Acupuncture in Fibromyalgia

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. Read our disclaimer for details. Identifier: NCT00010504
Recruitment Status : Completed
First Posted : February 5, 2001
Last Update Posted : March 7, 2008
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Pain Procedure: Acupuncture Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Pilot Study of Acupuncture in Fibromyalgia
Study Start Date : August 2000
Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00010504

United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Study Director: Thomas R. Cupps, M.D. Georgetown University Identifier: NCT00010504     History of Changes
Obsolete Identifiers: NCT00006338
Other Study ID Numbers: R01 AT000004-01M
R01AT000004-01 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2001    Key Record Dates
Last Update Posted: March 7, 2008
Last Verified: March 2008

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases