Mirror Visual Feedback as Therapeutic Modality in Unilateral Upper Extremity Complex Regional Pain Syndrome Type I
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 主要终点
- Pain perception
研究概览
简要总结
The aim is to evaluate the efficacy of Mirror Therapy on pain reduction and hand function in subjects with unilateral upper extremity Complex Regional Pain Syndrome Type I.
详细描述
Subjects were randomly divided into two groups. Group A carried out a ten-minute Mirror Therapy exercise daily, for a total duration of six weeks. Group B acted as a control group for six weeks followed by six weeks of Mirror Therapy with the same characteristics as Group A. Upper extremity active range of motion, strength, dexterity, limb volume, right-left temperature difference, and health-related quality of life were evaluated before and after each period. Daily records on the visual analogue scale were used for pain evaluation. Effectiveness was calculated using mixed-effects modelling for between-group comparisons and within-group variability and identifying significant predictors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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 CRPS I based on the Budapest criteria
排除标准
- •failure to meet the diagnostic Budapest clinical criteria for CRPS I
- •previous use of Mirror Therapy prior to the commencement of this study
- •substantial difficulties in cooperation
- •a significant change to the subjects' treatment regimen, outside of the study design
结局指标
主要结局
Pain perception
时间窗: Recordings performed every day from day 0 to day 42 (Group A) and from day 0 to day 84 (Group B); Follow-up on day 72 (Group A) and day 114 (Group B).
The participants in both groups made daily accounts of their pain level using 10 cm long visual analog scale (VAS) at rest as well as typical pain level during hand movement.
Dexterity
时间窗: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
Dexterity was evaluated by using a nine-hole PegBoard. The time taken to complete this task was measured.
Health-related Quality of Life
时间窗: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
Determined using the European Quality of Life-5 Dimensions-3 Levels questionnaire. A range of 0-100% is used, where a higher score means a better outcome.
Active Range of Motion
时间窗: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
Three attributes were measured: maximal active range of wrist flexion and extension (°) determined with goniometer measuring the angle between forearm and metacarpal bones
Strength
时间窗: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
The outcome parameter is the highest pressure (bar) performed during one maximal grip.
Volume of hand and forearm
时间窗: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
The volumetric measurements are based on the principle of water displacement.
Temperature
时间窗: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
Temperature was measured bilaterally in the thenar area using an infrared thermometer.
次要结局
未报告次要终点
研究者
Rudolf Cerny
Senior Investigator
University Hospital, Motol