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| Sponsor: | National Center for Complementary and Alternative Medicine (NCCAM) |
|---|---|
| Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
| ClinicalTrials.gov Identifier: | NCT00010504 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fibromyalgia Pain |
Procedure: Acupuncture |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Pilot Study of Acupuncture in Fibromyalgia |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, District of Columbia | |
| Georgetown University | |
| Washington, District of Columbia, United States, 20007 | |
| Study Director: | Thomas R. Cupps, M.D. | Georgetown University |
More Information
| Study ID Numbers: | R01 AT000004-01M, R01 AT000004-01 |
| Study First Received: | February 2, 2001 |
| Last Updated: | March 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00010504 History of Changes |
| Health Authority: | United States: Federal Government |
|
acupuncture fibromyalgia pain analgesia |
|
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Nervous System Diseases Rheumatic Diseases |