Kinesio® Tex Taping for Post Total Knee Replacement Patients
March 29, 2021 updated by: Istituto Ortopedico Galeazzi
Efficacy of Kinesio® Tex Taping on Edema and Early Functional Outcome of Post Total Knee Replacement Patients: a Randomized-controlled Trial
This study is designed to better understand the effect of Kinesio Taping applied using the Neurotaping technique on patients who underwent total knee arthroplasty surgery.
Patients will be randomized in two groups: in the first group patients will follow a protocol of usual rehabilitation, while the second group will do the same but add the Kinesio Taping application.
Main outcome will be the effect on edema, secondary outcome the effect on functionality after 13 days post surgery.
Study Overview
Study Type
Interventional
Enrollment (Actual)
71
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
-
-
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Milan, Italy, 20161
- IRCCS Istituto Ortopedico Galeazzi
-
-
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
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Program of total knee replacement;
- Signing and accepting informed consent.
Exclusion Criteria:
- pre-operative Barthel Index score < 70;
- program of revision of total knee replacement;
- grade III-IV heart failure;
- grade III-IV kidney failure;
- hypersensitive skin or intolerance to taping;
- Active cutaneous infection or open skin lesion on the sites of taping positioning;
- Body Mass Index > 34,9;
- Pregnant women;
- Not accepting informed consent;
- Impossibility to follow usual rehabilitation treatment.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kinesiotape
Kinesio Tex taping treatment for 10 days + usual care
|
Kinesio Tex tape on the operated limb
|
|
No Intervention: Control
usual care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee circumference
Time Frame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
Difference between pre-operative knee circumference and 13th post-operative day knee circumference expressed in cm
|
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go test
Time Frame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
Functional test
|
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
|
10 meters walking test
Time Frame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
Functional test
|
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
|
Barthel Index
Time Frame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
Autonomy outcome
|
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
|
Functional Independence Measure
Time Frame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
Autonomy outcome
|
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
|
Knee range of motion
Time Frame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
Flexion/extension passive/active range of motion of operated knee
|
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
|
Thigh circumference
Time Frame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
Thigh circumference expressed in cm
|
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
|
Leg circumference
Time Frame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
Leg circumference expressed in cm
|
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
|
Ankle circumference
Time Frame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
Ankle circumference expressed in cm
|
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
|
Pain Visual Analogue Scale
Time Frame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
The Pain Visual Analogue Scale scale consists of a straight line, 10 cm long, printed on a white sheet, the endpoints, 0 and 10, defining respectively "no pain at all" and "pain as bad as it could be".
The patient must mark the line to indicate his perception of his level of pain at that time.
|
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
|
R0 measured using bioimpedance
Time Frame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
body impedance
|
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Francesco Negrini, MD, IRCCS Istituto Ortopedico Galeazzi
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
- Williams S, Whatman C, Hume PA, Sheerin K. Kinesio taping in treatment and prevention of sports injuries: a meta-analysis of the evidence for its effectiveness. Sports Med. 2012 Feb 1;42(2):153-64. doi: 10.2165/11594960-000000000-00000.
- Morris D, Jones D, Ryan H, Ryan CG. The clinical effects of Kinesio(R) Tex taping: A systematic review. Physiother Theory Pract. 2013 May;29(4):259-70. doi: 10.3109/09593985.2012.731675. Epub 2012 Oct 22.
- Donec V, Krisciunas A. The effectiveness of Kinesio Taping(R) after total knee replacement in early postoperative rehabilitation period. A randomized controlled trial. Eur J Phys Rehabil Med. 2014 Aug;50(4):363-71. Epub 2014 May 13.
- Bade MJ, Stevens-Lapsley JE. Restoration of physical function in patients following total knee arthroplasty: an update on rehabilitation practices. Curr Opin Rheumatol. 2012 Mar;24(2):208-14. doi: 10.1097/BOR.0b013e32834ff26d.
- Wozniak-Czekierda W, Wozniak K, Hadamus A, Bialoszewski D. Use of Kinesiology Taping in Rehabilitation after Knee Arthroplasty: a Randomised Clinical Study. Ortop Traumatol Rehabil. 2017 Oct 31;19(5):461-468. doi: 10.5604/01.3001.0010.5828.
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)
May 14, 2018
Primary Completion (Actual)
February 18, 2020
Study Completion (Actual)
February 18, 2020
Study Registration Dates
First Submitted
September 20, 2018
First Submitted That Met QC Criteria
September 20, 2018
First Posted (Actual)
September 21, 2018
Study Record Updates
Last Update Posted (Actual)
April 1, 2021
Last Update Submitted That Met QC Criteria
March 29, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Kinesiotaping
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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