Fibromyalgia is the second most common rheumatic disorder, affecting approximately 8 - 10 million persons in the U.S. This condition is characterized by the presence of widespread musculoskeletal pain, and of soft tissue tenderness on examination. Although there are several therapeutic modalities that have been demonstrated to be somewhat effective in relieving the symptoms of fibromyalgia, despite these treatments most persons with this illness continue to be quite debilitated. Acupuncture, although considered an alternative therapy in the West, has been demonstrated to be effective in treating several conditions, and a growing data base suggests that acupuncture may be a particularly effective and safe intervention for a variety of pain syndromes. Since the cardinal manifestation of fibromyalgia is pain, and current treatments are frequently ineffective, fibromyalgia is an ideal disorder to examine for efficacy with this treatment modality. Although there have been anecdotal reports of the efficacy of fibromyalgia, there has only been one randomized controlled trial, and there are numerous methodological problems with this study that limit the interpretation of these data. This pilot study will examine numerous issues regarding the use of acupuncture as a therapeutic modality in fibromyalgia, so that a full scale randomized controlled trial (RCT) could be performed in this condition. The issues which will be examined include: 1) the optimal duration and frequency of treatment, 2) the independent and synergistic effects of needle placement and needle stimulation on efficacy, and 3) appropriate control strategies. The present proposal utilizes a randomized, blinded, sham-controlled design that incorporates several unique aspects to accomplish these aims. A 2 X 2 factorial design will be used examine the individual and synergistic effects of both needle placement and of needle stimulation on the efficacy of acupuncture. The four arms of the trial will include: 1) active site, with stimulation, 2) active site, without stimulation, 3) sham site, with stimulation, and 4) sham site, without stimulation. In each of the four arms of the trial, subjects will receive acupuncture in escalating frequency, beginning at once weekly and culminating in three times weekly. This """"""""forced-titration"""""""" design is commonly used in the preliminary phases of drug (development, to examine the optimal dose of a medication for each person in a trial. In this manner, we will be able to determine the """"""""dose-effect"""""""" for the analgesic effect of acupuncture in each person, and in each group. This design allows the detection of inter-patient differences in responsiveness to acupuncture, as well as the factors which may predict responsiveness (or a lack thereof). Secondary goals of the study are to collect pilot data on the mechanism, safety, and cost-effectiveness of acupuncture in fibromyalgia, and to determine the optimal outcome measures, for a full-scale RCT.
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