Trial of Acupuncture in the Treatment of Fibromyalgia

Study Overview
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Brief Summary
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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.

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

Conditions
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Fibromyalgia, Diffuse Myofascial Pain Syndrome, Fibromyalgia-Fibromyositis Syndrome, Fibromyositis-Fibromyalgia Syndrome, Myofascial Pain Syndrome, Diffuse

Intervention / Treatment
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* Procedure: Acupuncture
* Behavioral: Orientation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia Impact Questionnaire (FIQ) score |  | Twelve weeks from baseline | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Acupuncture, Randomized Controlled Trial, Pain, Quality of Life