Understanding how patients with nerve pain respond to high-concentration capsaicin treatment

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

This study is trying to see how well a high-concentration capsaicin patch helps people with nerve pain and which patients might benefit the most from it.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Annecy Genevois (Academic / other)
• Locations: 10 sites (Annecy and 9 other locations)
• Trial ID: NCT05817591 on ClinicalTrials.gov

What this trial studies

This observational multicenter cohort study aims to identify patient profiles that respond better to pain desensitization using a high-concentration capsaicin patch in individuals suffering from peripheral neuropathic pain. Participants will be assessed based on various factors, including the presence of allodynia, and will complete questionnaires to evaluate their pain levels and treatment responses. The study will take place in multiple centers across the Auvergne Rhône Alpes region, focusing on patients who have stable analgesic treatment and meet specific inclusion criteria.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with peripheral neuropathic pain who have stable analgesic treatment and meet specific pain assessment criteria.

Not a fit: Patients who have contraindications to capsaicin treatment or are not experiencing peripheral neuropathic pain may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify which patients are most likely to benefit from high-concentration capsaicin treatment for nerve pain.

How similar studies have performed: While the approach of using capsaicin for pain management is established, this specific study's focus on patient profiles and response variability is relatively novel.

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

Where this trial is running

Annecy and 9 other locations

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

Study contacts

• Principal investigator: Stéphane FERRANDO, Doctor — Centre Hospitalier Annecy Genevois
• Study coordinator: Marion GHIDI

Conditions Peripheral Neuropathic Pain