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

Centre Hospitalier Annecy Genevois400 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Peripheral Neuropathic Pain

Interventions

QuestionnairesOTHER

In current practice, capsaicin patch treatment is offered to patients with a 24-hour average pain level measured by the EN numerical scale : EN scale is \> 4 Pain monitoring questionnaires will be completed by patients every 6 weeks : Neuropathic Pain Symptom Invetory (NPSI Score), Patients' Global Impression of Change (PGIC scale), Numerical pain scale

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (10)

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

Outcomes

Primary Outcomes

Factors (profiles) associated with a better initial response to pain desensitization by capsaicin

A patient is a responder if he has a reduction in pain, as measured by a numerical pain scale, of at least 30% from baseline. The scale used is "EN - échelle numérique" in french, "NRS - Numerical Rating Scale" in english, between 0 and 10 (0 being the absence of pain and 10 the most intense pain).

Time frame: 12 months

Secondary Outcomes

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)

Time frame: 1.5 months after each consecutive patch

Proportion [95% CI] of patients "initial responder" at 50%

Time frame: 12 months

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

The NPSI scale is composed of 12 questions (10 descriptive questions of symptoms and 2 to evaluate the frequency and duration of pain). The score for the descriptive questions is between 0 and 100 (0 being the absence of pain and 10 the most intense pain).

Time frame: Each 3 months and over 12 months

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

Time frame: Each 3 months and over 12 months

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

The Patients' Global Impression of Change (PGIC) scale describe the change (if any) in activity limitations, symptoms, emotions, and overall quality of life. It is between 1 and 7 (1 being no change or conditions has got worse, and 7 is a great deal better and a considerable improvement that as made all the difference).

Time frame: Each 1.5 months and over 12 months

In the subpopulation of patients with allodynia (dynamic mechanical or static or thermal): proportion [95% CI] of "responders" at 7.5 months

Time frame: 7.5 months

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

Time frame: 12 months

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

Time frame: 12 months

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

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (10)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts