Response Profiles to High-concentration Capsaicin Desensitization in Patients with Peripheral Neuropathic Pain with or Without Allodynia: a Regional Multicenter Prospective Cohort

Last updated: February 11, 2025
Sponsor: Centre Hospitalier Annecy Genevois
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain (Pediatric)

Pain

Treatment

Capsaicin 8%

Questionnaires

Clinical Study ID

NCT05817591
19-50
  • Ages > 18
  • All Genders

Study Summary

Prospective multicenter cohort to determine patient profiles (associated factors, including allodynia) with a better response to pain desensitization by capsaicin delivered in the form of a high concentration patch (8%), in a population of patients with peripheral neuropathic pain and followed up in a pain consultation in the Auvergne Rhône Alpes region.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient over 18 years of age on the day of inclusion

  • Patient who has been informed and has not expressed opposition to participating inthe study,

  • Patient with peripheral neuropathic pain (whatever the etiology), defined by :

  • "Neuropathic Pain 4" score ("DN4" score) ≥ 4/10

  • AND pain according to the numerical scale (EN) > 4/10,

  • AND stable analgesic treatment for at least 1 month,

  • AND with or without mechanical allodynia according to the Quantitative SensoryTesting (QST) : Brush test (dynamic), Von Frey test (static)

  • AND with or without thermal allodynia to hot or cold as determined by aROLLTEMP-II® (Rolltemp is a device designed for quick screening of temperaturesensibility over large body areas).

  • Patient responding to an indication of desensitization to high concentrationcapsaicin concentration and not presenting any contra-indication.

  • Patient naïve of high concentration of Capsaicin on the concerned zone

  • Patient understanding French

Non-inclusion Criteria:

  • Patient with pain related to complex regional pain syndrome (criteria not meetingthe indication for capsaicin)

  • Patient with active cancer (underlying disease and treatments may modify painperception),

  • Patient receiving or having received in the last 3 months Botulinum toxin A on theconcerned area (this treatment of neuropathic pain may modulate the effect ofcapsaicin and disturb the demonstration of causality),

  • Patient with planned surgery within the next 12 months on the painful site (surgerymay cause neuropathic damage and/or bias the pain assessment),

  • Patient included in an interventional research protocol,

  • Patient under guardianship or curators,

  • Patient under legal protection

Exclusion

Exclusion Criteria:

None

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Capsaicin 8%
Phase:
Study Start date:
December 14, 2023
Estimated Completion Date:
June 15, 2026

Connect with a study center

  • Centre Hospitalier Annecy Genevois

    Annecy, 74370
    France

    Active - Recruiting

  • Hospices Civils de Lyon, Hôpital Pierre Wertheimer

    Bron, 69500
    France

    Site Not Available

  • Centre Hospitalier Métropole Savoie

    Chambéry, 73000
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Clermont-Ferrand

    Clermont-Ferrand, 63000
    France

    Site Not Available

  • Centre Hospitalier Universitaire Grenoble-Alpes

    Grenoble, 38043
    France

    Active - Recruiting

  • Centre Léon Bérard

    Lyon, 69373
    France

    Active - Recruiting

  • Hospices Civils de Lyon, Hôpital de la Croix Rousse

    Lyon, 69317
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Saint-Etienne

    Saint-Étienne, 42055
    France

    Site Not Available

  • Clinique Mutualiste Chirurgicale de Saint Etienne

    Saint-Étienne, 42100
    France

    Active - Recruiting

  • Médipôle Lyon Villeurbanne

    Villeurbanne, 69100
    France

    Site Not Available

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