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Trial of Acupuncture in the Treatment of Fibromyalgia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Santa Casa da Misericordia do Rio de Janeiro Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Santa Casa da Misericordia do Rio de Janeiro Hospital
ClinicalTrials.gov Identifier:
NCT01189994
First received: August 25, 2010
Last updated: September 3, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Fibromyalgia
Diffuse Myofascial Pain Syndrome
Fibromyalgia-Fibromyositis Syndrome
Fibromyositis-Fibromyalgia Syndrome
Myofascial Pain Syndrome, Diffuse
Procedure: Acupuncture
Behavioral: Orientation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pragmatic Randomized Controlled Trial of Acupuncture Effectiveness in the Treatment of Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Santa Casa da Misericordia do Rio de Janeiro Hospital:

Primary Outcome Measures:
  • Fibromyalgia Impact Questionnaire (FIQ) score [ Time Frame: Twelve weeks from baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weekly Likert scale in pain diary [ Time Frame: Twelve weeks from baseline ] [ Designated as safety issue: No ]
  • Visual Analog Scale (VAS) for pain [ Time Frame: Twelve weeks from baseline ] [ Designated as safety issue: No ]
  • Short Form 36 (SF-36) score for quality of life [ Time Frame: Twelve weeks from baseline ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire - Disability Index (HAQ-DI) score [ Time Frame: Twelve weeks from baseline ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression (HAD) Scale [ Time Frame: Twelve weeks from baseline ] [ Designated as safety issue: No ]
  • Fibromyalgia Impact Questionnaire (FIQ) score [ Time Frame: Twenty-four weeks from baseline ] [ Designated as safety issue: No ]
  • Weekly Likert scale in pain diary [ Time Frame: Twenty-four weeks from baseline ] [ Designated as safety issue: No ]
  • Visual Analog Scale (VAS) for pain [ Time Frame: Twenty-four weeks from baseline ] [ Designated as safety issue: No ]
  • Short Form 36 (SF-36) score for quality of life [ Time Frame: Twenty-four weeks from baseline ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire - Disability Index (HAQ-DI) score [ Time Frame: Twenty-four weeks from baseline ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression (HAD) Scale [ Time Frame: Twenty-four weeks from baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture
Patients will receive acupuncture treatment in addition to standard care, coming to twelve weekly acupuncture sessions
Procedure: Acupuncture
Needling of acupoints, some of them receiving electrostimulation
Active Comparator: Orientation
Patients will receive standard care only, coming to three monthly orientation sessions
Behavioral: Orientation
Orientation sessions focusing in fibromyalgia

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01189994

Contacts
Contact: Fernando P de Farias, MD, PhD (+5521) 9263-8673 fernandopfarias@gmail.com

Locations
Brazil
Santa Casa da Misericordia do Rio de Janeiro Hospital; Instituto de Acupuntura do Rio de Janeiro Recruiting
Rio de Janeiro, RJ, Brazil
Contact: Fernando P de Farias, MD, PhD    (+5521) 9263-8673    fernandopfarias@gmail.com   
Principal Investigator: Fernando P de Farias, MD, PhD         
Sub-Investigator: Washington Bianchi, MD         
Sub-Investigator: Orlando J Goncalves Filho, MD         
Sponsors and Collaborators
Santa Casa da Misericordia do Rio de Janeiro Hospital
Investigators
Principal Investigator: Fernando P de Farias, MD, PhD Santa Casa da Misericordia do Rio de Janeiro Hospital
  More Information

No publications provided

Responsible Party: Fernando Farias, MD, PhD, Santa Casa da Misericordia do Rio de Janeiro Hospital
ClinicalTrials.gov Identifier: NCT01189994     History of Changes
Other Study ID Numbers: SCMRJH-001
Study First Received: August 25, 2010
Last Updated: September 3, 2010
Health Authority: Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Keywords provided by Santa Casa da Misericordia do Rio de Janeiro Hospital:
Fibromyalgia
Acupuncture
Randomized Controlled Trial
Pain
Quality of Life

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Somatoform Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014