NCT01308801

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 4, 2011

Completed
28 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 17, 2025

Status Verified

January 1, 2016

Enrollment Period

4.4 years

First QC Date

December 17, 2010

Last Update Submit

December 9, 2025

Conditions

Fibromyalgia

Keywords

fibromyalgiapainrepetitive transcranial magnetic stimulationrehabilitation exercisequality of life

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • +2 more secondary outcomes

Study Arms (2)

active rTMS + rehabilitation exercise

EXPERIMENTAL

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

Device: active rTMS + rehabilitation exercise

placebo rTMS + rehabilitation exercise

PLACEBO COMPARATOR

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

Device: placebo rTMS+ rehabilitation exercise

Interventions

active rTMS + rehabilitation exerciseDEVICE

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

active rTMS + rehabilitation exercise
placebo rTMS+ rehabilitation exerciseDEVICE

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

placebo rTMS + rehabilitation exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Grenoble

Grenoble, Isère, 38043, France

Location

Related Publications (7)

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

    PMID: 8478854BACKGROUND

  • 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.

    PMID: 18464301BACKGROUND

  • Busch AJ, Barber KA, Overend TJ, Peloso PM, Schachter CL. Exercise for treating fibromyalgia syndrome. Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD003786. doi: 10.1002/14651858.CD003786.pub2.

    PMID: 17943797BACKGROUND

  • 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.

    PMID: 17009309BACKGROUND

  • 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.

    PMID: 11281066BACKGROUND

  • 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.

    PMID: 17872930BACKGROUND

  • 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.

    PMID: 31785190RESULT

MeSH Terms

Conditions

FibromyalgiaPain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Caroline Maindet-Dominici, MD

    Centre de la Douleur CHU de Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2010

First Posted

March 4, 2011

Study Start

April 1, 2011

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

December 17, 2025

Record last verified: 2016-01

Locations

FR(1)