Repetitive Transcranial Magnetic Stimulation in Fibromyalgia

Fibromyalgia Clinical Trial

— STIMALGI  

Official title:

Benefice Assessment of Repetitive Transcranial Magnetic Stimulation Used as an Additional Procedure to Rehabilitation Exercises in Patients Suffering From Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308801
• Other study ID #: 2010-A00865-34
• Status: Completed
• Phase: N/A
• First received: December 17, 2010
• Last updated: January 15, 2016
• Start date: April 2011
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : agence française de sécurité sanitaire des produits de santé (afssaps) - French Health Products Safety Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• 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

Locations

Country	Name	City	State
France	CHU de Grenoble	Grenoble	Isère

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Fondation Apicil

Country where clinical trial is conducted

France, 

References & Publications (6)

Burckhardt CS, Clark SR, Bennett RM. Fibromyalgia and quality of life: a comparative analysis. J Rheumatol. 1993 Mar;20(3):475-9. — View 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. Review. — View 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. Review. — View 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. — View Citation

Dauvilliers Y, Touchon J. [Sleep in fibromyalgia: review of clinical and polysomnographic data]. Neurophysiol Clin. 2001 Feb;31(1):18-33. Review. French. — View 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. Epub 2007 Sep 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pain Visual Analog Scale (VAS) at 14 weeks of treatment	Patient will note down each day the VAS for the last 24 hours.	Daily average VAS at baseline, week 2, week 4, week 8, week 14	No
Secondary	Change from base line in quality of life at 14 weeks and 26 weeks	Fibromyalgia Impact Questionnaire (FIQ)	At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program	No
Secondary	Change from base line in depression assessment at 14 weeks and 26 weeks	Beck Depression Inventory (BDI)	at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program	No
Secondary	Change from baseline in Covi's anxiety scale	Covi's anxiety scale	at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program	No
Secondary	Change from baseline in sleep quality at 14 weeks abd 26 weeks	Number of times awaking at night	At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program	No
Secondary	Change from baseline in neuromuscular fatigability at 14 weeks and 26 weeks	Maximal voluntary activation level	At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program	No
Secondary	Change from baseline in cardiac variability at 14 weeks and 26 weeks	RMSSD values, power of spectral density HF, KF, LF/HF, alpha index (baroreflex sensitivity)	At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program	No
Secondary	Evolution of the analgesic effect after the end of the program	Patient will note down each day the VAS for the last 24 hours.	Daily average VAS at the end (14 weeks) and 26 weeks after the end of the program	No