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

August 1, 2023 updated by: Moritz Wagner
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Tyrol
      • Sankt Johann In Tirol, Tyrol, Austria, 6380
        • BKH St. Johann in Tirol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Total Knee Arthroplasty (TKA)

Exclusion Criteria:

  • Venous insufficiency
  • BMI > 38
  • Vascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Standard pre- and postoperative physical therapy without manual lymphatic drainage.
Experimental: Manual lymphatic drainage before and after knee replacement
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.
Experimental: Manual lymphatic drainage after knee replacement
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume
Time Frame: 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].
Change in swelling weeks before the operation to one year after the operation
Function
Time Frame: 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]
Change in ROM weeks before the operation to one year after the operation
Knee Pain
Time Frame: 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.
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
Time Frame: Before the operation, five days after the operation and one year after the operation
WOMAC Score (Western Ontario and McMaster University Osteoarthritis Index)
Before the operation, five days after the operation and one year after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moritz Wagner

Collaborators

Bezirkskrankenhaus St. Johann in Tirol

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

February 8, 2023

Study Registration Dates

First Submitted

May 12, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (Actual)

November 15, 2021

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1466/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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