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Repetitive Transcranial Magnetic Stimulation in Fibromyalgia (STIMALGI)

Primary Purpose

Fibromyalgia

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

active rTMS + rehabilitation exercise

placebo rTMS+ rehabilitation exercise

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, pain, repetitive transcranial magnetic stimulation, rehabilitation exercise, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy 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

Sites / Locations

CHU de Grenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

active rTMS + rehabilitation exercise

placebo rTMS + rehabilitation exercise

Arm Description

14 weeks of active repetitive transcranial magnetic stimulation associated with rehabilitation exercise

14 weeks of placebo repetitive transcranial magnetic stimulation associated with rehabilitation exercise

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from base line in quality of life at 14 weeks and 26 weeks

Fibromyalgia Impact Questionnaire (FIQ)

Change from base line in depression assessment at 14 weeks and 26 weeks

Beck Depression Inventory (BDI)

Change from baseline in Covi's anxiety scale

Covi's anxiety scale

Change from baseline in sleep quality at 14 weeks abd 26 weeks

Number of times awaking at night

Change from baseline in neuromuscular fatigability at 14 weeks and 26 weeks

Maximal voluntary activation level

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)

Evolution of the analgesic effect after the end of the program

Patient will note down each day the VAS for the last 24 hours.

Full Information

NCT ID

NCT01308801

First Posted

December 17, 2010

Last Updated

January 15, 2016

Sponsor

University Hospital, Grenoble

Collaborators

Fondation Apicil

1. Study Identification

Unique Protocol Identification Number

NCT01308801

Brief Title

Repetitive Transcranial Magnetic Stimulation in Fibromyalgia

Acronym

STIMALGI

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

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Grenoble

Collaborators

Fondation Apicil

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

fibromyalgia, pain, repetitive transcranial magnetic stimulation, rehabilitation exercise, quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

active rTMS + rehabilitation exercise

Arm Type

Experimental

Arm Description

14 weeks of active repetitive transcranial magnetic stimulation associated with rehabilitation exercise

Arm Title

placebo rTMS + rehabilitation exercise

Arm Type

Placebo Comparator

Arm Description

14 weeks of placebo repetitive transcranial magnetic stimulation associated with rehabilitation exercise

Intervention Type

Device

Intervention Name(s)

active rTMS + rehabilitation exercise

Intervention Description

14 weeks program of active repetitive transcranial magnetic stimulation associated with rehabilitation exercise

Intervention Type

Device

Intervention Name(s)

placebo rTMS+ rehabilitation exercise

Intervention Description

14 week program of placebo repetitive transcranial magnetic stimulation associated with rehabilitation exercise

Primary Outcome Measure Information:

Title

Change from baseline in pain Visual Analog Scale (VAS) at 14 weeks of treatment

Description

Patient will note down each day the VAS for the last 24 hours.

Time Frame

Daily average VAS at baseline, week 2, week 4, week 8, week 14

Secondary Outcome Measure Information:

Title

Change from base line in quality of life at 14 weeks and 26 weeks

Description

Fibromyalgia Impact Questionnaire (FIQ)

Time Frame

At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program

Title

Change from base line in depression assessment at 14 weeks and 26 weeks

Description

Beck Depression Inventory (BDI)

Time Frame

at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program

Title

Change from baseline in Covi's anxiety scale

Description

Covi's anxiety scale

Time Frame

at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program

Title

Change from baseline in sleep quality at 14 weeks abd 26 weeks

Description

Number of times awaking at night

Time Frame

At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program

Title

Change from baseline in neuromuscular fatigability at 14 weeks and 26 weeks

Description

Maximal voluntary activation level

Time Frame

At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program

Title

Change from baseline in cardiac variability at 14 weeks and 26 weeks

Description

RMSSD values, power of spectral density HF, KF, LF/HF, alpha index (baroreflex sensitivity)

Time Frame

At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program

Title

Evolution of the analgesic effect after the end of the program

Description

Patient will note down each day the VAS for the last 24 hours.

Time Frame

Daily average VAS at the end (14 weeks) and 26 weeks after the end of the program

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Caroline Maindet-Dominici, MD

Organizational Affiliation

Centre de la Douleur CHU de Grenoble

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Grenoble

City

Grenoble

State/Province

Isère

ZIP/Postal Code

38043

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

8478854

Citation

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

Results Reference

background

PubMed Identifier

18464301

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.

Results Reference

background

PubMed Identifier

17943797

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.

Results Reference

background

PubMed Identifier

17009309

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.

Results Reference

background

PubMed Identifier

11281066

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.

Results Reference

background

PubMed Identifier

17872930

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.

Results Reference

background

PubMed Identifier

31785190

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.

Results Reference

derived

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Repetitive Transcranial Magnetic Stimulation in Fibromyalgia

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