Investigation of the Effectiveness of Virtual Reality-Assisted Physical Therapy in the Acute Period After Lumbar Disc Surgery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Pain Intensity (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Pain Intensity (VAS)
时间窗: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).
Pain severity will be assessed using a 10 cm Visual Analog Scale (VAS), where participants mark their perceived pain level ranging from 0 (no pain) to 10 (worst imaginable pain). Both resting pain and pain during the most difficult daily activity will be recorded.
Pain Pressure Threshold (Algometry)
时间窗: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).
Pressure pain thresholds will be measured using an algometer applied to quadratus lumborum, tibialis anterior, and iliopsoas muscles. This method provides an objective evaluation of pain sensitivity in targeted muscle groups.
Blood Biomediators (CRP, Cortisol, Leukocyte Count)
时间窗: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).
Blood samples will be collected to analyze inflammatory and stress-related biomarkers associated with postoperative pain. Routine venous blood collection (8-10 cc) will be performed, and analyses will be conducted in a central laboratory.
次要结局
- Functional Capacity (Timed Up and Go Test)(Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).)
- Functional Capacity (10-Meter Walk Test)(Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).)
- Kinesiophobia (Tampa Scale of Kinesiophobia)(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)(Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).)
- Treatment Satisfaction (Global Perceived Effect, GPE Scale)(Post-operative day 2 (after intervention completion).)
- Virtual Reality Sickness Questionnaire (VRSQ) (VR group only)(Immediately before and after each VR session, approximately 30 minutes apart.)
研究者
HATİCE ÇETİN
Assistant Professor, Department of Neurological Physiotherapy and Rehabilitation, Hacettepe University
Hacettepe University
