Status:
COMPLETED
Efficacy of Transcranial Magnetic Stimulation (TMS) in Chronic Idiopathic Pain Disorders
Lead Sponsor:
Hospital Ambroise Paré Paris
Conditions:
Fibromyalgia
Irritable Bowel Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 wil...
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 ma...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00374673
Start Date
October 1 2006
End Date
April 1 2012
Last Update
December 3 2015
Active Locations (1)
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1
Hôpital Ambroise Paré
Boulogne, France, 92100