Идёт набор NCT05300893

Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture

Без фазы С лечением Dupuytren Contracture Dupuytren's Disease

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: No night splint.
Кому может быть актуально: Состояния в реестре: Dupuytren Contracture, Dupuytren's Disease. 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: Швеция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture - a Randomised Controlled Multicenter Trial

Обзор

Dupuytren's contracture (DC) is associated with progressive finger flexion and extension deficit caused by fibrosis in the palm and digits. Treatment options include minimally invasive procedures such as percutaneous needle fasciotomy (PNF) and collagenase clostridium histolyticum injections as well as open fasciectomy. PNF has recently become more popular in Sweden because it is an office-based procedure which is relatively easy to perform without the usual risks and costs of open surgery. After treatment with PNF patients usually continue with supervised rehabilitation, which includes physical therapy and night splinting. Whether night splinting is beneficial in terms of reducing recurrence of DC is currently debated. This study aims to investigate whether night splinting after performed PNF helps to reduce recurrence rate or not. Patients who meet the inclusion criteria will be randomized into two groups: The first group will be treated as usual with physical therapy and night splinting after PNF. The second group will be treated with physical therapy without night splinting after PNF. Follow up includes physical examination regarding active range of motion, sensation and grip strength at procedure day and 2 weeks, 3, 12 and 36 months later as well as questionnaires regarding hand function, pain and quality of life at procedure day and 3, 12 and 36 months later. Patients who are randomized into the second group (no night splinting) will also be examined 3 weeks after PNF for observation in case of an early impairment regarding extension deficit.

Вмешательства

Другое No night splint
Instead of the usual treatment with a night splint for three months after percutaneous needle fasciotomy patients do not receive treatment with a night splint.

Первичные конечные точки

Reduction of finger joint contracture [Срок оценки: at 1 year follow up]

Вторичные конечные точки (7)

Change of active finger flexion [Срок оценки: before and after treatment, at 2 weeks, 3, 12 and 36 months follow-up]
Change of grip strength [Срок оценки: before and after treatment, at 2 weeks, 3, 12 and 36 months follow-up]
Pain assessed by a numeric rating scale (NRS) [Срок оценки: before treatment, at 3, 12 and 36 months follow-up]
Quality of life assessed by EQ-5D [Срок оценки: before treatment, at 3, 12 and 36 months follow-up]
Dupuytren-disease-associated disability assessed by URAM [Срок оценки: before treatment, at 3, 12 and 36 months follow-up]
Semmes-Weinstein monofilament test [Срок оценки: before treatment, at 3, 12 and 36 months follow-up]
Study specific questionnaire concerning the patient's medical history [Срок оценки: before treatment, at 3, 12 and 36 months follow-up]

Критерии участия

Критерии включения

18 years of age and older,
Palpable Dupuytren strand with passive extension deficit according to stadium 1 and 2 of the classification of Tubiana in one or two fingers excluding the thumb, defined as at least 30 degrees in the MCP joint and/or at least 20 degrees in the PIP joint and a maximum of 75 degrees in the MCP or PIP joint