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Completed

NCT Number: NCT01308801

Repetitive Transcranial Magnetic Stimulation in 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

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Grenoble

Grenoble, Isère, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active rTMS + rehabilitation exercise

Device

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

placebo rTMS+ rehabilitation exercise

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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)

  7. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Fondation Apicil

Registry information

Official study title

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

Acronym: STIMALGI

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Mar 4, 2011
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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