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Efficacy of Acupuncture in the Treatment of Fibromyalgia

NCT00010764 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2008-03-07

No results posted yet for this study

Summary

Fibromyalgia (FM), one of the most common rheumatic conditions, is a condition of unknown etiology characterized by widespread muscle pain and stiffness. Treatment is generally unsatisfactory and most randomized, controlled treatment trials have been unable to demonstrate a sustained effective intervention. A single, brief trial of electroacupuncture demonstrated remarkable improvement among patients with FM, although lasting effects were not evaluated. Nonetheless, the recently published National Institutes of Health Consensus Development Statement on Acupuncture says "musculoskeletal conditions such as fibromyalgia, myofascial pain ....are conditions for which acupuncture may be beneficial". Thus, 96 patients will be recruited from a referral clinic for fatigue for a 12 week (24 treatments) trial. These patients will be randomized into 3 control groups and 1 "true" acupuncture group. The control groups will consist of a group receiving acupuncture treatment for an unrelated condition (morning sickness), a group receiving needle insertion at non-channel, non-point locations, and a "true" placebo group. This latter group will have acupuncture needle guides tapped on the skin, then needles tapped. Thus, the specific aims of this study are to 1) evaluate the short and long term efficacy and side effects of a 12 week randomized, controlled trial of bi-weekly acupuncture in the treatment of FM; 2) establish the most useful and scientifically sound control group for studies of acupuncture using FM as a model for conditions characterized by chronic pain; 3) use both subjective and objective measures of overall health and pain to determine the optimal time length of treatment; and 4) examine the concordance of allopathic and acupuncture-based measures of outcome. For the purposes of this study, subjects will be asked to complete a unique set of study measures at enrollment, at 4, 8, and 12 weeks, and then again at 1 and 6 months post-treatment. Our primary outcomes will be patient global assessment, subjective pain, and mean number of tender points. Secondary outcomes will be pain threshold, analgesic use, physician global assessment, functional status, sleep, psychological distress, and fatigue. Thus, this trial will have both immediate and longer term implications for the scientific study of acupuncture as well as the clinical care of the estimated 5 million patients with FM in the US. From a methodological point of view, the proposed trial will establish the most appropriate methods for choosing a control group should larger trials be conducted, suggest the optimum duration of treatment, and evaluate the utility of diverse allopathic and alternative outcome measures. Of equal importance, however, this research will test and potentially establish the effectiveness of acupuncture.

Conditions

  • Fibromyalgia

Interventions

PROCEDURE

Acupuncture

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    lead NIH

Principal Investigators

  • Debra S. Buchwald, MD · Harborview Injury Prevention and Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-09-30
Completion
2002-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00010764 on ClinicalTrials.gov