Efficacy of Transcranial Magnetic Stimulation (TMS) in Chronic Idiopathic Pain Disorders
Condition: Fibromyalgia; Irritable Bowel Syndrome; Burning Mouth Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Irritable Bowel Syndrome; Burning Mouth Syndrome; Syndrome; Burns
Study type: Interventional
Phase: Phase 3

Summary: 
      Objectives : To investigate the analgesic effects of repeated sessions of unilateral rTMS in
      patients with chronic pain syndrome due to fibromyalgia, IBS or burning mouth syndrome.
      Primary outcome will be numerical pain scores.

      Methods : The study will be randomized and performed in parallel groups and double blind
      versus sham stimulation, and will include 90 patients (45 patients per treatment arm). The
      randomization will be computerized and performed for each aetiological group separately. The
      rTMS will be performed on the left motor cortex, 5 consecutive days , then once a week during
      3 weeks then twice a month during 2 months, then once a month during 6 months. Clinical
      assessment will include an assessment of pain, quality of life, sleep, depression and
      anxiety, catastrophizing, and a neuropsychological evaluation.

      Conclusion : this study should allow to determine for the first time the long term efficacy
      and safety of rTMS in the treatment of dysfunctional or idiopathic chronic pain syndromes
      which are often refractory to conventional treatments.
    

Detailed description: 
      Several lines of evidence suggest that fibromyalgia syndrome, Irritable Bowel syndrome (IBS)
      and burning mouth syndrome are chronic pain disorders affecting pain modulation. Repetitive
      transcranial magnetic stimulation (rTMS) is a recent, safe and non-invasive technique for
      stimulating the cerebral cortex, which has recently been reported to induce short term
      analgesic effects in patients with chronic focal pain. We have also recently shown in a
      double blind randomized trial, that rTMS could have short term analgesic effects in patients
      with fibromyalgia.

      Objectives : Our aim is to investigate the long term analgesic effects of repeated sessions
      of unilateral rTMS in patients with chronic pain syndrome due to fibromyalgia, IBS or burning
      mouth syndrome. Primary outcome will be numerical pain scores on brief pain inventory at each
      visit.

      Methods : This study will be randomized and performed in parallel groups and double blind
      versus sham stimulation. It will include at least 30 patients per pain disorder, ie 90
      patients. Randomization will be computerized and performed for each of the aetiological
      groups separately (ie, there will be 3 distinct randomization procedures for fibromyalgia,
      IBS and stomatodynia);. Stimulation will be applied to the right motor area corresponding to
      the contralateral hand. The treatment will consist in a first period of 5 consecutive days of
      stimulation, followed by a stimulation once a week during 3 weeks then a stimulation twice a
      month during 2 months then stimulation once a month during 3 additional months. Clinical
      assessment will be performed at baseline, then at day 1, 5, weeks 3, 5, 7, 9, 13 and 25. It
      will include depending on the visits an assessment of pain intensity and characteristics,
      quality of life, sleep, depression and anxiety, catastrophizing, and a brief
      neuropsychological evaluation (focusing on memory, attention and vigilance). In patients with
      fibromyalgia, the evaluation will also include specifically the number of tender points. In
      patients with IBS, evaluation of bowel dysfunction will also be performed.

      Conclusion : This study should allow to determine for the first time the long term efficacy
      and safety of rTMS in the treatment of dysfunctional or idiopathic chronic pain syndromes
      which are often refractory to conventional treatments.
    

Intervention name(s): Repetitive transcranial magnetic stimulation
Intervention type(s): Device
Intervention description(s): Repetitive transcranial magnetic stimulation of the motor cortex (10 Hz) every day during 5 days then every week for 3 weeks then every two weeks for 2 months then every month for 3 additional months
Other intervention name(s): placebo stimulation; rTMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TMS; chronic pain; fibromyalgia; IBS; burning mouth syndrome; predictive factors