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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 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
      • Nantes, Frankrig
        • Nantes university hospital
        • Kontakt:
          • Nantes University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Quantitative Sensory Testing and questionnaires
Quantitative Sensory Testing and questionnaires

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Composite criterion
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (1)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nantes University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. marts 2028

Studieafslutning (Anslået)

1. marts 2028

Datoer for studieregistrering

Først indsendt

15. juni 2026

Først indsendt, der opfyldte QC-kriterier

15. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RC25_0536

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