Trial of Acupuncture in the Treatment of Fibromyalgia

Not Applicable

• Conditions: Fibromyalgia; Diffuse Myofascial Pain Syndrome; Fibromyalgia-Fibromyositis Syndrome; Fibromyositis-Fibromyalgia Syndrome; Myofascial Pain Syndrome, Diffuse
• Interventions: Procedure: Acupuncture; Behavioral: Orientation

• Registration Number: NCT01189994
• Lead Sponsor: Santa Casa da Misericordia do Rio de Janeiro Hospital

Brief Summary

Fibromyalgia is a medical condition characterized by musculoskeletal pain, fatigue, sleep disturbances and depression. It affects population at a socioeconomically active age and represents a burden for the patients and the health care system due to its personal and functional implications. At this moment, there is no completely effective treatment for fibromyalgia, and acupuncture has been a promising alternative. This trial aims to evaluate if addition of acupuncture to standard care represents an improvement in comparison with standard care only. Thus, patients enrolled in this trial will be randomly allocated into one of two groups: group A, who besides standard treatment will receive 12 sessions of acupuncture; and group B, who will receive standard care with monthly orientation sessions for the same period. Patients will be evaluated at baseline, after completion of acupuncture treatment or orientation, and after an additional 12-week follow up. Evaluation will be based on diaries of pain and medication, and standard scales of pain, quality of life and disability.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-25
• Study First Submitted QC: 2010-08-26
• Study First Posted: 2010-08-27
• Status Verified: 2010-09
• Study Start: 2010-09
• Last Update Submitted: 2010-09-03
• Last Update Posted: 2010-09-06
• Primary Completion: 2011-09
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• American College of Rheumatology criteria for fibromyalgia
• elementary school
• drug treatment for at least 30 days (if any)

Exclusion Criteria

• disabling mental condition
• other rheumatic conditions
• other chronic medical conditions with musculoskeletal symptoms
• pregnancy
• conditions that impair walking
• conditions that impair weekly consultations
• acupuncture treatment in the twelve-month period prior to enrollment
• diabetes mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	Acupuncture	Patients will receive acupuncture treatment in addition to standard care, coming to twelve weekly acupuncture sessions
Orientation	Orientation	Patients will receive standard care only, coming to three monthly orientation sessions

Primary Outcome Measures

Name	Time	Method
Fibromyalgia Impact Questionnaire (FIQ) score	Twelve weeks from baseline

Secondary Outcome Measures

Name	Time	Method
Weekly Likert scale in pain diary	Twenty-four weeks from baseline
Visual Analog Scale (VAS) for pain	Twenty-four weeks from baseline
Short Form 36 (SF-36) score for quality of life	Twenty-four weeks from baseline
Health Assessment Questionnaire - Disability Index (HAQ-DI) score	Twenty-four weeks from baseline
Hospital Anxiety and Depression (HAD) Scale	Twenty-four weeks from baseline
Fibromyalgia Impact Questionnaire (FIQ) score	Twenty-four weeks from baseline

Trial Locations

Locations (1)

Santa Casa da Misericordia do Rio de Janeiro Hospital; Instituto de Acupuntura do Rio de Janeiro; 🇧🇷 Rio de Janeiro, RJ, Brazil