Repetitive Transcranial Magnetic Stimulation in Fibromyalgia
NCT ID: NCT01308801
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2011-04-30
2015-09-30
Brief Summary
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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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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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active rTMS + rehabilitation exercise
14 weeks of active repetitive transcranial magnetic stimulation associated with rehabilitation exercise
active rTMS + rehabilitation exercise
14 weeks program of active repetitive transcranial magnetic stimulation associated with rehabilitation exercise
placebo rTMS + rehabilitation exercise
14 weeks of placebo repetitive transcranial magnetic stimulation associated with rehabilitation exercise
placebo rTMS+ rehabilitation exercise
14 week program of placebo repetitive transcranial magnetic stimulation associated with rehabilitation exercise
Interventions
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active rTMS + rehabilitation exercise
14 weeks program of active repetitive transcranial magnetic stimulation associated with rehabilitation exercise
placebo rTMS+ rehabilitation exercise
14 week program of placebo repetitive transcranial magnetic stimulation associated with rehabilitation exercise
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Fondation Apicil
OTHER
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Caroline Maindet-Dominici, MD
Role: PRINCIPAL_INVESTIGATOR
Centre de la Douleur CHU de Grenoble
Locations
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CHU de Grenoble
Grenoble, Isère, France
Countries
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References
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Busch AJ, Barber KA, Overend TJ, Peloso PM, Schachter CL. Exercise for treating fibromyalgia syndrome. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003786. doi: 10.1002/14651858.CD003786.pub2.
Burckhardt CS, Clark SR, Bennett RM. Fibromyalgia and quality of life: a comparative analysis. J Rheumatol. 1993 Mar;20(3):475-9.
Busch AJ, Schachter CL, Overend TJ, Peloso PM, Barber KA. Exercise for fibromyalgia: a systematic review. J Rheumatol. 2008 Jun;35(6):1130-44. Epub 2008 May 1.
Cook DB, Nagelkirk PR, Poluri A, Mores J, Natelson BH. The influence of aerobic fitness and fibromyalgia on cardiorespiratory and perceptual responses to exercise in patients with chronic fatigue syndrome. Arthritis Rheum. 2006 Oct;54(10):3351-62. doi: 10.1002/art.22124.
Dauvilliers Y, Touchon J. [Sleep in fibromyalgia: review of clinical and polysomnographic data]. Neurophysiol Clin. 2001 Feb;31(1):18-33. doi: 10.1016/s0987-7053(00)00240-9. French.
Passard A, Attal N, Benadhira R, Brasseur L, Saba G, Sichere P, Perrot S, Januel D, Bouhassira D. Effects of unilateral repetitive transcranial magnetic stimulation of the motor cortex on chronic widespread pain in fibromyalgia. Brain. 2007 Oct;130(Pt 10):2661-70. doi: 10.1093/brain/awm189. Epub 2007 Sep 14.
Guinot M, Maindet C, Hodaj H, Hodaj E, Bachasson D, Baillieul S, Cracowski JL, Launois S. Effects of Repetitive Transcranial Magnetic Stimulation and Multicomponent Therapy in Patients With Fibromyalgia: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2021 Mar;73(3):449-458. doi: 10.1002/acr.24118.
Other Identifiers
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2010-A00865-34
Identifier Type: -
Identifier Source: org_study_id