Changing Lower Back Pain Through Virtual Reality: a Randomised Clinical Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Low back pain
研究概览
简要总结
The main objective of this randomized controlled trial is to investigate the efficacy of a 6-week therapeutic exercise program, performed with virtual reality (VR) manipulating visual proprioceptive information during all lumbar movements in the different therapeutic exercises (experimental group), on pain and disability, kinesiophobia, range of motion (ROM), catastrophizing, quality of life, and physical fitness in patients with chronic non-specific low back pain compared to the same therapeutic exercise program without VR (control group).
详细描述
Chronic pain is considered an urgent global public health problem. One of the most prevalent chronic pain pathologies worldwide is low back pain (LBP). Kinesophobia (fear of movement) has been largely associated with pain intensity, disability, worse quality of life and chronification in LBP; while physical reconditioning has been proposed in clinical practice as a key element in the treatment of LBP.(20-22) However, the efficacy of physical reconditioning programs developed so far would require considerable improvement. The induction of illusions in virtual reality (VR) through visual cues could be a valid alternative to evoke motion illusions and be able to modify proprioceptive integration, acting on kinesiophobia, in turn. The main objective of this randomized controlled trial is to investigate the efficacy of a 6-week therapeutic exercise program, performed with VR manipulating visual proprioceptive information during all lumbar movements in the different therapeutic exercises (experimental group), on pain and disability, kinesiophobia, range of motion (ROM), catastrophizing, quality of life, and physical fitness in patients with chronic non-specific low back pain compared to the same therapeutic exercise program without VR (control group).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic non-specific lower back pain according to the European COST B13 guideline.
- •Pain score of 3 or higher on the Numeric Rating Scale (NRS) in the last 6 months.
排除标准
- •Presence of spinal tumor.
- •Presence of infection.
- •Presence of fracture.
- •Presence of systemic disease.
- •Presence of fibromyalgia.
- •Presence of cauda equina syndrome.
- •Previous spinal surgery.
- •Presence of musculoskeletal injuries of the lower extremities.
结局指标
主要结局
Low back pain
时间窗: At six weeks
Measured with a Visual Analogue Scale (0-10 points). Higher scores mean a worse pain.
Range of movement
时间窗: At six weeks
Measured with an electrogoniometer
Disability
时间窗: At six weeks
Measured with the Roland Morris Questionnaire (0-24 points). Higher scores mean a worse disability.
次要结局
- The Quality of life(At six weeks)
- Physical activity(At six weeks)
- Catastrophizing(At six weeks)
- Kinesophobia(At six weeks)
- Physical capacity(At six weeks)
研究者
Juan F. Lisón Párraga, Dr
Principal Investigator
Cardenal Herrera University
