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NCT00010764 · ClinicalTrials.gov registry record · Phase 1
Efficacy of Acupuncture in the Treatment of Fibromyalgia
A Phase 1 study, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- Completed
- Registry status
- Phase 1
- Development phase
NCT00010764 is a Phase 1 study that has completed, run by National Center for Complementary and Integrative Health (NCCIH).
The verdict
NCT00010764, a Phase 1 study, has completed, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- COMPLETED
- Registry status
- Phase 1
- Development phase
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
Interventions
- PROCEDURE Acupuncture
Trial Details
| Field | Value |
|---|---|
| Start Date | 2000-09 |
| Est. Completion | 2002-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00010764
The ClinicalTrials.gov registry entry for NCT00010764 describes a study currently listed as completed, categorized as Phase 1. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Center for Complementary and Integrative Health (NCCIH), which has 203 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Acupuncture is the first listed.
NCT00010764 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00010764 about?
NCT00010764 is a clinical study titled "Efficacy of Acupuncture in the Treatment of Fibromyalgia". 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 inter...
What is the current status of trial NCT00010764?
This trial is currently completed. It is a Phase 1 study. The study started on 2000-09. Estimated completion is 2002-07.
What interventions are being tested in trial NCT00010764?
The interventions under investigation include: Acupuncture (PROCEDURE).
Who is sponsoring clinical trial NCT00010764?
This trial is sponsored by National Center for Complementary and Integrative Health (NCCIH), which has 203 total clinical trials registered on ClinicalTrials.gov.
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