Comparison Between Kinesiotaping and Cold Therapy After Total Knee Arthroplasty

April 19, 2016 updated by: Ertugrul Yuksel, Dokuz Eylul University

Comparison Between Kinesiotaping and Cold Therapy on Muscle Strength and Functional Performance Outcomes After Total Knee Arthroplasty: a Randomized Controlled Trial

The investigators aim was to compare the effectiveness of kinesiotaping and cold therapy on muscle strength and functional performance outcomes in patients with TKA during early postoperative period. One-hundred-eleven patents with TKA are going to randomly assigned to control, KT and CT groups (nC=nKT=nCT=37).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Total knee arthroplasty (TKA) has been established as a valuable procedure patients with end-stage osteoarthritis and the rates of elective TKA are increasing steadily each year. Ninety percent of patients reported reduced pain, improved functional ability, and greater health related quality of life after TKA. Kinesiotaping (KT), a type of elastic tape that is being increasingly used for the management of pain and oedema after surgery

  1. . Cold therapy (CT) can also help relieve pain and swelling during early postoperative period
  2. . These two application may have impact on functional performance outcomes in patients with TKA. The number of studies that include KT in the rehabilitation process is increasing, but there isn't any study that compare KT application and CT after TKA.

The aim was to compare the effectiveness of kinesiotaping and cold therapy on muscle strength and functional performance outcomes in patients with TKA during early postoperative period.

Methods One-hundred-eleven patents with TKA are going to randomly assigned to control, KT and CT groups (nC=nKT=nCT=37). KT group are going to receive KT for lymphatic correction and rectus femoris facilitation technique. CT group are going to receive CT immediately after operation and following postoperative days. After surgery, all patients will receive standard post-operative treatment including continuous passive motion, active-assistive and active range of motion exercises, isometric and isotonic strengthening exercises, gait training and transfer training. After operation, pain intensity, active range of motion and knee function score [Hospital for Special Surgery (HSS) score] Functional activities are going to evaluate using the Iowa Level of Assistance Scale, and walking speed was evaluated using the Iowa Ambulation Velocity Scale. Isometric muscle strength measure of quadriceps femoris and hamstring muscles assessed by Hand-Held Dynamometer. All measurements evaluated at the discharge. One way ANOVA is going to be used in statistical analysis.

Study Type

Interventional

Enrollment (Anticipated)

111

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

  • Turkey
      • İ̇zmi̇r, Turkey, 35340
        • Recruiting
        • Dokuz Eylul University
        • Contact:

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 40 years older above
  • have a primary total knee arthroplasty

Exclusion Criteria:

  • revision total knee arthroplasty
  • unable to understand verbal and written instructions
  • having previously orthopaedic or neurological disorder that causes gait disturbance and having surgery within six months.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kinesiotaping Group
Kinesiotaping group received kinesiotape for lymphatic correction and rectus femoris facilitation technique.
Other: KINESIOTAPING
Kinesiotaping group received kinesiotape for lymphatic correction and rectus femoris facilitation technique.
Active Comparator: Cold Therapy Group
Cold Therapy group received cold pack immediately after operation and following postoperative days.
Other: COLD THERAPY
Cold therapy group received cold packs immediately after operation and following postoperative days
No Intervention: Control Group
Control group have no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The maximum isometric muscle strength of Quadriceps and hamstring muscles of all the patients will be measured using Hand Held Dynamometer (Lafayette Instrument Company, Lafayette, Ind., USA).
Time Frame: Post-operative three months
Before the measurement, the subjects seat with the hips on the edge of the bed, knees at ninety degree of flexion, feet free and arms crossed on the chest, without a support. The subjects complete maximum knee extension during the test. When the knee extension was achieved, the participant will be asked to continue maximum isometric contraction for five seconds. Then the mean value of three consecutive maximum contraction measurements will be taken. For the maximum isometric muscle strength of hamstring muscles of all the patients will be measured using Hand Held Dynamometer. Before the measurement, subjects lay prone on the bed, knees at ninety degree of flexion. Same measurement techniques will be used.
Post-operative three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity of the knees will be measured by a numerical rating scale.
Time Frame: Post-operative three months
Subjects will be asked to verbally rate the pain in and around the knee during activity and rest on the numeric rating scale from 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.
Post-operative three months
The active knee range of motion will be measured using a full circle manual goniometer.
Time Frame: Post-operative three months
The active knee range of motion will measured using a full circle manual goniometer made of flexible clear plastic with arms 30 cm in length. The patient will be positioned in the prone position.
Post-operative three months

Collaborators and Investigators

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

Sponsor

Dokuz Eylul University

Investigators

  • Study Director: Vasfi Karatosun, Prof, Dokuz Eylul 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

January 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

March 27, 2016

First Submitted That Met QC Criteria

April 19, 2016

First Posted (Estimate)

April 22, 2016

Study Record Updates

Last Update Posted (Estimate)

April 22, 2016

Last Update Submitted That Met QC Criteria

April 19, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1886-GOA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) are going to be kept.

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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