to 48 hours after an injection. Minor complications are generally not life-threatening and usually go away with little to no treatment.

Some patients get an "epidural headache" when the needle is inserted too far into the dura, causing a leak of cerebrospinal fluid. This is a stressful and painful headache, but it usually completely resolves. Other minor complications include facial flushing, fainting, hypertension (high blood pressure) and increased pain.

4. Serious complications: No one really knows the complication rate of epidural steroid injections, due to under-reporting by doctors and the lack of standard guidelines.

Normally, the steroid will flow into the epidural space above and below where it was injected, but it can also flow into unintended places like the subdural or intrathecal spaces, cranial nerves, brain stem, and lower midbrain.

For example, if the injection accidentally goes into the spinal fluid, the procedure becomes a spinal block, not an epidural block. This may lead to potentially life-threatening complications. If this happens during an injection to the neck, it can spread upward, toward the top of the head and into the brain, leading to serious complications. 

Severe complications from an injection can include arachnoiditis, allergic reactions, stroke, brain edema, cauda equina syndrome, seizures, vasculitis, blindness, and death.

5. Off-Label Use: The FDA places epidural steroids in the category of "off-label" use that falls within the practice of medicine and is not FDA-approved. The FDA requires all glucocorticoid steroid warning labels to state:

The safety and effectiveness of epidural administration of corticosteroids have not been established and corticosteroids are not approved for this use… serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids.”

The FDA website also warns patients to seek emergency medical attention if they experience any unusual symptoms, such as loss of vision or vision changes, tingling in the arms or legs, sudden weakness or numbness, dizziness, severe headache or seizures.

If you have concerns regarding the use of epidural steroid injections, talk to your doctor.

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Dr. Margaret Aranda is a Stanford and Keck USC alumni in anesthesiology and critical care. She has dysautonomia and postural orthostatic tachycardia syndrome (POTS) after a car accident left her with traumatic brain injuries that changed her path in life to patient advocacy.

Margaret is a board member of the Invisible Disabilities Association. She has authored six books, the most recent is The Rebel Patient: Fight for Your Diagnosis. You can follow Margaret’s expert social media advice on Twitter, Google +, Blogspot, Wordpress. and LinkedIn.

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 Approves Advanced Spinal Cord Stimulator

By Pat Anson, Editor

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

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

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

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

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

MEDTRONIC PHOTO

MEDTRONIC PHOTO

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

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

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

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

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

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

Chronic Pain Patient: ‘They Are Killing Us Off’

By Pat Anson, Editor

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

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

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

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

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

ROB HALE

ROB HALE

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

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

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

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

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

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

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

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

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

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

Spouse Criticism Makes Back Pain Worse

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

Lyrica and Neurontin Face More Scrutiny

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

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

FDA Seeks Public Comment on Abuse of Lyrica

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

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

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

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

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

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

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

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

Pfizer did not respond to a request for comment.

Study Finds Rain Not Linked to Joint Pain

By Pat Anson, Editor

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

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

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

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

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

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

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

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

What do the findings mean?

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

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

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

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

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

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

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

Smart Underwear May Prevent Back Pain

By Pat Anson, Editor

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

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

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

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

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

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

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

VANDERBILT UNIVERSITY

VANDERBILT UNIVERSITY

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

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

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

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

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

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

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

Insurance Claims Climb for Lyme Disease

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

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

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

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

lyme disease rash

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

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

Do Depression and Back Pain Lead to More Opioids?

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

FDA Gives Fast Track Designation to New Pain Med

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

Can Vitamin D and Good Sleep Reduce Pain?

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

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