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Идёт набор NCT06202443

Function After Anterior Cervical Discectomy and Fusion Surgery: Timing of Physical Therapy

Без фазы С лечением Cervical Spine Degeneration ACDF Surgery

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: Early PT, Delayed PT.
Кому может быть актуально
Состояния в реестре: Cervical Spine Degeneration, ACDF Surgery. Базовые параметры: 18 лет — 75 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 →

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Официальное название

Improving Surgical Outcomes With Early Physical Therapy After Anterior Cervical Discectomy and Fusion

Обзор

The goal of this two-group randomized clinical trial is to examine the effects of early postoperative PT compared to delayed postoperative PT for improving outcomes after hospital discharge for ACDF surgery. The main question this clinical trial aims to answer are: * Whether early PT participants will demonstrate greater improvements in outcomes compared to delayed PT participants. * Whether improvements in handgrip strength, cervical endurance, and cervical range of motion will be associated with improvements in outcomes. Participants will be randomized to one of two groups (early PT or delayed PT) and outcomes compared across groups.

Подробное описание

This study is a prospective randomized controlled trial of early PT (within 3 months after surgery) versus delayed PT (greater than 3 months after surgery) in adults following ACDF surgery for degenerative conditions. The central hypothesis is that an early PT program will be effective in improving disability, pain, physical function, opioid use and return to work/duty. 76 participants will be enrolled and randomized (38 patients per randomized group), with 64 (85%) expected to be retained in the trial at the 12-month follow-up. Eligible patients undergoing ACDF surgery for a degenerative condition will be randomized to one of two groups (early PT or delayed PT). Patients will be enrolled prior to surgery, asked to complete a preoperative questionnaire prior to surgery and then randomized. Patients randomized to one of the PT groups will have their first PT visit scheduled for them by study staff prior to surgery. This visit will occur at approximately 2 weeks after hospital discharge for the early PT group and approximately 3 months after hospital discharge for the delayed PT group. All randomized patients will be asked to participate in follow-up visits approximately 3-, 6- and 12-months after hospital discharge.

Вмешательства

  • Другое Early PT
    Physical therapy delivered within the first three months after surgery.
  • Другое Delayed PT
    Physical therapy delivered greater than 3 months after surgery.

Первичные конечные точки

  • Disability [Срок оценки: 6 and 12 months after hospital discharge]
Вторичные конечные точки (5)
  • Pain Intensity [Срок оценки: 6 and 12 months after hospital discharge]
  • Pain Interference [Срок оценки: 6 and 12 months after hospital discharge]
  • Physical Function [Срок оценки: 6 and 12 months after hospital discharge]
  • Opioid Utilization [Срок оценки: 6 and 12 months after hospital discharge]
  • Return to work [Срок оценки: 6 and 12 months after hospital discharge]

Критерии участия

Критерии включения

  • Surgical treatment of a cervical degenerative condition using a 1- or 2-level ACDF procedure;
  • English speaking due to feasibility of employing study personnel to deliver and assess the study intervention; and
  • Age 18-75 years of age (individuals older than 75 are more likely to experience respiratory and nervous system complications and death following ACDF)

Критерии исключения

  • Surgery secondary to trauma, fracture, tumor, infection, or spinal deformity;
  • Undergoing cervical corpectomy;
  • Prior history of cervical spine surgery in last 5 years;
  • Diagnosis or presence of osteoporosis;
  • Diagnosis or presence of severe psychiatric disorder such as schizophrenia or bipolar disorder;
  • Documented history of alcohol and/or drug abuse;
  • Currently involved in litigation due to injury;
  • Currently undergoing treatment for cancer;
  • Patients not able to return for follow-up visits due to time and travel limitation or other reasons; and
  • Unable to provide a stable telephone or physical address

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
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 4 центра
  • Tripler Army Medical Center — Honolulu
  • Vanderbilt University Medical Center — Nashville
  • Booke Army Medical Center — Fort Sam Houston
  • Madigan Army Medical Center — Tacoma

Публикации

  • Coronado RA, Devin CJ, Pennings JS, Aaronson OS, Haug CM, Van Hoy EE, Vanston SW, Archer KR. Safety and feasibility of an early telephone-supported home exercise program after anterior cervical discectomy and fusion: a case series. Physiother Theory Pract. 2021 Oct;37(10):1096-1108. doi: 10.1080/09593985.2019.1683921. Epub 2019 Oct 30. PMID 31663795
  • Coronado RA, Devin CJ, Pennings JS, Vanston SW, Fenster DE, Hills JM, Aaronson OS, Schwarz JP, Stephens BF, Archer KR. Early Self-directed Home Exercise Program After Anterior Cervical Discectomy and Fusion: A Pilot Study. Spine (Phila Pa 1976). 2020 Feb 15;45(4):217-225. doi: 10.1097/BRS.0000000000003239. PMID 31490861

Идентификаторы

NCT: NCT06202443 · 231031

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗