NIH PROJECT TO STUDY NONDRUG TREATMENTS FOR FIBROMYALGIA COLUMBUS -- Some 6 million Americans suffer chronic pain resulting from fibromyalgia, a rheumatic disease with no known cause or cure. Conventional treatments have shown limited success, leaving many people unable to function efficiently at home or work. But a new National Institutes of Health study led by researchers in Ohio and North Carolina could lead to treatments that not only decrease pain, but improve physical and psychological functioning as well through exercise and training in pain coping skills, said Francis Keefe, professor of health psychology at Ohio University and principal investigator on the project. Called Project Uplift -- or Understanding Pain and Lifestyle Improvements in response to Fibromyalgia Treatments -- the effort is being carried out by a multidisciplinary team of health psychologists, rheumatologists and exercise physiologists at Ohio University, Ohio State University and Duke University Medical Center. “It’s one of the most common rheumatic diseases,” Keefe said. “It’s a chronic condition, but the course the disease takes over time is not well understood because it hasn’t been studied enough.” The researchers hope to enroll 180 fibromyalgia patients from central and southeastern Ohio and surrounding areas. Patients will follow one of four different protocols for 12 to 16 weeks and participate in a 19-month follow-up. Protocols include coping skills training, exercise therapy and a combination of the two. Earlier studies have explored coping skills training and physical exercise training for treatment of fibromyalgia and other rheumatic diseases, but most studies were small, not confined to fibromyalgia patients, and failed to consider a combined approach to treatment. “This project is the first large, well-controlled study that directly examines how coping skills training and exercise training can be used to help patients with fibromyalgia,” said Charles Emery, associate professor of psychology and coordinator of Ohio State University’s portion of the study. “We’re hoping this research leads to more effective treatments.” “Our review of the literature suggests our study will answer some of the questions not addressed in these earlier studies,” Keefe added. “We are particularly interested in the combination of coping skills training and exercise as a way to manage chronic pain associated with fibromyalgia.” Fibromyalgia is characterized by widespread pain and pain in 11 of 18 standard tender points on the body. Patients also are prone to sleep problems, fatigue, muscle stiffness, headaches, memory and concentration problems, dizziness, numbness and tingling, itching, fluid retention, crampy abdominal or pelvic pain and diarrhea, and several other symptoms. Fibromyalgia symptoms can be intensified during exposure to demanding physical activities, cold temperatures or during times of stress. Onset of the disease typically occurs between age 20 and 50, but the illness has been seen in children. And, for reasons scientists don’t fully understand, fibromyalgia is more likely to occur in women. About 20 percent of fibromyalgia patients do experience remission, but it’s not known if remission is permanent. People studying the cause of the disease are considering several theories: Some suspect the problem is primarily due to an abnormality in deep sleep patterns, while others think that disruptions of the immune and neuroendocrine systems, possibly related to sleep problems, may account for the disorder. To participate in the project, patients must be diagnosed with fibromyalgia by a physician, preferably a rheumatologist; be free from any other serious health condition or rheumatic disease such as arthritis; be age 21 or older; and be available to participate in the full duration of the study. Patients living in southeastern Ohio and surrounding areas will take part in studies at Ohio University’s Athens campus, while patients in central Ohio will participate at the Camera Center at 2050 Kenny Road. Before beginning the study, candidates are screened over the telephone to determine their eligibility and availability. The next step includes a battery of questionnaires designed to assess their symptoms and current activity level and identify how patients cope with their illness. Participants then undergo an exam by a rheumatologist, a treadmill test, and are then assigned randomly to one of the four protocols: -- Coping skills training: Patients attend 14 weekly group sessions where they learn about new research on the relationship of pain to thoughts, feelings and behavior. Participants in this group are taught to control their pain and other fibromyalgia symptoms through relaxation methods, goal setting, activity pacing, imagery, problem solving and relapse prevention techniques. -- Physical exercise training: Patients will participate in a supervised exercise program three times a week for 16 weeks. The program includes aerobic activities such as pool exercises, walking and cycling. -- Coping skills and physical exercise training: Patients will attend three exercise sessions and one group session each week for 16 weeks. -- Waiting list control group: During the 16-week test period and a three-month follow-up, patients will not take part in the physical exercise or coping skills training sessions. At the end of the follow-up, patients can enroll in any one of the three protocols, depending on which is offered in their region. The three-year, $1.1 million project began last year at Duke University Medical Center, where Keefe was a professor of medical psychology and director of the Pain Management Program. He moved his office and the grant to Ohio University in January. Sixty-five participants have enrolled in the program at Duke. While researchers have not completed evaluations of those patients, some of whom have completed the study, Keefe said preliminary findings suggest patients benefit from the different training programs. “We’re hoping to determine how effective these treatments are and what type of symptoms respond best to these treatments,” Keefe said. And since participants will not be required to discontinue any drug therapy they are taking, scientists also will monitor the effect of drug and nondrug therapies in the different groups. In southeastern Ohio, more information on Project Uplift is available by writing to Project Uplift, c/o Francis Keefe, 200 Porter Hall, Ohio University, Athens, OH 45701-2979, or by contacting Jana Drew, study coordinator, in Athens at (740) 593- 2960. In Columbus and central Ohio, call Jana Drew at (614) 293- 2800 ext. 6-0829. If calling either location, candidates should leave a name and phone number after the recording. # Contact: Frank Keefe, Ohio University Department of Psychology, (740) 593-2960 Charles Emery, Ohio State University Department of Psychology, (614) 688-3061