Fibromyalgia Clinical Trial
Official title:
Efficacy of Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Idiopathic Pain Syndromes : a Double Blind Sham Controlled Study
Verified date | December 2015 |
Source | Hospital Ambroise Paré Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Direction Générale de la Santé |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hôpital Ambroise Paré | Boulogne |
Lead Sponsor | Collaborator |
---|---|
Hospital Ambroise Paré Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average pain over the last 24 hours at each visit -pain diary at baseline to see the stability of the measures | Brief Pain inventory | at each visit before the stimulation session | No |
Secondary | Sensory and affective pain scores (McGill pain questionnaire) | Short form MPQ was used | at baseline, then day 1, 5, weeks 3, 9, and 25 after the induction phase | No |
Secondary | Quality of life (brief pain inventory) | Brief Pain inventory (Cleeland and Ryan 1992) interference items (7) | at baseline, days 1, 5,weeks 3, 9, and 25 after the induction phase | No |
Secondary | Disability ( FIQ) | FIQ only for fibromyalgia patients | at days 1, 5, weeks 3, 9 and 25 after the induction phase | No |
Secondary | Comorbidities (HAD) | 21 item Hospital anxiety and depression scale | at week 3 7, 13, 25 after the induction phase | No |
Secondary | Catastrophizing (PCS) | Pain Catastrophizing Scale (Sullivan et al 1995) | at weeks 3, 7, 13 and 25 after the induction phase | No |
Secondary | Predictors of the response based on psychological factors and measures of cortical excitability | at inclusion | No | |
Secondary | Safety including cognitive evaluation | Cognitive tests were performed by a neuropsychologists and included measures of attention and memory | at 6 months (cognitive evaluation) ; safety assessed every month for up to 12 months | Yes |
Secondary | Comparison of the efficacy of TMS between 3 different pain disorders | 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) | during the whole study period -ie, days 1, 5, then before each stimulation throughout the study | No |
Secondary | assessment of cortical excitability | determination of rest motor threshold, suprathreshold motor evoiked potentials (MEP), SICI and ICF, for the left hemisphere | day 1, 5, weeks 3, 9 and 21 after the induction phase | No |
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