Идёт набор NCT05177380

Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis

Без фазы С лечением Systemic Sclerosis Face Facial Involvement Rehabilitation

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: Personalized rehabilitation program of facial involvement in systemic sclerosis, Delivery of a standard prescription for facial rehabilitation.
Кому может быть актуально: Состояния в реестре: Systemic Sclerosis, Face, Facial Involvement, Rehabilitation. 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 →

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Обзор

Systemic sclerosis is a rare autoimmune disorder characterized by microangiopathy, activation of the immune system, and sclerosis of tissues including the skin. Facial involvement is frequent and disabling. It causes significant functional and aesthetic discomfort, and a major deterioration in quality of life. It results in a loss of suppleness of the skin and subcutaneous tissues, dysfunction of the temporomandibular joint, peribuccal rhagades, microstomia, and dry mouth causing difficulties in mouth opening, feeding, dental care, and weight loss. Facial involvement in systemic sclerosis can be assessed using the Mouth Handicap in Systemic Sclerosis (MHISS) score, a validated patient questionnaire assessing the functional and aesthetic consequences of systemic sclerosis on the face. Although common and disabling, facial involvement is underestimated and poorly managed. Immunosuppressive and/or anti-fibrosis drugs are not very effective. Facial rehabilitation could significantly improve the mouth handicap but facial rehabilitation is not currently performed in standard care in systemic sclerosis patients. The aim of the study is to evaluate the efficacy of a personalized rehabilitation program vs standard care in facial involvement of systemic sclerosis patients.

Вмешательства

Процедура Personalized rehabilitation program of facial involvement in systemic sclerosis
Personalized rehabilitation program of facial involvement in systemic sclerosis
Другое Delivery of a standard prescription for facial rehabilitation
Delivery of a standard prescription for facial rehabilitation

Первичные конечные точки

Mouth Handicap In Systemic Sclerosis (MHISS) score [Срок оценки: Week 6]

Вторичные конечные точки (12)

Mouth Handicap In Systemic Sclerosis (MHISS) score [Срок оценки: Week 2]
Mouth Handicap In Systemic Sclerosis (MHISS) score [Срок оценки: Week12]
Interincisal distance measurement [Срок оценки: Week 6]
Interincisal distance measurement [Срок оценки: Week 12]
Rodnan skin score on the face [Срок оценки: Week 6]
Rodnan skin score on the face [Срок оценки: Week 12]
Visual Analog Scale (VAS) for pain [Срок оценки: Week 2]
Visual Analog Scale (VAS) for pain [Срок оценки: Week 6]
Visual Analog Scale (VAS) for pain [Срок оценки: Week12]
HAQ questionnaire [Срок оценки: Week 6]
HAQ questionnaire [Срок оценки: Week 12]
SF12 questionnaire (12-item Short Form Survey) [Срок оценки: Week 6]

Критерии участия

Критерии включения

Age ≥ 18 yo
Systemic sclerosis according to the 2013 ACR/EULAR (American College of Rheumatology) classification criteria
Systemic sclerosis with facial involvement defined by a MHISS score > 6
Immunosuppressive and/or anti-fibrosis treatment stable for at least 1 month
Subject able to understand the objectives and risks of research and to give informed consent
Subject enrolment in the health insurance scheme