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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

Tracking Information
First Submitted Date  ICMJE August 25, 2010
First Posted Date  ICMJE August 27, 2010
Last Update Posted Date September 6, 2010
Study Start Date  ICMJE September 2010
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2010)
Fibromyalgia Impact Questionnaire (FIQ) score [ Time Frame: Twelve weeks from baseline ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2010)
  • Weekly Likert scale in pain diary [ Time Frame: Twelve weeks from baseline ]
  • Visual Analog Scale (VAS) for pain [ Time Frame: Twelve weeks from baseline ]
  • Short Form 36 (SF-36) score for quality of life [ Time Frame: Twelve weeks from baseline ]
  • Health Assessment Questionnaire - Disability Index (HAQ-DI) score [ Time Frame: Twelve weeks from baseline ]
  • Hospital Anxiety and Depression (HAD) Scale [ Time Frame: Twelve weeks from baseline ]
  • Fibromyalgia Impact Questionnaire (FIQ) score [ Time Frame: Twenty-four weeks from baseline ]
  • Weekly Likert scale in pain diary [ Time Frame: Twenty-four weeks from baseline ]
  • Visual Analog Scale (VAS) for pain [ Time Frame: Twenty-four weeks from baseline ]
  • Short Form 36 (SF-36) score for quality of life [ Time Frame: Twenty-four weeks from baseline ]
  • Health Assessment Questionnaire - Disability Index (HAQ-DI) score [ Time Frame: Twenty-four weeks from baseline ]
  • Hospital Anxiety and Depression (HAD) Scale [ Time Frame: Twenty-four weeks from baseline ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Acupuncture in the Treatment of Fibromyalgia
Official Title  ICMJE Pragmatic Randomized Controlled Trial of Acupuncture Effectiveness in the Treatment of Fibromyalgia
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Fibromyalgia
  • Diffuse Myofascial Pain Syndrome
  • Fibromyalgia-Fibromyositis Syndrome
  • Fibromyositis-Fibromyalgia Syndrome
  • Myofascial Pain Syndrome, Diffuse
Intervention  ICMJE
  • Procedure: Acupuncture
    Needling of acupoints, some of them receiving electrostimulation
  • Behavioral: Orientation
    Orientation sessions focusing in fibromyalgia
Study Arms  ICMJE
  • Experimental: Acupuncture
    Patients will receive acupuncture treatment in addition to standard care, coming to twelve weekly acupuncture sessions
    Intervention: Procedure: Acupuncture
  • Active Comparator: Orientation
    Patients will receive standard care only, coming to three monthly orientation sessions
    Intervention: Behavioral: Orientation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 26, 2010)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2011
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01189994
Other Study ID Numbers  ICMJE SCMRJH-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fernando Farias, MD, PhD, Santa Casa da Misericordia do Rio de Janeiro Hospital
Study Sponsor  ICMJE Santa Casa da Misericordia do Rio de Janeiro Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fernando P de Farias, MD, PhD Santa Casa da Misericordia do Rio de Janeiro Hospital
PRS Account Santa Casa da Misericordia do Rio de Janeiro Hospital
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP