Miss Understood: Vibrant Trial

(Editor’s note:  Several weeks ago we were contacted by a sales representative for Neurovative Technologies, a Canadian manufacturer of medical devices that use vibration to relieve chronic pain. These “Vibrant” devices sell for about $300 each and, we were told, “have been able to decrease pain and stiffness and increase range of motion in 95% of our OA, RA and Fibromyalgia patients.” The company was invited and agreed to provide a Vibrant device for back pain at no cost to PNN columnist Arlene Grau for a test run. Arlene suffers from fibromylagia and rheumatoid arthritis.)

By Arlene Grau, Columnist

There are many people who suffer the same pain day in and day out with little to no relief from medication, acupuncture, medical devices, etc. My pain begins in my back and spreads throughout my body. Recently, I was asked to give a drug free and non-invasive device called Vibrant a try to see if it helped with some of the pain I was suffering from. I received the device that is designed for back pain management.

During my time using the device, which was about two weeks, I have found that there is no change in my pain level or relief for my back pain.

The device is recommended for use in 16 minute sessions.  It can be used as many times as you'd like during the day, however it is not recommended that anyone use it for an extended period of time all at once.

It is extremely easy to use. You just push the “on” button and it does all the work. It also comes with a charger and backpack for storing or carrying, which I thought was pretty neat.

The Vibrant device reminded me of a massage chair, but I kept wanting to raise the level of intensity and couldn't because it doesn't come with that feature.

It did however help relieve minor aches and pains related to everyday life. My husband even tried it and said that he found it to be relaxing.

I also have a TENS unit which was prescribed by my pain management doctor and I feel like I get a lot more relief from that than the Vibrant device. As far as being able to target my pain and getting deep down into the problem areas, I feel like the Vibrant device fell short.

It's possible that it's meant for smaller aches and pains, but as far as rheumatoid arthritis and fibromyalgia patients go, there really are no minor pains related to our diseases.

Arlene Grau lives in southern California. She suffers from rheumatoid arthritis, fibromyalgia, lupus, migraine, vasculitis, and Sjogren’s disease.

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

Exercise Improves Pain and Mobility of Seniors

By Pat Anson, Editor

A low-impact exercise program can significantly reduce pain and improve mobility for older adults with arthritis and other musculoskeletal conditions, according to the Hospital for Special Surgery (HHS) in New York City.

For several years HHS has offered exercise programs at senior centers in Chinatown, Flushing, and Queens – and tracked the health of those who participated. The hospital’s most recent findings are being presented at the annual meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals in San Francisco.

"Getting seniors to be active in any way will generally improve their quality of life and help them function better in their everyday activities," said Linda Russell, MD, a rheumatologist and chair of the Public and Patient Education Advisory Committee at HHS. "People believe that if you have arthritis you shouldn't exercise, but appropriate exercises actually help decrease pain."

The eight-week exercise programs began in 2011 and are held once a week. They were originally developed for Asian seniors 65 and older, many of whom lived in poverty and suffered from musculoskeletal conditions.

The low-impact exercises included pilates, yoga, yoga-lates (a combination of yoga and pilates), t’ai chi and dance, and were led by certified instructors.

In surveys of over 200 participants, most reported that they experienced less pain and were better able to perform activities of daily living. Muscle and joint pain were reduced by nearly a third and mobility improved dramatically:

• 88% more participants could climb several flights of stairs
• 66% more participants could lift/carry groceries
• 63% more participants could bend, kneel, or stoop
• 91% of participants felt the program reduced their fatigue
• 97% of participants felt that the program reduced their stiffness
• 95% of participants felt their balance improved
• 96% of participants felt more confident that exercising would not make their symptoms worse

"The study results indicate that the hospital's Bone Health Initiative has a positive impact on the musculoskeletal health of the Asian senior population," said Huijuan Huang, MPA, program coordinator. "Providing free exercise programs to the community can play an important role in helping adults manage musculoskeletal conditions."

An earlier study at HHS found that exercise decreases pain, reduces the severity and frequency of falls, and improves the balance of people suffering from osteoarthritis. Exercise also improved their quality and enjoyment of life.

Rheumatoid Arthritis Raises Death Risk

By Pat Anson, Editor

Rheumatoid arthritis (RA) is not only painful and disabling – new research indicates it raises the risk of an early death, especially for patients with seropositive RA.

In a study of nearly 1,000 women with RA, researchers at Brigham and Women’s Hospital (BWH) in Boston found that RA significantly increased the women’s risk of death from cardiovascular and respiratory disease. The women are enrolled in the Nurses' Health Study, which has followed more than 100,000 female registered nurses since 1976.

"Because the Nurses' Health Study is so large and has been following participants for so long, we were able to gather much more information about our subjects - we could follow them before and after diagnosis, take their health behaviors into account and determine specific causes of death. By doing so, we found strong evidence of increased risk for respiratory, cardiovascular and overall mortality for patients with RA," said lead author Jeffrey Sparks, MD, a physician in BWH's Division of Rheumatology, Immunology and Allergy.

RA is a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing swelling, inflammation and bone erosion. Because RA is incurable, treatments focus on suppressing the immune system to reduce inflammation and slow progression of the disease.

Sparks and his colleagues evaluated 964 women in the Nurses’ Health Study and compared their mortality rates to women in the study without RA. The team controlled for other risk factors, including smoking, a known cause of respiratory and cardiovascular mortality, as well as age, body mass index, physical activity and diet.

They found that RA was associated with a 40 percent increased risk of death and that many RA patients died of chronic obstructive pulmonary disease (COPD).

Researchers also looked at differences between the two types of RA, "seropositive" and "seronegative." Patients with seropositive RA have auto-antibodies related to RA, and generally have more severe symptoms. The team found that participants with seropositive RA had nearly three times the risk of respiratory mortality than women who did not have RA. Seronegative RA was not significantly associated with increased risk of respiratory mortality.

"We found that whether participants with RA were seropositive or seronegative really mattered - those who were seropositive were at higher risk, particularly for respiratory mortality," said Sparks. "We hope that this study will encourage patients and clinicians to be more aware that patients with RA are at increased risk of both respiratory and cardiovascular mortality, particularly patients with seropositive RA."

A recent study by researchers in Mexico found that RA patients with no prior symptoms of heart disease were at higher risk of a heart attack. Their risk was higher even without other cardiovascular risk factors such as smoking and diabetes.

Many health experts believe the inflammation triggered by RA in the joints may cause inflammation throughout the body, including the heart’s coronary arteries.

According to the Arthritis Foundation, more than 50 percent of premature deaths in people with rheumatoid arthritis result from cardiovascular disease. The heightened risk of heart disease applies to all forms of arthritis, including osteoarthritis, gout, lupus and psoriatic arthritis.

Researchers Say Chronic Pain Changes Brain Chemistry

By Pat Anson, Editor

A new study by UK researchers raises an intriguing question: Does chronic pain change brain chemistry and make pain more tolerable?

The answer is yes, according to a small study at the University of Manchester. Researchers there used Positron Emission Tomography imaging (PET scans) to measure the spread of opioid receptors in the brains of 17 arthritis sufferers and nine healthy control subjects

When they applied heat to the skin of study participants to induce pain, researchers found that the more opioid receptors they had, the higher their ability was to withstand pain. The number of opioid receptors was highest in arthritis sufferers, suggesting their brain chemistry had changed in response to chronic pain.

"As far as we are aware, this is the first time that these changes have been associated with increased resilience to pain and shown to be adaptive,” said Dr. Christopher Brown. "Although the mechanisms of these adaptive changes are unknown, if we can understand how we can enhance them, we may find ways of naturally increasing resilience to pain without the side effects associated with many pain killing drugs."

image courtesy of university of manchester

It’s been known for a long time that we have receptors in our brains that respond to natural endogenous opioids such as endorphins. Those same receptors also respond to opioid pain medications.

Some people seem to cope better with pain than others, and knowing more about their resilience and coping mechanisms may lead to the development of new ways of treating pain.

"This is very exciting because it changes the way we think about chronic pain,” said Anthony Jones, a professor and director of the Manchester Pain Consortium. "There is generally a rather negative and fatalistic view of chronic pain. This study shows that although the group as a whole are more physiologically vulnerable, the whole pain system is very flexible and that individuals can adaptively upregulate their resilience to pain.

"It may be that some simple interventions can further enhance this natural process, and designing smart molecules or simple non-drug interventions to do a similar thing is potentially attractive."

Researchers at Stanford University in California have also been studying this subject, trying to learn why some chronic pain sufferers are more resilient to pain.

“I think this study emphasizes some very important points about pain resilience,” said Dr. Drew Sturgeon, a fellow in the Stanford University Pain Management Center and Stanford Systems Neuroscience and Pain Laboratory. “If you think about chronic pain as something that poses a constant challenge and requires frequent adaptation, it makes sense that we would see changes in the brain that correspond with this process.  We see it frequently from a psychological standpoint, where people are able to learn and develop better strategies for coping with pain and reduce their fear and negative thoughts about pain after dealing with it for a while.”

Sturgeon and his colleagues say resilience may also stem from an enhanced ability to enjoy the rewarding parts of life – which makes it easier to cope with pain.  

“The idea would be that if a person had more opioid receptors available they would be more sensitive to the good stuff in life, and therefore more motivated by pleasurable experiences, such as spending time with friends, exercising -- rewards that get us back on the road to living a meaningful life,” said Beth Darnall, PhD, a pain psychologist, clinical associate professor at Stanford University and author of Less Pain, Fewer Pills.

“Theoretically, people who are known to be resilient probably have more endogenous opioids -- or they have made choices in life to optimize their experience of endogenous opioids and therefore have honed an internal reward system.”

Whatever the cause of resilience, many patients hope further studies will uncover new ways of treating pain.

"As a patient who suffers chronic pain from osteoarthritis, I am extremely interested in this research. I feel I have developed coping mechanisms to deal with my pain over the years, yet still have to take opioid medication to relieve my symptoms,” said Val Derbyshire. “The notion of enhancing the natural opiates in the brain, such as endorphins, as a response to pain, seems to me to be infinitely preferable to long term medication with opiate drugs.”

The University of Manchester study is being published in Pain, the official journal of the International Association of the Study of Pain.

Drug Shows Promise for Treating Psoriatic Arthritis

By Pat Anson, Editor

An injectable drug used to treat plaque psoriasis may also be effective in treating psoriatic arthritis, according to new research published in the New England Journal of Medicine.

Secukinumab – which is sold by Novartis under the brand name Cosentyx – helped reduce swollen joints in a double-blind Phase III study involving over 600 patients with psoriatic arthritis. Treatment with Cosentyx resulted in rapid and significant improvements in about half of the patients compared to a placebo.

The study was neither large enough or long enough to evaluate side effects associated with long-term use of Cosentyx.

Psoriatic arthritis is a form of arthritis that affects about a third of people who have psoriasis — a condition that features red skin lesions. Joint pain, stiffness and swelling are the main symptoms of psoriatic arthritis, which can affect any part of the body, including the fingertips and spine.  

No cure for psoriatic arthritis exists, so the focus is on controlling symptoms and preventing further damage to joints.

Cosentyx was approved in Europe early this year as a first-line treatment for moderate-to-severe plaque psoriasis. The drug is also approved in the U.S. as a treatment for plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy).

Novartis has applied for Cosentyx to be used as a treatment for psoriatic arthritis and ankylosing spondylitis.

Psoriatic arthritis can develop at any time, but it most commonly appears between the ages of 30 and 50, according to the National Psoriasis Foundation. Genes, the immune system and environmental factors all appear to play a role in the onset of the disease. About 10 percent of people inherit one or more of the genes that could eventually lead to psoriasis, but only 2 to 3 percent actually develop the disease.

Yoga Reduces Chronic Pain of Arthritis

By Pat Anson, Editor

A few weeks of yoga can significantly improve the health and mental well-being of people suffering from the two most common forms of arthritis, according to a new study at Johns Hopkins University.

Researchers found that 8 weeks of yoga classes reduced pain and improved the energy, mood and physical activity of patients with rheumatoid arthritis or knee osteoarthritis. The study, published in the Journal of Rheumatology, is believed to be the largest randomized trial to examine the effect of yoga on the physical and psychological health of arthritis sufferers.

"There's a real surge of interest in yoga as a complementary therapy, with 1 in 10 people in the U.S. now practicing yoga to improve their health and fitness," said Susan Bartlett, PhD, an adjunct associate professor of medicine at Johns Hopkins and associate professor at McGill University.

"Yoga may be especially well suited to people with arthritis because it combines physical activity with potent stress management and relaxation techniques, and focuses on respecting limitations that can change from day to day."

Rheumatoid arthritis (RA) is a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing pain, inflammation and bone erosion. About 1.5 million Americans and 1% of adults worldwide suffer from RA.

Knee osteoarthritis (OA) is even more common and affects over 250 million people worldwide. Nearly 40 percent of Americans over the age of 45 have some degree of knee OA, which causes thinning of cartilage and progressive joint damage.

Johns Hopkins researchers recruited 75 sedentary adults with either knee osteoarthritis or RA. Participants were randomly assigned to either a wait list or eight weeks of twice-weekly yoga classes, plus a weekly practice session at home. Their physical and mental well-being were assessed before and after the yoga sessions by researchers who did not know which group the participants had been assigned to.

Those doing yoga reported a 20% improvement in pain, energy levels, mood and physical function, including their ability to complete physical tasks. Walking speed also improved to a lesser extent, though there was little difference between the groups in tests of balance and upper body strength. Improvements in those who completed yoga were still apparent nine months later.

"For people with other conditions, yoga has been shown to improve pain, pain-related disability and mood," said Clifton Bingham III, MD, associate professor of medicine at Johns Hopkins University School of Medicine and director of the Johns Hopkins Arthritis Center.

"But there were no well-controlled trial of yoga that could tell us if it was safe and effective for people with arthritis, and many health professionals have concerns about how yoga might affect vulnerable joints given the emphasis on changing positions and on being flexible. Our first step was to ensure that yoga was reasonable and safe option for people with arthritis.”

Participants were screened by their doctors prior to joining the study, and continued to take their regular arthritis medication. Instructors in the yoga classes also had additional training to modify poses to accommodate people with limited physical ability.

“Find a teacher who asks the right questions about limitations and works closely with you as an individual. Start with gentle yoga classes. Practice acceptance of where you are and what your body can do on any given day," Bingham said.

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

“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

“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."

Miss Understood: A Taste of Remission

By: Arlene Grau, Columnist

If you ask me to plan something, almost anything that requires me being somewhere on a certain day for any amount of time, I would have to decline because I never know how I'll be feeling on any given day.

Now ask me to plan a family vacation that would take me to Hawaii, where I would be 5 hours away from my doctor by plane – well, that would be insane.

However, I did just that and the results were better than expected.

I had my Rituxan infusion a month prior to leaving in hopes that it would kick in just before I left. My body, however, had a different agenda. I began feeling ill the week after my treatment. On top of that, I suffered a bad fall at home. I sprained my ankle, bruised my hip, and hurt my knee.

Instead of making progress, I was taking several steps backwards. I had tried to prepare my body for months and it was beginning to feel like it was all in vain.

But my husband and doctor didn't allow me to give up. My doctor prepared an emergency plan for me before I left. He prescribed backup antibiotics in case I became ill, started me on a temporary prednisone dosage, printed up my most recent patient summary (since I was taking so many medications with me), and gave me contact information for a rheumatologist in Hawaii in the event that I needed to be seen. He even called the other doctor ahead of time and told me to email him for anything.

Although my body wasn't completely ready, I felt like I had the tools necessary to handle any medical emergency I may have.

Now, I don't know if it was the simple fact that I removed myself from all the stressors in my life, but I felt so much better while I was in Hawaii during that one week than I have since I was first diagnosed with rheumatoid arthritis eight years ago.

My theory is that the change in climate helped with the inflammation I was suffering from. I know that when it's very cold and dry, I tend to flare up and feel very ill. And when it's really hot and the sun is pounding down on me, I feel my weakest and just as sick.

But out there I was met with humidity and sunlight that didn't feel like it was stripping away every ounce of energy I had.

I had one or two trying days; granted I was doing a lot more than I've ever done at home as far as activities and walking go. But I was extremely proud of everything I was participating in. I even got to enjoy my 30th birthday in Hawaii, one I never thought I would live to see.

I knew as soon as we got home that something was different because I woke up feeling like I had been hit by a truck. As quickly as the swelling and inflammation left, it returned. My insomnia is back and my migraines are more intense.

But I got taste of what remission might be like.

It was a great vacation with a bittersweet ending because, instead of dreaming about the visual paradise I was in, I'm left day dreaming about the physical paradise I felt -- the one that had less limitations and more of my old self.

Arlene Grau lives in southern California. She suffers from rheumatoid arthritis, fibromyalgia, lupus, migraine, vasculitis, and Sjogren’s disease.

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

Discovery Could Lead to Earlier RA Treatment

By Pat Anson, Editor

Scientists have discovered a new protein that regulates the severity of tissue damage caused by rheumatoid arthritis, a finding that could help identify RA patients earlier for more aggressive treatment.

The protein – known as C5orf30 – was found in DNA and biopsy samples from the joints of over 1,000 RA patients in the UK and Ireland.

"Our findings provide a genetic marker that could be used to identify those RA patients who require more aggressive treatments or personalized medicine," said Professor Gerry Wilson from the School of Medicine and Medical Science, University College Dublin, who led the research.

"They also point to the possibility that increasing the levels of C5orf30 in the joints might be a novel method of reducing tissue damage caused by RA".

Rheumatoid arthritis is a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing joint pain, inflammation and bone erosion. About 1.5 million Americans and 1% of adults worldwide suffer from RA.

"These exciting findings will prompt us to further explore the role of this highly conserved protein that we know so little about, and its significance in human health and disease,” said co-author Dr. Munitta Muthana from the Medical School at the University of Sheffield.

The study, funded by Arthritis Ireland and the University of Sheffield, is published in the journal PNAS.

It is estimated that 30% of patients with rheumatoid arthritis are unable to work within 10 years of onset of the disease. It affects more women than men, and often more severely. RA is most common between the ages of 40 and 70, but it can affect people of all ages, including children.

Although there is no cure for RA, new drugs are available to treat the disease and slow joint damage. Self-management of the condition by patients, including exercise, is also known to reduce pain and disability.

One of the biggest problems in treating RA is early diagnosis and treatment, which can reduce the amount of joint damage.  

"Treatments for arthritis have improved enormously over the last number of years. Thirty years ago, rheumatologists' waiting rooms were filled with people in wheelchairs. Today, that is no longer the case. The outlook for a person diagnosed with arthritis in 2015 is much brighter than it used to be,” said John Church, CEO of Arthritis Ireland.

British researchers recently said they were close to developing a blood test that could detect both RA and osteoarthritis in its earliest stages.

Osteoarthritis (OA) 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.

Researchers at the University of Warwick’s Medical School identified a biomarker linked to both forms of arthritis. Diagnostic blood tests already exist for RA, but the newly identified biomarker could lead to one which can diagnose both RA and osteoarthritis.

“This discovery raises the potential of a blood test that can help diagnose both RA and OA several years before the onset of physical symptoms," said lead researcher Naila Rabbani, PhD.

Rabbani’s research focused on citrullinated proteins (CPs), a biomarker present in the blood of people with early stage rheumatoid arthritis. Patients with RA have antibodies to CPs and the Warwick researchers established for the first time that CPs levels also increase in early-stage OA.

That research is published online in Nature Scientific Reports.

Quell Device Relieves Variety of Pain Conditions

By Pat Anson, Editor

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

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

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

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

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

image courtesy of neurometrix

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

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

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

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

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

Stress and Anxiety in RA Patients Leads to Heart Disease

By Pat Anson, Editor

In addition to pain and disability, rheumatoid arthritis patients often have to cope with depression, stress, anxiety, and lack of social support.

New research shows that toxic brew of emotions also makes them more likely to develop atherosclerosis, a buildup of fatty deposits in the arteries that leads to cardiovascular disease. The study, published in Arthritis Care & Research, recommends that RA patients be screened and treated for psychological issues to lower their risk of heart problems.

Rheumatoid arthritis is a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing joint pain, inflammation and bone erosion. About 1.5 million Americans and 1% of adults worldwide suffer from RA.

Previous studies have shown that cardiovascular disease is more prevalent in RA patients, but until now the exact was unknown.

The new study looked at data from the Evaluation of Subclinical Cardiovascular Disease and Predictors of Events in Rheumatoid Arthritis Study (ESCAPE), which examined the prevalence, progression, and risk factors for cardiovascular disease in RA.

Nearly 200 RA patients underwent computed tomography and ultrasound tests to measure their coronary artery calcium (CAC) and carotid artery thickness for plaque build-up. Researchers found that patients with higher anxiety and anger scores, depression and caregiver stress were more likely to have high CAC scores – a sign of moderate to severe atherosclerosis.

"Our study shows that depression, stress, anxiety, and anger are associated with atherosclerosis markers, which are known predictors of cardiovascular risk in RA," said Dr. Ying Liu, the first author of the study. "These findings highlight the importance of screening and treatment of heart disease risks factors to limit not only health care costs, but prevent morbidity and mortality for RA patients."

Researchers also found that RA patients had an increased risk of carotid plaque buildup due to job stress. Having a strong social support network was linked to lower carotid artery thickness.

"Our study is the first to investigate the association between psychosocial comorbidities and elevated risk of atherosclerosis in RA patients," said  lead investigator Dr. Jon Giles, Assistant Professor of Medicine at Columbia University, College of Physicians & Surgeons in New York City. "Understanding the risk factors that lead to greater mortality in those with chronic conditions like RA is extremely important.”

A recent study by researchers in Mexico found that one quarter of patients with rheumatoid arthritis had ischaemia or infarction – decreased blood flow to the heart which can lead to a surprise heart attack.

“The condition nearly doubles the risk of a heart attack but most patients never knew they had heart disease and were never alerted about their cardiovascular risk," said Adriana Puente, MD, a cardiologist at the National Medical Center in Mexico City.

Many health experts believe the inflammation triggered by RA in the joints may raise inflammation throughout the whole body, including the heart’s coronary arteries.

According to the Arthritis Foundation, more than 50 percent of premature deaths in people with rheumatoid arthritis result from cardiovascular disease. The heightened risk of heart disease applies to all forms of arthritis, including osteoarthritis, gout, lupus and psoriatic arthritis.

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."

Experimental RA Vaccine Shows Promise

By Pat Anson, Editor

Australian researchers have developed an experimental vaccine for rheumatoid arthritis (RA)  that could prevent the disease from developing in high-risk patients who have a genetic predisposition for RA.

In a small Phase I clinical study, researchers say the "Rheumavax" vaccine was safe and effective in suppressing the immune system response that triggers RA -- a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing swelling, inflammation and bone erosion. About 1% of adults worldwide suffer from RA.

"Current therapies only treat the symptoms and slow the progression of the disease,” said Professor Ranjeny Thomas of the University of Queensland Diamantina Institute. “We have designed a vaccine-style treatment or ‘immunotherapy’ specifically for individuals carrying high-risk rheumatoid arthritis genes and specific rheumatoid arthritis antibodies, called anti-CCP."

CCP antibodies are present in about 60% to 70% of people with RA and can be detected years before symptoms appear.

The personalized Rheumavax vaccine is made by taking a sample of each patient's blood and extracting an immune system cell called dendritic cells. Those cells are then challenged with a foreign peptide and an immune system modulator to create a vaccine that is then injected back into the patient.

Researchers say Rheumavax "teaches" the patient’s immune system to ignore a naturally occurring peptide that triggers the production of CCP antibodies that cause inflammation. In the study, 18 patients received a single injection of Rheumavax and one month later showed no signs of inflammation or RA disease flares.

“At this stage, the technique would not be ideal for widespread treatment or prevention of rheumatoid arthritis because it’s costly and time-consuming," said Thomas. “However, the promising results of this trial lay the foundations for the development of a more cost-effective, clinically-practical vaccine technology that could deliver similar outcomes for patients." 

"This research is such an exciting advancement for arthritis sufferers.  To know that someday in the future, hopefully the near future, there may be a treatment that actually treats the cause, not just the symptoms of rheumatoid arthritis, makes me very hopeful," said  Jennifer Martin, a rheumatoid arthritis sufferer and columnist for Pain News Network.  

"I often worry that my son could have inherited this awful illness from me and that one day he will begin to show symptoms.  To think that there may be a treatment that is effective very early on, or even before symptoms arise if they are able to detect the gene is very reassuring."

Professor Thomas says if Rheumavax proves successful treating RA, it could also be applied to other autoimmune diseases, such as Type 1 diabetes.  The study is published in the journal Science Translational Medicine. 

Until the late 1990s, one in three RA patients were permanently disabled within five years of disease onset. Although there are no cures for RA, in recent years there has been significant improvement in treatment, with disease control now possible for many patients who receive biologic drugs.

Poor Sleep Makes Osteoarthritis Worse

By Pat Anson, Editor

A new study is adding to the growing body of evidence linking poor sleep habits to chronic pain.

Researchers at Johns Hopkins University School of Medicine say patients with knee osteoarthritis (OA) who slept poorly had greater central sensitization -- which amplifies the amount of pain they feel. They are also more likely to catastrophize -- a clinical term meaning they were consumed by thoughts about pain.

Osteoarthritis is a joint disorder that leads to thinning of cartilage and progressive joint damage. Nearly 40 percent of Americans over the age of 45 have some degree of knee OA.

"Our study is the largest and most comprehensive examination of the relationship between sleep disturbance, catastrophizing and central sensitization in knee OA," said lead author Claudia Campbell, PhD, from the Department of Psychiatry & Behavioral Sciences at Johns Hopkins University School of Medicine. The study is published in Arthritis Care & Research.

The study included 208 participants who were categorized into four groups: OA patients with insomnia, OA patients with normal sleep habits, healthy controls with insomnia, and healthy controls without pain and normal sleep habits. Most of the participants were female.

Results showed that patients with knee OA and insomnia had the greatest degree of central pain sensitization compared to the controls. Researchers also found that patients with poor sleep and high catastrophizing scores reported higher levels of central sensitization -- which was associated with increased  pain.

"While no causal processes may be determined from this study, our data suggest that those with low sleep efficiency and higher catastrophizing have the greatest central sensitization. Understanding the intricate relationship between sleep, central sensitization, and catastrophizing has important clinical implications for treating those with chronic pain conditions such as knee OA," said Campbell.

A recent study in Norway found that getting a good night’s sleep plays a key role in determining how bad your pain levels are doing the day.  Those who had trouble sleeping at least once a week had a 52% lower pain tolerance. The study, which was published in the journal PAIN,  is the first to link insomnia and impaired sleep to reduced pain tolerance in a large, general population sample.  

A previous study in Norway found that women who have trouble sleeping are at greater risk of developing fibromyalgia.

Fatigue Often Stops RA Patients from Working

By Pat Anson, Editor

Fatigue and pain are the top reasons rheumatoid arthritis (RA) patients in the U.S. stop working, according to a new survey that found only about a third of RA patients are still employed full-time.

The “RA in America” survey of over 3,500 patients was conducted online by Health Union, a healthcare research and marketing company. It found that RA had a severe impact on patients’ quality of life, employment, and ability to afford treatment.

RA is a chronic and disabling autoimmune disease that causes pain and stiffness in joints. It affects about 1.3 million Americans and about one percent of the global population.

Ninety-four percent of respondents said they cannot do as much as they were able before acquiring the disease. Only 37% said they were still working full time.

Although fatigue is often overlooked as a symptom of RA, it had the greatest impact on the respondents’ ability to work – with 92% reporting they were tired while on the job. Pain, physical limitations, and a lack of understanding by colleagues also presented challenges.

“My biggest complaint is fatigue,” wrote one poster on a Health Union Facebook page.  “I am an invalid due to RA. I am in bed 24/7, I can't even sit up. I sleep a lot, not much else to do, but no matter how much I sleep, when I wake I'm exhausted. It's so crazy. I can sleep for 20 hours, and I'm exhausted the minute I open my eyes.”

“I was forced from my job because of exhaustion,” wrote another woman. “The meds contributed to the sleepiness, so I am careful about which I take. (I have) developed Lupus, OA and several related syndrome in addition to the RA.”

Many people who were surveyed said they were diagnosed with other conditions, including depression and anxiety (39%), high blood pressure (33%), fibromyalgia (32%) and migraine (25%).

Survey respondents also reported they needed help with daily activities, such as cleaning (75%) and other household chores (52%). Over a third (41%) needed assistance from a caregiver, which was typically a spouse, to help manage their RA.

"Many people do not know rheumatoid arthritis is a progressive, autoimmune disease and not the result of aging and wear on the body, like osteoarthritis the most common form of arthritis," said Andrew Lumpe, PhD, an RA patient. "Treatment can help slow the damage, but rheumatoid arthritis frequently alters the lives of both patients and their families."

The survey found some good news to report. Over a third (34%) of respondents said their RA had gone into remission at some point, usually for less than a year. Nearly three-fourths (74%) said the remission occurred after they began taking medication.

About half the survey respondents reported satisfaction with their treatments and only 21% were dissatisfied. Those on biologics, a newer and more expensive medication that can cost over $20,000 a year, had a slightly higher satisfaction rate. Over a third of respondents (38%) have avoided medications because of cost.

"The affordability of effective rheumatoid arthritis treatments is a serious concern," said Mariah Leach, an RA patient. "When you consider the burden this disease places on patients in terms of quality of life and employment, it is clear that supporting these individuals with treatment options can yield many benefits."