Ignite Creation Date:
2024-05-06 @ 9:20 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02958423
Status:
UNKNOWN
Last Update Posted:
2016-11-08
First Post:
2016-11-01
Brief Title:
tDCS Versus tsDCS for Endometriosis-related Chronic Pelvic Pain Treatment
Sponsor:
Jean Schoenen
Organization:
University of Liege
Study Overview
Official Title:
Transcranial Direct Current Stimulation tDCS vs Trans-spinal Direct Current Stimulation tsDCS for Endometriosis-related Chronic Pelvic Pain Treatment A Single Center Prospective Randomized Controlled Parallel Group Pilot Study
Status:
UNKNOWN
Status Verified Date:
2016-11
Last Known Status:
RECRUITING
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:
DCSErCPP
Brief Summary:
The purpose of the study is to compare the analgesic effect of 2 mA anodal direct current stimulation on the right primary motor cortex M1 tDCS with a similar stimulation on the spine D10 tsDCS in healthy volunteers HV followed by a pilot study in patients suffering of endometriosis-related chronic pelvic pain CPP
Detailed Description:
- 2 groups of 5 HV will receive tDCS or tsDCS 2mA anodal 20min and the thermonociceptive threshold will be measured before and after the stimulation over the abdomen hypogastric The HAD scale and SF-36 will also be tested
The treatments that produces the greatest increase in pain thresholds will be chosen to treat 10 patients
- 10 patients suffering from endometriosis-related chronic pelvic pain will be treated by the most efficient treatment tDCS or tsDCS for 4 weeks 5 daily 20-min sessions per week or if no treatment modality was superior in HV 5 patients will be treated by tDCS and 5 by tsDCS Patients will fill in daily a dedicated diary 2 weeks before treatment during the4-week treatment period and after this period as long as their pain level remains below 80 of their baseline pain intensity VAS Analgesic intake will also be monitored as well as HAD and SF-36 scores
The treatments that produces the greatest increase in pain thresholds will be chosen to treat 10 patients
- 10 patients suffering from endometriosis-related chronic pelvic pain will be treated by the most efficient treatment tDCS or tsDCS for 4 weeks 5 daily 20-min sessions per week or if no treatment modality was superior in HV 5 patients will be treated by tDCS and 5 by tsDCS Patients will fill in daily a dedicated diary 2 weeks before treatment during the4-week treatment period and after this period as long as their pain level remains below 80 of their baseline pain intensity VAS Analgesic intake will also be monitored as well as HAD and SF-36 scores
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