Acupuncture in Fibromyalgia

NCT ID: NCT00010504

Last Updated: 2008-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31
• Study Completion Date: 2003-07-31

Brief Summary

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.

Conditions

Fibromyalgia; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Acupuncture

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: lead

Principal Investigators

Thomas R. Cupps, M.D.

Role: STUDY_DIRECTOR

Georgetown University

Locations

Georgetown University

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

R01AT000004-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01 AT000004-01M

Identifier Type: -

Identifier Source: org_study_id

NCT00006338

Identifier Type: -

Identifier Source: nct_alias