Repetitive Transcranial Magnetic Stimulation in Fibromyalgia

Study Overview
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Brief Summary
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The purpose of this study is to determine the analgesic effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) used as an additional procedure to rehabilitation exercises in patient suffering from fibromyalgia. A double blind clinical trial with two randomized parallel groups: Placebo rTMS and rehabilitation exercise Active rTMS and rehabilitation exercise

Detailed Description
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Fibromyalgia is the most frequent chronic diffuse painful disease (3 to 4% of the general population). Analgesic drugs are widely used in fibromyalgia, pain being the main symptom. However the effectiveness of analgesic drugs is often insufficient. Among non-drug therapies, rehabilitation exercise plays an important role with a special interest in terms of the quality of life, strain and pain. More recently the Transcranial Magnetic Stimulation effects have been evaluated in patients suffering from fibromyalgia with a statistically significative analgesic effect. Both rehabilitation exercise and Transcranial Magnetic Stimulation (rTMS) have shown their respective analgesic effectiveness in fibromyalgia. It now seems important to evaluate the combination of these two therapies. Main objective: To evaluate the analgesic effect of rTMS in fibromyalgia patients doing rehabilitation exercise. Primary endpoint: The evaluation methode used is a visual analog scale (VAS) of pain. Patients will note down every day VAS of over the last 24 hours. The evolution of the VAS during the treatment period with respect to baseline, will be compared in both groups, active rTMS and placebo rTMS. The investigators will analyze the average daily VAS for different weeks (W2, W4, W8, W14) compared to the average daily VAS at the baseline. After a baseline period of 15 days, patients will begin sessions of rTMS and rehabilitation exercise for a period of 14 weeks. The study is composed of three assessment visits : a baseline visit, a visit corresponding to the end of the therapy with exercise period and a last assessment visit at 26 weeks after the end of the treatment. These visits will include clinical examination, blood test, an effort test, an orthostatic test, a resistance to fatigue test and polysomnography.

Official Title
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Benefice Assessment of Repetitive Transcranial Magnetic Stimulation Used as an Additional Procedure to Rehabilitation Exercises in Patients Suffering From Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: active rTMS + rehabilitation exercise
* Device: placebo rTMS+ rehabilitation exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary fibromyalgia according to the American College of Rheumatology no contraindication to rehabilitation exercise pain with VAS > 4 during at least six months FIQ score > 50 no change in drug therapy over the last month affiliation to French Health Service Exclusion Criteria: BMI > 35kg/m² patient who has already benefited from rTMS rTMS contraindication restless legs symptom patient suffering from major depression patient suffering from inflammatory rheumatism, autoimmune disease, other chronic pain pathology sleep apnea syndrome no contraindication to rTMS or MRI pregnant women

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active rTMS + rehabilitation exercise<br>14 weeks of active repetitive transcranial magnetic stimulation associated with rehabilitation exercise | Device: active rTMS + rehabilitation exercise<br>* 14 weeks program of active repetitive transcranial magnetic stimulation associated with rehabilitation exercise<br>|
| Placebo Comparator: placebo rTMS + rehabilitation exercise<br>14 weeks of placebo repetitive transcranial magnetic stimulation associated with rehabilitation exercise | Device: placebo rTMS+ rehabilitation exercise<br>* 14 week program of placebo repetitive transcranial magnetic stimulation associated with rehabilitation exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pain Visual Analog Scale (VAS) at 14 weeks of treatment | Patient will note down each day the VAS for the last 24 hours. | Daily average VAS at baseline, week 2, week 4, week 8, week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from base line in quality of life at 14 weeks and 26 weeks | Fibromyalgia Impact Questionnaire (FIQ) | At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program | 
| Change from base line in depression assessment at 14 weeks and 26 weeks | Beck Depression Inventory (BDI) | at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program | 
| Change from baseline in Covi's anxiety scale | Covi's anxiety scale | at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program | 
| Change from baseline in sleep quality at 14 weeks abd 26 weeks | Number of times awaking at night | At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program | 
| Change from baseline in neuromuscular fatigability at 14 weeks and 26 weeks | Maximal voluntary activation level | At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program | 
| Change from baseline in cardiac variability at 14 weeks and 26 weeks | RMSSD values, power of spectral density HF, KF, LF/HF, alpha index (baroreflex sensitivity) | At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program | 
| Evolution of the analgesic effect after the end of the program | Patient will note down each day the VAS for the last 24 hours. | Daily average VAS at the end (14 weeks) and 26 weeks after the end of the program | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibromyalgia, pain, repetitive transcranial magnetic stimulation, rehabilitation exercise, quality of life