Trial of Acupuncture in the Treatment of Fibromyalgia

Pragmatic Randomized Controlled Trial of Acupuncture Effectiveness in the Treatment of Fibromyalgia

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • RJ
      • Rio de Janeiro, RJ, Brazil
        • Recruiting
        • Santa Casa da Misericordia do Rio de Janeiro Hospital; Instituto de Acupuntura do Rio de Janeiro
        • Contact:
        • Principal Investigator:
          • Fernando P de Farias, MD, PhD
        • Sub-Investigator:
          • Washington Bianchi, MD
        • Sub-Investigator:
          • Orlando J Goncalves Filho, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture
Patients will receive acupuncture treatment in addition to standard care, coming to twelve weekly acupuncture sessions
Needling of acupoints, some of them receiving electrostimulation
Active Comparator: Orientation
Patients will receive standard care only, coming to three monthly orientation sessions
Orientation sessions focusing in fibromyalgia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fibromyalgia Impact Questionnaire (FIQ) score
Time Frame: Twelve weeks from baseline
Twelve weeks from baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fernando P de Farias, MD, PhD, Santa Casa da Misericordia do Rio de Janeiro Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

September 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

August 25, 2010

First Submitted That Met QC Criteria

August 26, 2010

First Posted (Estimate)

August 27, 2010

Study Record Updates

Last Update Posted (Estimate)

September 6, 2010

Last Update Submitted That Met QC Criteria

September 3, 2010

Last Verified

September 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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