Acupuncture in Fibromyalgia
This study has been completed.
First Posted: February 5, 2001
Last Update Posted: March 7, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
Fibromyalgia is the second most common rheumatic disorder, affecting approximately 8-10 million persons in the U.S., and is characterized by widespread musculoskeletal pain and soft tissue tenderness upon examination. This study focuses on the use of acupuncture as a mode of therapy for fibromyalgia. The issues under examination are: 1) the optimal duration of treatment, 2) the independent and synergistic effects of needle placement and needle stimulation, and 3) appropriate control strategies. The proposal utilizes a randomized, blinded, sham-controlled design to achieve these aims. Subjects are randomly assigned to one of four groups: 1)active site with stimulation, 2) active site, without stimulation, 3) sham site with stimulation, and 4) sham site, without stimulation. All subjects will receive acupuncture at escalating frequency, beginning at once per week and ending at 3 times per week. This "forced titration" design allows for the detection of inter-subject differences in responsiveness to acupuncture, as well as the factors which may predict responsiveness (or lack thereof). Secondary goals of the study are to collect data on the mechanism, safety, and cost-effectiveness of acupuncture in fibromyalgia, and to determine the optimal outcome measures, for a full scale research clinical trial.
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||Pilot Study of Acupuncture in Fibromyalgia
| Study Start Date:
| Estimated Study Completion Date: