Influence of Transcranial Direct Current Stimulation of the Primary Motor Cortex on Pain Sensation in Patients Suffering From Fibromyalgia Syndrome

Study Overview
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Brief Summary
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Fibromyalgia is a common chronic pain syndrome characterized by bad treatable chronic widespread pain present at a similar level for at least 3 months. The aim of this study is to examine if 3 weeks of transcranial direct current stimulation is a suitable therapy to reduce chronic pain.

Official Title
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Influence of Transcranial Direct Current Stimulation of the Primary Motor Cortex on Pain Sensation in Patients Suffering From Fibromyalgia Syndrome

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: transcranial direct current stimulation
* Device: sham treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have an established diagnosis of fibromyalgia according to the 1990 criteria of the American College of Rheumatology Symptoms have been present at a similar level for at least 3 months Stable medication for at least 2 months visual analog scale ≥ 3 (0=no pain; 10=worst possible pain) The patient does not have a disorder that would otherwise explain the pain Exclusion Criteria: Alcohol/substance abuse Pregnancy Neuropsychiatric disorders Metal implants near stimulation area Cardiac pace maker Local injuries Inflammatory rheumatic disease Acute tumor Acute fracture Well-defined neuropathic induced pain

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: transcranial direct current stimulation<br>transcranial direct current stimulation of the primary motor cortex | Device: transcranial direct current stimulation<br> <br> |
| Sham Comparator: sham treatment<br> | Device: sham treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analoge Scale |  | Difference Baseline - after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life - SF-36 |  | baseline / after treatment / 1 , 2, 3 months after treatment | 
| Fibromyalgia Impact Questionaire |  | baseline / after treatment / 1,2,3, months after treatment | 
| IL-10 ELISA |  | baseline / after treatment / 1,2,3, months after treatment | 
| Visual analog scale |  | 1,2,3 months after treatment | 
| IL-6 ELISA |  | baseline / after treatment / 1,2,3, months after treatment | 
| IL-4 ELISA |  | baseline / after treatment / 1,2,3, months after treatment | 
| TNF-alpha ELISA |  | baseline / after treatment / 1,2,3, months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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widespread chronic pain, transcranial direct current stimulation, fibromyalgia