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Acupuncture in Fibromyalgia

This study has been completed.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH) Identifier:
First received: February 2, 2001
Last updated: March 5, 2008
Last verified: March 2008
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Pilot Study of Acupuncture in Fibromyalgia

Resource links provided by NLM:

Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

Study Start Date: August 2000
Estimated Study Completion Date: July 2003

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information Identifier: NCT00010504     History of Changes
Obsolete Identifiers: NCT00006338
Other Study ID Numbers: R01 AT000004-01M
R01AT000004-01 ( U.S. NIH Grant/Contract )
Study First Received: February 2, 2001
Last Updated: March 5, 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 processed this record on August 22, 2017