Efficacy of Transcranial Magnetic Stimulation (TMS) in Chronic Idiopathic Pain Disorders

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nadine ATTAL, Hôpital Ambroise Paré
ClinicalTrials.gov Identifier:
NCT00374673
First received: September 8, 2006
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Irritable Bowel Syndrome
Burning Mouth Syndrome
Device: Repetitive transcranial magnetic stimulation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Idiopathic Pain Syndromes : a Double Blind Sham Controlled Study

Resource links provided by NLM:


Further study details as provided by Hôpital Européen Marseille:

Primary Outcome Measures:
  • Average pain over the last 24 hours at each visit -pain diary at baseline to see the stability of the measures [ Time Frame: at each visit before the stimulation session ] [ Designated as safety issue: No ]
    Brief Pain inventory


Secondary Outcome Measures:
  • Sensory and affective pain scores (McGill pain questionnaire) [ Time Frame: at baseline, then day 1, 5, weeks 3, 9, and 25 after the induction phase ] [ Designated as safety issue: No ]
    Short form MPQ was used

  • Quality of life (brief pain inventory) [ Time Frame: at baseline, days 1, 5,weeks 3, 9, and 25 after the induction phase ] [ Designated as safety issue: No ]
    Brief Pain inventory (Cleeland and Ryan 1992) interference items (7)

  • Disability ( FIQ) [ Time Frame: at days 1, 5, weeks 3, 9 and 25 after the induction phase ] [ Designated as safety issue: No ]
    FIQ only for fibromyalgia patients

  • Comorbidities (HAD) [ Time Frame: at week 3 7, 13, 25 after the induction phase ] [ Designated as safety issue: No ]
    21 item Hospital anxiety and depression scale

  • Catastrophizing (PCS) [ Time Frame: at weeks 3, 7, 13 and 25 after the induction phase ] [ Designated as safety issue: No ]
    Pain Catastrophizing Scale (Sullivan et al 1995)

  • Predictors of the response based on psychological factors and measures of cortical excitability [ Time Frame: at inclusion ] [ Designated as safety issue: No ]
  • Safety including cognitive evaluation [ Time Frame: at 6 months (cognitive evaluation) ; safety assessed every month for up to 12 months ] [ Designated as safety issue: Yes ]
    Cognitive tests were performed by a neuropsychologists and included measures of attention and memory

  • Comparison of the efficacy of TMS between 3 different pain disorders [ Time Frame: during the whole study period -ie, days 1, 5, then before each stimulation throughout the study ] [ Designated as safety issue: No ]
    this can only be made when the two other groups of patients will have finished the enrollment - for now the study on fibromyalgia is finished and results analysed - the other groups are still being recruited (ie, IBS, burning mouth syndrome)

  • assessment of cortical excitability [ Time Frame: day 1, 5, weeks 3, 9 and 21 after the induction phase ] [ Designated as safety issue: No ]
    determination of rest motor threshold, suprathreshold motor evoiked potentials (MEP), SICI and ICF, for the left hemisphere


Enrollment: 60
Study Start Date: October 2006
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: transcranial magnetic stimulation
repetitive transcranial magnetic stimulation of the motor cortex
Device: Repetitive transcranial magnetic stimulation
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 Names:
  • placebo stimulation
  • rTMS
Sham Comparator: placebo stimulation
repetitive placebo stimulation of the motor cortex
Device: Repetitive transcranial magnetic stimulation
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 Names:
  • placebo stimulation
  • rTMS

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pain related to Fibromyalgia (ACR criteria) or IBS (Rome II criteria) or burning mouth syndrome (IHS criteria 2004)
  • Chronic pain for at least 6 months
  • Pain for at least 4 days a week
  • Mean average pain score at inclusion and randomization ≥ 4/10 (numerical scale)
  • Patients aged 18 years and less than 80 years
  • Informed consent
  • Stable antalgic treatment

Exclusion Criteria:

  • Contraindications to TMS (electroconvulsive therapy, epilepsy, head trauma, intracranial hypertension, metallic clip, pace maker, pregnancy)
  • Major depression (DSM IV criteria) or psychosis
  • Disorder preventing an accurate understanding of the testing and protocol
  • Intermittent pain
  • Pain for less than 6 months
  • Other pain more severe than the pain evaluated for the trial
  • Alcohol/psychoactive drugs abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374673

Locations
France
Hôpital Ambroise Paré
Boulogne, France, 92100
Sponsors and Collaborators
Hôpital Européen Marseille
Investigators
Principal Investigator: Nadine ATTAL, MD, PhD INSERM U 987 and AP-HP
  More Information

No publications provided

Responsible Party: Nadine ATTAL, Clinical principal investigator, Hôpital Ambroise Paré
ClinicalTrials.gov Identifier: NCT00374673     History of Changes
Other Study ID Numbers: TMS-chronic pain 1
Study First Received: September 8, 2006
Last Updated: September 12, 2012
Health Authority: France: Direction Générale de la Santé

Keywords provided by Hôpital Européen Marseille:
TMS
chronic pain
fibromyalgia
IBS
burning mouth syndrome
predictive factors

Additional relevant MeSH terms:
Burning Mouth Syndrome
Burns
Fibromyalgia
Myofascial Pain Syndromes
Irritable Bowel Syndrome
Mouth Diseases
Stomatognathic Diseases
Wounds and Injuries
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 22, 2014