Clinical trial NCT01308801: Repetitive Transcranial Magnetic Stimulation in Fibromyalgia
Official title: Benefice Assessment of Repetitive Transcranial Magnetic Stimulation Used as an Additional Procedure to Rehabilitation Exercises in Patients Suffering From Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia
pain
repetitive transcranial magnetic stimulation
rehabilitation exercise
quality of life
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Fondation Apicil
First posted: 2011-03-04
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in pain Visual Analog Scale (VAS) at 14 weeks of treatment
timeFrame: Daily average VAS at baseline, week 2, week 4, week 8, week 14
Secondary outcomes:
measure: Change from base line in quality of life at 14 weeks and 26 weeks
timeFrame: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
measure: Change from base line in depression assessment at 14 weeks and 26 weeks
timeFrame: at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
measure: Change from baseline in Covi's anxiety scale
timeFrame: at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
measure: Change from baseline in sleep quality at 14 weeks abd 26 weeks
timeFrame: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
measure: Change from baseline in neuromuscular fatigability at 14 weeks and 26 weeks
timeFrame: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
measure: Change from baseline in cardiac variability at 14 weeks and 26 weeks
timeFrame: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
measure: Evolution of the analgesic effect after the end of the program
timeFrame: Daily average VAS at the end (14 weeks) and 26 weeks after the end of the program
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de Grenoble
state: Isère
Study officials:
affiliation: Centre de la Douleur CHU de Grenoble
name: Caroline Maindet-Dominici, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burckhardt CS, Clark SR, Bennett RM. Fibromyalgia and quality of life: a comparative analysis. J Rheumatol. 1993 Mar;20(3):475-9.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.