About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Use adequate contraceptive measures;
Disqualifiers
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).
Trial design
Single group
Treatments tested in this trial
Quantitative Sensory Testing and questionnaires
Other interventionQuantitative Sensory Testing and questionnaires
Treatment groups
Trial outcomes
Primary outcomes
Composite criterion
Composite criterion constructed from a Principal Component Analysis including the differences between Day 0 (before patch application) and Day 30 in pain perception thresholds (to cold, heat, pressure, and mechanical stimulation) in both the area treated with the high-concentration capsaicin patch and the corresponding dermatome, as well as the change in the pain receptive field area in the treated zone and the area under the curve of temporal summation measurements.
Secondary outcomes
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (1)
Difference in pressure pain thresholds in the treated area
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (2)
Difference in mechanical stimulation pain thresholds
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (3)
Difference in cold pain thresholds in the treated area
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (4)
Difference in heat pain thresholds in the treated area
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: