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

NCT05817591 | Recruiting

• 1 other identifier: 19-50
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Peripheral Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Factors (profiles) associated with a better initial response to pain desensitization by capsaicin

  A patient is a responder if he has a reduction in pain, as measured by a numerical pain scale, of at least 30% from baseline. The scale used is "EN - échelle numérique" in french, "NRS - Numerical Rating Scale" in english, between 0 and 10 (0 being the absence of pain and 10 the most intense pain).

  12 months

Secondary Outcomes (9)

• Proportion [95% Confidence Interval (CI)] of patients "responder at 30%" at 1.5 months after each consecutive patch (e.g. at M4.5 for a second patch applied at M3)

  1.5 months after each consecutive patch

• Proportion [95% CI] of patients "initial responder" at 50%

  12 months

• Distribution of Neuropathic Pain Symptom Inventory (NPSI) score values over time: at inclusion, 3 months, 6 months, 9 months,12 months, and between inclusion and the end of follow-up

  Each 3 months and over 12 months

• Distribution of NPSI subscores values (Q8, Q9, Q10) over time: at inclusion, 3 months, 6 months, 9 months,12 months, and between inclusion and the end of follow-up

  Each 3 months and over 12 months

• Distribution of Patients' Global Impression of Change (PGIC) scale score values over time: at 1.5 months, 3 months, 4.5 months, 6 months, 7.5 months, 9 months,10.5 months, 12 months, and between inclusion and the end of follow-up

  Each 1.5 months and over 12 months

Study Arms (1)

Patients with peripheral neuropathic pain and having an indication of capsaicin patches

All patients will receive as part of routine care: * Three consecutive patches of 8% capsaicin in localized application for 30 to 60 minutes once every 3 months : at M0 (study inclusion), M3 and M6, or until pain scale \< 4/10 (between 0 and 10), * Pain assessment every 1.5 months (+/-7 days), to evaluate clinical response, * 8% capsaicin patches if the pain assessment rises again to pain scale \> 4/10, after an initial response to treatment

Other: Questionnaires

Interventions

Questionnaires OTHER

In current practice, capsaicin patch treatment is offered to patients with a 24-hour average pain level measured by the EN numerical scale : EN scale is \> 4 Pain monitoring questionnaires will be completed by patients every 6 weeks : Neuropathic Pain Symptom Invetory (NPSI Score), Patients' Global Impression of Change (PGIC scale), Numerical pain scale

Patients with peripheral neuropathic pain and having an indication of capsaicin patches

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eligible patients are identified during consultations for the treatment of their pain, carried out in the Chronic Pain Structures of the Auvergne Rhône-Alpes region. These patients must present peripheral neuropathic pain, whatever the etiology, and validated by a DN4 score ≥ 4/10 and a pain scale \> 4/10, with a stable analgesic treatment for at least one month and for whom the investigator proposes a desensitization to high concentration Capsaicin. Inclusion of consecutive patients in a consultation/day hospitalization setting.

You may qualify if:

• Patient who has been informed and has not expressed opposition to participating in the 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 Sensory Testing (QST) : Brush test (dynamic), Von Frey test (static)
• AND with or without thermal allodynia to hot or cold as determined by a ROLLTEMP-II® (Rolltemp is a device designed for quick screening of temperature sensibility over large body areas).
• Patient responding to an indication of desensitization to high concentration capsaicin concentration and not presenting any contra-indication.
• Patient naïve of high concentration of Capsaicin on the concerned zone
• Patient understanding French
• Patient with pain related to complex regional pain syndrome (criteria not meeting the indication for capsaicin)
• Patient with active cancer (underlying disease and treatments may modify pain perception),
• Patient receiving or having received in the last 3 months Botulinum toxin A on the concerned area (this treatment of neuropathic pain may modulate the effect of capsaicin and disturb the demonstration of causality),
• Patient with planned surgery within the next 12 months on the painful site (surgery may cause neuropathic damage and/or bias the pain assessment),
• Patient included in an interventional research protocol,

You may not qualify if:

• None

Sponsors & Collaborators

• Centre Hospitalier Annecy Genevois: lead

Study Sites (10)

Centre Hospitalier Annecy Genevois

Annecy, 74370, France

RECRUITING

Hospices Civils de Lyon, Hôpital Pierre Wertheimer

Bron, 69500, France

NOT YET RECRUITING

Centre Hospitalier Métropole Savoie

Chambéry, 73000, France

RECRUITING

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

Centre Hospitalier Universitaire Grenoble-Alpes

Grenoble, 38043, France

RECRUITING

Hospices Civils de Lyon, Hôpital de la Croix Rousse

Lyon, 69317, France

NOT YET RECRUITING

Centre Léon Bérard

Lyon, 69373, France

RECRUITING

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, 42055, France

NOT YET RECRUITING

Clinique Mutualiste Chirurgicale de Saint Etienne

Saint-Etienne, 42100, France

RECRUITING

Médipôle Lyon Villeurbanne

Villeurbanne, 69100, France

NOT YET RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Stéphane FERRANDO, Doctor

  Centre Hospitalier Annecy Genevois

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion GHIDI

CONTACT

+33450637031; drci.promotion@ch-annecygenevois.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 18, 2023
• Study Start: December 14, 2023
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

FR (10)