Clinical trial NCT00374673: Efficacy of Transcranial Magnetic Stimulation (TMS) in Chronic Idiopathic Pain Disorders
Official title: Efficacy of Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Idiopathic Pain Syndromes : a Double Blind Sham Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Irritable Bowel Syndrome
Burning Mouth Syndrome
Keywords: TMS
chronic pain
fibromyalgia
IBS
burning mouth syndrome
predictive factors
Lead sponsor: Hospital Ambroise Paré Paris
Sponsor class: OTHER
First posted: 2006-09-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Average pain over the last 24 hours at each visit -pain diary at baseline to see the stability of the measures
timeFrame: at each visit before the stimulation session
Secondary outcomes:
measure: Sensory and affective pain scores (McGill pain questionnaire)
timeFrame: at baseline, then day 1, 5, weeks 3, 9, and 25 after the induction phase
measure: Quality of life (brief pain inventory)
timeFrame: at baseline, days 1, 5,weeks 3, 9, and 25 after the induction phase
measure: Disability ( FIQ)
timeFrame: at days 1, 5, weeks 3, 9 and 25 after the induction phase
measure: Comorbidities (HAD)
timeFrame: at week 3 7, 13, 25 after the induction phase
measure: Catastrophizing (PCS)
timeFrame: at weeks 3, 7, 13 and 25 after the induction phase
measure: Predictors of the response based on psychological factors and measures of cortical excitability
timeFrame: at inclusion
measure: Safety including cognitive evaluation
timeFrame: at 6 months (cognitive evaluation) ; safety assessed every month for up to 12 months
measure: Comparison of the efficacy of TMS between 3 different pain disorders
timeFrame: during the whole study period -ie, days 1, 5, then before each stimulation throughout the study
measure: assessment of cortical excitability
timeFrame: day 1, 5, weeks 3, 9 and 21 after the induction phase
Other outcomes:
Locations:
city: Boulogne
country: France
facility: Hôpital Ambroise Paré
Study officials:
affiliation: INSERM U 987 and AP-HP
name: Nadine ATTAL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: