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

NCT05119764 | Completed DMC

• 1 other identifier: 1466/2020
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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).

Conditions

Total Knee Arthroplasty; Manual Lymphatic Drainage; MLD; Rehabilitation; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Subjective patient reported outcome

  Before the operation, five days after the operation and one year after the operation

Study Arms (3)

Control Group

NO INTERVENTION

Standard pre- and postoperative physical therapy without manual lymphatic drainage.

Manual lymphatic drainage before and after knee replacement

EXPERIMENTAL

Manual lymphatic drainage before and after knee replacement

Procedure: Manual Lymphatic Drainage

Manual lymphatic drainage after knee replacement

EXPERIMENTAL

Manual lymphatic drainage after knee replacement

Procedure: Manual Lymphatic Drainage

Interventions

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.

Manual lymphatic drainage after knee replacement; Manual lymphatic drainage before and after knee replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Total Knee Arthroplasty (TKA)

You may not qualify if:

• Venous insufficiency
• BMI \> 38
• Vascular disease

Sponsors & Collaborators

• Moritz Wagner: lead
• Bezirkskrankenhaus St. Johann in Tirol: collaborator

Study Sites (1)

BKH St. Johann in Tirol

Sankt Johann in Tirol, Tyrol, 6380, Austria

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Dr. med. univ. Moritz Wagner

Model Details: Randomized controlled trial with three treatment groups, two intervention groups and one control group

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: November 15, 2021
• Study Start: March 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 8, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-08

Locations

AU (1)