Acupuncture in Fibromyalgia

March 5, 2008 updated by: National Center for Complementary and Integrative Health (NCCIH)

Pilot Study of Acupuncture in Fibromyalgia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Study Completion

July 1, 2003

Study Registration Dates

First Submitted

February 2, 2001

First Submitted That Met QC Criteria

February 2, 2001

First Posted (Estimate)

February 5, 2001

Study Record Updates

Last Update Posted (Estimate)

March 7, 2008

Last Update Submitted That Met QC Criteria

March 5, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01 AT000004-01M
  • R01AT000004-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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