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

Recruiting now

Conditions studied: Peripheral Neuropathic Pain

In brief

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.

Key facts

Study ID

NCT05817591

Run by

Centre Hospitalier Annecy Genevois

People needed

400

Starts

2023-12-14

Expected to finish

2026-06-15

Last updated by the study team

2025-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• None

Where it is running

• Centre Hospitalier Métropole Savoie — Chambéry, France (enrolling)
• Centre Léon Bérard — Lyon, France (enrolling)
• Centre Hospitalier Universitaire Grenoble-Alpes — Grenoble, France (enrolling)
• Clinique Mutualiste Chirurgicale de Saint Etienne — Saint-Etienne, France (enrolling)
• Centre Hospitalier Annecy Genevois — Annecy, France (enrolling)
• Médipôle Lyon Villeurbanne — Villeurbanne, France
• Hospices Civils de Lyon, Hôpital Pierre Wertheimer — Bron, France
• Centre Hospitalier Universitaire de Clermont-Ferrand — Clermont-Ferrand, France
• Hospices Civils de Lyon, Hôpital de la Croix Rousse — Lyon, France
• Centre Hospitalier Universitaire de Saint-Etienne — Saint-Etienne, France

Full record on ClinicalTrials.gov

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