Fibromyalgia Clinical Trial
Official title:
Benefice Assessment of Repetitive Transcranial Magnetic Stimulation Used as an Additional Procedure to Rehabilitation Exercises in Patients Suffering From Fibromyalgia
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
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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