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Набор скоро начнётся NCT07660510

Evolution of Different Sensitivity Levels in Patients With Chronic Neuropathic Pain in the Pelvi-perineal Region After Treatment With High-concentration Capsaicin Patches

Без фазы С лечением Neuropathic Pain Nociplastic 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: Quantitative Sensory Testing and questionnaires.
Кому может быть актуально
Состояния в реестре: Neuropathic Pain, Nociplastic 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
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Обзор

The primary objective of this study will be to demonstrate a change in pain sensitization parameters before and after the application of the high-concentration capsaicin patch.

Подробное описание

Category 2 Study (Interventional Research with Minimal Risks and Constraints), monocentric, uncontrolled, non-randomized, open-label and prospective.

This study involves conducting tests and questionnaires before and 1 month after the application of a patch administered as part of standard clinical practice.

Вмешательства

  • Другое Quantitative Sensory Testing and questionnaires
    Quantitative Sensory Testing and questionnaires

Первичные конечные точки

  • Composite criterion [Срок оценки: Difference between Day 0 and Day 30]
Вторичные конечные точки (12)
  • Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (1) [Срок оценки: Between before and 30 days after patch application]
  • Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (2) [Срок оценки: Between before and 30 days after patch application]
  • Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (3) [Срок оценки: Between before and 30 days after patch application]
  • Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (4) [Срок оценки: Between before and 30 days after patch application]
  • Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (5) [Срок оценки: Between before and 30 days after patch application]
  • Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (1) [Срок оценки: Between before and 1 month after patch application.]
  • Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (2) [Срок оценки: Between before and 1 month after patch application.]
  • Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (3) [Срок оценки: Between before and 1 month after patch application.]
  • Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (4) [Срок оценки: Between before and 1 month after patch application.]
  • Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (5) [Срок оценки: Between before and 1 month after patch application.]
  • Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (6) [Срок оценки: Between before and 1 month after patch application.]
  • Measure the patient's therapeutic response to the treatment [Срок оценки: Day 30]

Критерии участия

Критерии включения

  • Men or women ≥ 18 years old.
  • Patients suffering from chronic pelvi-perineal neuralgia (>3 months) with a DN4 score ≥4 at the inclusion visit, with or without symptoms of central sensitization, and with an indication for topical treatment with high-concentration capsaicin patch (PCHC).
  • Patients who have signed the informed consent form for the study at the inclusion visit.
  • Women must meet one of the following criteria at the time of inclusion:
  • Use adequate contraceptive measures;
  • or Be postmenopausal (aged over 50 years with amenorrhea for at least 12 months after discontinuation of all exogenous hormonal treatments);
  • or (If aged under 50 years) have been amenorrheic for at least 12 months after discontinuation of exogenous hormonal treatments, with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels consistent with postmenopausal levels;
  • or Have undergone irreversible surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), with documentation of the procedure.

Критерии исключения

  • Patients under guardianship, curatorship, or legal protection.
  • Pregnant or breastfeeding women.
  • Patients with contraindications to the use of the high-concentration capsaicin patch (PCHC): application on damaged skin, hypersensitivity to any of its components.
  • Patients simultaneously starting a treatment that may influence central sensitization (e.g., antidepressants, antiepileptics, psychotherapy, physical activity, transcutaneous electrical nerve stimulation).
  • Patients not affiliated with the French Social Security system.
  • Patients with insufficient cooperation and/or understanding to strictly comply with the protocol requirements.
  • Patients who have taken analgesics within the 12 hours prior to measurements.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Франция · 1 центр
  • Nantes University Hospital — Nantes

Идентификаторы

NCT: NCT07660510 · RC25_0536

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗