Extended Reality-Assisted Therapy for Chronic Pain Management: Can Immersive Virtual Reality Improve Range of Motion and Disability in Patients With Chronic Low Back Pain?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Brief Pain Inventory
研究概览
简要总结
The goal of this clinical trial is to test a home-based virtual reality rehabilitation application in patients with chronic low back pain. The main question it aims to answer are:
Is a prototype of a novel VR software application effective at reducing pain, improving daily function, improving range of motion, and reducing fear of movement in adult patients with chronic low back pain compared with a passive VR intervention? Participants in the treatment group will use the application daily for 20 minutes for a period of 3 weeks at home and unsupervised. Researchers will compare use of the VR application with a control group that watches 2D video to see if the treatment group have improved pain, disability, range of motion, and fear of movement.
详细描述
This is a two-arm randomized parallel controlled trial designed to test a prototype of a VR software application that the investigators have developed for patients with chronic low back pain. The app contains (1) educational messages delivered by a virtual therapist, (2) gamified exercises in which the patient has to move to reach goals or avoid objects, (3) therapeutic exercises, in which patients perform difficult or feared movements, (4) relaxation/mindfulness. There will be two groups consisting of adult patients of both sexes with persistent low back pain. Patients (n = 100) will be randomly assigned to either an interventional VR treatment (n = 50) or a control treatment (n = 50).
Patients in the VR intervention group will use the VR software application daily for a 20-minute training program. In the virtual reality application, they will be embodied into an avatar through congruent visuotactile and visuomotor stimulation (observed in first person) and will perform gamified movements and exercises for 15-20 minutes. These exercises will increase in difficulty for 3 weeks and will include educational and relaxation components. The control treatment will consist of a passive VR intervention in which the patient watches a TV show on a 2D screen but while wearing the virtual reality headset. They will be able to choose from three popular TV series with short episodes (20 minutes). The investigators will use validated outcome measures to assess changes in pain and function. These will be measured at baseline, after treatment (3 weeks), and at 1 month follow-up for both the treatment group and the control group. Both groups will be advised to continue their normal daily activities and routines, with no restrictions on activity or exercise, in addition to VR treatment.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 of either sex
- •Diagnosis of chronic low back pain of >12 weeks, with or without associated somatic referred leg pain
- •Average pain intensity over the previous month ≤7/10 and ≥ 2/10)
排除标准
- •Spondylolysis, fracture, cauda equina syndrome, active spinal infection
- •Acute radiculopathy or compromised nerve root
- •Recent spinal surgery (<12 months) or lower limb surgery (<3 months)
- •Major depressive symptoms as indicated by the Patient Health Questionnaire-2 depression screen score of 4 or more.
- •Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, balance disorder, or other neurological diseases that may prevent the use of virtual reality or adverse effects.
- •Cardiopulmonary or pulmonary disorder with contraindication to physical exercise
- •Pregnancy
结局指标
主要结局
Brief Pain Inventory
时间窗: Baseline, 4 weeks, 8 weeks
Allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. Minimum score 0, maximum score 70, higher score = worse outcome.
次要结局
- Patient Global Impression of Change(Baseline, 4 weeks, 8 weeks)
- Pain Catastrophization Scale(Baseline, 4 weeks, 8 weeks)
- Roland-Morris Disability Questionnaire(Baseline, 4 weeks, 8 weeks)
- Short-Form 12(Baseline, 4 weeks, 8 weeks)
研究者
Prof. Maria V. Sanchez-Vives
Professor
Institut d'Investigacions Biomèdiques August Pi i Sunyer