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NCT05119764 Clinical Trial

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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05119764
Other study ID # 1466/2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date February 8, 2023

Study information
Verified date August 2023
Source Bezirkskrankenhaus St. Johann in Tirol
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 112
Est. completion date February 8, 2023
Est. primary completion date February 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Total Knee Arthroplasty (TKA) Exclusion Criteria: - Venous insufficiency - BMI > 38 - Vascular disease

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Manual Lymphatic Drainage
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.

Locations
Country Name City State
Austria BKH St. Johann in Tirol Sankt Johann In Tirol Tyrol

Sponsors (2)
Lead Sponsor Collaborator
Moritz Wagner Bezirkskrankenhaus St. Johann in Tirol

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
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