Peripheral Nerve Stimulation Study Confirms Benefit For Chronic Migraine Patients

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, has announced publication of results from the first large-scale study of peripheral nerve stimulation (PNS) of the occipital nerves in patients suffering from chronic migraine. The study results, published online by Cephalalgia the journal of the International Headache Society, show a significant reduction in pain, headache days and migraine-related disability.


Conducted at 15 medical centers in the U.S., the study followed 157 participants who, on average, suffered from headache approximately 21 days per month. At 12 weeks, patients receiving PNS therapy reported an average of six fewer headache days a month.


Additional key findings at 12 weeks were as follows:

 

• 43 percent improvement in overall disability scores, as measured using the Migraine Disability 
• Assessment questionnaire (MIDAS)
• 53 percent of the patients ranked their relief as excellent or good
• Patients reported a 42 percent improvement in pain relief

"One of the primary reasons that patients seek therapy is to try to find a way to lessen the number of days they experience migraine," said Stephen D. Silberstein, M.D., past president of the American Headache Society, director of the Jefferson Headache Center, and the principal investigator in the study. "For the millions who suffer from chronic migraine, these study results are important, as they confirm that peripheral nerve stimulation (PNS) of the occipital nerve may help improve their quality of life and lessen the number of days per month they suffer with this debilitating condition."

PNS therapy for this condition involves the delivery of mild electrical pulses to the occipital nerves that are located just beneath the skin at the back of the head. A small electrical lead or leads are placed under the skin and connected to a neurostimulator, which produces pulses of stimulation.

In this prospective, randomized, controlled study, participants were implanted with the St. Jude Medical Genesis™ neurostimulator and randomly assigned to an active or control group for 12 weeks. The active group received stimulation immediately upon implantation, while patients in the control group did not receive stimulation until after the first 12 weeks. Both the investigators and the patients were blinded to treatment.

Although statistical significance was demonstrated across most measures, it was not observed for the primary endpoint (defined as the difference in the percentage of patients in the active group versus control who achieved 50 percent or greater pain reduction at 12 weeks). However, patients in the active group were more likely than control patients to experience 30 percent or greater pain reduction, which is considered clinically meaningful.

"When this study was initially designed, the primary endpoint was based on a reduction in pain, which at the time was the standard measurement for neurostimulation studies," said, Dr. Mark Carlson, chief medical officer and senior vice president of research and clinical affairs for the St. Jude Medical Implantable Electronic Systems Division. "However during the course of the study, many neurologists began to recognize reduction in the number of headache days as a more significant improvement in patient quality of life than the measurement of pain reduction alone."

The most common adverse event was persistent pain and/or numbness at the implant site, followed by lead migration. The majority of adverse events were classified as mild or moderate in severity.

Preliminary data from this study was presented at the International Headache Congress (IHC) in 2011. The Genesis neurostimulation system used in this study is approved in Europe and Australia for the management of the pain and disability associated with intractable chronic migraine.

About Chronic Migraine

Chronic migraine is a disabling neurological disorder that can last for hours or days at a time. The World Health Organization (WHO) estimates that 1.7 to 4 percent of adults have headache on more than 15 days per month. Compared with people who periodically experience migraine headache, individuals with chronic migraine experience significantly greater disability, economic burden, and impairments in health-related quality of life. According to the European Journal of Neurology the total annual cost attributed to migraine amounts to €111 billion in the EU. 


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Back Pain? Steroid Shots May Raise Fracture Risk

Steroid injections to the spine were widely considered to be safe before being linked to an outbreak of fungal meningitis that by mid-week had killed 24 people in 17 states.

But a study out today raises new concerns about the injections that are used to treat millions of back pain sufferers every year -- and it has nothing to do with the tainted steroids blamed for the meningitis outbreak.

Spine Injections May Raise Fracture Risk

Epidural steroid shots are injected into the space around the spinal cord. The steroid works to curb inflammation in the area, leading to pain relief.

The study suggests that epidural shots increase the risk of spinal bone fractures, and researchers say patients with bone loss should be warned about this risk.

The research was presented today in Dallas at the annual meeting of the North American Spine Society.
Bone fractures of the spine are the most common fractures in patients with osteoporosis.

According to the American College of Rheumatology, one in two women over 50 and one in six men will suffer a fracture related to osteoporosis.

"For a patient population already at risk for bone fractures, steroid injections carry a greater risk than previously thought," says researcher Shalom Mandel, MD, of Henry Ford Hospital in Detroit.

While other steroid treatments, such as those taken orally or by IV, have long been linked to bone loss, epidural steroid shots are thought to have little impact on bones because they are delivered directly to the problem area and believed to have less effect on the rest of the body.

But Mandel says this may not be the case.

"If epidural steroids are causing fractures, it is probably because the treatment is not localized," he says. "The drug may be entering the circulatory system."

More Study Needed, Doctor Says

The Henry Ford Hospital researchers examined data on 6,000 patients treated for back pain between 2007 and 2010.

Half the patients were treated with at least one epidural steroid shot and the other half had never had the treatment.

According to the analysis, spinal fracture risk increased by 29% with each steroid shot. This was an association though, and does not prove cause and effect.
Mandel still uses epidural steroid shots to treat patients with back pain, and he says he has even had the injections himself.
"They were very helpful," he says. "There is definitely a place for this treatment."

But he adds that patients at risk for fractures should be warned about the risk and followed closely if they have the treatment.

Orthopaedic surgeon Neil S. Ross, MD, of Lenox Hill Hospital in New York City, who reviewed the research, says the study does not convince him that epidural spinal shots increase fracture risk.
While he does not give the shots, Ross says he has referred many patients to doctors who do.
"I would not change my recommendations about this treatment based on this study," he says, adding that more study is needed to confirm the findings.


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Pain Level After Car Crash Could Depend on Your Genes, Studies Say

The amount and severity of pain that you experience after an automobile accident may depend on your genes, early new research suggests.

In two studies based on data collected from 948 adult car accident victims, scientists from the University of North Carolina found that inherited genetic variations affected participants' response to pain intensity, both immediately following the accident and six weeks later.

"The findings are important because currently patients who experience persistent pain, who don't have things you can see that are obviously damaged, are often viewed with lots of suspicion and they don't get the treatment they need," said senior study author Dr. Samuel McLean, an assistant professor of anesthesiology. "This shows a biologic basis for the development of these symptoms."

The studies are scheduled to be presented Tuesday at the American Society of Anesthesiologists (ASA) annual meeting in Washington, D.C.

Previous research has suggested that pain after a car accident isn't due solely to tissue damage from trauma but may also be strongly influenced by physiologic systems involved in the body's response to the collision, study authors said. Participants in the current research provided a blood sample after being treated in a hospital emergency room and were also evaluated for extent and severity of pain at the emergency visit and six weeks later.

The first study examined the role of dopamine -- a neurotransmitter that helps regulate pain processing. It found that genetic variants associated with the dopamine receptor 2 contribute to the pain severity felt in the immediate aftermath of a collision.

The second study evaluated the role of a hormonal system known as the hypothalamic-pituitary adrenal axis, which helps regulate the body's response to stressful events. It found that a gene variant was linked to a 20 percent higher risk of moderate to severe neck pain six weeks after a collision, as well as greater body pain.
"The one thing we're learning is that the physiological machinery that's activated when one is exposed to a life-threatening situation, such as a car crash or a very stressful situation, can lead to persistent pain if things don't go just right," McLean said. "For car crashes, historically, the whole challenge has been . . . if something is wrong with [patients], we would be able to see it, find it on an X-ray or MRI scan, and that discussion continues. But we missed this important point -- there's a whole biology that can cause pain that has nothing to do with broken bone or torn muscle."

The research may eventually open doors to new ways of tailoring pain treatments to each patient to better ease their suffering, said Dr. John Dombrowski, director of the Washington Pain Center in Washington, D.C.
"I think it's fascinating because I'm a clinician who's in the trenches taking care of patients," said Dombrowski, also chair of the ASA's committee on communications. "This kind of information helps me make sense of how to better deliver care."

Study author McLean cautioned, however, that the studies represent a broad first step toward individualizing pain care, noting that identifying the biology of pain is a huge accomplishment in itself.
"We're in much more the early stages, where we're trying to figure out the biology of this illness and then, later on, how that biology varies from person to person," he said.

Research presented at scientific conferences has not been peer-reviewed and results are considered preliminary.

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Study Ties Common Back Ailment to Faulty Gene

Lower back pain that occurs when discs in the spine deteriorate over time may be linked to a specific gene, according to a new study.

Researchers at King's College London said their findings could lead to the development of new treatments for this common type of back pain, known as lumbar disc degeneration.

Vertebrates develop bony growths called osteophytes when the discs next to them become dehydrated and lose height. These growths can lead to lower back pain. More than one-third of middle-aged women have at least one degenerate disc, the researchers said, and between 65 and 80 percent of the people with this condition inherited it.

By comparing the spines of 4,600 people using MRI images and mapping their genes, the study found the PARK2 gene, in particular, was linked to those with degenerating discs. This gene, they explained, may be turned off in people with lumbar disc degeneration. The researchers also said this gene could affect how quickly discs in the spine deteriorate.

It's still unclear how the PARK2 gene may get turned off in people with lumbar disc degeneration. The researchers suggested environmental factors, such as lifestyle or diet, could play a role.

"Further work by disc researchers to define the role of this gene will, we hope, shed light on one of the most important causes of lower back pain," said Dr. Frances Williams, senior lecturer from the department of twin research and genetic epidemiology at King's College London, in a college news release.

The study authors added that more research is needed to fully explain how this condition is triggered. Their research uncovered an association between the gene and disc problems, not a cause and effect.
"It is feasible that if we can build on this finding and improve our knowledge of the condition, we may one day be able to develop new, more effective treatments for back pain caused by this common condition," Williams added.

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New Guidelines for Doctors Treating Low Back Pain

Experts have developed evidence-based guidelines to help doctors manage patients with acute low back pain.

Low back pain is one of the most common reasons for outpatient visits to doctors, but there is a lack of consistency in how best to handle these cases, according to the team that developed the guidelines, which were published in the October issue of the Journal of the American College of Radiology.

"The approach to the workup and management of low back pain by physicians and other practitioners is inconstant," article co-author Dr. Scott Forseen said in a journal news release. "There is significant variability in the diagnostic workup of back pain among physicians within and between specialties."

He and his colleagues at Emory University Hospital and Georgia Health Sciences University developed a process for how doctors should manage patients with low back pain.

During their first visit, patients should be categorized into one of three groups after a thorough medical history and physical examination: non-specific low back pain; low back pain potentially associated with compression of a nerve in the spine (radiculopathy) or abnormal narrowing of the spinal canal (spinal stenosis); or low back pain potentially associated with a specific cause.

The guidelines also provide evidence-based information for each category of patient to guide doctors through the process of evaluation, management and follow-up of patients, including recommendations for appropriate imaging and laboratory tests and referral for consultation about surgery or other procedures.

"We have presented a logical method of choosing, developing and implementing clinical decision support interventions that is based on the best available evidence," Forseen said. "These templates may be reasonably expected to improve patient care, decrease inappropriate imaging utilization, reduce the inappropriate use of steroids and narcotics, and potentially decrease the number of inappropriate invasive procedures."

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'Half-Match' Marrow Transplants Help Some With Sickle Cell

 In what might one day prove to be a breakthrough for those suffering from sickle cell anemia, new research suggests that bone marrow transplants based on partially matched donors can, in some cases, turn out as well for patients as fully matched transplants.

But, the finding is based on a very small study involving just 17 patients, and was described as "preliminary" in nature.

Still, with fully matched donors in drastically short supply, the notion that so-called "half-matched" transplants might also work raises the possibility that many more patients could avail themselves of a treatment for what can be an extremely painful, debilitating and ultimately fatal illness.

"We're trying to reformat the blood system and give patients new blood cells to replace the diseased ones, much like you would replace a computer's circuitry with an entirely new hard drive," study author Dr. Robert Brodsky, director of the division of hematology at Johns Hopkins and the Johns Hopkins Family Professor of Medicine and Oncology in Baltimore, said in a university news release.

"[But] while bone marrow transplants have long been known to cure sickle cell disease, only a small percentage of patients have fully matched eligible donors," he added.

Brodsky and his colleagues discussed the donor dilemma and their efforts to broaden transplant options in the Sept. 6 online edition of the journal Blood.

Roughly 100,000 Americans live with sickle cell anemia, a genetic disorder that impedes the normal workings of hemoglobin molecules responsible for transporting oxygen within red blood cells. The stiffening and misshaping of such cells into the telltale form of a "sickle" ultimately leads to cell clumping. In the end, oxygen delivery to organs and tissues shuts down.

As the illness progresses, patients typically struggle with excruciating pain, along with a risk complications, including kidney failure, stroke, lung disease and blood clots. Many die of the disease before the age of 50.
Treatment is often centered around the use of narcotics for pain control, along with frequent blood transfusions and hospitalizations.

The good news: bone marrow transplants involving fully matched tissue donors have shown the potential to effect a cure in some patients.

The bad news: the vast majority of patients are black (with about one in every 400 blacks struck by the disease) and national donor registries are limited, leaving many to wait in vain for a donor match.
Brodsky and his team performed bone marrow transplants involving both fully matched donors (three cases) and half-matched donors (14 cases), among patients between 15 and 46 years of age.

Both full and partial donor matches were drawn from family members such as parents, children and/or siblings. And all patients underwent a comparatively "gentle" pre-procedure prep regimen of immuno-suppression, chemotherapy and radiation treatment, the study authors said.

The result: 11 of the 17 transplants were deemed "successful." And of these 11 patients, eight had undergone half-matched operations.

The study authors said there were no fatalities. They concluded that the half-matched approach appeared to produce a success rate greater than 50 percent.

Dr. Zora Rogers, clinical director of the General Hematology Program at the Children's Medical Center in Dallas, said that while the findings are "encouraging," they should be interpreted with caution.

"First of all," she said, "it's important to recognize that this half-matched procedure performed predominantly among adults was not as good as a fully matched transplant performed among children would be, where the cure rate exceeds 90 percent. In fact, when you look at the 11 patients they say got better, six of them, if you will, were really 'cured' of their disease, while the other five of them remained a mixture of someone with the disease and without."

"But more importantly," Rogers added, "I would also point out that what a success rate of a little bit over 50 percent means is that you could go through this very big deal transplant, put your life at risk, and have it fail about half the time. Now, sickle cell is a horrible disease. Don't get me wrong. But unlike in leukemia or other malignancies where a transplant is your only hope, with sickle cell it's just an option. So, for patients who wish to pursue a cure this may expand their choices. But they need to consider this information carefully."

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New Study Debunks Virus Theory for Chronic Fatigue Syndrome

Confirming earlier scientific doubts, a new study concludes that chronic fatigue syndrome is not caused by two viruses known as XMRV and pMLV.

Researchers from the U.S. National Institutes of Health, the U.S. Centers for Disease Control and Prevention, Columbia University and other institutions, including some scientists who did the original research, examined 147 patients with chronic fatigue syndrome from sites across the country and compared them to 146 healthy patients.

Bottom line? "This analysis reveals no evidence of either XMRV or pMLV infection," the authors wrote. The study is published in the September/October issue of the journal mBio.

Chronic fatigue syndrome, also called myalgic encephalomyelitis, affects about 1 million people in the United States, according to a Columbia news release, with women more likely to have the diagnosis. The condition is marked by unexplained fatigue that doesn't get better with bed rest.

Patients also report problems with memory or other thinking skills, muscle or joint pain, headache and other symptoms.

In 2009, a paper published in the journal Science connected the syndrome to infection with a mouse virus known as XMRV, for xenotropic murine leukemia virus-related virus.

In 2010, another study found a virus, polytropic murine leukemia virus, called pMLV, in some patients, which lent more support to a viral theory.

However, editors at Science later retracted the 2009 report, saying follow-up findings failed to confirm the original findings.

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Chronic Pain May Cost U.S. $635 Billion a Year

Americans spend as much as $635 billion each year on the direct and indirect costs associated with chronic pain, according to a new study.

That's more than the annual costs associated with cancer, heart disease and diabetes, said study authors Darrell Gaskin and Patrick Richard, health economists at Johns Hopkins University. They based their estimate on health care costs and lost worker productivity associated with chronic pain.

The researches analyzed the 2008 Medical Expenditure Panel Survey to measure the incremental health care costs for people affected by chronic pain -- including pain that interferes with work, joint pain, arthritis and disabilities -- and compared them to costs for people without chronic pain. The study involved more than 20,200 U.S. adults.

The costs of certain conditions were calculated for a variety of payers of health care services, the researchers noted.

The study, published in the Journal of Pain, found average health care costs for adults were $4,475. People suffering from moderate pain paid $4,516 more in health care costs than those without pain, the researchers said. Patients with severe pain spent $3,210 more than people with only moderate pain. Costs were also $4,048 higher for those with joint pain, $5,838 higher for people with arthritis and $9,680 more for those with functional disabilities.

When prevalence of pain conditions was assessed, moderate pain accounted for 10 percent, severe pain accounted for 11 percent and disability represented 12 percent. Estimates for joint pain and arthritis were higher. They accounted for 33 percent and 25 percent of prevalence estimates, respectively.

The researchers noted that adults affected by chronic pain missed more workdays than people without pain. This affected their annual hours worked and hourly wages. The study concluded the total cost associated with pain in the United States was at least $560 billion and possibly as high as $635 billion, according to a release from the American Pain Society.

Broken down, the total incremental costs of health care resulting from chronic pain ranged from $261 billion to $300 billion. And the costs associated with lost productivity ranged from $299 billion to $334 billion. Although the per-person cost of pain is less than the cost of other diseases, the researchers said the total cost of chronic pain is higher. They said the costs associated with chronic pain would be even greater if they took into account nursing home residents, military personnel, prisoners, children and caregivers.

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Morton's Neuroma

Morton's neuroma facts

• Morton's neuroma is a swollen, inflamed nerve in the foot.
• Morton's neuroma causes a "burning" sharp pain on the bottom of the foot.
• Treatments for Morton's neuroma include resting the foot, better-fitting shoes, anti-inflammation medications, ice packs, and operation.

What is Morton's neuroma?

A neuroma is growth (benign tumor) that arises in nerve cells. A Morton's neuroma is a swollen, inflamed nerve located between the bones at the ball of the foot. The most common location of a Morton's neuroma is in either the second or the third spacing from the base of the big toe.

What causes a Morton's neuroma?

A Morton's neuroma is caused by compression of the nerve of sensation between the ends of the metatarsal bones at the base of the toes.

What are risk factors for developing a Morton's neuroma?

Improper footwear that excessively binds the forefoot can lead to a Morton's neuroma.

What are symptoms of a Morton's neuroma?

A Morton's neuroma causes a "burning" sharp pain and numbness on the bottom of the foot in the involved area, and this pain and numbness can radiate to the nearby toes. The pain is usually increased by walking or when the ball of the foot is squeezed together and decreased with massaging. It may force a person to stop walking or to limp from the pain.

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Rotator Cuff Disease

What is the rotator cuff?

The rotator cuff is the group of four tendons that stabilize the shoulder joint. The tendons hook up to the four muscles that move the shoulder in various directions.
There are four muscles whose tendons form the rotator cuff: the subscapularis muscle, which moves the arm by turning it inward (internal rotation); the supraspinatus muscle, which is responsible for elevating the arm and moving it away from the body; the infraspinatus muscle, which assists the lifting of the arm during turning the arm outward (external rotation); and the teres minor muscle, which also helps in the outward turning of the arm.

What causes rotator cuff disease?

Rotator cuff disease is damage to the rotator cuff from any cause. It can be from an acute injury or from repetitive strains. This condition is one of the most common causes of shoulder pain.

How is the rotator cuff injured?

The rotator cuff can be injured because of degeneration with aging or inflammation due to tendinitis, bursitis, or arthritis of the shoulder. The rotator cuff is commonly injured by trauma (such as from falling and injuring the shoulder or overuse in sports). Rotator cuff injury is particularly common in people who perform repetitive overhead motions that can stress the rotator cuff. These motions are frequently associated with muscle fatigue.

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Health Tip: Help Ease Fibromyalgia Symptoms

If you've gone to the doctor complaining of widespread aches and pains without an obvious cause, it's possible you've been diagnosed with fibromyalgia.

The womenshealth.gov website provides these suggestions to help manage this often-misunderstood disorder:

• Get plenty of quality sleep each night.
• Be physically active. Perform gentle exercises, if possible.
• Make adjustments at the office, such as cutting back on hours to adjusting the type of work you do.
• Eat a healthy, balanced and nutritious diet.

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Juggling a Hospital Job and Family Can Be Painful

The greater the conflict between their job and family demands, the more likely it is that nurses and other hospital workers will suffer musculoskeletal pain, a new study finds.

Researchers surveyed nearly 1,200 patient care workers at two Boston hospitals. Overall, those who reported high levels of conflict between their work duties and obligations at home were twice as likely to suffer from any kind of musculoskeletal pain in the previous three months.

They were twice as likely to have neck or shoulder pain, and those with the greatest home-work imbalance were nearly three times more likely to have arm pain. There was no link between work-family conflict and lower back pain.

The study was published online Sept. 27 in the American Journal of Industrial Medicine.

"Work-family conflict can be distracting and stressful for hospital employees," lead author Seung-Sup Kim, a postdoctoral scientist and professorial lecturer in environmental and occupational health at the George Washington University School of Public Health and Health Services, said in a university news release.
"Hospitals that adopt policies to reduce the juggling act might gain a host of benefits, including a more productive workforce, one that is not slowed down by chronic aches and pains," Kim suggested.

Further research is required to confirm a direct link between work-family conflict and an increased risk of musculoskeletal pain. But even these initial findings should convince hospital administrators to assess working conditions in their facilities, the researchers said.

"Hospital employees who don't have to juggle extreme work hours and family obligations might be happier and more productive on the job. And that's a win-win situation that will benefit not just hospitals but also workers, patients -- and family members," Kim noted.

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Which Route Leads from Chronic Back Pain to Depression?

A path analysis on direct and indirect effects using the cognitive mediators catastrophizing and helplessness/hopelessness in a general population sample.

Abstract

BACKGROUND:

Chronic pain and depression are highly comorbid; however, the longitudinal link is only partially understood. This study examined direct and indirect effects of chronic back pain on depression using path analysis in a general population sample, focussing on cognitive mediator variables.

METHODS:

Analyses are based on 413 participants (aged 18-75 years) in a population-based postal survey on back pain who reported chronic back pain at baseline. Follow-up data were collected after 1 year. Depression was measured with the Center for Epidemiologic Studies Depression Scale (CES-D). Fear-avoidance-beliefs (FABQ), catastrophizing and helplessness/hopelessness (KRSS) were considered as cognitive mediators. Data were analyzed using path analysis.

RESULTS:

Chronic back pain had no direct effect on depression at follow-up when controlling for cognitive mediators. A mediating effect emerged for helplessness/hopelessness but not for catastrophizing or fear-avoidance beliefs.

CONCLUSIONS:

These results support the cognitive mediation hypothesis which assumes that psychological variables mediate the association between pain and depression. The importance of helplessness/hopelessness is of relevance for the treatment of patients with chronic back pain.

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Overview of out-patient pain treatment in Austria

Abstract

BACKGROUND:

Chronic pain is a widespread social problem. This paper reports on the care situation for patients with chronic pain in out-patient community settings in Austria.

MATERIALS AND METHODS:

The study took the form of a telephone survey together with internet research. Every second out-patient pain service (from a total of 83) was contacted and 21 out of 42 agreed to participate.

RESULTS:

The number of community-based physicians with a certificate in pain therapy as well as the number of out-patient pain services showed considerable regional variation. Partial or full interdisciplinary teams are a feature of approximately 50% of out-patient pain units and 76% of such services use guidelines according to their own estimation. Pain perception tends to be measured using pain rating scales rather than pain questionnaires. A wide range of treatments is offered either directly or via referral.

CONCLUSIONS:

Quality criteria relating to the structure of care established by the Austrian Society for Pain have only been partially implemented. Potential for improvement exists particularly with regards to the prevalence of pain-specific training, interdisciplinary teamwork and the measurement of outcomes.

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