Acupuncture in Fibromyalgia - Full Text View

Purpose

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 III

MedlinePlus related topics:

Acupuncture Fibromyalgia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Pilot Study of Acupuncture in Fibromyalgia

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010504

Locations


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

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators


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

More Information

Study ID Numbers:	R01 AT000004-01M, R01 AT000004-01
First Received:	February 2, 2001
Last Updated:	March 5, 2008
ClinicalTrials.gov Identifier:	NCT00010504
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

acupuncture

fibromyalgia

pain

analgesia

Study placed in the following topic categories:

Muscular Diseases

Neuromuscular Diseases

Musculoskeletal Diseases

Myofascial Pain Syndromes

Fibromyalgia

Pain

Rheumatic Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00010504