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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNantes University Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Quantitative Sensory Testing and questionnaires

    Other intervention

    Quantitative Sensory Testing and questionnaires

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Pain sensitization parameter testingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Difference between Day 0 and Day 30

Secondary outcomes

1

Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (1)

Difference in pressure pain thresholds in the treated area

Time frame
Between before and 30 days after patch application
2

Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (2)

Difference in mechanical stimulation pain thresholds

Time frame
Between before and 30 days after patch application
3

Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (3)

Difference in cold pain thresholds in the treated area

Time frame
Between before and 30 days after patch application
4

Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (4)

Difference in heat pain thresholds in the treated area

Time frame
Between before and 30 days after patch application

Other outcomes

Sponsors and contacts

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