Trial of Acupuncture Added to Usual Treatment for Fibromyalgia
Early Phase 1
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial of Acupuncture Added to Usual Treatment for Fibromyalgia|
- VAS(Visual Analogical Scale)
- SF-36(Short Form 36)
- Myalgic Index
- Number of tender points
- VAS(Visual Analogical Scale)(5 times)
- SF-36(Short Form 36)(5 times)
- Myalgic Index(5 times)
- Number of tender points(5 times)
|Study Start Date:||April 2000|
|Estimated Study Completion Date:||May 2002|
Fibromyalgia is a diffuse musculoskeletal pain syndrome with multiple tender points which are widely and symmetrically distributed throughout the body. The main symptom is widespread musculoskeletal pain, lasting longer than three months, which is associated with chronic fatigue, cognitive dysfunction, sleep disorder, morning stiffness, anxiety and depression. The etiology of fibromyalgia remains unknown.
In Brazil, fibromyalgia is estimated to affect two-and-half percent of the population . This incidence is similar to other countries .Acupuncture, which involves inserting needles at specific points on the patient’s skin, is one of the oldest forms of therapy and is widely practiced in the United States. Each year about one million Americans undergo acupuncture treatments, mainly to relieve pain caused by a variety of ailments . A consensus statement from the U.S. National Institutes of Health (NIH) concluded that acupuncture may be useful as an adjunct treatment or may be an acceptable alternative treatment in a comprehensive management program for fibromyalgia patients (NIH Consensus Conference, 1998.In Brazil, there is increased interest in acupuncture; in 1995, a federal law established that the procedure can only be performed by physicians.
Systematic reviews looking at the effectiveness of acupuncture for fibromyalgia have found a limited amount of high quality scientific studies. These reviews concluded that acupuncture was more effective than sham (placebo) acupuncture in improving symptoms of fibromyalgia. There is a need for acupuncture trials that include a large sample size of patients with similar and well-defined pain conditions. Such trials should utilize standardized and well-described acupuncture stimuli. These should be placed effectively in the skin in accordance with classical Chinese experience and utilizing unequivocal primary outcome measures for the effect.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379496
|Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo|
|Sao Paulo, Brazil, 05403010|
|Principal Investigator:||Rosa A Targino, MD||University of Sao Paulo-School of Medicine|