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

Starting soon · Not applicable

Conditions studied: Neuropathic Pain, Nociplastic Pain

In brief

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.

Key facts

Study ID

NCT07660510

Run by

Nantes University Hospital

People needed

30

Starts

2026-09-01

Expected to finish

2028-03-01

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Nantes University Hospital — Nantes, France

Full record on ClinicalTrials.gov

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