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Идёт набор NCT07030582

Efficacy of Internet-Based Cognitive Behavioral Therapy for Back Muscle Strength Loss, Chronic Pain, and Poor Patient Recovery Perceptions After Lumbar Fusion

Без фазы С лечением Internet-Based Cognitive Behavioral Therapy

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: Internet-delivered cognitive behavioral therapy, Basic Postoperative Care, Conventional Postoperative Care.
Кому может быть актуально
Состояния в реестре: Internet-Based Cognitive Behavioral Therapy. Базовые параметры: 18 лет — 55 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This study aims to develop an Internet-based Cognitive Behavioral Therapy protocol for core muscle training, based on an understanding of factors impeding postoperative core muscle training in lumbar surgery patients. The protocol is designed to reconstruct patients' cognition, eliminate adverse behaviors, and promote healthy behaviors such as core muscle training among LDH patients. The ultimate objectives are to alleviate postoperative pain, enhance lumbar stability, and facilitate disease rehabilitation in patients following lumbar surgery.

Вмешательства

  • Поведенческое Internet-delivered cognitive behavioral therapy
    The intervention group received a comprehensive core muscle training protocol delivered through a digital rehabilitation platform from hospital admission to 6 months post-surgery. The protocol began with initial screening, including online assessments of cognitive misconceptions, kinesiophobia, and posture analysis. Pain-related cognitive restructuring was addressed through virtual reality sessions, educational videos, and mindfulness breathing guidance. Behavioral activation incorporated graded
  • Поведенческое Basic Postoperative Care
    All participants were instructed to maintain their usual daily activities and abstain from additional treatments throughout the 6-month study period.
  • Поведенческое Conventional Postoperative Care
    The control group received conventional postoperative care, which included the establishment of a WeChat support group and provision of a rehabilitation manual focusing on core muscle training on the first postoperative day. Physical therapists provided individualized bedside instruction to ensure proper exercise techniques. Structured follow-up was conducted via telephone or social media (weekly during the first month, then monthly from months 2-6, with each session lasting at least 15 minutes)

Первичные конечные точки

  • TSK Scores [Срок оценки: The TSK scores were collected at baseline and at 1 week, 1 month, 3 months, and 6 months post-intervention.]
  • Exercise Adherence [Срок оценки: Exercise adherence scores were collected at baseline and at follow-up intervals of 1 week, 1 month, 3 months, and 6 months post-intervention.]
  • Pain Intensit [Срок оценки: Pain scores were collected at baseline and follow-up intervals of 1 week (at discharge), 1 month, 3 months, and 6 months post-intervention.]
Вторичные конечные точки (4)
  • Lumbar Function [Срок оценки: The JOA scores were collected at baseline, 3 months, and 6 months post-intervention.]
  • Trunk Shift (Spinal Alignment) [Срок оценки: Measurements were obtained at baseline, 3 months, and 6 months post-intervention.]
  • Pelvic Torsion [Срок оценки: Measurements will be obtained at baseline, 3 months, and 6 months post-intervention.]
  • Maximum Vertebral Rotation [Срок оценки: Measurements will be obtained at baseline, 3 months, and 6 months post-intervention.]

Критерии участия

Критерии включения

  • age between 18 and 55 years
  • diagnosis of lumbar disc herniation requiring single-level lumbar fusion surgery - no previous history of lumbar surgery
  • Surgical procedures performed by the same surgical team
  • willingness to comply with the study protocol and restrictions
  • availability of a home WiFi connection

Критерии исключения

  • lumbar surgery secondary to neoplasm, tuberculosis, infection, or inflammation
  • postoperative infection or revision surgery
  • presence of cauda equina syndrome
  • diagnosis of schizophrenia, cognitive impairment, or other psychiatric disorders
  • coexisting severe cardiovascular or cerebrovascular diseases, or congenital conditions precluding exercise participation.

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

Китай · 1 центр
  • Affiliated 2 Hospital of Nantong University — Nantong

Публикации

  • Wang T, Jiang J, Li C, Xuan Q, Sun L, Xu G, Gu H, Gao H. Effects of internet-based cognitive behavioral therapy on kinesiophobia, exercise adherence, and back muscle function after lumbar fusion surgery. BMC Musculoskelet Disord. 2026 Mar 18;27(1):357. doi: 10.1186/s12891-026-09617-z. PMID 41845320

Идентификаторы

NCT: NCT07030582 · TWang

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗