Trial of Acupuncture Added to Usual Treatment for Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Early Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Antidepressants
acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Acupuncture, Randomized study
Eligibility Criteria
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.
Sites / Locations
- Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Outcomes
Primary Outcome Measures
VAS(Visual Analogical Scale)
SF-36(Short Form 36)
Myalgic Index
Number of tender points
Secondary Outcome Measures
VAS(Visual Analogical Scale)(5 times)
SF-36(Short Form 36)(5 times)
Myalgic Index(5 times)
Number of tender points(5 times)
Full Information
NCT ID
NCT00379496
First Posted
September 21, 2006
Last Updated
September 21, 2006
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00379496
Brief Title
Trial of Acupuncture Added to Usual Treatment for Fibromyalgia
Official Title
A Randomized Controlled Trial of Acupuncture Added to Usual Treatment for Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
4. Oversight
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Acupuncture, Randomized study
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
58 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Antidepressants
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Primary Outcome Measure Information:
Title
VAS(Visual Analogical Scale)
Title
SF-36(Short Form 36)
Title
Myalgic Index
Title
Number of tender points
Secondary Outcome Measure Information:
Title
VAS(Visual Analogical Scale)(5 times)
Title
SF-36(Short Form 36)(5 times)
Title
Myalgic Index(5 times)
Title
Number of tender points(5 times)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa A Targino, MD
Organizational Affiliation
University of Sao Paulo-School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05403010
Country
Brazil
12. IPD Sharing Statement
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