For the first time, researchers will test whether two treatments are better than one for patients with fibromyalgia.
With a $5.5 million grant from the National Institutes of Health, scientists from the University of Rochester Medical Center and the University of Washington School of Medicine will evaluate the combination of a drug and behavioral health treatments in easing the chronic, widespread pain characteristic of the condition.
Calls for such a study – from experts and advocates, to patients and families – stem from the very modest benefits available therapies provide for the estimated 3 to 6 million Americans, mostly women, with the often debilitating disorder.
“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,” said Robert H. Dworkin, Ph.D., professor in the Department of Anesthesiology and the Center for Human Experimental Therapeutics at the University of Rochester Medical Center. “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.”
Dworkin, a principal investigator who will conduct the study with lead researcher and long-time collaborator Dennis C. Turk, Ph.D., the John and Emma Bonica Professor of Anesthesiology and Pain Research at the University of Washington, says no other studies have looked at the combination of medication and behavioral treatment in any chronic pain condition.
The team 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 – to determine if a drug and one of the behavioral health treatments together is better than either one alone. 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 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,” said Dworkin. “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.”
Increasing physical activity and enhancing sleep quality are major goals of the behavioral health treatments that will be provided in the trial. Ellen Poleshuck, Ph.D., associate professor in the Department of Psychiatry at the Medical Center, who will also help run the trial, says the behavioral health treatments were designed specifically for patients with fibromyalgia. Participants will learn about fibromyalgia and various strategies for improved coping, 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.
Researchers will measure pain reduction using daily pain diaries completed just prior to and at the end of treatment. 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 and will be used to measure the quality of participants’ sleep as well.
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. Dworkin and Turk hypothesize that a group 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.
Researchers hope to enroll approximately 250 patients in Rochester and Seattle over the next four years. Enrollment will likely begin this summer.
The study is funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases at the National Institutes of Health. In addition to Dworkin and Turk, James P. Robinson, M.D., Ph.D., associate professor of Rehabilitation Medicine at the University of Washington School of Medicine, will serve as principal investigator. From the University of Rochester, Janet Pennella-Vaughan, M.S., N.P., Cornelia Kamp and graduate student Shannon Smith will also participate in the research.