Trial of Acupuncture in the Treatment of Fibromyalgia
Primary Purpose
Fibromyalgia, Diffuse Myofascial Pain Syndrome, Fibromyalgia-Fibromyositis Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Acupuncture
Orientation
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Acupuncture, Randomized Controlled Trial, Pain, Quality of Life
Eligibility 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
Sites / Locations
- Santa Casa da Misericordia do Rio de Janeiro Hospital; Instituto de Acupuntura do Rio de JaneiroRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Acupuncture
Orientation
Arm Description
Patients will receive acupuncture treatment in addition to standard care, coming to twelve weekly acupuncture sessions
Patients will receive standard care only, coming to three monthly orientation sessions
Outcomes
Primary Outcome Measures
Fibromyalgia Impact Questionnaire (FIQ) score
Secondary Outcome Measures
Weekly Likert scale in pain diary
Visual Analog Scale (VAS) for pain
Short Form 36 (SF-36) score for quality of life
Health Assessment Questionnaire - Disability Index (HAQ-DI) score
Hospital Anxiety and Depression (HAD) Scale
Fibromyalgia Impact Questionnaire (FIQ) score
Weekly Likert scale in pain diary
Visual Analog Scale (VAS) for pain
Short Form 36 (SF-36) score for quality of life
Health Assessment Questionnaire - Disability Index (HAQ-DI) score
Hospital Anxiety and Depression (HAD) Scale
Full Information
NCT ID
NCT01189994
First Posted
August 25, 2010
Last Updated
September 3, 2010
Sponsor
Santa Casa da Misericordia do Rio de Janeiro Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01189994
Brief Title
Trial of Acupuncture in the Treatment of Fibromyalgia
Official Title
Pragmatic Randomized Controlled Trial of Acupuncture Effectiveness in the Treatment of Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Santa Casa da Misericordia do Rio de Janeiro Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Diffuse Myofascial Pain Syndrome, Fibromyalgia-Fibromyositis Syndrome, Fibromyositis-Fibromyalgia Syndrome, Myofascial Pain Syndrome, Diffuse
Keywords
Fibromyalgia, Acupuncture, Randomized Controlled Trial, Pain, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Patients will receive acupuncture treatment in addition to standard care, coming to twelve weekly acupuncture sessions
Arm Title
Orientation
Arm Type
Active Comparator
Arm Description
Patients will receive standard care only, coming to three monthly orientation sessions
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
Needling of acupoints, some of them receiving electrostimulation
Intervention Type
Behavioral
Intervention Name(s)
Orientation
Intervention Description
Orientation sessions focusing in fibromyalgia
Primary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire (FIQ) score
Time Frame
Twelve weeks from baseline
Secondary Outcome Measure Information:
Title
Weekly Likert scale in pain diary
Time Frame
Twelve weeks from baseline
Title
Visual Analog Scale (VAS) for pain
Time Frame
Twelve weeks from baseline
Title
Short Form 36 (SF-36) score for quality of life
Time Frame
Twelve weeks from baseline
Title
Health Assessment Questionnaire - Disability Index (HAQ-DI) score
Time Frame
Twelve weeks from baseline
Title
Hospital Anxiety and Depression (HAD) Scale
Time Frame
Twelve weeks from baseline
Title
Fibromyalgia Impact Questionnaire (FIQ) score
Time Frame
Twenty-four weeks from baseline
Title
Weekly Likert scale in pain diary
Time Frame
Twenty-four weeks from baseline
Title
Visual Analog Scale (VAS) for pain
Time Frame
Twenty-four weeks from baseline
Title
Short Form 36 (SF-36) score for quality of life
Time Frame
Twenty-four weeks from baseline
Title
Health Assessment Questionnaire - Disability Index (HAQ-DI) score
Time Frame
Twenty-four weeks from baseline
Title
Hospital Anxiety and Depression (HAD) Scale
Time Frame
Twenty-four weeks from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernando P de Farias, MD, PhD
Phone
(+5521) 9263-8673
Email
fernandopfarias@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando P de Farias, MD, PhD
Organizational Affiliation
Santa Casa da Misericordia do Rio de Janeiro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Casa da Misericordia do Rio de Janeiro Hospital; Instituto de Acupuntura do Rio de Janeiro
City
Rio de Janeiro
State/Province
RJ
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando P de Farias, MD, PhD
Phone
(+5521) 9263-8673
Email
fernandopfarias@gmail.com
First Name & Middle Initial & Last Name & Degree
Fernando P de Farias, MD, PhD
First Name & Middle Initial & Last Name & Degree
Washington Bianchi, MD
First Name & Middle Initial & Last Name & Degree
Orlando J Goncalves Filho, MD
12. IPD Sharing Statement
Learn more about this trial
Trial of Acupuncture in the Treatment of Fibromyalgia
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