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

Sponsor

Moritz Wagner (Other)

Overall Status

Recruiting

CT.gov ID

NCT05119764

Collaborator

Bezirkskrankenhaus St. Johann in Tirol (Other)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Total Knee Arthroplasty Manual Lymphatic Drainage MLD Rehabilitation Knee Osteoarthritis	Procedure: Manual Lymphatic Drainage	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trial with three treatment groups, two intervention groups and one control groupRandomized controlled trial with three treatment groups, two intervention groups and one control group

Masking:

Single (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).

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Feb 28, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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 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 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.

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

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

Manual lymphatic drainage after knee replacement

Procedure: Manual Lymphatic Drainage

Outcome Measures

Primary Outcome Measures

Swelling [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].
Function [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]
Pain [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 pain in the last 24 hours with 0 meaning no pain and 10 meaning most severe pain. The unit is [n](0 best-10 worst)

Secondary Outcome Measures

Subjective patient reported outcome [Before the operation, five days after the operation and one year after the operation]
WOMAC Score (Western Ontario and McMaster University Osteoarthritis Index)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Total Knee Arthroplasty (TKA)

Exclusion Criteria:

Venous insufficiency
BMI > 38
Vascular disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BKH St. Johann in Tirol	Sankt Johann In Tirol	Tyrol	Austria	6380

Sponsors and Collaborators

Moritz Wagner
Bezirkskrankenhaus St. Johann in Tirol

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Moritz Wagner, Principal Investigator, Dr. med. univ. Moritz Wagner, Bezirkskrankenhaus St. Johann in Tirol

ClinicalTrials.gov Identifier:

NCT05119764

Other Study ID Numbers:

1466/2020

First Posted:

Nov 15, 2021

Last Update Posted:

Nov 15, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of Nov 15, 2021