NCT05817591 Response Profiles to High-concentration Capsaicin Desensitization in Patients with Peripheral Neuropathic Pain with or Without Allodynia: a Regional Multicenter Prospective Cohort
| NCT ID | NCT05817591 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Annecy Genevois |
| Condition | Peripheral Neuropathic Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-12-14 |
| Primary Completion | 2026-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2023-12-14 with a primary completion date of 2026-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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 Non-inclusion Criteria: * 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 Exclusion Criteria: None
Contact & Investigator
Stéphane FERRANDO, Doctor
PRINCIPAL INVESTIGATOR
Centre Hospitalier Annecy Genevois
Frequently Asked Questions
Who can join the NCT05817591 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Neuropathic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05817591 currently recruiting?
Yes, NCT05817591 is actively recruiting participants. Contact the research team at drci.promotion@ch-annecygenevois.fr for enrollment information.
Where is the NCT05817591 trial being conducted?
This trial is being conducted at Annecy, France, Bron, France, Chambéry, France, Clermont-Ferrand, France and 6 additional locations.
Who is sponsoring the NCT05817591 clinical trial?
NCT05817591 is sponsored by Centre Hospitalier Annecy Genevois. The principal investigator is Stéphane FERRANDO, Doctor at Centre Hospitalier Annecy Genevois. The trial plans to enroll 400 participants.