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

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

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.

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.

Inclusion Criteria:

• Patient aged 18 to 85 years, suffering from pelvic pain for more than one year (excluding musculoskeletal causes).
• Patient with stable ongoing medication (analgesic or otherwise) for at least one month.
• Patient for whom lack of response to conventional treatments has led the pain specialist or referring physician to consider non-pharmacological therapeutic options.
• Patient reporting a pain intensity score >3 on the Numeric Visual Pain Scale (NVPS) during pre-screening.
• Patient affiliated with the national health insurance system or an equivalent scheme.
• Patient who has provided written informed consent.

Exclusion Criteria:

• History of drug addiction.
• History of psychiatric disorders likely to interfere with the proper conduct of the study.
• Patient with skin lesions in the lumbar region.
• Person unable to understand the study protocol.
• Individuals covered by Articles L1121-5 to L1121-8 of the French Public Health Code, corresponding to all protected persons: pregnant women, women in labor, breastfeeding mothers, individuals deprived of liberty by judicial or administrative decision, or under legal protection.
• Subject currently in the exclusion period of another clinical trial