Evolution of Different Sensitivity Levels in Patients With Chronic Neuropathic Pain in the Pelvi-perineal Region After Treatment With High-concentration Capsaicin Patches

Evolution of Different Sensitivity Levels in Patients With Chronic Neuropathic Pain in the Pelvi-perineal Region After Treatment With High-concentration Capsaicin Patches

The primary objective of this study will be to demonstrate a change in pain sensitization parameters before and after the application of the high-concentration capsaicin patch.

Category 2 Study (Interventional Research with Minimal Risks and Constraints), monocentric, uncontrolled, non-randomized, open-label and prospective.

This study involves conducting tests and questionnaires before and 1 month after the application of a patch administered as part of standard clinical practice.

Inclusion Criteria:

• Men or women ≥ 18 years old.
• Patients suffering from chronic pelvi-perineal neuralgia (>3 months) with a DN4 score ≥4 at the inclusion visit, with or without symptoms of central sensitization, and with an indication for topical treatment with high-concentration capsaicin patch (PCHC).
• Patients who have signed the informed consent form for the study at the inclusion visit.
• Women must meet one of the following criteria at the time of inclusion:
• Use adequate contraceptive measures;
• or Be postmenopausal (aged over 50 years with amenorrhea for at least 12 months after discontinuation of all exogenous hormonal treatments);
• or (If aged under 50 years) have been amenorrheic for at least 12 months after discontinuation of exogenous hormonal treatments, with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels consistent with postmenopausal levels;
• or Have undergone irreversible surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), with documentation of the procedure.

Exclusion Criteria:

• Patients under guardianship, curatorship, or legal protection.
• Pregnant or breastfeeding women.
• Patients with contraindications to the use of the high-concentration capsaicin patch (PCHC): application on damaged skin, hypersensitivity to any of its components.
• Patients simultaneously starting a treatment that may influence central sensitization (e.g., antidepressants, antiepileptics, psychotherapy, physical activity, transcutaneous electrical nerve stimulation).
• Patients not affiliated with the French Social Security system.
• Patients with insufficient cooperation and/or understanding to strictly comply with the protocol requirements.
• Patients who have taken analgesics within the 12 hours prior to measurements.