‘Chili Pepper’ Patch Works Better Than Lyrica

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

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

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

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

Are Opioids or Economics Killing White Americans?

By Pat Anson, Editor

Opinions are all over the map about a recent study by two Princeton University researchers, who estimate that nearly half a million white Americans died in the last 15 years due to a quiet epidemic of pain, suicide, alcohol abuse and opioid overdoses.

The husband and wife research team of Angus Deaton and Anne Case were careful not to point a finger at any one cause, but speculated that financial stress caused by unemployment and stagnant incomes may be behind the rising mortality of middle-aged whites. The deaths were concentrated in baby boomers with a high school education or less.

But some were quick to blame the “opioid epidemic.”

“An opioid overdose epidemic is at the heart of this rise in white middle-age mortality,” wrote psychiatrist Richard Friedman, MD, in an editorial that appeared in the New York Times under the headline “How Doctors Helped Drive the Addiction Crisis.”

“Driving this opioid epidemic, in large part, is a disturbing change in the attitude within the medical profession about the use of these drugs to treat pain,” said Friedman. “It is physicians who, in large part, unleashed the current opioid epidemic with their promiscuous use of these drugs; we have a large responsibility to end it.”

And what should doctors do to end the epidemic?

bigstock-Health-Care-United-States-Flag-1719607.jpg

Friedman said there was “strong evidence” that Motrin, Tylenol and other nonsteroidal anti-inflammatory drugs (NSAIDS) were “safer and more effective for many painful conditions than opioid painkillers.”

The Fresno Bee took a more nuanced view of what it called “the epidemic of pain and heartbreak.”

“If ever a set of numbers cried out for deeper examination, it is this one. Human frailty may be epidemic, but surely it is also no surprise that a generation raised with the expectation of a secure future might sink into depression, hostility, illness, anguish and rage when that future fails to transpire,” The Bee said in an editorial. “Whether the solution is better jobs, cheaper schools, more mental health care or less reliance on painkillers, the distress of America’s white working class has become a public health crisis.”

“White Americans who used to be able to support a family are now struggling even in dual income households, and there's a corresponding loss in stature and self-esteem. They are turning to prescription opioids in greater numbers than minorities,” said the Baltimore Sun. “The transition to a 21st (century) economy is literally killing some people, and the United States can ill afford to ignore this disturbing development.”

Overseas news outlets also tended to blame the rising death rate on a “ruthless economy.”

“These people are dying because history has unexpectedly thrown them on the scrapheap,” said The Guardian. “White baby boomers had high expectations of the future, yet many of them have lived to discover that they will be worse off than their parents.”

“(The) findings should awaken Americans to the price we pay for pursuing economic policies that enrich the few at the expense of the many,” said David Cay Johnston in a column for Al Jezeera America. “The harsh reality is that our economy is in many ways stuck in 1998 and that for poorly educated Americans, the economy has become a living nightmare with no expectation of a brighter tomorrow. The rise in drug and alcohol poisonings as well as the rising tide of suicides should not surprise. But these trends should disturb.”

What do you think? Is the economy to blame for the increasing number of deaths? Or is it opioids?

Power of Pain: NERVEmber

By Barby Ingle, Columnist  

In a few short days Nerve Pain Awareness month begins – a global movement known in the pain community as NERVEmber.

I began the NERVEmber project in 2009 as a way to bring more attention to chronic nerve pain conditions such as Reflex Sympathetic Dystrophy (RSD/CRPS) and diabetic neuropathy. The term NERVEmber is derived from the burning pain people with neuropathy feel, combined with the month of November. 

The Power of Pain Foundation hosts the official NERVEmber project events each year. Since its inception, tens of thousands of nerve pain patients and organizations have signed on to help promote NERVEmber and bring awareness to the 150 plus conditions that have nerve pain as a symptom.  

The color orange is the international color for chronic pain awareness, which also fits right in with the fall colors we typically see.

Our largest spotlight throughout the month shines on RSD, which is one of the most painful conditions known to mankind. Yet, like many chronic pain conditions, RSD is misunderstood, mistreated and often misdiagnosed. 

Each day during the month of NERVEmber the Power of Pain Foundation will present an awareness task that we can all participate in. This year we are also giving away over $1,000 in prizes -- available to anyone who registers to participate and uses special hashtags on social media, completes daily tasks, and hosts or attends an event. The more you participate in official NERVEmber events, the more chances you have to win!

You can bring more awareness to conditions like RSD, CRPS and diabetes by posting every day in NERVEmber using social media tags on your posts such as @powerofpain and #PaintTheWorldOrange. Using these tags will earn participants chances to win some great prizes.

The Power of Pain Foundation and the #NERVEmber project is also supporting the #CRPSdayofaction, #RSDdayofaction, @theproject3x5’s, #OrangeInitiative,  #ColorTheWorldOrange, and #ColourTheWorldOrange. 

Official events include tasks shared on social media, wearing t-shirts, Paint the World Orange, and educational series.

The daily calendar of events are available here on the NERVEmber webpage.

One of our newest additions to the project is #painPOP. We are asking people to get involved by popping a balloon and challenging others to do the same or make a donation to help the Power of Pain Foundation continue our education, awareness and access to care programs.

We are asking participants to text, post or say something similar to, “I have the NERVE to be HEARD!"

We will also be posting educational videos on YouTube and our website. Watching videos and commenting on them gives participants more ways to win great prizes. For #PaintTheWorldOrange, we ask participants to post their #NERVEmber pictures on social media and to share your pics as you #PaintTheWorldOrange. Be sure to hashtag it #NERVEmber #PaintTheWorldOrange to increase awareness and your chances to win POP prizes.

Participants are also invited to create graphics of their own using #NERVEmber and #PaintTheWorldOrange. Don’t forget to WEAR ORANGE all month long! You can upload your orange photos to help us paint the world.

Tens of thousands have participated in past years from around the world and we are expecting even more this year. Don’t miss out on being part of a movement to make a difference.

For more information on NERVEmber visit http://powerofpain.org/nervember

Barby Ingle suffers from Reflex Sympathetic Dystrophy (RSD) and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the Power of Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website.

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.

Sunlight May Delay Onset of Multiple Sclerosis

By Pat Anson, Editor

Exposure to sunlight may elevate your risk of sunburn, skin cancer and other health problems, but it appears to have a beneficial effect in delaying the onset of multiple sclerosis (MS).

Danish researchers found that MS patients who spent time in the sun every day during the summer as teenagers developed the disease later in life than those who spent their summers indoors. Their study, which was published in the online issue of Neurology, also found that people who were overweight at age 20 developed MS earlier.

"The factors that lead to developing MS are complex and we are still working to understand them all, but several studies have shown that vitamin D and sun exposure may have a protective effect on developing the disease," said study author Julie Hejgaard Laursen, MD, of Copenhagen University Hospital in Denmark. "This study suggests that sun exposure during the teenage years may even affect the age at onset of the disease."

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

Ultraviolet rays (UVB) in sunlight are a principal source of Vitamin D, which has a wide range of positive health effects, such as strengthening bones and inhibiting the growth of some cancers.

In the Danish study, over 1,100 people with MS filled out questionnaires and gave blood samples. They were put into two groups based on their sun habits during their teenage years: those who spent time in the sun every day and those who did not. They were also asked about their use of vitamin D supplements during their teenage years and how much fatty fish they ate at age 20.

The people who spent time in the sun every day had an average onset of MS that was nearly two years later than those who did not spend time in the sun. On average, they developed MS at age 33, compared to 31 for those who were not in the sun every day.

"It appears that both UVB rays from sunlight and vitamin D could be associated with a delayed onset of MS," Laursen said. "However, it's possible that other outdoor factors play a role, and these still have to be identified."

Those who were overweight at age 20 developed MS about 1.6 years earlier than those of average weight and 3.1 years earlier than those who were underweight.

Previous studies have shown a relationship between MS and childhood obesity. Obese people are also known to have lower blood levels of vitamin D.

"The relationship between weight and MS might be explained by a vitamin D deficiency, but there's not enough direct evidence to establish this yet," Laursen said.

"A limitation of the study is the risk of recall bias because participants were asked to remember their sun, eating and supplement habits from years before," Laursen said. "In particular, someone with a long history of MS and onset of the disease at an early age, may wrongly recall a poor sun exposure. Additionally, only Danish patients were included into the study, so there should be caution when extending the results to different ethnic groups living in different geographic locations."

New Wearable Devices for Chronic Pain

By Pat Anson, Editor

With opioid pain medications becoming harder to get and many patients looking for safer alternatives with fewer side effects, a growing number of companies are offering wearable “electrotherapy” devices for pain relief.

There’s the Cefaly headband for migraines, ActiPatch for sore muscles, AcuKnee for osteoarthritis, and the Quell nerve stimulator, which is designed to treat a range of chronic pain conditions. All are part of a fast growing $2.8 billion market for wearable medical devices.

“There’s a big problem brewing on the horizon. And that is the pain medications are being removed from the market, slowly but surely,” says Phillip Muccio, President and founder of Axiobionics, which has been making customized electrotherapy devices for 20 years.

“Electrical stimulation has a way of reaching into the body and interacting and coordinating what happens to the body. That’s why it a fascinating area of medicine because not a lot of things will do that, especially non-invasively and non-pharmacologically.”

Most of the new devices use a form of electrical stimulation to block or mask pain signals – a technique developed decades ago known as Transcutaneous Electric Nerve Stimulation (TENS).

Unlike the old TENS units, which are typically used for about 30 minutes, wearable devices are designed to be worn for several hours at a time or even while sleeping.

image courtesy of axiobionics

image courtesy of axiobionics

“TENS is like a short acting opioid. It’s basically only effective when it’s on,” said Shai Gozani, MD, President and CEO of Neurometrix. “If you’re going to deal with chronic pain, you have to have a wearable, chronically usable device, because pain can be two hours a day or it could be 24 hours a day. TENS devices historically haven’t been designed at all for wear-ability or continuous use.”

Neurometrix recently introduced Quell, an electrotherapy device that Gozani compares to a spinal cord stimulator. But instead of being surgically implanted near the spine like a stimulator, Quell is worn externally on the upper calf below the knee.

image courtesy of neurometrix

image courtesy of neurometrix

“We really look at spinal cord stimulation as the model. We’re trying to make that available but in a non-invasive, wearable way -- versus TENS devices which are really intended for local muscle stimulation. We don’t stimulate the muscles, we stimulate the nerve alone,” Gozani told Pain News Network.

“The upper calf has a lot of nerves. It’s comfortable. It’s discrete. So it meets the requirement to have a large segment of nerves to stimulate, but it’s also highly usable from a wear-ability perspective.”

A small study recently conducted by Neurometrix found that over 80% of Quell users had a significant reduction in pain and two-thirds were able to reduce the amount of pain medication they were taking.  Participants in the study had several different types of of chronic pain, including fibromyalgia, sciatica, neuropathy and arthritis.

When it comes to clinical studies, medical device makers have a clear advantage over pharmaceutical companies, which often have to spend years and tens of millions of dollars proving the safety and effectiveness of their drugs before they’re approved by the Food and Drug Administration. Device makers are held to a lower regulatory standard.

“Devices are approved by FDA basically for safety and not necessarily for efficacy. It’s a lot easier to demonstrate that with a device than if you have to demonstrate a new drug. You basically run one study or two and show that nobody got electrocuted by a TENS unit and you’re good to go,” said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management.

Device makers can even get fast track approval from the FDA without any clinical studies -- if they say a new device is substantially equivalent to an older device already on the market.  Quell, for example, was given clearance by the FDA because of its similarity to Sensus, another Neurometrix device that's worn below the knee for pain relief.

A significant disadvantage for device makers is that most are not covered by public or private health insurers – meaning patients have to pay for them out of pocket. Three years ago, Medicare stopped covering TENS for low back pain, saying the technology was “not reasonable and necessary.”

The lack of reimbursement also makes many doctors unwilling to prescribe wearable devices and unfamiliar with the technology behind them, which stifles innovation.  For that reason, Neurometrix took an unconventional path and made Quell available without a prescription – bypassing insurers and doctors so it could market directly to consumers for $249 a unit.

“We thought it was imperative to get it over the counter. We wanted to make sure it was accessible to patients," said Gozani. "Wear-ability changes everything. Wear-ability is the game changer in terms of optimizing pain relief. I think it's huge."

Smoking Accelerates Multiple Sclerosis

By Pat Anson, Editor

Smoking is never a good idea for anyone – especially people in chronic pain -- but according to a new study it is particularly bad for multiple sclerosis patients, both before and after diagnosis.

Cigarette smoking is already a known risk factor for developing multiple sclerosis (MS), but in a first of its kind study published in JAMA Neurology, Swedish researchers found that continuing to smoke after diagnosis significantly accelerates progression of the disease.

MS is a chronic and incurable disease which attacks the body’s central nervous system, causing numbness in the limbs, difficulty walking, paralysis, loss of vision, fatigue and pain. Symptoms begin with a series of irregular relapses, and after about 20 years MS worsens into a secondary progressive (SP) stage of the disease.

In a study of over 700 MS patients who continued to smoke after their diagnosis, researchers found that each additional year of smoking accelerated the time to SP conversion by 4.7 percent.  

Looking at it another way, the study found that patients who continued to smoke converted to SP faster (at an average age of 48) than those who quit smoking (at age 56).

“This study demonstrates that smoking after MS diagnosis has a negative impact on the progression of the disease, whereas reduced smoking may improve patient quality of life, with more years before the development of SP disease,” said lead author Jan Hillert, MD, Department of Clinical Neuroscience, Karolinska University Hospital Solna in Stockholm.

“Evidence clearly supports advising patients with MS who smoke to quit. Health care services for patients with MS should be organized to support such a lifestyle change.”

Getting MS patients to quit is important not only for patients, but for society as a whole because of the high cost of treating MS. Disease modifying drugs such as fingolimod and natalizumab, cost about $30,000 per year and are not always effective.

“This study adds to the important research demonstrating that smoking is an important modifiable risk factor in MS. Most importantly, it provides the first evidence, to our knowledge, that quitting smoking appears to delay onset of secondary progressive MS and provide protective benefit,”  said Myla Goldman, MD, of the University of Virginia, and Olaf Stüve, MD, of the University of Texas Southwestern Medical Center in an accompanying editorial in JAMA Neurology.

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.

Quell Device Relieves Variety of Pain Conditions

By Pat Anson, Editor

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

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

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

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

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

image courtesy of neurometrix

image courtesy of neurometrix

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

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

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

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

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

Wear, Tear & Care: The Quell Pain Relief Device

By Jennifer Kain Kilgore, Columnist

When presented with the Quell pain relief device, people make one of two assumptions about me: 1.) I injured my knee, or 2.) I am a paroled felon wearing a very forgiving Velcro GPS.

As I said in my recent guest column, I have made it my mission to test as many pain relief products and therapies as possible. Some of them might be familiar to you; others will be of the “new and bizarre” variety. Whatever they are, I will be your Friendly Neighborhood Guinea Pig and review them for your convenience. I only draw the line at “Made for TV” products that are out to swindle the desperate consumer.

Pain patients are certainly desperate. We have a constant refrain humming through our bodies that plays a different tune for each person. Doctors are the musicians taught to hear those tunes -- but how can they possibly learn all the music? How can they hear your specific song and have the knowledge necessary to fix it?

The problem is that sometimes they cannot. They are deaf to your pain, just like that one whale who sings higher than every other whale -- none of them can hear her.

Thus far, doctors have been unable to hear the song that thrills along my nerve endings. This leaves me with no choice but to fend for myself. I could take the route at which they have hinted: find some street drugs and wait for the undertow to take me (not that this is the problem the media makes it out to be). Or I could travel a different road and at the same time realize that this life of mine includes pain. If I can’t get rid of it, I can at least muffle it.

image courtesy of neurometrix

image courtesy of neurometrix

As I said recently in my blog -- Wear, Tear, & Care -- I have been trying the Quell pain relief device, which is made in the great state of Massachusetts (i.e., my backyard). I have been using it every day for more than a month. Here are my findings:

  • It absolutely works. I have been wearing it for 35 days. I assume there was some psychosomatic effect at first because I was so excited to try the device after months of hype. Once the initial thrill wore off, I was left with the knowledge that, yes, I have reduced my number of Motrin from 16 a day to four, give or take. I am still on Cymbalta and Lyrica for pain control and situational depression, though I can now contemplate reducing the Lyrica entirely. Before, that was not even a possibility.
  • Wearing any kind of medical device during the summer is difficult. I can make the Stride of Pride and show if off with a skirt or shorts; otherwise I have to find pants under which the device can comfortably fit. This means that a good portion of my wardrobe (leggings, skinny jeans, etc.) is not compatible with the Quell. This is a minor concern.
  • The Quell is $249.00. Replacement electrodes cost $30 and last for two weeks. I have worn mine for longer than that because A.) I can, and B.) I’m cheap. The electrodes break down quickly, but as a whole they are more durable than traditional electrodes and do not irritate my skin. With the EMPI device, the electrodes left blisters on my back.
  • The iPhone app is quite lovely. It has a countdown clock so you can see how long the therapy has lasted or how far away it is. I have become adept at the internal calculation of 60 minutes on, 60 minutes off.
  • Unlike other TENS devices I have tried, the stimulation is not distracting, so wearing it at the office is fine.

This is all well and good. But how does the Quell work?

According to their research paper presented to the FDA, the Quell works not unlike other devices that latch onto a dense cluster of nerves in the upper calf. Generally it is best for lower-body pain (sciatica and the like), diabetic neuropathy, and fibromyalgia. I myself have fibromyalgia-ish symptoms, since my pain radiates all over my body. However, I apparently do not actually have the inflammation that is fibro’s hallmark. Doctors will only commit to “chronic pain syndrome.” Since the device works for me, I can say confidently that it treats more than those three conditions.

The Quell is twice as strong as conventional TENS units, does not irritate the skin like traditional electrodes, is less conspicuous, has a mobile app, and can be worn at night. (They say it can be worn at night; I personally found the stimulation too distracting.) It activates endogenous opioids in the body (natural opioids, to say it in English), a different system than the one on which prescription opiates work.

It is, simply put, a wearable intensive nerve stimulator that follows the Pain Gate Theory: The impulses generated by the Quell block pain signals from reaching the brain. As it was cleared to be sold over-the-counter, it is currently not covered by insurance.

I know you pain patients out there loathe the numbers system (What is your pain on a scale of 1 to 10?). I also despise it; this is the only one that has come close to working for me. That’s why I have created a new system. Instead of assigning an arbitrary number to my pain, I am going to tell you what I can do now that I couldn’t do before.

1. I can cut down my daily over-the-counter medication.

2. I can walk for longer periods of time (36 days ago I could walk about 10 minutes before starting to limp; now I can make it almost 30 minutes).

3. I can sit for longer periods of time during the work day (prior to the Quell I’d last 10 minutes before having to get up and move around; now I can make it to 30 before movement becomes necessary).

4. I can focus better on immediate tasks.

5. I have more energy during the daytime, which makes me more social. I have been hanging out with friends more. However, I still practice the chronic pain version of sundowning in the evenings (i.e., I crash).

6. I have been able to resume my almost-daily yoga practice. I even did a 55-minute video the other day (which was   Aroga Yoga’s yoga class for those with chronic illness).

7. I have been able to resume my aqua aerobics practice two to three times per week.

8. I wear my emergency back brace less frequently.

9. I have fewer flares.

FINAL DIAGNOSIS: The Quell device has worked brilliantly for me. While it doesn’t get rid of all the pain I feel, it dampens enough of it so that I can more fully live my life. I hope that it can bring others as much relief.

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

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

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

Pain Maps: Raising Awareness About CRPS

By Jessica Mendes, Guest Columnist

There is no shortage of books, articles, research projects and other initiatives dedicated to raising awareness or finding treatments for chronic pain. And rightly so. According to the American Academy of Pain Medicine, a recent market research report indicated more than 1.5 billion people worldwide suffer from it.

What we are sorely lacking in is education about pain, and how “patient as agent” is critical to avoiding a lifetime of disability. By this I mean public discourse to promote initiative and understanding on the part of the person afflicted with pain; including their participation and engagement in their own healing process.

This is an assertion I am fully qualified to make. A year ago I stubbed my toe; now, I am fighting for my ability to walk. I have Complex Regional Pain Syndrome (CRPS), and if this condition was better understood, especially among health practitioners, I wouldn’t be where I am today.

Luckily, I am not lacking initiative. It didn’t take me long to realize that mainstream medicine had nothing to offer me, so I committed myself to research. The sheer complexity of CRPS and its highly individual nature makes it very difficult to define, let alone treat. But the frequency with which I am asked about it continues to remind me how poor awareness is of this troubling condition. I feel a responsibility to share my take on CRPS in the hopes of shining more light in it.

CRPS – also known as Reflex Sympathetic Dystrophy (RSD) – is a disorder of the nervous system characterized by severe, unrelenting nerve pain. Its origins are in the brain’s maps or “pain maps.” The extent and nature of this dysfunction varies from person to person. In essence, CRPS causes a distortion or enlargement of these maps.

Brain maps responsible for pain also regulate other bodily functions such as temperature, pressure, vibration, sensation of movement and sympathetic control. Given that the nature of plasticity is competitive, if a map is taken over or “pirated” by pain, its other duties also suffer. This is a simplified interpretation of what I have learned.

As you can imagine, there is no exact science to how this manifests, so this is where individual symptomatology comes in. The way I see it, “hard" neuroscience defines a set group of symptoms and assigns them to a box called CRPS; but this disorder actually falls within the realm of “soft” neuroscience. It’s not western-medicine friendly.

Self-education and a multi-pronged approach are central to healing from CRPS. And that means understanding how your nervous system has gone off the rails, because it’s not going to be the same for everyone.

In my case, I have dysfunction in the sensory neurons that process temperature, pressure and vibration, but how I experience that changes from day to day. My lower leg often cannot tolerate the light breeze of a fan, the touch of cotton fabric or the pressure of a pillow beneath it, so nights are long as I struggle to find sleep. The vibration of a car’s motor, on a bad day, can immobilize me for a week. When I shower, I have to ensure the temperature of the water is precisely what my foot will allow. Slightly warm will inflame it, whereas cool will set off a firestorm of pain. Sometimes cool water feels warm and vice versa.

The nerve cells that process my sensation of movement aren’t working properly either. I cannot do yoga, and walking has to be rationed to gradually increase tolerance. Today, I may take the garbage out; tomorrow I might walk one block. I used to be able to do gentle swimming; now I do ankle rolls in bath water. The trick is to calm and balance your nervous system so that you can gradually “desensitize” and tolerate what is normally healthy, like movement and exercise. Reducing stress is paramount.

Many of the websites, articles or advocacy groups I have come across on CRPS parade images of fire or brain circuitry peppered with ominous red blotches. I get it. On an average day my foot feels ablaze or like it wants to explode. I might feel as if the skin is ripped off the sole or that I am walking on broken glass.

These sensations are real and part of the pathology for all who suffer from CRPS. The problem is that thinking about, focusing on, or agonizing over these sensations strengthens the connections in the brain that are feeding them, further enlarging the pain maps. And these images don’t help.

Another focus for a lot of these groups is the espousal of the mantra “there is no cure” in an effort to raise awareness and galvanize health practitioners to take action. But how do we define cure? Conventionally, this often refers to pharmacology in some form or another, if not surgical interventions. In this sense there truly is no cure. But if you spend any amount of time researching how CRPS develops, you realize how utterly impossible it is to find a one-size-fits-all solution.

And the term “cure,” as it is most commonly used, applies to a fix-it model that doesn’t really demand much from the patient. Not only does that framework lock us in as victims, it is pernicious for CRPS.

For these reasons I avoid the term “cure” and instead use “healing”, “treatment”, “regression” or “reversal”. All of these things are within reach for those with CRPS/RSD, the means of which can be found on a website I created called Pain Maps. But they demand our active participation in the healing process, and a deep-seated belief that a life without pain is possible.

Jessica Mendes is the founder of Pain Maps, an online resource center dedicated to neuroplastic approaches to healing pain and neurological dysfunction. It offers material, sources and ideas that enable non-invasive, drug-free options to reducing nerve pain while exploring new dimensions in the narrative of neuroscience.

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.

‘Amazing’ New Stem Cell Treatment for Neuropathy

By Pat Anson, Editor

Researchers at Duke University say an experimental stem cell therapy being tested on animals shows great potential to provide long-lasting pain relief for people suffering from diabetic neuropathy or other types of nerve damage.

In a study published in the Journal of Clinical Investigation, researchers said mice injected with a type of stem cell known as bone marrow stromal cells (BMSCs) were much less sensitive to nerve pain.

"This analgesic effect was amazing," said Ru-Rong Ji, PhD, a professor of anesthesiology and neurobiology in the Duke School of Medicine. "Normally, if you give an analgesic, you see pain relief for a few hours, at most a few days. But with bone marrow stem cells, after a single injection we saw pain relief over four to five weeks."

BMSCs are known to produce an array of healing factors and can be coaxed into forming other types of cells in the body. They are already being used to treat people with serious burns, inflammatory bowel disease, heart damage and stroke.  

"Based on these new results, we have the know-how and we can further engineer and improve the cells to maximize their beneficial effects," said Ji.

Researchers injected the mice with stem cells through a lumbar puncture, infusing them into the fluid that bathes the spinal cord.

The picture on the right shows how the injected stem cells (in red) migrated to the site of the nerve injury and were still present four weeks after treatment.

A molecule emitted from the injured nerve cells -- which has previously been linked to neuropathic pain – is believed to act as a “homing signal” and attract the stem cells.

Researchers measured levels of anti-inflammatory molecules in the mice and found that one in particular, TGF-β1, was present in higher amounts in the spinal fluid of the stem cell-treated animals.

TGF-β1 is a protein that is secreted by immune cells and is common throughout the body. Research has shown that people with chronic pain have too little TGF-β1.

courtesy duke university

courtesy duke university

Injecting TGF-β1 directly into spinal cord fluid provides pain relief, but only for a few hours, according to Ji. By contrast, bone marrow stromal cells stay on site for as much as three months after the infusion.

Ji’s research team is working to identify stem cells that produce more TGF-β1, as well as other types of pain relieving molecules. In addition to diabetic neuropathy, researchers believe stem cell therapy could also be used to treat pain from chemotherapy, surgical amputation, lower back pain and spinal cord injuries.

Nearly 26 million people in the United States have diabetes and about half have some form of neuropathy, according to the American Diabetes Association.  Diabetic peripheral neuropathy causes nerves to send out abnormal signals. Patients feel pain or loss of feeling in their toes, feet, legs, hands and arms. It may also include a persistent burning, tingling or prickling sensation. The condition can lead to injuries, chronic foot ulcers and even amputations.

Another recent animal study by researchers in the U.S. and South Korea found that diabetic rats given intramuscular injections of bone marrow stromal cells experienced both angiogenesis (blood vessel growth) and a restoration of the myelin sheath -- a protective covering over nerve cells damaged by neuropathy.

"Currently, the only treatment options available for DN (diabetic neuropathy) are palliative in nature, or are directed at slowing the progression of the disease by tightly controlling blood sugar levels," said Dr. John Sladek, Jr., Professor of Neurology, Pediatrics, and Neuroscience, Department of Neurology at the University of Colorado School of Medicine.

"This study offers new insight into the benefits of cell therapy as a possible treatment option for a disease that significantly diminishes quality of life for diabetic patients.”

The study is being published in the journal Cell Transplantation.

Cymbalta and Lyrica in Legal Battles

By Pat Anson, Editor

The makers of Cymbalta and Lyrica – two blockbuster drugs widely used to treat fibromyalgia and other chronic pain conditions – face legal battles this summer that could potentially cost the companies billions of dollars.

In London, a court case begins next week on Pfizer’s efforts to keep doctors in the U.K. from prescribing pregabalin – a cheaper generic version of Lyrica.

And in Los Angeles, a federal judge this week ordered Eli Lilly to face claims in lawsuits alleging that the company misled consumers about the side effects of withdrawal from Cymbalta.

Over 5,000 patients have filed suit against Lilly claiming that Cymbalta caused “brain zaps” – electric shocking sensations – as well as nausea, vomiting and insomnia when they stopped taking the drug.  The first two cases will be heard in August.

“The withdrawal symptoms from Cymbalta were hell,” wrote Crystal Lindell, a Pain News Network columnist in a recent article.

“Less than a week after my last pill, I was getting so dizzy that I seriously thought I had a new disease. Then, there was this thing called the brain zaps that I didn’t understand until they happened to me. In short, it literally felt like my brain was being, well, zapped by electricity. There was also nausea and vertigo and just an overall feeling of falling off a skyscraper.” 

Several readers shared their own experiences with Cymbalta.

“My neurologist put me on Cymbalta, I took 2 pills, I thought my head was going to explode,” wrote Judy Dunn.

“I suffered from 6 weeks of vertigo, nausea, dizziness, and MASSIVE headaches,” said Andy, who was prescribed Cymbalta to treat depression. “I will never take Cymbalta again. EVER.”

“While on the drug I did get a better mood and it helped a lot, but it raised my blood pressure and I was shaky and jittery. I also went through the brain ZAPS!!” wrote Candra Clark.

“We believe in our defenses to these claims and we will continue to defend Lilly vigorously,” Scott MacGregor, a Lilly spokesman told Bloomberg Business.

Cymbalta generated annual sales of $5 billion for Lilly until its patent expired in 2013 and cheaper generic versions of Doluxetine became available.

Lyrica Legal Battle

Like Cymbalta, Lyrica wasn’t originally developed to treat pain. It was used as a treatment for anxiety and epilepsy until drug maker Pfizer realized it could also be effective for fibromyalgia and neuropathic pain.

Pfizer’s patent on Lyrica for epilepsy and anxiety expired last year, but its secondary patent for pain is good until July of 2017 – and that is the essence of its legal fight in the U.K.

Rival drug makers started making pregabalin – the generic version of Lyrica – when its original patent expired. But it didn’t take long for doctors to also start prescribing pregabalin for pain.

According to Pharmalot, about 80% of all U.K. patients on pregabalin are using it to treat pain and Pfizer has launched an aggressive campaign to stop that. Last year the company wrote an unusual letter to physician groups in the U.K. warning them that prescribing pregabalin for pain was a violation of its patent.

“Pfizer believes the supply of generic pregabalin for use in the treatment of pain whilst the pain patent remains in force in the U.K. would infringe Pfizer’s patent rights,” the company said in the letter.

The Royal College of Physicians, which represents 29,000 U.K. doctors, responded with a statement of its own.

“Pregabalin is a useful drug for many patients and, given the current financial pressures the NHS (Britain’s National Health Service) is under, it is disappointing that a pharmaceutical company has made a move that will, potentially, prevent some patients from getting access to it,” a spokesman said.

The NHS has since issued guidance to doctors telling them to use the brand name Lyrica when prescribing pregabalin for pain “so far as reasonably possible.” Pfizer is seeking a stronger statement from the British High Court.

Ironically, Pfizer paid $2.3 billion dollars in 2009 to settle criminal and civil charges in the U.S. for the “off-label” marketing of Lyrica and other medications – the very sort of off-label use it is trying to stop in the U.K.

Lyrica remains one of Pfizer’s top selling drugs, generating $5.1 billion in revenue in 2014.  

New Drugs Could Relieve Neuropathy Pain

By Pat Anson, Editor

After more than a decade of study, researchers at Boston Children’s Hospital are close to developing a new class of non-narcotic drugs that relieve chronic nerve pain by targeting a protein that enhances pain and inflammation.

Their findings, reported in the journal Neuron, could lead to new treatments for diabetic peripheral neuropathy, post-herpetic neuralgia, and inflammatory diseases like rheumatoid arthritis. Current treatments provide meaningful pain relief in only about 15 percent of patients.

"Most pain medications that have been tested in the past decade have failed in Phase II human trials despite performing well in animal models," notes Clifford Woolf, MD, PhD, director of Boston Children's F.M. Kirby Neurobiology Center and a co-senior investigator on the study. "Here, we used human genetic findings to guide our search from the beginning."

Previous research by Woolf and his colleagues found that people with variants of the gene for GTP cyclohydrolase (GCH1) -- about 2 percent of the population -- are at markedly lower risk for chronic pain. GCH1 is needed to synthesize the protein tetrahydrobiopterin (BH4), and people with GCH1 variants produced less BH4 after a nerve injury. This suggested that BH4 regulates pain sensitivity.

To test their theory, researchers took a "reverse engineering" approach in genetic experiments on mice.  First they showed that mice with severed sensory nerves produce excess BH4, created by the injured nerve cells and by macrophages-- immune cells that infiltrate damaged nerves and inflamed tissue.

Mice that were genetically engineered to make excess BH4 had heightened pain sensitivity even when they were uninjured. Conversely, mice that were genetically unable to produce BH4 had lower pain hypersensitivity after a peripheral nerve injury.

"We then asked, if we could reduce production of BH4 using a drug, could we bring about reduction of pain?" said Alban Latremoliere, PhD, also of Boston Children's Kirby Center, who led the current study.

The answer was yes. The researchers blocked BH4 production using a specifically designed drug that targets sepiapterin reductase (SPR), a key enzyme that makes BH4. The drug reduced the pain hypersensitivity induced by nerve injury and without any detectable side effects.

Because BH4 plays an important role in the brain and blood vessels, the goal of any treatment would be to dial down excessive BH4 production, but not eliminate it entirely. Latremoliere showed that blocking SPR still allowed minimal BH4 production through a separate pathway and reduced pain without causing neural or cardiovascular side effects.

"Our findings suggest that SPR inhibition is a viable approach to reducing clinical pain hypersensitivity," says Woolf. "They also show that human genetics can lead us to novel disease pathways that we can probe mechanistically in animal models, leading us to the most suitable targets for human drug development."

Vegan Diet Reduces Neuropathy Pain

By Pat Anson, Editor

A vegetarian diet coupled with a daily vitamin B12 supplement significantly reduced pain and improved the quality of life of people with diabetic neuropathy, according to the findings of a small study published in Nutrition & Diabetes. Participants also lost an average of 14 pounds.

Nearly 26 million people in the United States have diabetes and about half have some form of neuropathy, according to the American Diabetes Association.  Diabetic peripheral neuropathy causes nerves to send out abnormal signals. Patients feel burning, tingling or prickling sensations in their toes, feet, legs, hands and arms.

Many drugs used to treat neuropathic pain, such as Neurontin and Lyrica, often don’t work or have unpleasant side effects.

Researchers at California State University, East Bay, and the George Washington University School of Medicine put 17 adults on a low-fat vegan diet that focused on vegetables, fruits, grains and legumes. Typical meals included oatmeal with raisins, pasta with marinara sauce, vegetable stir-fry with rice, and lentil stew.

Participants also took a daily vitamin B12 supplement, as did a control group that did not alter its diet.

After 20 weeks, patients on the vegan diet not only had less neuropathic pain, they had lower blood pressure and cholesterol levels and had lost weight.

"A dietary intervention reduces the pain associated with diabetic neuropathy, apparently by improving insulin resistance" said Neal Barnard, MD, president of the Physicians Committee for Responsible Medicine at CSU East Bay.

Researchers also noted there was significant improvement in pain and other symptoms in the control group.  The magnitude of the improvement suggests that the B12 supplement, intended to serve as a placebo, may have had real effects in both groups.

One in three children born in the U.S. in 2000 will develop diabetes at some point in his or her life. The average lifetime cost to treat type 2 diabetes is $85,200, half of which is spent on diabetes complications.

"The dietary intervention is easy to prescribe and easy to follow," says Cameron Wells, a registered dietician and acting director of nutrition education for the Physicians Committee. "Steel-cut oats, leafy greens, and lentils are widely available at most food markets and fit well into most budgets."

My Life with Trigeminal Neuralgia

By Pat Akerberg

Most of us don’t focus on the idea of pain until we find ourselves in it for one reason or another.  We just know that we’re glad when it’s gone. 

But what if it doesn’t go away? 

Challenging conditions occur for some of us that catapult us into a life of chronic, intractable pain.  You know you are one of the unlucky ones when meetings with doctors end with statements like:

“There is nothing we can do.”

“You’ll just have to live with it.”

“It’s all in your head.”

That last statement is the one that literally began my life-altering journey with pain. An outgoing, upbeat owner of a thriving consulting practice, I was on a business trip enjoying dinner with a favorite client six years ago.  My meal started with a typical salad.  By the second bite, I was writhing through volleys of shocking pain shooting through the roots of my teeth on my left side.

PAT AKERBERG

PAT AKERBERG

I later learned that this neurological disorder of the 5th cranial nerve was trigeminal neuralgia -- also known as the “suicide disease” or “worst pain known to mankind.”  I had to cut my trip short and fly home to see my dentist, pronto.  Little did I know then that this event would mark the end my of work life, one of the growing list of ongoing losses for me to grieve.

I was both unfortunate and fortunate during my short search to find a proper diagnosis, one that often takes many months or years to receive.  Unfortunate in that trigeminal neuralgia (TN) is so rare, the cause is unknown, treatments do not offer a permanent cure, and sometimes create more pain issues.  Fortunate in that I escaped the needless root canals or extractions that most are subjected to prior to an accurate diagnosis.

Research became my middle name as I sought to learn everything that I could to get my problem “fixed.” I was driven to get back to my career and serve my clients.  Research collectively pointed to an invasive brain surgery done by a neurosurgeon.  It seemed to have the best odds for a cure, with the least chance of further damage to the nerve. 

Unfortunately, permanent nerve damage is exactly what occurred.  Imagine my concern when I awoke from surgery with my face immovable; frozen like a block of concrete, numb with pulling sensations, and the stabbing pain in my teeth now constant. 

The neurosurgeon who held out a sure cure quickly distanced himself -- perceiving me as “too anxious” about the devastating impairments and pain frequency.  With dispatch and without explanation, my case was closed.    

Left on my own to seek out answers and help, I pursued consultations with several other leading TN experts.  With honesty and compassion, each one delivered the same bad news: medicine and science have not caught up with how to effectively treat a damaged trigeminal nerve.  Advising against further procedures, my lifetime membership into the intractable pain club was validated. 

“Invisible” Pain

Being a co-habitant with an intrusive bully like intractable pain has been all consuming.  Any illusions I had of control have been shattered. 

There’s also an invisible aspect to my pain that can create issues with believability.

Most people are unaware of orphan diseases like trigeminal neuralgia, and have little understanding and compassion towards those who have them. 

Family members, who are turned into caregivers overnight, scramble to figure out how to relate to a frightening pain condition.  Many close friends eventually drift away when you don’t get better, are unable to keep up, or cancel plans too often. And busy medical professionals can skeptically question what they cannot see or touch.  

That’s partly because we are so often judged by how we look versus what we say. If we don’t look sick or in pain, then the erroneous assumption follows that we can’t be that bad.  But we can be! 

When I report that I am unable to chew solid food (eat out), talk, smile, laugh (socialize), move my face or have anything touch it (brush teeth, take walks, exercise) without triggering unbearable facial pain; most people can’t square such an unthinkable loss of natural life functions with how I appear to them.

I agree. It is hard to fathom, yet with neuropathic pain disorders like TN, simple things that normally don’t cause pain now do. Combine those quality of life diminishments and misconceptions with disabling pain and the ingredients for a lonely, isolated existence can’t be denied. 

Often I feel as if I am living in an inescapable bubble, missing out while the rest of the world goes by without me. It takes tremendous fortitude daily for me to counter those negative effects in my life with meaningful ones.  Some days are more successful than others. 

Like most who suffer with chronic pain, the search for any kind of relief becomes a way to keep hope alive.  In the meantime, I do find it helpful to post, blog, and reach out to connect with people like myself whenever I can.  It reminds me that I am not alone in this often debilitating journey.

Pat Akerberg lives in Florida. Pat is a member of the TNA Facial Pain Association and serves as a moderator for their online support forum.

Pat is also a supporter of the Trigeminal Neuralgia Research Foundation.

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.

Two Drug Combo Relieves Neuropathy Pain

By Pat Anson, Editor

British researchers say a combination of two widely used drugs – an antidepressant and an opioid – can significantly relieve pain and other symptoms caused by neuropathy.

In a study published in the journal PAIN, researchers at Queens University say combining the painkiller morphine with the antidepressant nortriptyline relieved chronic neuropathic pain in nearly 90 percent of patients – significantly better than when either drug is used alone.

"Morphine and nortriptyline are excellent candidates for pain management because of the extensive research conducted on them, their low cost, and widespread availability all over the world," said Ian Gilron, MD, a professor in Queen's School of Medicine and anesthesiologist at Kingston General Hospital.

"Current neuropathic pain treatments are ineffective or intolerable for many sufferers so this new evidence supporting the morphine-nortriptyline combination is important news for patients."

Nortriptyline, an antidepressant sold under the brand names Aventyl and Pamelor, is already being used to treat pain in the arms and legs caused by multiple sclerosis. Morphine has long been used to treat both acute and chronic pain.

Neuropathic pain is characterized by tingling or burning sensations that develop as result of nerve damage caused by conditions such as shingles, diabetes, amputation, inflammation, and cancer. About 8% of adults worldwide suffer from neuropathy. Many drugs used to treat neuropathic pain, such as Neurontin and Lyrica, often don’t work or have unpleasant side effects.

In the double-blind, randomized study, 52 neuropathy patients were given a choice of trying every one of three treatments: morphine alone, nortriptyline alone, and a combination of the two drugs over six-week treatment periods. Patients were asked to record their pain levels and side effects during each treatment.

The average daily pain before treatment was 5.6, measured using a rating scale from 0-10. Average daily pain dropped to 2.6 when patients received the two drug combination. Patients taking nortriptyline and morphine alone rated their pain at 3.1 and 3.4, respectively.

Researchers said that common side effects for both drugs, which include constipation and dry mouth, did not worsen with the combined treatment.

"It's important to remember that we don't want to completely eliminate patients' ability to sense pain as it's a warning system for us, but we do want to find the right balance of pain relief and drug side effects," said Gilron

Nortriptyline and morphine are currently not available in a combined formulation. According to the Mayo Clinic, using the two drugs together is usually not recommended because they both cause sedation.