Fibromyalgia Clinical Trial
Official title:
A Randomized Controlled Trial of Acupuncture Added to Usual Treatment for Fibromyalgia
The aim of this study was to evaluate the effect of acupuncture as a treatment for this condition. Fifty-eight women diagnosed with fibromyalgia were randomly allocated to two groups. One group received acupuncture (n=34) twice a week for 20 sessions in addition to tricyclic antidepressants and exercises. The control group (n=24) received only tricyclic antidepressants and exercises. A blinded assessor evaluated patients’ pain using visual analog scale (VAS), tender points number (TePsN) and myalgic index (MI). The same assessor also evaluated quality of life (QoL) using SF-36. These evaluations were done prior to treatments, at the end of the 20 sessions, and again at six months, one year and two years after the first evaluation. At the end of the 20 sessions, patients who had received acupuncture were significantly better than those who had not in all measures of pain (VAS, TePsN, MI) and in five subscales of SF-36. After six months, the acupuncture group was significantly better than the control group in some measures of pain (TePsN and MI) and in three subscales of SF-36. After one year, the acupuncture group showed significant advantage in only one subscale of SF-36; at two years there were no significant differences between the two groups on all outcome measures. The addition of acupuncture to usual treatment for fibromyalgia is beneficial for pain and quality of life, but only in first six months.
Status | Completed |
Enrollment | 58 |
Est. completion date | May 2002 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Patients had to report moderate to severe pain intensity (VAS > four), and they had to be using antidepressant medication in an analgesic dose (between 12.5mg/day and 75mg/day). Exclusion Criteria: - Patients were excluded in the case of severe psychiatric disease, the presence of neurological deficits, cardiac disease or glaucoma, and treatment with acupuncture within one year prior to the start of the study. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VAS(Visual Analogical Scale) | |||
Primary | SF-36(Short Form 36) | |||
Primary | Myalgic Index | |||
Primary | Number of tender points | |||
Secondary | VAS(Visual Analogical Scale)(5 times) | |||
Secondary | SF-36(Short Form 36)(5 times) | |||
Secondary | Myalgic Index(5 times) | |||
Secondary | Number of tender points(5 times) |
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