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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Manual Lymphatic Drainage
  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.
Other: Control
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.
Other: Control
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.
Other: Kinesio Taping
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings