Manual Lymphatic Drainage Following Total Knee Arthroplasty Surgery

August 1, 2018 updated by: Claude Pichonnaz, Haute Ecole de Santé Vaud

Outcome of Manual Lymphatic Drainage Following Total Knee Arthroplasty Surgery

The purpose of this study is to evaluate the efficiency of manual lymphatic drainage to decrease the swelling of the knee after total knee replacement surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background There is scientific evidence that rehabilitation has a positive influence on patients'recovery after total knee arthroplasty (TKA). According to the literature, conventional rehabilitation aims to improve knee range of motion, lower limb strength, gait, activities and pain. Although swelling is a systematic consequence of TKA surgery, less focus is put on swelling reduction. Patients develop swelling due to periarticular edema, hematoma and joint effusion. Inflammation, pain, stiffness, alteration of gait pattern, quadriceps contraction inhibition and slowing of rehabilitation are reported as consequences of swelling. Accordingly, it is likely that a therapy that would promote resorption of swelling would decrease the negative impact of swelling on patients'recovery. Manual lymph drainage (MLD) could possibly accelerate edema resorption after TKA surgery. Several authors advise MLD after TKA, and physiotherapists currently apply MLD to reduce postsurgical swelling. Its positive effect on chronic lymphedema resorption is largely accepted. Results on pain and range of motion seem interesting from an empirical point of view but, to our knowledge, no scientifically driven studies have confirmed these positive effects after orthopaedic surgery.

Aim This study aims to evaluate the effect of MLD on swelling, and parameters possibly influenced by swelling (pain, knee range of motion, knee objective and subjective function and gait pattern).

Methods This study is a randomized controlled clinical trial. Patients will be blinded from goals of the treatments and evaluators will be blinded from the treatment delivered to the patient. The effects of MLD (5 treatments of 30 minutes from the second to the eighth postsurgical day) will be compared to those of a placebo (relaxation sessions). MLD or placebo will be added to the conventional rehabilitation program of our Orthopaedic Department. Assessments will be conducted one day before surgery, two days, 8 days and 3 months after surgery. Evolution and differences between groups will be statistically assessed at each step.

Significance This project aims to improve knowledge on the efficiency of rehabilitation treatments following TKA. It will contribute to effective evaluation of the effects of a widely applied treatment. The results will help physiotherapists and medical doctors to take clinical decisions based on documented evidence. This will make a contribution to better quality of care and better allocation of resources to rehabilitation.

Study Type

Interventional

Enrollment (Actual)

60

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

  • Switzerland
      • Lausanne, Switzerland, 1005
        • Département de l'Appareil Locomoteur - CHUV
      • Lausanne, Switzerland, 1011
        • Haute Ecole Cantonale Vaudoise de Santé

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • knee replacement surgery

Exclusion Criteria:

  • pacemaker
  • cardiac defibrillator
  • pathology of the lymphatic system
  • lower limb impairment which interferes with gait
  • neurological disease
  • unability to understand patient information letter or to give informed consent
  • unability to understand and complete questionnaires in French
  • contraindication to manual lymphatic drainage : thrombosis, infection, right cardiac insufficiency, active cancer
  • non standard knee replacement surgery
  • high dose anticoagulation
  • post surgical complication

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Manual lymphatic drainage
this arm will receive 5 manual lymphatic drainage treatments from day 2 to day 7 post surgery
Other: Manual lymphatic drainage
Each patient will receive 5 treatments of 30 minutes by a trained physiotherapist, from day 2 to day 7 post surgery
Other Names:
  • MLD
  • lymphatic drainage
  • manual lymph drainage
Placebo Comparator: Relaxation
This arm will receive 5 relaxation treatments from day 2 to day 7 post surgery
Other: relaxation
Each patient will receive 5 treatments of 30 minutes of tape recorded relaxation , from day 2 to day 7 post surgery
Other Names:
  • eriksonian hypnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioimpedance Percentage Difference Healthy/Operated
Time Frame: presurgery, 2 days, 7 days and 3 months post surgery
The bioimpedance, i.e. a measurement in ohms of the opposition to current flow between electrodes was evaluated for each limb. Then the bioimpedance percentage difference between operated and healthy limb was calculated.
presurgery, 2 days, 7 days and 3 months post surgery
Lower Limb Volume Percentage Difference Operated/Healthy
Time Frame: presurgery, and 2 days, 7 days and 3 months after surgery
The limb volume was evaluated for each limb using circumferential tape measurements at 4 cm intervals. Then the tape measurementy were converted into limb volume using the validated truncated-cone method, and the percentage difference between the operated and the healthy limb was calculated.
presurgery, and 2 days, 7 days and 3 months after surgery

Collaborators and Investigators

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

Sponsor

Haute Ecole de Santé Vaud

Collaborators

University of Lausanne Hospitals
University of Applied Sciences of Western Switzerland

Investigators

  • Principal Investigator: Claude Pichonnaz, physiother, Haute Ecole Cantonale Vaudoise de Santé + Département de l'Appareil Locomoteur - CHUV
  • Study Director: Brigitte M Jolles, PD MER MSc, Département de l'Appareil Locomoteur - CHUV + Faculté des sciences et techniques de l'ingénieur (STI) - EPFL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2008

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

July 8, 2008

First Submitted That Met QC Criteria

July 8, 2008

First Posted (Estimate)

July 9, 2008

Study Record Updates

Last Update Posted (Actual)

January 18, 2019

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FNS-DORE 13DPD3-120298
  • SAGEX: 21267 (Other Identifier: HES-SO)
  • RéSaR 10/O/07 (Other Identifier: HES-SO)
  • Ré-Sa-R 13-07 (Other Identifier: HES-SO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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