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Trial of Acupuncture in the Treatment of Fibromyalgia

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ClinicalTrials.gov Identifier: NCT01189994
Recruitment Status : Unknown
Verified September 2010 by Santa Casa da Misericordia do Rio de Janeiro Hospital.
Recruitment status was:  Recruiting
First Posted : August 27, 2010
Last Update Posted : September 6, 2010
Sponsor:
Information provided by:
Santa Casa da Misericordia do Rio de Janeiro Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Diffuse Myofascial Pain Syndrome Fibromyalgia-Fibromyositis Syndrome Fibromyositis-Fibromyalgia Syndrome Myofascial Pain Syndrome, Diffuse Procedure: Acupuncture Behavioral: Orientation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pragmatic Randomized Controlled Trial of Acupuncture Effectiveness in the Treatment of Fibromyalgia
Study Start Date : September 2010
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : December 2011

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Fibromyalgia Impact Questionnaire (FIQ) score [ Time Frame: Twelve weeks from baseline ]

Secondary Outcome Measures :
  1. Weekly Likert scale in pain diary [ Time Frame: Twelve weeks from baseline ]
  2. Visual Analog Scale (VAS) for pain [ Time Frame: Twelve weeks from baseline ]
  3. Short Form 36 (SF-36) score for quality of life [ Time Frame: Twelve weeks from baseline ]
  4. Health Assessment Questionnaire - Disability Index (HAQ-DI) score [ Time Frame: Twelve weeks from baseline ]
  5. Hospital Anxiety and Depression (HAD) Scale [ Time Frame: Twelve weeks from baseline ]
  6. Fibromyalgia Impact Questionnaire (FIQ) score [ Time Frame: Twenty-four weeks from baseline ]
  7. Weekly Likert scale in pain diary [ Time Frame: Twenty-four weeks from baseline ]
  8. Visual Analog Scale (VAS) for pain [ Time Frame: Twenty-four weeks from baseline ]
  9. Short Form 36 (SF-36) score for quality of life [ Time Frame: Twenty-four weeks from baseline ]
  10. Health Assessment Questionnaire - Disability Index (HAQ-DI) score [ Time Frame: Twenty-four weeks from baseline ]
  11. Hospital Anxiety and Depression (HAD) Scale [ Time Frame: Twenty-four weeks from baseline ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: September 6, 2010
Last Verified: September 2010

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
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
 Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Mental Disorders