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Kinesio® Tex Taping for Post Total Knee Replacement Patients

Primary Purpose

Knee Osteoarthritis

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Kinesio Tex
Sponsored by
Istituto Ortopedico Galeazzi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee Osteoarthritis, Total Knee Arthroplasty, Kinesiotaping, Neuro taping, Rehabilitation

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IRCCS Istituto Ortopedico Galeazzi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Kinesiotape

Control

Arm Description

Kinesio Tex taping treatment for 10 days + usual care

usual care

Outcomes

Primary Outcome Measures

Knee circumference
Difference between pre-operative knee circumference and 13th post-operative day knee circumference expressed in cm

Secondary Outcome Measures

Timed Up and Go test
Functional test
10 meters walking test
Functional test
Barthel Index
Autonomy outcome
Functional Independence Measure
Autonomy outcome
Knee range of motion
Flexion/extension passive/active range of motion of operated knee
Thigh circumference
Thigh circumference expressed in cm
Leg circumference
Leg circumference expressed in cm
Ankle circumference
Ankle circumference expressed in cm
Pain Visual Analogue Scale
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.
R0 measured using bioimpedance
body impedance

Full Information

First Posted
September 20, 2018
Last Updated
March 29, 2021
Sponsor
Istituto Ortopedico Galeazzi
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1. Study Identification

Unique Protocol Identification Number
NCT03681106
Brief Title
Kinesio® Tex Taping for Post Total Knee Replacement Patients
Official Title
Efficacy of Kinesio® Tex Taping on Edema and Early Functional Outcome of Post Total Knee Replacement Patients: a Randomized-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to the health crisis triggered by the COVID-19 pandemic and the consequent sanitary-organizational arrangements set up for its contrast it was necessary to interrupt the study before reaching the established sample size.
Study Start Date
May 14, 2018 (Actual)
Primary Completion Date
February 18, 2020 (Actual)
Study Completion Date
February 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Galeazzi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee Osteoarthritis, Total Knee Arthroplasty, Kinesiotaping, Neuro taping, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Randomization list has been already generated but will not be available to the recruiters to avoid allocation bias. Statistician that will handle the data analysis will not know which group is the interventional and which group is the control. We were not able to mask the using of tape to the patients or the investigators because it is an evident treatment.
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesiotape
Arm Type
Experimental
Arm Description
Kinesio Tex taping treatment for 10 days + usual care
Arm Title
Control
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Device
Intervention Name(s)
Kinesio Tex
Intervention Description
Kinesio Tex tape on the operated limb
Primary Outcome Measure Information:
Title
Knee circumference
Description
Difference between pre-operative knee circumference and 13th post-operative day knee circumference expressed in cm
Time Frame
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Secondary Outcome Measure Information:
Title
Timed Up and Go test
Description
Functional test
Time Frame
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Title
10 meters walking test
Description
Functional test
Time Frame
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Title
Barthel Index
Description
Autonomy outcome
Time Frame
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Title
Functional Independence Measure
Description
Autonomy outcome
Time Frame
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Title
Knee range of motion
Description
Flexion/extension passive/active range of motion of operated knee
Time Frame
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Title
Thigh circumference
Description
Thigh circumference expressed in cm
Time Frame
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Title
Leg circumference
Description
Leg circumference expressed in cm
Time Frame
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Title
Ankle circumference
Description
Ankle circumference expressed in cm
Time Frame
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Title
Pain Visual Analogue Scale
Description
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.
Time Frame
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Title
R0 measured using bioimpedance
Description
body impedance
Time Frame
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Negrini, MD
Organizational Affiliation
IRCCS Istituto Ortopedico Galeazzi
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Istituto Ortopedico Galeazzi
City
Milan
ZIP/Postal Code
20161
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22124445
Citation
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.
Results Reference
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PubMed Identifier
23088702
Citation
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.
Results Reference
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PubMed Identifier
22249349
Citation
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.
Results Reference
background
PubMed Identifier
29154230
Citation
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.
Results Reference
background
PubMed Identifier
24819349
Citation
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.
Results Reference
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Kinesio® Tex Taping for Post Total Knee Replacement Patients

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