Back to resultsManual Lymphatic Drainage Before and After Total Knee Replacement, a Single-center Observer-blinded Randomized Controlled Trial
Primary Purpose
Total Knee Arthroplasty, Manual Lymphatic Drainage, MLD
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Manual Lymphatic Drainage
Sponsored by
About this trial
This is an interventional treatment trial for Total Knee Arthroplasty
Eligibility Criteria
Inclusion Criteria:
- Total Knee Arthroplasty (TKA)
Exclusion Criteria:
- Venous insufficiency
- BMI > 38
- Vascular disease
Sites / Locations
- BKH St. Johann in Tirol
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control Group
Manual lymphatic drainage before and after knee replacement
Manual lymphatic drainage after knee replacement
Arm Description
Standard pre- and postoperative physical therapy without manual lymphatic drainage.
Manual lymphatic drainage before and after knee replacement
Manual lymphatic drainage after knee replacement
Outcomes
Primary Outcome Measures
Volume
The swelling/volume is calculated through measurements of the circumference at 7 distinct points of the leg. The unit is [mm].
Function
Knee range of motion (ROM), active and passive. The unit is [degrees]
Knee Pain
Visual analogue scale from 0 to 10 on the average level of knee pain in the last 24 hours.
Secondary Outcome Measures
Subjective patient reported outcome
WOMAC Score (Western Ontario and McMaster University Osteoarthritis Index)
Full Information
NCT ID
NCT05119764
First Posted
May 12, 2021
Last Updated
August 1, 2023
Sponsor
Moritz Wagner
Collaborators
Bezirkskrankenhaus St. Johann in Tirol
1. Study Identification
Unique Protocol Identification Number
NCT05119764
Brief Title
Manual Lymphatic Drainage Before and After Total Knee Replacement, a Single-center Observer-blinded Randomized Controlled Trial
Official Title
Manual Lymphatic Drainage Before and After Total Knee Replacement, a Single-center Observer-blinded Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 8, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Moritz Wagner
Collaborators
Bezirkskrankenhaus St. Johann in Tirol
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty, Manual Lymphatic Drainage, MLD, Rehabilitation, Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with three treatment groups, two intervention groups and one control group
Masking
Investigator
Masking Description
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).
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Standard pre- and postoperative physical therapy without manual lymphatic drainage.
Arm Title
Manual lymphatic drainage before and after knee replacement
Arm Type
Experimental
Arm Description
Manual lymphatic drainage before and after knee replacement
Arm Title
Manual lymphatic drainage after knee replacement
Arm Type
Experimental
Arm Description
Manual lymphatic drainage after knee replacement
Intervention Type
Procedure
Intervention Name(s)
Manual Lymphatic Drainage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Volume
Description
The swelling/volume is calculated through measurements of the circumference at 7 distinct points of the leg. The unit is [mm].
Time Frame
Change in swelling weeks before the operation to one year after the operation
Title
Function
Description
Knee range of motion (ROM), active and passive. The unit is [degrees]
Time Frame
Change in ROM weeks before the operation to one year after the operation
Title
Knee Pain
Description
Visual analogue scale from 0 to 10 on the average level of knee pain in the last 24 hours.
Time Frame
Change in pain weeks before the operation to one year after the operation
Secondary Outcome Measure Information:
Title
Subjective patient reported outcome
Description
WOMAC Score (Western Ontario and McMaster University Osteoarthritis Index)
Time Frame
Before the operation, five days after the operation and one year after the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Total Knee Arthroplasty (TKA)
Exclusion Criteria:
Venous insufficiency
BMI > 38
Vascular disease
Facility Information:
Facility Name
BKH St. Johann in Tirol
City
Sankt Johann In Tirol
State/Province
Tyrol
ZIP/Postal Code
6380
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Manual Lymphatic Drainage Before and After Total Knee Replacement, a Single-center Observer-blinded Randomized Controlled Trial
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