Management of Proximal Interphalangeal (PIP) Joint Injuries

Официальное название

An Innovative Approach to the Management of Proximal Interphalangeal (PIP) Joint Injuries

Обзор

This project seeks to compare the treatment efficacy of two different approaches to treating interphalangeal joint (PIP) joint injuries. The investigators will compare two participant groups undergoing treatment using the current treatment standard (Coban wrap) as well as an innovative treatment approach (neoprene sleeve) in treating the PIP joint injury.

Подробное описание

Hand injuries, specifically those involving the proximal interphalangeal joint (PIP) can be difficult to treat. These stubborn injuries leave patients with pain, edema, and limitation in function and changes in the aesthetics of the hand. This project would randomize patients with PIP joint injuries including dislocation, volar plate, intra-articular fracture and chip avulsion fracture with ligamentous injury into two groups. The first group will receive the usual treatment including active range motion, edema control - contrast bath and coban. The second group would receive similar treatment except a custom neoprene sleeve will be used in place coban. Outcome measures would include: Numeric Pain Rating Scale (NPRS), measure of patient satisfaction and compliance with the coban vs a custom neoprene sleeve and a measure of hand function (Patient Rated Wrist/Hand Evaluation) as well as a range of motion and edema.

Вмешательства

• Другое Coban wrap
  A Coban bandage or wrap is a self-adhering elastic wrap that sticks to itself but not to skin or clothing. It is commonly used as a wrap on limbs due to its ability to adhere to itself and not loosen. Coban is often used as a compression bandage
• Другое Neoprene sleeve
  Neoprene sleeve is an innovative treatment approach, it consists of a synthetic rubber-like material used to provide compressive support. Neoprene sleeves can provide protection, light compression and mild extension support while allowing full finger flexion.

Первичные конечные точки

• Changes in Edema [Срок оценки: The outcome measures will be collected at various intervals, such as initial visit, 2 weeks, 4 weeks, 3 months and 6 months.]
• Changes in Pain [Срок оценки: The outcome measures will be collected at various intervals, such as initial visit, 2 weeks, 4 weeks, 3 months and 6 months.]

Вторичные конечные точки (2)

• Range of Motion [Срок оценки: The outcome measures will be collected at various intervals, such as initial visit, 2 weeks, 4 weeks, 3 months and 6 months.]
• Function and Appearance [Срок оценки: The outcome measures will be collected at various intervals, such as initial visit, 2 weeks, 4 weeks, 3 months and 6 months.]

Критерии участия

Критерии включения

• Read/write and speak/understand English
• Capable of understanding the various questionnaires that will be employed to collect outcome measures

Критерии исключения

• Participants who do not meet all of the aforementioned criteria
• Participants with any injuries specific to the treatment finger, or if there is any underlying disease affecting the PIP joint

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Unity Health Toronto — Toronto

Идентификаторы

NCT: NCT06951607 · 23-240

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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