Идёт набор NCT05817591

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

— Наблюдательное Peripheral Neuropathic Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Questionnaires.
Кому может быть актуально: Состояния в реестре: Peripheral Neuropathic Pain. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

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.

Вмешательства

Другое Questionnaires
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

Первичные конечные точки

Factors (profiles) associated with a better initial response to pain desensitization by capsaicin [Срок оценки: 12 months]

Вторичные конечные точки (9)

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) [Срок оценки: 1.5 months after each consecutive patch]
Proportion [95% CI] of patients "initial responder" at 50% [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 12 months]

Критерии участия

Критерии включения

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