Trial of Acupuncture Added to Usual Treatment for Fibromyalgia

NCT00379496 | Completed Early Phase 1

• 1 other identifier: 843/99
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fibromyalgia; Acupuncture; Randomized study

Outcome Measures

Primary Outcomes (4)

• VAS(Visual Analogical Scale)

• SF-36(Short Form 36)

• Myalgic Index

• Number of tender points

Secondary Outcomes (4)

• VAS(Visual Analogical Scale)(5 times)

• SF-36(Short Form 36)(5 times)

• Myalgic Index(5 times)

• Number of tender points(5 times)

Interventions

Antidepressants PROCEDURE

acupuncture PROCEDURE

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, 05403010, Brazil

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Antidepressive Agents; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Complementary Therapies; Therapeutics

Study Officials

• Rosa A Targino, MD

  University of Sao Paulo-School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 21, 2006
• First Posted: September 22, 2006
• Study Start: April 1, 2000
• Study Completion: May 1, 2002
• Last Updated: September 22, 2006

Record last verified: 2006-09

Locations

BR (1)