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Идёт набор NCT06913920

Mechanical Modalities vs. Standard Care for Edema and Pain Management After DRF Fixation

Без фазы С лечением Distal Radius Fractures

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: Continuous Passive Motion (CPM), Intermittent Pneumatic Compression (IPC), Standard Therapy Program.
Кому может быть актуально
Состояния в реестре: Distal Radius Fractures. Базовые параметры: 18 лет — 65 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
Египет
Следующий шаг
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Официальное название

A Two-Arm, Single-Blinded Randomized Controlled Trial Evaluating the Effectiveness of Mechanical Modalities Combined With Standard Therapy Versus Standard Therapy Alone for Edema and Pain Management After Distal Radius Fracture Fixation

Обзор

This single-blinded, randomized controlled trial (RCT) will evaluate the added benefit of mechanical modalities (continuous passive motion (CPM) and intermittent pneumatic compression (IPC)) when integrated into standard therapy for managing postoperative edema and pain in patients undergoing distal radius fracture (DRF) fixation. The primary outcomes are edema volume (measured via volumeter) and pain intensity (Numeric Pain Rating Scale, NPRS) at 6 weeks post-operation. Secondary outcomes include wrist/forearm range of motion (ROM), grip strength, Patient-Rated Wrist Evaluation (PRWE), and adverse events.

Вмешательства

  • Устройство Continuous Passive Motion (CPM)
    Materials: A CPM device configured for wrist flexion-extension with an adjustable range of motion set between 0° and 30°. Procedure: The participant's wrist is gently secured in the device. The CPM device is programmed to deliver 20 minutes of continuous, passive motion through the set range. Device settings (e.g., speed) may be modified if the participant reports pain \>4/10 on the NPRS.
  • Устройство Intermittent Pneumatic Compression (IPC)
    Materials: An IPC sleeve designed for the forearm-to-hand region with a baseline compression setting of approximately 30 mmHg. Procedure: After CPM treatment, the IPC device is applied to the affected limb. The sleeve provides 15 minutes of intermittent compression with programmed intervals of inflation and deflation. Compression levels may be adjusted based on participant comfort and pain ratings.
  • Поведенческое Standard Therapy Program
    Procedures: Active/active-assisted wrist/forearm range of motion exercises led by a certified hand/physical therapist. Progressive grip-strengthening exercises using resistance bands or putty. Manual edema management techniques, including gentle massage and manual lymphatic drainage, as well as scar mobilization if needed.

Первичные конечные точки

  • Edema Volume [Срок оценки: Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation.]
  • Pain Intensity [Срок оценки: Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation.]
Вторичные конечные точки (3)
  • Wrist/Forearm Range of Motion (ROM) [Срок оценки: Measured at baseline, 6 weeks, and 3 months postoperatively.]
  • Grip Strength [Срок оценки: Assessed at baseline, 6 weeks, and 3 months postoperatively.]
  • Incidence of Adverse Events [Срок оценки: Continuously monitored from baseline to the 3-month follow-up.]

Критерии участия

Критерии включения

Adults aged 18 years or older. Undergoing surgical treatment for distal radius fracture with stable internal fixation.

Able to initiate formal rehabilitation approximately 2 weeks postoperatively. Willing and able to attend in-clinic therapy sessions at the outpatient hand therapy center.

Критерии исключения

Unstable fixation or need for further surgical intervention. Pre-existing conditions that would significantly affect upper limb function (e.g., severe arthritis, neurological disorders).

History of skin conditions or allergies that contraindicate the use of mechanical devices.

Any contraindication to mechanical modalities (for example, severe peripheral vascular disease).

Inability to comply with study procedures or follow-up visits. Pregnant or breastfeeding individuals.

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

Египет · 1 центр
  • Faculty of Physical Therapy, Al Hayah University — Cairo

Идентификаторы

NCT: NCT06913920 · MMDRF2025-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗