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Идёт набор NCT05783245

Effect of Cooling Therapy for Post-Operative Pain in Open Carpal Tunnel Release

Без фазы С лечением Carpal Tunnel Syndrome Perioperative/Postoperative Complications

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: Polarcare Machine, Standard of care ice therapy.
Кому может быть актуально
Состояния в реестре: Carpal Tunnel Syndrome, Perioperative/Postoperative Complications. 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

This study seeks to perform an appropriately-powered study to evaluate any clinical difference between continuous cooling therapy and traditional ice for treatment of post-operative pain in open CTR surgery.

Подробное описание

Post-operative pain control is paramount to all operative procedures and involves several modalities. Both pharmaceutical and non-pharmaceutical measures are frequently used. Carpal tunnel release (CTR) surgery is one of the most common surgeries performed in the U.S. with over 400,000 procedures per year.2 Frequently, ice is used as a treatment modality following surgical CTR.3 Several products have been developed in the past decades to improve ice therapy in the rehabilitation period. One such product is the Polar Care which provides up to 6-8 hours of continuous icing.

While there is good data supporting the use of cooling therapy (ice) for post-operative pain, there is lack of data surrounding the use of continuous cooling therapy machines such as the PolarCare following carpal tunnel release (CTR). The two papers that evaluated the efficacy of continuous cooling therapy following CTR had conflicting results on any added benefit of continuous cooling therapy over traditional icing.

There is no standard of care for post-operative icing at UCMC following CTR. Clinicians currently decide whether to give patients a PolarCare machine on the day of surgery without any algorithm. All other patients are encouraged to use traditional icing methods. This study seeks to perform an appropriately-powered study to evaluate any clinical difference between continuous cooling therapy and traditional ice for treatment of post-operative pain in open CTR surgery.

The investigators hypothesize that participants receiving continuous cooling therapy will have a statistically significantly lower pain score compared to those receiving traditional ice therapy.

Вмешательства

  • Другое Polarcare Machine
    Use of Polar Care ice machine as often as possible, but a minimum of three 15 minute uses per day, for the first 3 days after surgery. No single use should last longer than 30 minutes.
  • Другое Standard of care ice therapy
    Use of commercial reusable ice packs as often as possible, but a minimum of three 15 minute uses per day, for the first 3 days after surgery. No single use should last longer than 30 minutes.

Первичные конечные точки

  • Visual Analog Scale (VAS) for pain [Срок оценки: 3 days]
Вторичные конечные точки (1)
  • Disabilities of the Arm, Shoulder, and Hand questionnaire [Срок оценки: 1 week]

Критерии участия

Критерии включения

  • Age 18 or older
  • Indicated for open carpal tunnel release
  • Able and willing to complete online questionnaires

Критерии исключения

  • Prior carpal tunnel surgery for ipsilateral extremity
  • Additional procedures to be performed on ipsilateral or contralateral extremity
  • Current opioid or narcotic pain medication usage

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
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • University of Chicago Medicine — Chicago

Идентификаторы

NCT: NCT05783245 · IRB21-1298

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗