Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00374673
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2006-09-08
Brief Title:
Efficacy of Transcranial Magnetic Stimulation TMS in Chronic Idiopathic Pain Disorders
Sponsor:
Hospital Ambroise Paré Paris
Organization:
Hospital Ambroise Paré Paris
Study Overview
Official Title:
Efficacy of Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Idiopathic Pain Syndromes a Double Blind Sham Controlled Study
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None