Effects of Immersive Virtual Reality-based Exercise on Somatosensory Function, Pain, and Psychological and Functional Recovery in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Quantitative Sensory Testing (QST): Specifically including Conditioned Pain Modulation (CPM) and Temporal Summation (TS) protocols.
研究概览
简要总结
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.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-40 years.
- •Non-specific chronic low back pain lasting ≥3 months.
- •Baseline pain intensity VAS ≥4/
- •Kinesiophobia (TSK-13) ≥
- •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.
排除标准
- •Severe pain making participation infeasible: VAS ≥8/
- •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
- •Vulnerable populations excluded: minors, older adults, individuals with psychiatric disorders or cognitive impairment, and pregnant persons.
研究组 & 干预措施
VR Exercise Group
Participants perform a 15-minute exercise program using immersive virtual reality (FitXR app with Meta Quest 3s).
干预措施: Immersive Virtual Reality-based Exercise (FitXR, Meta Quest 3s) (Behavioral)
Non-VR Exercise Group
Participants perform the same 15-minute exercise program, but without VR equipment.
干预措施: Conventional Exercise Program (Matched Exercise, without VR) (Behavioral)
结局指标
主要结局
Quantitative Sensory Testing (QST): Specifically including Conditioned Pain Modulation (CPM) and Temporal Summation (TS) protocols.
时间窗: Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).
CPM measures the efficiency of the body's pain-inhibiting pathways. A higher positive value indicates a more effective pain modulation system (better outcome). TS measures pain sensitization. A higher score indicates greater central sensitization to pain (worse outcome).
次要结局
- Tampa Scale for Kinesiophobia-13 (TSK-13)(Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).)
- Pain Catastrophizing Scale (PCS)(Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).)
- Oswestry Disability Index (ODI)(Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).)
- Fear-Avoidance Beliefs Questionnaire (FABQ)(Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).)
- Visual Analog Scale (VAS)(Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).)
- Lumbar Range of Motion (ROM)(Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).)
研究者
dongmin kang
Master's Degree Candidate
Sahmyook University