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	Treatment or Intervention	Phase
Fibromyalgia Pain	Procedure: Acupuncture	Phase III

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Must be a resident of the Washington DC area.
• Having met ACR criteria for fibromyalgia.
• Continued widespread pain for more than 50% of days.
• Willing to limit the introduction of any new medications or treatment modalities for control of fibromyalgia symptoms during the 13 weeks of active treatment.
• Able to travel to acupuncture site up to 3 times per week.
• Capable of giving informed consent.

Exclusion Criteria:

• Knowledge of acupuncture sufficient to prevent "blinding" of the subject.
• Presence of a known coagulation abnormality that would prevent safe use of acupuncture.
• Presence of a concurrent autoimmune or inflammatory disease that causes pain.
• Routine daily use of narcotic analgesics or history of substance abuse.
• Participation in other concurrent therapeutic trials.
• Pregnant or nursing mothers.
• Disability insurance payments.
• Ongoing litigation related to fibromyalgia.
• Contraindication for the use of acetaminophen or ibuprofen.
• Any impairment, activity, or situation that in the judgement of the Study Coordinator would prevent satisfactory completion of the study protocol.

District of Columbia
      Georgetown University, Washington,  District of Columbia,  20007,  United States

Study chairs or principal investigators

Thomas R. Cupps, M.D.,  Study Director,  Georgetown University   

Study ID Numbers:  1 R01 AT00004-01M; 1 R01 AT00004-01
Record last reviewed:  September 2003
Record first received:  February 2, 2001
ClinicalTrials.gov Identifier:  NCT00010504
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-25