Effectiveness of Virtual Reality-Assisted Physical Therapy in the Acute Phase After Lumbar Disc Surgery

Официальное название

Investigation of the Effectiveness of Virtual Reality-Assisted Physical Therapy in the Acute Period After Lumbar Disc Surgery

Обзор

The goal of this clinical trial is to evaluate the effectiveness of virtual reality-assisted physical therapy in the acute postoperative period after lumbar disc surgery. The main questions it aims to answer are: * Does virtual reality-assisted physical therapy reduce pain more effectively than conventional physical therapy? * Does it improve functional recovery, pain threshold, and blood biomediator levels? * Does it reduce anxiety and kinesiophobia in the early rehabilitation period? Researchers will compare virtual reality-assisted physical therapy with standard physical therapy to determine whether virtual reality provides additional therapeutic benefits. Participants will: * Undergo standard postoperative physical therapy after lumbar disc surgery. * Some participants will additionally perform virtual reality-based rehabilitation exercises. * Be evaluated for pain severity, functional improvement, blood biomediators, pain threshold, and psychological outcomes.

Подробное описание

Lumbar disc herniation (LDH) is one of the most common musculoskeletal disorders and a major cause of low back pain worldwide. It occurs when the intervertebral disc extends beyond its anatomical boundaries, compressing neural structures and leading to pain, disability, and reduced quality of life. Although most patients are treated conservatively, approximately 15% require surgical intervention. Postoperative pain is one of the most significant challenges after lumbar disc surgery, reported in up to 70% of patients in the acute period. Insufficient pain management may delay mobilization, prolong hospitalization, increase healthcare costs, and negatively affect both physical and psychological recovery.

Pharmacological treatments, such as NSAIDs, opioids, muscle relaxants, and neuropathic pain agents, are commonly used for postoperative pain control. However, their potential side effects and limited efficacy have raised interest in non-pharmacological interventions. Conventional physical therapy protocols-mobilization, exercise, manual therapy, and patient education-are central to postoperative rehabilitation, improving mobility, functional recovery, and independence. Early mobilization within the first days after surgery has been shown to reduce complications and accelerate healing.

In recent years, technology-based approaches have emerged as complementary or alternative rehabilitation methods. Among them, virtual reality (VR) offers interactive, multisensory, and engaging environments that can contribute to both physical and psychological recovery. VR has shown therapeutic potential in pain management by diverting attention, reducing anxiety and stress, and promoting patient engagement in rehabilitation. Importantly, VR has demonstrated effectiveness in musculoskeletal conditions, neurological rehabilitation, and postoperative care in other surgical populations.

Despite growing evidence, there is a lack of comprehensive studies evaluating VR in the acute postoperative phase after lumbar disc surgery, particularly in comparison with conventional physical therapy protocols. This study aims to address this gap by investigating the effectiveness of VR-assisted physical therapy versus conventional physical therapy in patients undergoing lumbar discectomy.

The primary outcomes include pain intensity, pain threshold, and blood biomediator levels. Secondary outcomes include functional recovery, kinesiophobia, and anxiety. By systematically comparing both interventions, this trial seeks to determine the advantages and limitations of VR-assisted rehabilitation, with the goal of developing innovative, safe, and effective strategies for postoperative care.

Вмешательства

• Другое Virtual Reality-Assisted Physical Therapy
  VR Assisted PT intervention, combines a standardized postoperative physical therapy program with an additional 20-minute immersive VR session. The VR component is relaxation-focused and interactive, making the total session length 60 minutes. The distinguishing feature is the integration of VR technology into early rehabilitation after lumbar disc surgery, which is not part of conventional therapy.
• Другое Conventional Physical Therapy
  This intervention consists of the same standardized physical therapy program as the VR group, delivered for 60 minutes daily by increasing exercise repetitions and intensity. The distinguishing feature is that it does not include any VR component, allowing direct comparison of physical therapy alone versus VR-assisted therapy.

Первичные конечные точки

• Pain Intensity (VAS) [Срок оценки: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).]
• Pain Pressure Threshold (Algometry) [Срок оценки: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).]
• Blood Biomediators (CRP, Cortisol, Leukocyte Count) [Срок оценки: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).]

Вторичные конечные точки (6)

• Functional Capacity (Timed Up and Go Test) [Срок оценки: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).]
• Functional Capacity (10-Meter Walk Test) [Срок оценки: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).]
• Kinesiophobia (Tampa Scale of Kinesiophobia) [Срок оценки: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).]
• Anxiety and Depression (Hospital Anxiety and Depression Scale, HADS) [Срок оценки: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).]
• Treatment Satisfaction (Global Perceived Effect, GPE Scale) [Срок оценки: Post-operative day 2 (after intervention completion).]
• Virtual Reality Sickness Questionnaire (VRSQ) (VR group only) [Срок оценки: Immediately before and after each VR session, approximately 30 minutes apart.]

Критерии участия

Критерии включения

• Adults aged 18-65 years.
• Undergoing lumbar discectomy surgery (L4-L5 or L5-S1 levels).
• Able to start postoperative physical therapy on day 1 after surgery.
• Willing and able to provide informed consent.
• Sufficient cognitive and physical ability to participate in physical therapy and virtual reality sessions.

Критерии исключения

• History of previous lumbar spine surgery.
• Severe neurological deficits (e.g., cauda equina syndrome, progressive motor weakness).
• Diagnosed epilepsy, severe psychiatric illness, or other conditions contraindicate VR use.
• Significant visual or vestibular impairments preventing safe VR participation.
• Uncontrolled systemic diseases (e.g., cardiovascular, respiratory, or metabolic instability).
• Pregnancy.
• Inability to understand study instructions or complete outcome assessments.

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

Turkey (Türkiye) · 2 центра

• Hacettepe University Faculty of Physical Therapy and Rehabilitation — Ankara
• Hacettepe University Hospital Neurosurgery Department — Ankara

Публикации

• Avila L, da Silva MD, Neves ML, Abreu AR, Fiuza CR, Fukusawa L, de Sa Ferreira A, Meziat-Filho N. Effectiveness of Cognitive Functional Therapy Versus Core Exercises and Manual Therapy in Patients With Chronic Low Back Pain After Spinal Surgery: Randomized Controlled Trial. Phys Ther. 2024 Jan 1;104(1):pzad105. doi: 10.1093/ptj/pzad105. PMID 37548608
• He W, Wang Q, Hu J, Lin S, Zhang K, Wang F, Xu C, Li F, Xiao J, Li X, Tang F. A randomized trial on the application of a nurse-led early rehabilitation program after minimally invasive lumbar internal fixation. Ann Palliat Med. 2021 Sep;10(9):9820-9829. doi: 10.21037/apm-21-2294. PMID 34628908

Идентификаторы

NCT: NCT07204197 · VRLDHS1D

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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