Clinical trial NCT05817591: Response Profiles to High-concentration Capsaicin Desensitization in Patients with Peripheral Neuropathic Pain with or Without Allodynia: a Regional Multicenter Prospective Cohort
Official title: Response Profiles to High-concentration Capsaicin Desensitization in Patients with Peripheral Neuropathic Pain with or Without Allodynia: a Regional Multicenter Prospective Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Neuropathic Pain
Lead sponsor: Centre Hospitalier Annecy Genevois
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible patients are identified during consultations for the treatment of their pain, carried out in the Chronic Pain Structures of the Auvergne Rhône-Alpes region. These patients must present peripheral neuropathic pain, whatever the etiology, and validated by a DN4 score ≥ 4/10 and a pain scale \> 4/10, with a stable analgesic treatment for at least one month and for whom the investigator proposes a desensitization to high concentration Capsaicin.

Inclusion of consecutive patients in a consultation/day hospitalization setting.

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

Primary outcomes:
measure: Factors (profiles) associated with a better initial response to pain desensitization by capsaicin
timeFrame: 12 months
Secondary outcomes:
measure: Proportion [95% Confidence Interval (CI)] of patients "responder at 30%" at 1.5 months after each consecutive patch (e.g. at M4.5 for a second patch applied at M3)
timeFrame: 1.5 months after each consecutive patch
measure: Proportion [95% CI] of patients "initial responder" at 50%
timeFrame: 12 months
measure: Distribution of Neuropathic Pain Symptom Inventory (NPSI) score values over time: at inclusion, 3 months, 6 months, 9 months,12 months, and between inclusion and the end of follow-up
timeFrame: Each 3 months and over 12 months
measure: Distribution of NPSI subscores values (Q8, Q9, Q10) over time: at inclusion, 3 months, 6 months, 9 months,12 months, and between inclusion and the end of follow-up
timeFrame: Each 3 months and over 12 months
measure: Distribution of Patients' Global Impression of Change (PGIC) scale score values over time: at 1.5 months, 3 months, 4.5 months, 6 months, 7.5 months, 9 months,10.5 months, 12 months, and between inclusion and the end of follow-up
timeFrame: Each 1.5 months and over 12 months
measure: In the subpopulation of patients with allodynia (dynamic mechanical or static or thermal): proportion [95% CI] of "responders" at 7.5 months
timeFrame: 7.5 months
measure: In the subpopulation of initial responders at the 30% threshold: proportion [95% CI] of patients relapsing at 12 months, defined as pain scale (EN) > 4/10, indicating a new capsaicin patch
timeFrame: 12 months
measure: Number of new initiation of analgesic treatment, defined by the addition of a molecule to the treatment given at the time of application of the first capsaicin patch
timeFrame: 12 months
measure: Number of reduction of analgesic treatment, defined by the stop of a molecule compared to the treatment given at the time of the application of the first capsaicin patch
timeFrame: 12 months
Other outcomes:
Locations:
city: Annecy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Bron
country: France
facility: Hospices Civils de Lyon, Hôpital Pierre Wertheimer
city: Chambéry
country: France
facility: Centre Hospitalier Métropole Savoie
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire Grenoble-Alpes
city: Lyon
country: France
facility: Hospices Civils de Lyon, Hôpital de la Croix Rousse
city: Lyon
country: France
facility: Centre Léon Bérard
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire de Saint-Etienne
city: Saint-Étienne
country: France
facility: Clinique Mutualiste Chirurgicale de Saint Etienne
city: Villeurbanne
country: France
facility: Médipôle Lyon Villeurbanne
Study officials:
affiliation: Centre Hospitalier Annecy Genevois
name: Stéphane FERRANDO, Doctor
role: PRINCIPAL_INVESTIGATOR
References: