The Post-operative Analgesia of the Virtual Reality Using a Mirror Therapy After Total Knee Arthroplasty: Prospective, Single-blind, Parallel Group, Randomized, Single Cohort Clinical Trial of Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 6 minute walk test
研究概览
简要总结
It was well known that the mirror therapy could decrease pain of upper-limb amputated patients.
The mirror therapy is known to make a plastic change some parts of the brain perceiving the painful body part and modulating its signal by feedback of visual information mirrored with the corresponding contra-lateral normal parts.
In this study, post-operative analgesic efficiency of the virtual reality using a mirror therapy after total knee arthroplasty will be evaluated.
This clinical trial will be performed in the form of prospective, single-blind (i.e. assessor-blind), parallel group, randomized (allocation ratio 1:1), single cohort.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who were transferred to RM after unilateral TKA
排除标准
- •patients cannot freely move the contralat. leg d/t neurologic or musculoskeletal problems
- •patients are not enough clear to indicate VAS
- •patients cannot look at the virtual reality monitor d/t visual problem
- •refusal of the participation
结局指标
主要结局
6 minute walk test
时间窗: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
The distance walked at a self-selected speed along a 40 cm corridor in 6 min. The distance was measured in meters, and more the meters better the result. A walking aid was used if needed.
次要结局
- Tridol consumption per week(after the 1st and 2nd session (5 days) intervention)
- Active ROM of flexion and extension on the knee(shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention)
- Timed-stands test(shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention)
- Side effects(after the 1st and 2nd session (5 days) intervention)
- Visual analogue scale (VAS) while moving(shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention)
- WOMAC index(shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention)
- Graded ambulation distances(shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention)
- Visual analogue scale (VAS) while resting(shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention)
研究者
Chang Ho Hwang
Associate Professor
Ulsan University Hospital