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Trial of Acupuncture Added to Usual Treatment for Fibromyalgia

NCT00379496 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2006-09-22

No results posted yet for this study

Summary

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.

Conditions

  • Fibromyalgia

Interventions

PROCEDURE

Antidepressants

PROCEDURE

acupuncture

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Rosa A Targino, MD · University of Sao Paulo-School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-04-30
Completion
2002-05-31

Countries

  • Brazil

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 NCT00379496 on ClinicalTrials.gov