The Effects of Manual Lymphatic Drainage and Kinesiotaping on Lower Extremity Edema

November 14, 2019 updated by: HANDE GUNEY, Hacettepe University

The Effects of Manual Lymphatic Drainage and Kinesiotaping on Lower Extremity Edema and Functional Outcomes in Patients With Total Knee Arthroplasty

Significant trauma and muscular tightness often result during Total Knee Arthroplasty (TKA) surgery and thus act to restrict tissue fluid movement resulting with lower extremity edema. Kinesio Taping® is applied directly on the skin for restoration of normal fluid perfusion, removing congestion of lymphatic fluid or hemorrhages. In addition Manual Lymphatic Drainage (MLD) enhances blood circulation and stimulates the lymphatic movement and unblocks lymphatic territories. The aim of the study was to investigate the effectiveness of Kinesio Taping® and MLD in reducing postoperative edema and pain in the early stage after TKA.

Study Overview

Detailed Description

Procedures: Patients who underwent unilateral TKA were randomized as Kinesio Taping® group, MLD group and control group. For all patients, postoperative rehabilitation program included early mobilization and physical therapy twice a day during the stay in orthopedic traumatology department. On the second day after surgery, lymphatic correction method was used on the Kinesio Taping® group patients and a standardized 30-minute MLD treatment was applied to the MLD group patients. Control group received only physiotherapy treatment. Circumference measurements were applied on preoperatively and the second, third, fourth day and 6th weeks after surgery. Knee Injury and Osteoarthritis Outcome Score (KOOS) was used to determine the functional outcomes on the 6th weeks after surgery. Repeated measures of variance analysis was used to determine time differences between groups.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

45 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • TKA surgery

Exclusion Criteria:

  • active infection
  • malignant tumor
  • major cardiac pathology, or thrombus or venous obstruction that was pre-diagnosed or revealed on a routine preadmission hospital screening

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
Active Comparator: Kinesio Taping
Lymphatic correction method is applied via Kinesiotaping depending on the size of the leg two or three fan-cut tape was applied with light paper-off tension on the frontal, medial and lateral aspects of the limb. Certified Kinesio Tape practitioner applied Kinesiotaping on the second day (day 2) post-surgery and once a week.
  1. Lymphatic correction method was used via the KinesioTaping® to patients group.
  2. Standardized 30-minute Manuel Lymphatic Drainage treatment was applied to the MLD group.
  3. Control group received only physiotherapy treatment.
Knee-based exercises were undertaken in supine (active- assisted knee flexion using a bandage, inner range quadriceps contractions, and straight-leg raises), seated (active-assisted knee flexion using the contralateral limb and inner range quadriceps contractions), and standing (hip and knee flexion, active hamstring curls, lunges on a step, hamstring stretches) postures. These exercises were undertaken in sets of 10 repetitions, 3 times daily; the physiotherapist was present to assist, as required, on 2 occasions per day for the first 3 postoperative days and then once daily from day 4 until hospital discharge.
Active Comparator: Manual Lymphatic Drainage
A standardized 30-minute manual lymphatic drainage (MLD) treatment is applied to MLD group. On the second day (day 2) post-surgery, patients allocated to the MLD group underwent a standardized 30 minute MLD treatment on the operated limb by an experienced remedial massage therapist trained in delivering MLD.
Knee-based exercises were undertaken in supine (active- assisted knee flexion using a bandage, inner range quadriceps contractions, and straight-leg raises), seated (active-assisted knee flexion using the contralateral limb and inner range quadriceps contractions), and standing (hip and knee flexion, active hamstring curls, lunges on a step, hamstring stretches) postures. These exercises were undertaken in sets of 10 repetitions, 3 times daily; the physiotherapist was present to assist, as required, on 2 occasions per day for the first 3 postoperative days and then once daily from day 4 until hospital discharge.
Depending on the size of the leg two or three fan cut tapes were applied with light paper-off tension on the frontal, medial and lateral aspects of the limb. Kinesio taping was applied by certified Kinesio Tape practitioner once a week to Kinesiotaping group.
No Intervention: Control
Standard postoperative rehabilitation program is applied to Control Group. Knee-based exercises were undertaken in supine (active- assisted knee flexion using a bandage, inner range quadriceps contractions, and straight-leg raises), seated (active-assisted knee flexion using the contralateral limb and inner range quadriceps contractions), and standing (hip and knee flexion, active hamstring curls, lunges on a step, hamstring stretches) postures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circumference measurements
Time Frame: This outcome measure is assessing a change from the postoperative day 2 at 3rd month after surgery
Circumference measurements
This outcome measure is assessing a change from the postoperative day 2 at 3rd month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: This outcome measure is assessing a change from the postoperative day 2 at 3rd month after surgery
Knee Injury and Osteoarthritis Outcome Score (KOOS) evaluates the functional status of knee joint. total points range between 0-100 points. higher points represents a better outcome. total score is the averaged subscales.
This outcome measure is assessing a change from the postoperative day 2 at 3rd month after surgery

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Hande Güney Deniz, assoc. prof., Hacettepe University

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.

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)

January 1, 2015

Primary Completion (Actual)

August 30, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

June 14, 2018

First Submitted That Met QC Criteria

November 14, 2019

First Posted (Actual)

November 15, 2019

Study Record Updates

Last Update Posted (Actual)

November 15, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO15-152

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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