- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07660510
Evolution of Different Sensitivity Levels in Patients With Chronic Neuropathic Pain in the Pelvi-perineal Region After Treatment With High-concentration Capsaicin Patches (CAPSASENS)
Обзор исследования
Статус
Вмешательство/лечение
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Amélie LEVESQUE, MD
- Номер телефона: +33240083912
- Электронная почта: amelie.levesque@chu-nantes.fr
Места учебы
-
-
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Nantes, Франция
- Nantes university hospital
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Контакт:
- Nantes University Hospital
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Pain sensitization parameter testing
Pre-inclusion visit (routine care consultation): Verification of inclusion and exclusion criteria. Inclusion visit (Day 0): Consent signing, questionnaires (ConvergencePP Score/Central Sensitization Inventory, DN4), and a series of tests, followed by the application of the high-concentration capsaicin patch (PCHC) (performed during routine care). Day 30 visit (±7 days): Questionnaires (same as V1 + PGI-c) and a series of tests. |
Quantitative Sensory Testing and questionnaires
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Composite criterion
Временное ограничение: Difference between Day 0 and Day 30
|
Composite criterion constructed from a Principal Component Analysis including the differences between Day 0 (before patch application) and Day 30 in pain perception thresholds (to cold, heat, pressure, and mechanical stimulation) in both the area treated with the high-concentration capsaicin patch and the corresponding dermatome, as well as the change in the pain receptive field area in the treated zone and the area under the curve of temporal summation measurements.
|
Difference between Day 0 and Day 30
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (1)
Временное ограничение: Between before and 30 days after patch application
|
Difference in pressure pain thresholds in the treated area
|
Between before and 30 days after patch application
|
|
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (2)
Временное ограничение: Between before and 30 days after patch application
|
Difference in mechanical stimulation pain thresholds
|
Between before and 30 days after patch application
|
|
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (3)
Временное ограничение: Between before and 30 days after patch application
|
Difference in cold pain thresholds in the treated area
|
Between before and 30 days after patch application
|
|
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (4)
Временное ограничение: Between before and 30 days after patch application
|
Difference in heat pain thresholds in the treated area
|
Between before and 30 days after patch application
|
|
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (5)
Временное ограничение: Between before and 30 days after patch application
|
Difference in pain receptive field area
|
Between before and 30 days after patch application
|
|
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (1)
Временное ограничение: Between before and 1 month after patch application.
|
Difference in pressure pain thresholds in an area of the dermatome not directly treated by the patch:
|
Between before and 1 month after patch application.
|
|
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (2)
Временное ограничение: Between before and 1 month after patch application.
|
Difference in mechanical stimulation pain thresholds in an area of the dermatome not directly treated by the patch
|
Between before and 1 month after patch application.
|
|
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (3)
Временное ограничение: Between before and 1 month after patch application.
|
Difference in cold pain thresholds in an area of the dermatome not directly treated by the patch.
|
Between before and 1 month after patch application.
|
|
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (4)
Временное ограничение: Between before and 1 month after patch application.
|
Difference in heat pain thresholds in an area of the dermatome not directly treated by the patch.
|
Between before and 1 month after patch application.
|
|
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (5)
Временное ограничение: Between before and 1 month after patch application.
|
Difference in the area under the curve of temporal summation measurements in the treated area
|
Between before and 1 month after patch application.
|
|
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (6)
Временное ограничение: Between before and 1 month after patch application.
|
Difference in the duration of pain persistence after the end of temporal summation (in seconds).
|
Between before and 1 month after patch application.
|
|
Measure the patient's therapeutic response to the treatment
Временное ограничение: Day 30
|
Patient Global Impression of Change (PGI-C).
The therapeutic response is defined as a patient who scores 1 to 3 on the PGI-C.
|
Day 30
|
|
Evaluate the predictive value of temporal summation with regard to the therapeutic response to the high-concentration capsaicin patch
Временное ограничение: Between before and 1 month after patch application.
|
Investigation of a relevant threshold for temporal summation to predict the therapeutic response.
Quantification of the positive predictive value.
|
Between before and 1 month after patch application.
|
|
Measure the correlation between Convergences PP scores, CSI, and semi-objective sensitization data
Временное ограничение: Between before and 1 month after patch application
|
Measure the correlation between Convergences PP scores, CSI, and semi-objective sensitization data. The Convergences PP score is a clinical questionnaire used to diagnose sensitization in the pelvic region. A score is considered positive from 5/10 (sensitivity = 95%, specificity = 87%). The Central Sensitization Inventory (CSI) is a self-administered questionnaire used to diagnose central sensitization. A score is considered positive from 40/100. Correlations between the Convergences PP score, CSI, and semi-objective sensitization data (pain thresholds and temporal summation) will be measured using Spearman's correlation coefficient to explore the relationships between these variables. |
Between before and 1 month after patch application
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Боль
- Неврологические проявления
- Заболевания нервной системы
- Нервно-мышечные заболевания
- Заболевания периферической нервной системы
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Невралгия
- Ноципластическая боль
- Качество, доступ и оценка здравоохранения
- Следственные методы
- Эпидемиологические методы
- Сбор данных
- Механизмы оценки здравоохранения
- Качество здравоохранения
- Общественное здравоохранение
- Окружающая среда и общественное здравоохранение
- Обследования и анкеты
Другие идентификационные номера исследования
- RC25_0536
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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