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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Hospitalier Annecy Genevois
  Annecy, France Recruiting
• Centre Hospitalier Métropole Savoie
  Chambéry, France Recruiting
• Centre Hospitalier Universitaire Grenoble-Alpes
  Grenoble, France Recruiting
• Centre Léon Bérard
  Lyon, France Recruiting
• Clinique Mutualiste Chirurgicale de Saint Etienne
  Saint-Etienne, France Recruiting
• Hospices Civils de Lyon, Hôpital Pierre Wertheimer
  Bron, France Not yet recruiting

Study contacts

• Principal investigator: Stéphane FERRANDO, Doctor — Centre Hospitalier Annecy Genevois
• Study coordinator: Marion GHIDI
• Email: drci.promotion@ch-annecygenevois.fr
• Phone: +33450637031

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.