NCT07237165

Evaluation of the Analgesic Effect of Direct Current Stimulation in the Treatment of Pelvic Pain, Comparing Three Groups: Trans-spinal Stimulation, Ganglionic Stimulation, and Placebo. A Randomized Double-blind Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the analgesic effectiveness of direct current stimulation (tsDCS) in the treatment of pelvic pain by comparing three groups: * Trans-spinal tsDCS stimulation, * Ganglionic tsDCS stimulation, * Placebo (sham) tsDCS stimulation.

Detailed description

Conduct of study: Entry into the study: After informed consent, patients will be randomised. The physician responsible for conducting neurostimulation sessions will make the randomization via Redcap. Only this physician will have the knowledge of the group allocated to the patient. Baseline : Patients, will record on a diary form, a daily Visual Numeric Scale(VNS) of Pain Intensity for 1 week. Treatment sessions: after the baseline, sessions of neurostimulation will begin for 5 weeks. After the end of neurostimulation sessions, patients will be followed for 2 weeks. Throughout their participation in the study, patients will plot on a diary form their daily VNS.

Conditions

• Chronic Pelvic Pain

Interventions

Type	Name	Description
DEVICE	Non-invasive device-based neuromodulation	Direct current stimulation (tsDCS) protocol consist of one daily session for five consecutive days during the first week, followed by one session per week until week 5, after which the treatment period ends and post-treatment follow-up begins.

Timeline

• Start date: 2025-12-01
• Primary completion: 2028-11-01
• Completion: 2029-11-01
• First posted: 2025-11-19
• Last updated: 2025-11-19

Locations

2 sites across 1 country: France