Primary Fibromyalgia Syndrome (PFS) is one of the most common disorders seen by the rheumatologist. Although PFS patients appear """"""""healthy"""""""" bases on objective physical examination, pain and functional impairment are significant problems for this patient group. Despite the reported short term benefits of pharmacological management or physical therapy programs, there is no controlled study reporting long term benefits. Indeed PFS is a myofascial pain condition which often""""""""waxes and wanes"""""""" for years. Psychological factors play a significant role in the maintenance and exacerbation of PFS. Nevertheless, there has been no controlled study to assess the effectiveness of a psychological intervention among these patients.
The specific aims of this project are as follows: 1. Assess the short and long term outcome of a relaxation training/biofeedback program (group 1), a conditioning physical therapy program (group 2), or an interdisciplinary combined treatment program (group 3) on improvements in pain, psychological distress, muscle tension, and functional status of PFS patients. 2. Factors most related to the above outcome will be identified. After stratification on psychological distress and duration of PFS symptoms variables, the 120 subjects will be randomly assigned to one of the three treatment groups or to an attention placebo control group which receives an educational program. The interdisciplinary group participates in both the relaxation training/biofeedback and physical therapy programs. Subjects will then participate in a six week training program followed by a three year maintenance program. Evaluation of the effectiveness of these treatment programs will be based on pain, psychological distress, psychophysiological functioning, tender points, and functional status measures. These treatment programs will be compared at the end of the six week training program. To determine the long term effectiveness of these interventions, patients will be assessed at 6, 21, and 36 months following completion of the 6 week training program and while still participating in the maintenance program. Treatment, psychological, and demographic variables associated with changes in pain and functional ability will be identified. The availability of a proven intervention program for PFS and identification of treatment and subject variables which produce positive outcomes will significantly improve the care of PFS patients.
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