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Completed

NCT Number: NCT05119764

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

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).

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Key information

Conditions

Total Knee Arthroplasty Arthritis Joint Diseases Knee Osteoarthritis MLD Manual Lymphatic Drainage Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rehabilitation Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BKH St. Johann in Tirol

Sankt Johann in Tirol, Tyrol, 6380, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Total Knee Arthroplasty (TKA)

Exclusion criteria

  • Venous insufficiency
  • BMI > 38
  • Vascular disease

Treatment and study plan

Manual Lymphatic Drainage

Procedure

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 outcomes

  1. 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].

  2. 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]

  3. 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.

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Moritz Wagner

Other

Collaborators

  • Bezirkskrankenhaus St. Johann in Tirol

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 15, 2021
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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