Current therapies leave most fibromyalgia patients “still living with considerable pain.”
With a $5.5 million grant from the National Institutes of Health, scientists at the University of Rochester (NY) Medical Center and the University of Washington School of Medicine (Seattle) are planning a clinical trial to evaluate the ability of behavior-change therapy added to the pain drug tramadol to ease fibromyalgia’s chronic, widespread pain.
The trial will enroll approximately 250 patients in Rochester and Seattle over the next four years, with enrollment likely to begin this summer.
Calls for such a study – from doctors, advocates, patients and their families – stem from the very modest benefits that available therapies provide for the millions, mostly women, who struggle with this often debilitating disorder (3 to 6 million in the US alone).
“Overall, current treatments for fibromyalgia are only partially effective: No more than half of patients get relief, and the other half stop therapy because they don’t get relief or they don’t like the side effects,” says Robert H. Dworkin, PhD, a professor in U of Rochester’s Center for Human Experimental Therapeutics. “Of those patients who do get relief, their pain doesn’t decrease dramatically; it goes down by a third, a half at most, so they are still living with considerable pain.”
And no other studies have looked at the combination of medication and behavioral treatment in any chronic pain condition, he suggests.
Dr. Dworkin will collaborate in the study with lead investigator Dennis C. Turk, PhD, a professor in the department of anesthesiology and pain research at the U of Washington. An internationally recognized leader in pain research, Dr. Turk specializes in the study of fibromyalgia.
Drs. Turk and Dworkin will study the effects of tramadol (brand name Ultram, a drug approved for the treatment of acute and chronic pain), combined with either cognitive-behavioral therapy or health education treatment – both of which work to change the way people think about their condition to ultimately improve the way they act and feel.
The objective: to determine if a drug plus one of the behavioral health treatments could be better than either one alone.
More Activity Critical to Quality of Life
Researchers are not only interested in the combo’s influence on pain, but on patients’ ability to carry out the activities of daily life, as well.
Past research, and Drs. Dworkin and Turks’ own experience studying fibromyalgia, suggest that increasing activity is critical in helping patients get better.
“When you are more active and can do the things you want to do - go to the movies with your family, walk around the mall, do housework - it takes your mind off the pain and makes you feel better about your life overall,” says Dr. Dworkin. Major goals will be to measure both physical activity and enhanced sleep quality, he adds. “I liken it to a virtuous circle or a positive loop: When you are more physically active you sleep better, and when you sleep better you have less pain, and when you have less pain you can do more of the things you love to do.”
Behavioral Treatments Were Designed for Fibro
The behavioral health treatments that will be used in the study were designed specifically for fibromyalgia patients, says U Rochester Prof. Ellen Poleshuck, PhD, who will help run the trial.
Participants will learn about fibromyalgia and various strategies for improved coping. Strategies will include, for example:
• Pacing – understanding how much activity they can manage and monitoring themselves accordingly,
• And sleep hygiene, such as not doing anything in bed besides sleeping.
The researchers will measure pain reduction using daily pain diaries completed just prior to and at the end of treatment.
Device Will Help Measure Activity Level, Sleep Patterns
Patients will also wear a wrist watch-like device that includes an accelerometer to provide an objective measure of changes in activity level. The device, called an ActiGraph, also determines sleep patterns and circadian rhythms so will be used to measure the quality of participants’ sleep as well.
Biological Processes Linked to Good Response
Finally, researchers will examine the psychological and biological processes that may cause patients to respond well to treatment.
• One theory is that we all have a built-in pain control system by which our bodies can turn off or decrease pain – an idea that explains why injured soldiers can continue fighting even when they are in excruciating pain.
• Drs. Dworkin and Turk hypothesize that a subgroup of fibromyalgia patients may have impairments in the ability of their own bodies to lessen their pain, and that reductions in pain through treatment may be accounted for by repairing or restoring this internal pain-control function.
The study is funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases at the National Institutes of Health.
Source: Based on University of Rochester Medical Center news release, Feb 27, 2012