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

Centre Hospitalier Annecy Genevois

Status: Enrolling

Conditions: Peripheral Neuropathic Pain

Treatments: Other: Questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT05817591

19-50

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 1 patient group

Patients with peripheral neuropathic pain and having an indication of capsaicin patches

Description:

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

Treatment:

Other: Questionnaires