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Набор по приглашению NCT07207083

Can Virtual Reality Exercise Help Restore Both Body and Mind in Chronic Low Back Pain

Без фазы С лечением Virtual Reality Kinesiophobia Chronic Low Back Pain (CLBP) Central Sensitization

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: Immersive Virtual Reality-based Exercise (FitXR, Meta Quest 3s), Conventional Exercise Program (Matched Exercise, without VR).
Кому может быть актуально
Состояния в реестре: Virtual Reality, Kinesiophobia, Chronic Low Back Pain (CLBP), Central Sensitization. Базовые параметры: 18 лет — 40 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
South Korea
Следующий шаг
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Официальное название

Effects of Immersive Virtual Reality-based Exercise on Somatosensory Function, Pain, and Psychological and Functional Recovery in Patients With Chronic Low Back Pain

Обзор

The goal of this clinical trial is to learn if an immersive virtual reality (VR) exercise program can help reduce back pain and improve physical function and psychological well-being in adults with chronic low back pain. The main questions it aim to answer are * Does the virtual reality (VR) exercise reduce back pain? * Does it lead to positive changes in how participants perceive pain? * Does it improve back flexibility and reduce disability in daily activities? * Does it help reduce the fear of movement and negative thoughts related to pain? Method Wear a Meta Quest 3s device and participate in a 15-minute virtual reality exercise program called 'FitXR'. Be evaluated for their back pain, sensory test, range of motion, and level of disability in daily life before and after the exercise program. Complete questionnaires about their thoughts and feelings regarding their pain and movement.

Вмешательства

  • Поведенческое Immersive Virtual Reality-based Exercise (FitXR, Meta Quest 3s)
    participants assigned to the intervention group will perform a 15-minute immersive virtual reality (VR) exercise program using the FitXR application on the Meta Quest 3s headset. This program provides interactive, visually immersive exercise tasks designed to engage participants in physical activity while reducing fear of movement and enhancing functional recovery.
  • Поведенческое Conventional Exercise Program (Matched Exercise, without VR)
    Participants assigned to this arm will perform the same 15-minute exercise program without virtual reality equipment. This allows comparison between immersive VR-based exercise and conventional exercise of equivalent intensity and duration.

Первичные конечные точки

  • Quantitative Sensory Testing (QST): Specifically including Conditioned Pain Modulation (CPM) and Temporal Summation (TS) protocols. [Срок оценки: Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).]
Вторичные конечные точки (6)
  • Tampa Scale for Kinesiophobia-13 (TSK-13) [Срок оценки: Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).]
  • Pain Catastrophizing Scale (PCS) [Срок оценки: Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).]
  • Oswestry Disability Index (ODI) [Срок оценки: Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).]
  • Fear-Avoidance Beliefs Questionnaire (FABQ) [Срок оценки: Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).]
  • Visual Analog Scale (VAS) [Срок оценки: Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).]
  • Lumbar Range of Motion (ROM) [Срок оценки: Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).]

Критерии участия

Критерии включения

  • Age 18-40 years.
  • Non-specific chronic low back pain lasting ≥3 months.
  • Baseline pain intensity VAS ≥4/10.
  • Kinesiophobia (TSK-13) ≥34.
  • Able to perform physical activity using immersive VR (screened as suitable for head-mounted display-based activity).
  • Understands the study purpose and procedures and provides written informed consent.

Критерии исключения

  • Severe pain making participation infeasible: VAS ≥8/10.
  • Lumbar spine surgery within the past 6 months.
  • Severe musculoskeletal disorders (e.g., advanced osteoarthritis, pathological vertebral fracture).
  • Neurological disorders (e.g., multiple sclerosis, Parkinson's disease, stroke).
  • Cardiovascular disease (e.g., heart failure, clinically significant arrhythmia, recent myocardial infarction).
  • Simulator Sickness Questionnaire (SSQ): total score ≥20 or any single item scored 3.
  • Vulnerable populations excluded: minors, older adults, individuals with psychiatric disorders or cognitive impairment, and pregnant persons.

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
Лечение

Центры проведения

South Korea · 1 центр
  • Sahmyook University, Science Hall 3 — Seoul

Идентификаторы

NCT: NCT07207083 · SYU 2025-08-019-002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗