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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-14

Study Completion Date

2026-06-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Neuropathic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Questionnaires

Intervention Type 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

Interventions

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Questionnaires

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

Intervention Type OTHER

Eligibility Criteria

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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 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,
* Patient under guardianship or curators,
* Patient under legal protection