Manual Lymphatic Drainage Before and After Total Knee Replacement, a Single-center Observer-blinded Randomized Controlled Trial

Study Overview
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Brief Summary
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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).

Official Title
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Manual Lymphatic Drainage Before and After Total Knee Replacement, a Single-center Observer-blinded Randomized Controlled Trial

Conditions
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Total Knee Arthroplasty, Manual Lymphatic Drainage, MLD, Rehabilitation, Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Manual Lymphatic Drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Total Knee Arthroplasty (TKA) Exclusion Criteria: Venous insufficiency BMI > 38 Vascular disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with three treatment groups, two intervention groups and one control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Standard pre- and postoperative physical therapy without manual lymphatic drainage. | |
| Experimental: Manual lymphatic drainage before and after knee replacement<br>Manual lymphatic drainage before and after knee replacement | Procedure: Manual Lymphatic Drainage<br>* Manual Lymphatic Drainage is a form of physical therapy with the primary goal of accelerating lymphatic drainage. In this study, the manual lymphatic drainage is applied by experienced physical therapists 5 days in a row for 30 minutes each; after and/or before the surgery.<br>|
| Experimental: Manual lymphatic drainage after knee replacement<br>Manual lymphatic drainage after knee replacement | Procedure: Manual Lymphatic Drainage<br>* Manual Lymphatic Drainage is a form of physical therapy with the primary goal of accelerating lymphatic drainage. In this study, the manual lymphatic drainage is applied by experienced physical therapists 5 days in a row for 30 minutes each; after and/or before the surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume | The swelling/volume is calculated through measurements of the circumference at 7 distinct points of the leg. The unit is [mm]. | Change in swelling weeks before the operation to one year after the operation | 
| Function | Knee range of motion (ROM), active and passive. The unit is [degrees] | Change in ROM weeks before the operation to one year after the operation | 
| Knee Pain | Visual analogue scale from 0 to 10 on the average level of knee pain in the last 24 hours. | Change in pain weeks before the operation to one year after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective patient reported outcome | WOMAC Score (Western Ontario and McMaster University Osteoarthritis Index) | Before the operation, five days after the operation and one year after the operation |