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

15 juni 2026 bijgewerkt door: Nantes University Hospital
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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Frankrijk
      • Nantes, Frankrijk
        • Nantes university hospital
        • Contact:
          • Nantes University Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Pain sensitization parameter testing

Pre-inclusion visit (routine care consultation): Verification of inclusion and exclusion criteria.

Inclusion visit (Day 0): Consent signing, questionnaires (ConvergencePP Score/Central Sensitization Inventory, DN4), and a series of tests, followed by the application of the high-concentration capsaicin patch (PCHC) (performed during routine care).

Day 30 visit (±7 days): Questionnaires (same as V1 + PGI-c) and a series of tests.
Ander: Quantitative Sensory Testing and questionnaires
Quantitative Sensory Testing and questionnaires

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Composite criterion
Tijdsspanne: Difference between Day 0 and Day 30
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.
Difference between Day 0 and Day 30

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (1)
Tijdsspanne: Between before and 30 days after patch application
Difference in pressure pain thresholds in the treated area
Between before and 30 days after patch application
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (2)
Tijdsspanne: Between before and 30 days after patch application
Difference in mechanical stimulation pain thresholds
Between before and 30 days after patch application
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (3)
Tijdsspanne: Between before and 30 days after patch application
Difference in cold pain thresholds in the treated area
Between before and 30 days after patch application
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (4)
Tijdsspanne: Between before and 30 days after patch application
Difference in heat pain thresholds in the treated area
Between before and 30 days after patch application
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (5)
Tijdsspanne: Between before and 30 days after patch application
Difference in pain receptive field area
Between before and 30 days after patch application
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (1)
Tijdsspanne: Between before and 1 month after patch application.

Difference in pressure pain thresholds in an area of the dermatome not directly treated by the patch:

  • Ipsilateral retro-malleolar groove (S2 root) for inferior cluneal nerve neuralgia treatment,
  • Posterior iliac crest relief, 7 cm from the midline (L1) for ilio-inguinal or ilio-hypogastric neuralgia treatment,
  • Perineal body (S4) for sacrococcygeal plexus neuralgia treatment.
Between before and 1 month after patch application.
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (2)
Tijdsspanne: Between before and 1 month after patch application.
Difference in mechanical stimulation pain thresholds in an area of the dermatome not directly treated by the patch
Between before and 1 month after patch application.
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (3)
Tijdsspanne: Between before and 1 month after patch application.
Difference in cold pain thresholds in an area of the dermatome not directly treated by the patch.
Between before and 1 month after patch application.
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (4)
Tijdsspanne: Between before and 1 month after patch application.
Difference in heat pain thresholds in an area of the dermatome not directly treated by the patch.
Between before and 1 month after patch application.
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (5)
Tijdsspanne: Between before and 1 month after patch application.
Difference in the area under the curve of temporal summation measurements in the treated area
Between before and 1 month after patch application.
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (6)
Tijdsspanne: Between before and 1 month after patch application.
Difference in the duration of pain persistence after the end of temporal summation (in seconds).
Between before and 1 month after patch application.
Measure the patient's therapeutic response to the treatment
Tijdsspanne: Day 30
Patient Global Impression of Change (PGI-C). The therapeutic response is defined as a patient who scores 1 to 3 on the PGI-C.
Day 30
Evaluate the predictive value of temporal summation with regard to the therapeutic response to the high-concentration capsaicin patch
Tijdsspanne: Between before and 1 month after patch application.
Investigation of a relevant threshold for temporal summation to predict the therapeutic response. Quantification of the positive predictive value.
Between before and 1 month after patch application.
Measure the correlation between Convergences PP scores, CSI, and semi-objective sensitization data
Tijdsspanne: Between before and 1 month after patch application

Measure the correlation between Convergences PP scores, CSI, and semi-objective sensitization data. The Convergences PP score is a clinical questionnaire used to diagnose sensitization in the pelvic region. A score is considered positive from 5/10 (sensitivity = 95%, specificity = 87%).

The Central Sensitization Inventory (CSI) is a self-administered questionnaire used to diagnose central sensitization. A score is considered positive from 40/100.

Correlations between the Convergences PP score, CSI, and semi-objective sensitization data (pain thresholds and temporal summation) will be measured using Spearman's correlation coefficient to explore the relationships between these variables.
Between before and 1 month after patch application

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Nantes University Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 maart 2028

Studie voltooiing (Geschat)

1 maart 2028

Studieregistratiedata

Eerst ingediend

15 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

15 juni 2026

Eerst geplaatst (Werkelijk)

22 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

15 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • RC25_0536

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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