Fibromyalgia
Conditions
Keywords
fibromyalgia, pain, repetitive transcranial magnetic stimulation, rehabilitation exercise, quality of life
Brief summary
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
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.
Interventions
DEVICEactive rTMS + rehabilitation exercise
14 weeks program of active repetitive transcranial magnetic stimulation associated with rehabilitation exercise
DEVICEplacebo rTMS+ rehabilitation exercise
14 week program of placebo repetitive transcranial magnetic stimulation associated with rehabilitation exercise
Sponsors
Fondation Apicil
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in pain Visual Analog Scale (VAS) at 14 weeks of treatment | Daily average VAS at baseline, week 2, week 4, week 8, week 14 | Patient will note down each day the VAS for the last 24 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from base line in depression assessment at 14 weeks and 26 weeks | at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program | Beck Depression Inventory (BDI) |
| Change from baseline in Covi's anxiety scale | at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program | Covi's anxiety scale |
| Change from baseline in sleep quality at 14 weeks abd 26 weeks | At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program | Number of times awaking at night |
| Change from base line in quality of life at 14 weeks and 26 weeks | At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program | Fibromyalgia Impact Questionnaire (FIQ) |
| Change from baseline in cardiac variability at 14 weeks and 26 weeks | At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program | RMSSD values, power of spectral density HF, KF, LF/HF, alpha index (baroreflex sensitivity) |
| Evolution of the analgesic effect after the end of the program | Daily average VAS at the end (14 weeks) and 26 weeks after the end of the program | Patient will note down each day the VAS for the last 24 hours. |
| Change from baseline in neuromuscular fatigability at 14 weeks and 26 weeks | At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program | Maximal voluntary activation level |
Countries
France
Outcome results
None listed