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Идёт набор NCT07406997

Rehabilitation With Empowered STrategies to Optimize REcovery

Без фазы С лечением Lumbar Spine Degenerative Changes Lumbar Spine 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: Empowered Relief, Education.
Кому может быть актуально
Состояния в реестре: Lumbar Spine Degenerative Changes, Lumbar Spine Surgery. Базовые параметры: 18 лет — 85 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

Rehabilitation With Empowered STrategies to Optimize REcovery After Spine Surgery

Обзор

The main goal of this clinical trial is to understand the benefits of remotely delivered Empowered Relief in patients undergoing lumbar spine surgery. The main question the trial aims to answer is: Does a postoperative behavioral intervention, Empowered Relief, performed early after back surgery have a measurable impact on postoperative outcomes? Additional questions are whether changes in pain catastrophizing are related to improvements in outcomes and whether preoperative pain catastrophizing is a moderator of response to treatment. Researchers will compare remotely delivered Empowered Relief to remotely delivered education to see if Empowered Relief helps patients manage their pain and functional limitations after back surgery. Participants will: * Complete one group session of remotely delivered Empowered Relief or Education after back surgery * Complete surveys before surgery and 3- and 6-months after surgery

Подробное описание

The proposed study will conduct a phase II, two-group randomized controlled trial in patients undergoing lumbar spine surgery. Patients will be enrolled and randomized prior to spine surgery from a civilian medical center and military treatment facilities. Patients will be randomized to either (1) 1-session Empowered Relief or (2) 1-session Education. Both interventions are delivered remotely in a group setting through a web-based platform by licensed health care professionals. Outcome assessments will be conducted by evaluators blinded to group assignment at 3-months and 6-months after surgery.The results of our clinical trial will advance research on remote nonpharmacologic strategies for managing pain and improving quality of life post-surgery in both civilian and military patient populations.

Вмешательства

  • Поведенческое Empowered Relief
    Empowered Relief (ER) is a single-session group class that has two main components of pain neuroscience education and pain coping skills based on cognitive-behavioral principles.
  • Другое Education
    Education program is a single-session group class that includes information on how to manage pain and disability, prevent future injury and stay healthy after back surgery.

Первичные конечные точки

  • Pain Interference [Срок оценки: 3 and 6 months after hospital discharge]
Вторичные конечные точки (4)
  • Physical Function [Срок оценки: 3 and 6 months after hospital discharge]
  • Disability [Срок оценки: 3 and 6 months after hospital discharge]
  • Pain Intensity [Срок оценки: 3 and 6 months after hospital discharge]
  • Opioid Use [Срок оценки: 3 and 6 months after hospital discharge]

Критерии участия

Критерии включения

  • Surgical treatment of a lumbar degenerative condition using a laminectomy with or without fusion procedure
  • English speaking
  • Age between 18-85 years

Критерии исключения

  • Surgery due to trauma, fracture, tumor, infection, or spinal deformity
  • Revision surgery
  • Prior history of lumbar spine surgery in last 12 months
  • Involved in litigation or a workers' compensation claim due to injury
  • Currently undergoing treatment for cancer
  • Unable to access a reliable internet connection
  • Unable to provide a stable telephone or physical address
  • Unable to participate in follow-up assessment for 6 months after surgery

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
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 4 центра
  • Tripler Army Medical Center — Honolulu
  • Vanderbilt University Medical Center — Nashville
  • Brooke Army Medical Center — Fort Sam Houston
  • Madigan Army Medical Center — Joint Base Lewis McChord

Идентификаторы

NCT: NCT07406997 · 251516 · HT9425-25-1-0925

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗