Critics Question Oxygen Therapy for Fibromyalgia

By Pat Anson, Editor

Some experts are challenging the findings of a new clinical study that found that hyperbaric oxygen therapy (HBOT) could be used to treat -- and possibly even cure -- fibromyalgia.

Israeli researchers gave HBOT therapy to dozens of women suffering from fibromyalgia and found there was a significant improvement in their pain and other symptoms. The women were put in pressurized air chambers and breathed pure oxygen for 90 minutes, five times a week for two months.

Researchers say brain scans of the women before and after HBOT proved their theory that additional oxygen alters brain pathology and "repairs" parts of the brain overly sensitized by chronic pain. 

"Brain pathology? This is speculation being presented as established knowledge," said John Quintner, MD, an Australian rheumatologist who maintains that fibromyalgia is not a disease, but a "symptom cluster" that could have many different causes.

tHE INTERIOR OF A HYPERBARIC CHAMBER. COURTESY OF Sagol Center for Hyperbaric Medicine and Research

Fibromyalgia is a poorly understood disorder that is characterized by deep tissue pain, headaches, fatigue, depression and insomnia. The cause is unknown.

"This clinical trial is using a methodology that is predicated upon fibromyalgia being a distinct medical condition," said Quintner, telling Pain News Network that the study proved little, but was "good news for those who manufacture portable HBOT units." 

Researchers at the Sagol Center for Hyperbaric Medicine and Research at the Assaf Harofeh Medical Center and Tel Aviv University were studying the use of HBOT on stroke and concussion patients when they realized that oxygen therapy might also change the neural activity of patients with fibromyalgia.

"Patients who had fibromyalgia in addition to their post-concussion symptoms had complete resolution of the symptoms," said Shai Efrati, MD,  lead author of the study that is published online in PLoS ONE. 

Efrati said some patients will require follow-up sessions of HBOT and some won't need to.

"We have learned, for example, that when fibromyalgia is triggered by traumatic brain injury, we can expect complete resolution without any need for further treatment. However, when the trigger is attributed to other causes, such as fever-related diseases, patients will probably need periodic maintenance therapy."

HBOT puts more oxygen into the bloodstream, which delivers it to the brain. Efrati's earlier studies found that HBOT induces neuroplasticity, which leads to repair of chronically impaired brain functions. Most of the women who participated in the new study had fibromyalgia that the researchers believe was triggered by brain trauma.

DR. SHAI EFRATI

"Symptoms in about 70 percent of the women who took part have to do with the interpretation of pain in their brains," said Eshel Ben-Jacob, a study co-author who is an adjunct professor of biosciences at Rice University. "They're the ones who showed the most improvement with hyperbaric oxygen treatment. We found significant changes in their brain activity.

"Most people have never heard of fibromyalgia. And many who have, including some medical doctors, don't admit that this is a real disorder. I learned from my MD friends that this is not the only case in which disorders that target mainly women raise skepticism in the medical community as to whether they're real or not."

HBOT Claims Called "Crazy" 

One of those skeptics is Fred Wolfe, MD, a prominent fibromyalgia researcher who says the Israeli study lacks proper controls used in most clinical studies -- such as patients being "blinded" to whether they are receiving treatment or a placebo.  

"The fibromyalgia study world is filed with positive studies based on unacceptable controls," said Wolfe. "While I don't know enough about this treatment to be sure, I would tend to think the symptomatic improvement could be based on control and blinding problems. It is possible that the demonstrated effect on the brain of oxygen is separate from the effect of symptoms." 

Wolfe is particularly troubled by a recommendation at the end of the study that fibromyalgia patients should undergo HBOT therapy now, "rather than wait until future studies are completed.”  

"I could only characterize (that) as crazy. Crazy because of the money it would cost and crazy because it posits fibromyalgia as brain disease. FM is not a disease and there is a difference between mechanism and causes. One needs some replication before jumping in," said Wolfe in an email to Pain News Network. 

Many fibromyalgia patients are ready to jump in, based on the comments from readers to our first report about the Israeli study.

"Where do you find studies like this to volunteer? I would so do this," wrote one fibromyalgia sufferer.

"I would so try this. I often feel like I'm not getting enough oxygen," said another.

"Sign me up, please," a woman wrote.

"Is this available in Tucson or Phoenix, Arizona?" asked another woman.

Many fibromyalgia sufferers are desperate for any kind of treatment that would provide relief, much less a cure. In the Israeli study, several patients either drastically reduced or eliminated their use of pain medications.

"The results are of significant importance since, unlike the current treatments offered for fibromyalgia patients, HBOT is not aiming for just symptomatic improvement," said Efrati. "HBOT is aiming for the actual cause -- the brain pathology responsible for the syndrome. It means that brain repair, including even neuronal regeneration, is possible even for chronic, long-lasting pain syndromes, and we can and should aim for that in any future treatment development."

John Quintner is not convinced.

"I have thought long and hard about this issue and have come to the conclusion that we have been dealing with a 'symptom cluster' rather than with a syndrome," he said. "According to my understanding, fibromyalgia is best explained as an  'idiom of human distress' and, as such, is outside the purview of the biomedical model." 

Can Oxygen Therapy Treat Fibromyalgia?

By Pat Anson, Editor

Hyperbaric oxygen therapy – also known as HBOT – has been used for decades to treat infections, severe burns, carbon monoxide poisoning, even scuba divers recovering from decompression sickness.

Patients undergoing HBOT are put in a pressurized room or tube. The higher air pressure allows lungs to gather more oxygen than they would normally – helping the body to heal faster.

Promising new research out of Israel suggests that HBOT can also be used to treat fibromyalgia patients by causing neuroplasticity – a “re-wiring” of the brain that can change neural activity in areas overly sensitized by chronic pain. The study has been published in the journal PLoS ONE.

“This study provides evidence that HBOT can improve quality of life and well-being of many FMS (fibromyalgia) patients. It shows for the first time that HBOT can induce neuroplasticity and significantly rectify brain activity in pain related areas of FMS patients,” wrote lead author Shai Afrati, MD, of the Institute of Hyperbaric Medicine, Assaf Harofeh Medical Center.

file photo of a woman getting hyperbaric oxygen therapy

Fibromyalgia is a poorly understood disorder that is characterized by deep tissue pain, headaches, fatigue, depression and insomnia. The cause is unknown and there is no cure.

Afrati, who has also studied oxygen therapy on stroke and concussion victims, enrolled 60 female fibromyalgia patients in his latest study. For five days each week they were given 90 minutes of HBOT with oxygen enriched air.

“It is plausible that increasing oxygen concentration by HBOT can change the brain metabolism and glial function to rectify the FMS-associated brain abnormal activity. It has already been demonstrated that exposure to hyperbaric oxygen induces significant anti-inflammatory effect in different conditions and pathologies,” said Afrati.

After two months, brain imaging showed the women had significant changes in neural activity, and they reported less pain and fewer tender points. Several said that they had either reduced or stopped taking pain medication.

However, not everyone could handle being placed in a pressurized air chamber. Five women dropped out of the study, complaining of dizziness, claustrophobia and an inability to adjust to the air pressure.

But Afrati is encouraged by the results.  

“Follow-up studies are needed in order to investigate the durability of the HBOT effects on FMS. It might be that some patients will need more HBOT sessions,” he wrote. “Since there is currently no solution for FMS patients, and since HBOT is obviously leading to significant improvement, it seems reasonable to let FMS patients benefit from HBOT, if possible, now rather than wait until future studies are completed.”

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."

Better Sleep Means Less Pain

By Pat Anson, Editor

Getting a good night’s sleep plays a key role in determining how bad your pain levels are doing the day, according to a large new study by researchers in Norway.

The study included more than 10,400 adults from an ongoing Norwegian health study. Each participant underwent a standard test of pain sensitivity -- the cold pressor test -- in which they were asked to keep their hand submerged in a cold water bath for 106 seconds.

Only 32% of participants were able to keep their hand in cold water throughout the experiment. Those who suffered from insomnia were more likely to take their hand out early: 42% did so, compared with 31% of those without insomnia.

Pain sensitivity also increased depending on the frequency of insomnia. Those who had trouble sleeping at least once a week had a 52% lower pain tolerance, while those who reported insomnia once a month had a 24% lower tolerance for pain.

"While there is clearly a strong relationship between pain and sleep, such that insomnia increases both the likelihood and severity of clinical pain. It is not clear exactly why this is the case," wrote lead author Børge Sivertsen, PhD, of the Norwegian Institute of Public Health.

The study, which is published in the journal PAIN,  is the first to link insomnia and impaired sleep to reduced pain tolerance in a large, general population sample. The results suggest that psychological factors may contribute to the relationship between sleep problems and pain, but they do not fully explain it.

“We conclude that impaired sleep significantly increases the risk for reduced pain tolerance. As comorbid sleep problems and pain have been linked to elevated disability, the need to improve sleep among chronic pain patients, and vice versa, should be an important agenda for future research,” the study said.

A previous study in Norway found that women who have trouble sleeping are at greater risk of developing fibromyalgia – although it’s not clear if there’s a cause and effect relationship between the two symptoms.

Another study, recently published in PLoS One, found that insomnia – not surprisingly – made chronic pain patients less likely to exercise. Researchers followed 119 chronic pain patients, most of whom suffered low back pain, and found that quality of sleep was the best predictor of physical activity the next day – not mood or pain intensity.

Weird Mushroom Could Lead to New Painkillers

By Pat Anson, Editor

A creepy looking parasitic mushroom that lives on caterpillars could help British researchers develop a new class of painkillers to treat osteoarthritis and other chronic pain conditions.

Scientists at the University of Nottingham are exploring the painkilling potential of cordycepin, a compound found in cordyceps mushrooms, which have been used in traditional Chinese medicine for thousands of years.

The mushroom acts as a parasite in the larvae of ghost moths – growing inside the caterpillar until it eventually kills it. The stalk-like mushroom then grows out of the caterpillar’s mummified body.

Food pellets containing the compound were given to rats and mice to see if cordycepin could relieve pain from a joint injury. The results, according to researchers, were startling.

"When we first started investigating this compound it was frankly a bit of a long-shot and there was much skepticism from the scientific community," said Dr. Cornelia de Moor. "But we were stunned by the response from the pilot study, which showed that it was as effective as conventional painkillers in rats.

A CORDYCEPS MUSHROOM (LEFT) EMERGES FROM A DEAD CATERPILLAR

"This study is the first step in a potential drug development for a new class of drugs for osteoarthritis, although there are a number of hurdles we have to go through - necessarily so - before it gets nearer patients. To the best of our knowledge, cordycepin has never been tested as a lead compound for osteoarthritis pain."

Native Tibetan healers have used cordyceps mushrooms as a tonic to treat a wide variety of conditions. They claim it improves energy, appetite, stamina, libido, endurance, and sleeping.

Researchers believe cordycepin blocks the inflammatory process that cause pain in osteoarthritis, but does so in a way that is completely different than painkillers like corticosteroids and non-steroidal-anti-inflammatory drugs (NSAIDs) such as ibuprofen.  Still unclear is whether cordycepin acts on the knee joint or on the nerves that send pain signals from the knee to the spinal cord.

Until clinical trials can be held to test the safety and effectiveness of cordycepin – which could take years – de Moor warns against people experimenting with herbal products containing the cordyceps mushroom.

"The lack of quality control means that cordyceps preparations for sale in Europe rarely contain much cordycepin, and may contain other harmful compounds," said de Moor, who is also investigating cordycepin as a possible treatment for cancer.

"Dr de Moor's research is certainly novel, and we believe may hold promise as a future source of pain relief for people with osteoarthritis. There is currently a massive gap in available, effective, side-effect-free painkillers for the millions of people with arthritis who have to live with their pain every day, so new approaches are very much-needed,"  said Dr. Stephen Simpson, director of research at Arthritis Research UK, which is helping to fund de Moor’s research.

Osteoarthritis is a progressive joint disorder caused by painful inflammation of soft tissue, which leads to thinning of cartilage and joint damage in the knees, hips, fingers and spine. The World Health Organization estimates that about 10% of men and 18% of women over age 60 have osteoarthritis.

Physical Therapy Lowers Healthcare Cost of Back Pain

By Pat Anson, Editor

Early physical therapy for low back pain significantly lowers healthcare costs by reducing the use of expensive treatments such as spinal surgery, injections, imaging and painkillers, according to a large new study published in the journal BMC Health Services Research.

About a quarter of Americans report an incidence of low back pain (LBP) within the previous three months and it is one of the most common reasons to visit a physician. Most LBP episodes resolve within 2 to 4 weeks, but about 25% of patients will experience recurring back pain for a year or more. 

Researchers analyzed health care records for over 122,000 patients in the U.S. Military Health System who went to a primary care physician for an initial episode of low back pain and received physical therapy within 90 days. 

Over 17,000 patients in the study received early physical therapy within 14 days – and it was this group that made significantly less use of advanced imaging, spinal injections, spine surgery and opioids than patients who started physical therapy later. 

Health care costs on average were 60% lower (about $1,200) over a two year period for patients who had early physical therapy compared to those who delayed therapy.

"Physical therapy as the starting point of care in your low back pain episode can have significant positive implications," said physical therapy researcher John Childs, PhD. "Receiving physical therapy treatment that adheres to practice guidelines even furthers than benefit."

Medical guidelines recommended for low back pain are to avoid opioids and advanced imaging as a first-line of treatment. However, recent research shows those guidelines are often ignored.

A large new study by pharmacy benefit manager Prime Therapeutics found that about one in five opioid prescriptions were written to treat low back pain.

"Low back pain was the most common diagnosis among all members taking an opioid, even though medical guidelines suggest the risks are likely greater than the benefits for these individuals," said Catherine Starner, PharmD, lead health researcher for Prime Therapeutics.

Another study of older adults with low back pain found that spending thousands of dollars on advanced imaging such as CT scans or MRI’s within six weeks of visiting a primary care doctor was often a waste of money.  

“Early imaging was not associated with better one-year outcomes. The value of early diagnostic imaging in older adults for back pain without radiculopathy is uncertain,” said Jeffrey G. Jarvik, MD, a professor of radiology in the University of Washington School of Public Health, who studies the cost effectiveness of treatments for patients with low back pain.

Combined direct and indirect costs for low back pain in the U.S. are estimated to be between $85 billion and $238 billion a year.

"Given the enormous burden of excessive and unnecessary treatment for patients with low back pain, cost savings from physical therapy at the beginning of care has important implications for single-payer health care systems," said Paul Rockar, President of the American Physical Therapy Association.

Physical Therapy vs. Surgery for Spinal Stenosis

By Pat Anson, Editor

Physical therapy works just as well as surgery in relieving pain and other symptoms of lumbar spinal stenosis in older patients, according to researchers at the University of Pittsburgh.

Their two year-year study, published in the Annals of Internal Medicine, is believed to be the first that compares outcomes between surgery and physical therapy (PT) for spinal stenosis, a condition caused by narrowing of the spinal canal that causes pain, numbness and weakness in the lower back.  Decompression surgery to relieve pressure on spinal nerves has become a fast-growing intervention in today's older population.

"Probably the biggest point to put across to physicians, patients and practitioners is: Patients don't exhaust all of their non-surgical options before they consent to surgery. And physical therapy is one of their non-surgical options," said principal investigator Anthony Delitto, PhD, chair of the Department of Physical Therapy, University of Pittsburgh School of Health and Rehabilitation Sciences.

Delitto, a physical therapist, was puzzled why some patients responded well to physical therapy  and others to surgery.

In his study, 169 patients aged 50 and older with spinal stenosis agreed to be randomly assigned to two groups: Those who would have decompression surgery and those who would have two standardized physical therapy sessions each week for six weeks.

In his study, 169 patients aged 50 and older with spinal stenosis agreed to be randomly assigned to two groups: Those who would have decompression surgery and those who would have two standardized physical therapy sessions each week for six weeks.

After both groups were re-examined at intervals of six months, one year and two years, the patient outcomes appeared to be about equal. There were no detectable differences between the groups in how their pain abated and the degree to which function was restored in their backs, buttocks and legs.

"The idea we had was to really test the two approaches head to head," said Delitto. "Both groups improved, and they improved to the same degree. Now, embedded in that, there are patients who did well in surgery, and patients who failed in surgery. There are patients who did well in PT, and there are patients who failed with PT. But when we looked across the board at all of those groups, their success and failure rates were about the same."

The research project also revealed issues surrounding physical therapy and the cost of co-pay – which apparently discourage some patients from continuing their treatment.

"One of the big things that we know held patients back from PT were co-payments," Dr. Delitto added. "Patients were on Medicare, and a lot of them were on fixed incomes. Some of those co-payments had to come out of pocket at $25, $30, $35 per visit. That adds up, and some of the patients just couldn't afford it."

Most patients didn't finish the PT regimen allowed under Medicare and one-third of the patients failed to complete even half of the regimen. About one in six didn't show for a single treatment, though they had agreed to consider physical therapy.

Counseling and Behavioral Therapy Help Vets in Chronic Pain

By Pat Anson, Editor

An innovative two-step program that combines analgesics with deep breathing, relaxation techniques and counseling significantly reduced pain levels in U.S. military veterans who suffer from chronic pain, according to a new study at a VA Medical Center.

Researchers at the Roudebush VA Medical Center in Indianapolis, the Regenstrief Institute and the Indiana University School of Medicine studied 241 veterans who returned from deployments in Iraq and Afghanistan. Findings from the ESCAPE trial -- short for Evaluation of Stepped Care for Chronic Pain – are being published in JAMA Internal Medicine.

It is a critical health issue among veterans, many of whom had multiple, often lengthy deployments. Many have significant long-term pain. We know that medications alone are only modestly successful in helping them; current pain treatments haven't made much of a dent,” said Matthew Blair, MD, the study’s lead investigator and an associate professor of medicine at Indiana University.

A recent study found that nearly half of the American soldiers deployed to Iraq and Afghanistan return home to the U.S. in chronic pain, and about one in seven were using opioid pain relievers. Although pain is a common condition, researchers say no intervention studies had been conducted on the best ways to treat chronic pain in these veterans.

“The absence of studies is concerning because chronic pain may prove even more disabling in veterans of recent conflicts than in veterans of previous eras owing to the high combat intensity,” said Bair, who served for eight years as a U.S. Army physician.

The veterans in the ESCAPE study suffered from moderate to severe chronic pain in the back, knee, neck or shoulder for at least three months. Veterans with substance or abuse problems were excluded from the study, as were those with suicidal thoughts, active psychosis or schizophrenia.

In the first phase of ESCAPE, patients were given 12 weeks of pain medication, ranging from acetaminophen to opioids. Because analgesics may not relieve pain sufficiently when used alone, the veterans were educated about self-management strategies such as goal setting, problem solving, deep breathing and relaxation techniques. Patients were also encouraged to minimize bed rest, return to normal activities, and perform stretching and strengthening exercises.

Step two involved 12 weeks of cognitive behavioral therapy that included psychological counseling for both pain and depression. Nurse care managers consulted with veterans over the telephone, helping them counter negative thoughts – such as helping them understand that while they may not be able to perform the same physical activities they enjoyed before deployment, a substitute activity like swimming might be achievable and decrease their pain.

Those who received the two-step ESCAPE program saw improvement in their function and a decrease in pain severity and pain interference -- how pain interferes with their mood, physical activity, work, relationships, sleep and enjoyment of life.

“The decrease in pain severity and 30 percent improvement in pain-related disability we achieved in the ESCAPE study are clinically significant, and we found that improvement lasted for at least nine months," said Blair.

Researchers say the ESCAPE program could be duplicated to treat chronic pain at other VA medical centers and other large health care systems outside the VA. However, implementing the program in smaller community settings or in private settings may be challenging.

"This is an important, methodologically rigorous study that underscores the value of psychobehavioral treatment in chronic pain,” said Beth Darnall, PhD, a pain psychologist and author of Less Pain, Fewer Pills. “Cognitive-behavioral therapy and the use of relaxation strategies work exceedingly well within the context of a comprehensive pain management program, and when the techniques are used regularly.”

Darnall recommends the same techniques used in the VA study in her own private practice.

“It’s important for people to know that the results from psychobehavioral skills build over time.  In other words, use them daily and your results will unfold and strengthen over the course of weeks and months,” she wrote in an email to Pain News Network.

How to be Healthy When You're Sick

By Crystal Lindell, Columnist

I’m trying to find ways to be healthy despite the fact that I constantly feel like I’m dying.

Having chronic pain is like waking up every single day feeling like you’ve just been mugged, then hit by a semi-truck, and simultaneously come into contact with the plague.

And when it first hits you, you’re like, “I can’t be expected to function under these conditions. Nobody could function under these conditions. I must call in sick to life.”

But after a month of laying on the couch watching every episode of Burn Notice three times, you suddenly realize you’re probably not going to be getting better any time soon, so maybe you should try to, you know, shower or something.

That’s where the drugs come in. And suddenly, you wake up one day and you’re literally taking six different medications before you even get out of bed in the morning. But hey! At least you’re getting out of bed.

And over the next few months or years or whatever it takes for you, you just sort of live in this drugged-up state of barely existing. It’s how I would imagine high school pot heads hope their life turns out, except without all the stupid stabbing pain in my ribs (or wherever yours may be). 

Aside from being high daily, you find all the shortcuts you can. For me, I ended up working from home. I moved in with my mom because doing my own laundry and washing my own dishes is literally too difficult. I shower once a week to save my energy. I shop online. And I never, ever, ever wear high heels. Ever!

On one level, I’m just happy that I’m no longer in so much pain that I literally hope I don’t wake up alive in the morning. But on another, I don’t really like what I see when I look down the long, dark road that’s probably going to be my life for, what? Another 50? Or even 60 years if I’m terribly unlucky?

Which brings me to the yoga. Yes, it’s true. I have started doing yoga. I’m hoping this is the next stage in the chronic pain life cycle, which will be followed quickly by, “Find a cure, and live happily ever after.”

While I’m here though, barely living, I figure I might as well get really good at downward dog. I started with a 30-minute PM yoga session for beginners on DVD. The hardest part is when I had to take two deep breaths in a plank pose. And, guess what? It didn’t suck.

I mean, I can admit when I’m wrong. And I was totally wrong about yoga. I really, really thought that bending my body in new, crazy ways would only make things worse. It’s just the human intuition in me, saying, “You’re in pain, stop doing stuff.” But, with chronic pain, you have to learn to override that voice.

And so, I’ve even done the 30-minute AM session, and I didn’t even die from that either. Plus, I also found another DVD by the same soothing instructor that’s 51-mintues long, and I did that one too, all without any trips to the hospital or anything! I’m pretty excited about the whole situation.

After each session I feel really relaxed, and it seems like I’m going through fewer pain pills when I do the yoga as opposed to when I don’t.

I’ve also started drinking tea. Back in the day, when my body didn’t hate me, I used to say things like, “Tea is literally just dirty water. Ick.”  But now, I’m sicker and wiser -- and I need to find ways to bring a sense of peace to my wounded body.

So, yeah, tea. It’s got to be better than Coke, right?

There’s a morning tea that seems to ward off the overwhelming feeling of being high that the meds give me. And then there’s a night tea that helps me poop — something I’ve really missed doing ever since my prescription pills took that seemingly natural bodily function away from me.

Truth be told, I am secretly hoping all these new changes will help me lose some of the 50 stupid pounds I’ve gained since getting sick. But if they even help me do more than shower or something, I’d be cool with that too.

Crystal Lindell is a journalist who lives in Illinois. She loves Taco Bell, watching "Burn Notice" episodes on Netflix and Snicker's Bites. She has had intercostal neuralgia since February 2013.

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

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.

Nerve Stimulation Effective in Treating Cluster Headache (VIDEO)

By Pat Anson, Editor

A neuromodulation device that stimulates a nerve in the neck substantially reduced the number and frequency of attacks in patients suffering from cluster headache, according to small study published in the journal Neurology. 

Image courtesy of electrocore

Seventy-nine percent of patients who completed the study (15 out of 19) reported an overall improvement in their condition after using gammaCore, a nerve stimulator that sends electrical signals along the vagus nerve, which runs through the neck to the brain. Eleven of the patients had chronic cluster headaches, and eight were classified as episodic.

“Cluster headache is a dreadful, extremely painful and disabling condition that can be very complex to manage. Given the unmet need for effective and safe treatments, we were excited to see the outcomes in these patients of an approach offering very considerable promise for future development.” said Peter Goadsby, PhD, who led the research at the Royal Free Hospital in London and the Beaumont Hospital in Dublin.

Cluster headache is a neurological disorder characterized by recurring, severe headaches on one side of the head, often around the eye. Attacks occur suddenly and can range from 15 minutes to three hours. Recommended treatments for cluster headaches include oxygen or triptan. 

Nearly half (47%) of the acute attacks treated with gammaCore ended in an average of 11 minutes.  Ten patients reduced their use of oxygen by 55% and nine patients reduced their triptan use by 48%. Preventative use of the gammaCore device resulted in a substantial reduction in the frequency of attacks, from 4.5 attacks every 24 hours to 2.6 after treatment. 

The treatment, which is self-administered by the patient for two minutes, involves placing the hand-held gammaCore device on the skin of the neck over the vagus nerve. In the study, patients administered two to three rounds of neurostimulation twice per day. Acute attacks were treated with up to six doses at the onset of the attack. Patients reported no serious side events.

GammaCore, which is manufactured by New Jersey based electroCore, is not currently approved by the Food and Drug Administration and is not available in the United States. 

The company is seeking FDA approval for gammaCore in the treatment and prevention of cluster headache. The device currently has regulatory approval for the acute and/or prophylactic treatment of cluster headache, migraine and medication overuse headache in the European Union, South Africa, India, New Zealand, Australia, Colombia, Brazil, Malaysia, and Canada. 

“It is not certain how vagus nerve stimulation treats and prevents migraines and cluster headaches, but data suggest that it may work by sending signals into the brain that reduce the amount of a substance, called glutamate, that has been associated with headache symptoms,” the company says in a statement on its website.

ElectroCore is developing Vagus Nerve Stimulation (nVNS) therapies for the treatment of multiple conditions in neurology, psychiatry, gastroenterology and respiratory fields. The company’s initial focus is on the treatment of primary headaches (migraine and cluster headache), and the associated chronic co-morbidities of gastric motility, psychiatric, sleep, and pain disorders.

ElectroCore has raised more than $80 million from investors including Merck’s Global Healthcare Innovation fund.

Gene Therapy Lessens Pain of Diabetic Neuropathy (VIDEO)

By Pat Anson, Editor

An experimental gene therapy reduces pain and other symptoms by over 50 percent in patients with diabetic peripheral neuropathy, according to a new study at Northwestern University.

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 (DPN) 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.

Keith Wenckowski, who has type-one diabetes, says it felt “like walking on glass” when he walked barefoot in sand.   

Wenckowski and 83 other participants in the Northwestern study received two low doses of a non-viral gene therapy called VM202. They went to a clinic twice in a two-week period for a series of injections into their calf muscles and lower legs. Some received injections of a saline placebo, others a low dose of the therapy and others a higher dose.

"Those who received the therapy reported more than a 50 percent reduction in their symptoms and virtually no side effects," said Dr. Jack Kessler, lead author of the study. "Not only did it improve their pain, it also improved their ability to perceive a very, very light touch."

After three months, patients in the low-dose group experienced a significant reduction in pain compared to the placebo group. The effect persisted at six and nine months in the low-dose group.

"I can now go to a beach and walk on the sand without feeling like I am walking on glass," says Wenckowski, more than a year after receiving the therapy. "I am hoping the effects I am feeling do not cease."

VM202 contains the human hepatocyte growth factor (HGF) gene. Growth factor is a naturally occurring protein in the body that acts on nerve cell to keep them alive, healthy and functioning. Future studies will investigate if the therapy can actually regenerate damaged nerves and reverse the neuropathy.

Patients with the most extreme form of the DPN feel intense pain with a slight graze or touch. The pain can interfere with daily activities, sleep, mood and can diminish quality of life. Many drugs used to treat DPN, such as Neurontin and Lyrica, either don’t work or have unpleasant side effects.

"We are hoping that the treatment will increase the local production of hepatocyte growth factor to help regenerate nerves and grow new blood vessels and therefore reduce the pain," said Senda Ajroud-Driss, MD, an attending physician at Northwestern Memorial Hospital and an author of the study.

"We found that the patients who received the low dose had a better reduction in pain than the people who received the high dose or the placebo. Side effects were limited to injection site reaction."

The results of this Phase II, double-blind, placebo-controlled study are being published in the journal Annals of Clinical and Translation Neurology.A future, much larger Phase III study will soon be underway.

"Right now there is no medication that can reverse neuropathy," Kessler said. "Our goal is to develop a treatment. If we can show with more patients that this is a very real phenomenon, then we can show we have not only improved the symptoms of the disease, namely the pain, but we have actually improved function."

Spider Venom Could Take the Sting Out of Chronic Pain

By Pat Anson, Editor

Black widow spiders are well known for their dangerous, painful and sometimes even lethal bites. The venom of a female black widow is 15 times as toxic as a rattlesnake’s.

But that venom also contains an ingredient that could be developed into a new class of potent painkilllers.

Researchers in Australia have identified seven compounds in the venom of spiders that block the body's ability to send signals to the brain through what is called the pain pathway – also known as Nav 1.7 channels.

"A compound that blocks Nav 1.7 channels is of particular interest for us. Previous research shows indifference to pain among people who lack Nav 1.7 channels due to a naturally-occurring genetic mutation - so blocking these channels has the potential of turning off pain in people with normal pain pathways," said study leader Glenn King, PhD, of The University of Queensland's Institute for Molecular Bioscience.

King and his colleagues built a system that can rapidly analyze the protein molecules in spider venoms. They studied the venom of over 200 spider species and found that 40% of the venoms contained at least one compound that blocked human Nav 1.7 channels. Of the seven promising compounds identified so far, one is particularly potent and has a chemical structure that suggests it has a high level of chemical, thermal, and biological stability, which would be essential for administering in a new medicine.

"Untapping this natural source of new medicines brings a distinct hope of accelerating the development of a new class of painkillers that can help people who suffer from chronic pain that cannot be treated with current treatment options," said researcher Julie Kaae Klint, PhD.

Researchers have only scratched the surface. There are over 45,000 species of spiders, many of which kill their prey with venoms that contain hundreds - or even thousands - of protein molecules that block nerve activity.

"A conservative estimate indicates that there are nine million spider-venom peptides, and only 0.01% of this vast pharmacological landscape has been explored so far," says Klint.

The study is published in the British Journal of Pharmacology.

Researchers are also studying the potential of venom in cone snails for its potential for blocking pain signals in humans. German scientists at the Pharmaceutical Institute of the University of Bonn say one advantage of the peptides found in snail venom is that they decompose quickly and are unlikely to cause dependency.

A pharmaceutical drug derived from cone snail neurotoxins has already been developed and marketed under the brand name Prialt. The drug is injected in spinal cord fluid to treat severe pain caused by failed back surgery, injury, AIDS, and cancer.

Study Finds Acupuncture Has Placebo Effect

By Pat Anson, Editor

When it comes to acupuncture, perception apparently does matter.

British researchers found in a new study that people with back pain who believe acupuncture will not help or do little to relieve their symptoms will gain less benefit from treatment than people who believe it works.

And people who feel they can manage their back pain have less disability as a result of acupuncture treatment.

“They experienced less disability over the course of treatment when they came to see their back pain as more controllable, when they felt they had better understanding of their back pain, when they felt better able to cope with it, were less emotional about it, and when they felt their back pain was going to have less of an impact on their lives," said Felicity Bishop, PhD, an Arthritis Research UK career development fellow.

Bishop and her colleagues at the University of Southampton wanted to find out why some people with back pain gain more benefit from acupuncture than others. They recruited 485 people with back pain and asked them to complete questionnaires before they saw an acupuncturist; as well as two weeks, three months and six months after starting treatment. The questions measured psychological factors, clinical and demographic characteristics, and back-related disability.

The study, which was funded by Arthritis Research UK, is being published in The Journal of Clinical Pain.

"The analysis showed that psychological factors were consistently associated with back-related disability," said Bishop, who believes acupuncturists should consider helping patients think more positively about their back pain as part of their treatment.

"People who started out with very low expectations of acupuncture -- who thought it probably would not help them -- were more likely to report less benefit as treatment went on,” she said.

Previous research has shown that many factors -- other than the insertion of needles – can play a role in the effectiveness of acupuncture, such as the relationship that the patient develops with the acupuncturist and the patient's belief about acupuncture.

"This study emphasises the influence of the placebo effect on pain. The process whereby the brain's processing of different emotions in relation to their treatment can influence outcome is a really important area for research,” said Dr. Stephen Simpson, director of research at Arthritis Research UK.

Acupuncture, which was originally developed as part of traditional Chinese medicine, is one of the most widely practiced forms of alternative medicine. As many as 3 million Americans receive acupuncture treatments, most often for relief of chronic pain.

While there is little consensus in the medical community about acupuncture’s value, a study in the Archives of Internal Medicine found that relief offered by acupuncture is real and should be considered a viable form of treatment .

Focusing on patients who reported chronic back and neck pain, osteoarthritis, chronic headache and shoulder pain, researchers at Memorial Sloan-Kettering Cancer Center in New York conducted a meta-analysis (a study of studies) of 29 studies involving nearly 18,000 adults.

“Acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo,” the study concluded. “However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.