Repetitive Transcranial Magnetic Stimulation in Fibromyalgia (STIMALGI)
Status
Conditions
Treatments
Details and patient eligibility
About
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
Full description
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
42 participants in 2 patient groups, including a placebo group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal