Outcome of Manual Lymphatic Drainage Following Total Knee Arthroplasty Surgery
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
- 4
- 主要终点
- Bioimpedance Percentage Difference Healthy/Operated
研究概览
简要总结
The purpose of this study is to evaluate the efficiency of manual lymphatic drainage to decrease the swelling of the knee after total knee replacement surgery
详细描述
Background There is scientific evidence that rehabilitation has a positive influence on patients'recovery after total knee arthroplasty (TKA). According to the literature, conventional rehabilitation aims to improve knee range of motion, lower limb strength, gait, activities and pain. Although swelling is a systematic consequence of TKA surgery, less focus is put on swelling reduction. Patients develop swelling due to periarticular edema, hematoma and joint effusion. Inflammation, pain, stiffness, alteration of gait pattern, quadriceps contraction inhibition and slowing of rehabilitation are reported as consequences of swelling. Accordingly, it is likely that a therapy that would promote resorption of swelling would decrease the negative impact of swelling on patients'recovery. Manual lymph drainage (MLD) could possibly accelerate edema resorption after TKA surgery. Several authors advise MLD after TKA, and physiotherapists currently apply MLD to reduce postsurgical swelling. Its positive effect on chronic lymphedema resorption is largely accepted. Results on pain and range of motion seem interesting from an empirical point of view but, to our knowledge, no scientifically driven studies have confirmed these positive effects after orthopaedic surgery.
Aim This study aims to evaluate the effect of MLD on swelling, and parameters possibly influenced by swelling (pain, knee range of motion, knee objective and subjective function and gait pattern).
Methods This study is a randomized controlled clinical trial. Patients will be blinded from goals of the treatments and evaluators will be blinded from the treatment delivered to the patient. The effects of MLD (5 treatments of 30 minutes from the second to the eighth postsurgical day) will be compared to those of a placebo (relaxation sessions). MLD or placebo will be added to the conventional rehabilitation program of our Orthopaedic Department. Assessments will be conducted one day before surgery, two days, 8 days and 3 months after surgery. Evolution and differences between groups will be statistically assessed at each step.
Significance This project aims to improve knowledge on the efficiency of rehabilitation treatments following TKA. It will contribute to effective evaluation of the effects of a widely applied treatment. The results will help physiotherapists and medical doctors to take clinical decisions based on documented evidence. This will make a contribution to better quality of care and better allocation of resources to rehabilitation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •knee replacement surgery
排除标准
- •pacemaker
- •cardiac defibrillator
- •pathology of the lymphatic system
- •lower limb impairment which interferes with gait
- •neurological disease
- •unability to understand patient information letter or to give informed consent
- •unability to understand and complete questionnaires in French
- •contraindication to manual lymphatic drainage : thrombosis, infection, right cardiac insufficiency, active cancer
- •non standard knee replacement surgery
- •high dose anticoagulation
- •post surgical complication
研究组 & 干预措施
Manual lymphatic drainage
this arm will receive 5 manual lymphatic drainage treatments from day 2 to day 7 post surgery
干预措施: Manual lymphatic drainage (Other)
Relaxation
This arm will receive 5 relaxation treatments from day 2 to day 7 post surgery
干预措施: relaxation (Other)
结局指标
主要结局
Bioimpedance Percentage Difference Healthy/Operated
时间窗: presurgery, 2 days, 7 days and 3 months post surgery
The bioimpedance, i.e. a measurement in ohms of the opposition to current flow between electrodes was evaluated for each limb. Then the bioimpedance percentage difference between operated and healthy limb was calculated.
Lower Limb Volume Percentage Difference Operated/Healthy
时间窗: presurgery, and 2 days, 7 days and 3 months after surgery
The limb volume was evaluated for each limb using circumferential tape measurements at 4 cm intervals. Then the tape measurementy were converted into limb volume using the validated truncated-cone method, and the percentage difference between the operated and the healthy limb was calculated.
次要结局
未报告次要终点
研究者
Claude Pichonnaz
Associate professor
Haute Ecole de Santé Vaud
