Fibromyalgia syndrome (FMS) is characterized by diffuse pain in muscle, fascia and tendons, generalized muscular stiffness, and fatigue. FMS is among the most common musculoskeletal maladies seen by primary care physicians and rheumatologists. FMS patients (pts) typically report high levels of use of medical resources, functional disability and psychosocial distress. Multifaceted treatment regimens are often recommended, including non-narcotic analgesics, antidepressants, muscle relaxants and exercise. Usually, however, these are only incompletely effective in allaying symptoms of FMS, and may be inconvenient, expensive, and/or poorly tolerated. FMS pts often seek treatment by non- medical practitioners, e.g., chiropractors, and express interest in various manipulation therapies, including massage. We propose to evaluate the response of FMS pts to a standard treatment protocol (analgesics, nonsteroidal antiinflammatory drugs, anti- depressants, muscle relaxants, patient education and an exercise program) supplemented by Swedish massage therapy provided by a registered nurse trained in this technique. Massage treatments will initially be administrated weekly, with increases in the interval between treatments over a 7 month period (13 visits). Comparisons will be made between outcomes in this experimental group and those in a control group of FMS pts who will be seen by a rheumatologists utilizing the above treatment protocol, but without massage, with 5 visits over the 7 month period. A third group of FMS pts (attention-control) will receive rheumatologist- delivered care (also without massage) supplemented by telephone calls made by a nurse at a frequency comparable to that of the clinic visits made by the experimentals group. During the phone calls, the nurse will discuss the pts' symptoms, resolve questions and encourage compliance with the treatment program. Sixty pts will be randomly assigned to each treatment (20/group). Health-care costs will be extracted from the pt's computerized medical record. Information regarding costs will be supplemented by pt diaries. Pts will periodically complete the Fibromyalgia Assessment and Symptom Tally (FAST), Quality of Well-Being (QWB), and psychological instruments, Rheumatology Attitudes Index (RAI) and Coping Strategies Questionnaire (CSQ). Between-group difference in outcome will be expressed as disease-specific and general health status outcomes (FAST and QWB, respectively), attitudes and coping strategies, direct cost of medical care, quality-adjusted life years (QALY) experienced, and cost utility (cost to produce a QALY under each condition).
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