Manual Lymphatic Drainage Before and After Total Knee Replacement, a Single-center Observer-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Knee Pain
研究概览
简要总结
The aim of this observer-blinded randomized controlled trial is the evaluation of the influence of manual lymphatic drainage (MLD) on the outcome of patients receiving total knee replacement (TKA).
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 (Investigator)
盲法说明
Observer/Investigators are unaware of the treatment arm of each patient. Patients cannot be blinded, due to the obvious treatment intervention (manual lymphatic drainage 15 minutes for 5 days).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Total Knee Arthroplasty (TKA)
排除标准
- •Venous insufficiency
- •BMI > 38
- •Vascular disease
结局指标
主要结局
Knee Pain
时间窗: Change in pain weeks before the operation to one year after the operation
Visual analogue scale from 0 to 10 on the average level of knee pain in the last 24 hours.
Volume
时间窗: Change in swelling weeks before the operation to one year after the operation
The swelling/volume is calculated through measurements of the circumference at 7 distinct points of the leg. The unit is \[mm\].
Function
时间窗: Change in ROM weeks before the operation to one year after the operation
Knee range of motion (ROM), active and passive. The unit is \[degrees\]
次要结局
- Subjective patient reported outcome(Before the operation, five days after the operation and one year after the operation)
研究者
Moritz Wagner
Principal Investigator, Dr. med. univ. Moritz Wagner
Bezirkskrankenhaus St. Johann in Tirol