Endometriosis Clinical Trial
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
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)
- 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 treatment(s) 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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