Repetitive Transcranial Magnetic Stimulation in Fibromyalgia (STIMALGI)

January 15, 2016 updated by: University Hospital, Grenoble

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Isère
      • Grenoble, Isère, France, 38043
        • CHU de Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: active rTMS + rehabilitation exercise
14 weeks of active repetitive transcranial magnetic stimulation associated with rehabilitation exercise
Device: active rTMS + rehabilitation exercise
14 weeks program of active repetitive transcranial magnetic stimulation associated with rehabilitation exercise
Placebo Comparator: placebo rTMS + rehabilitation exercise
14 weeks of placebo repetitive transcranial magnetic stimulation associated with rehabilitation exercise
Device: placebo rTMS+ rehabilitation exercise
14 week program of placebo repetitive transcranial magnetic stimulation associated with rehabilitation exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in pain Visual Analog Scale (VAS) at 14 weeks of treatment
Time Frame: Daily average VAS at baseline, week 2, week 4, week 8, week 14
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from base line in quality of life at 14 weeks and 26 weeks
Time Frame: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
Fibromyalgia Impact Questionnaire (FIQ)
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
Time Frame: at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
Beck Depression Inventory (BDI)
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
Time Frame: at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
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
Time Frame: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
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
Change from baseline in neuromuscular fatigability at 14 weeks and 26 weeks
Time Frame: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
Maximal voluntary activation level
At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
Change from baseline in cardiac variability at 14 weeks and 26 weeks
Time Frame: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
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
Evolution of the analgesic effect after the end of the program
Time Frame: Daily average VAS at the end (14 weeks) and 26 weeks 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Fondation Apicil

Investigators

  • Principal Investigator: Caroline Maindet-Dominici, MD, Centre de la Douleur CHU de Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

December 17, 2010

First Submitted That Met QC Criteria

March 3, 2011

First Posted (Estimate)

March 4, 2011

Study Record Updates

Last Update Posted (Estimate)

January 18, 2016

Last Update Submitted That Met QC Criteria

January 15, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-A00865-34

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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