Study 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.
Kinesio® Tex Taping for Post Total Knee Replacement Patients
Efficacy of Kinesio® Tex Taping on Edema and Early Functional Outcome of Post Total Knee Replacement Patients: a Randomized-controlled Trial
1 other identifier
interventional
71
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable knee-osteoarthritis
Started May 2018
Typical duration for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 14, 2018
CompletedFirst Submitted
Initial submission to the registry
September 20, 2018
CompletedFirst Posted
Study publicly available on registry
September 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2020
CompletedApril 1, 2021
March 1, 2021
1.8 years
September 20, 2018
March 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Knee circumference
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 Outcomes (10)
Timed Up and Go test
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
10 meters walking test
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Barthel Index
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Functional Independence Measure
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Knee range of motion
pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
- +5 more secondary outcomes
Study Arms (2)
Kinesiotape
EXPERIMENTALKinesio Tex taping treatment for 10 days + usual care
Control
NO INTERVENTIONusual care
Interventions
Eligibility Criteria
You may qualify if:
- Program of total knee replacement;
- Signing and accepting informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Istituto Ortopedico Galeazzi
Milan, 20161, Italy
Related Publications (5)
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.
PMID: 22124445BACKGROUNDMorris 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.
PMID: 23088702BACKGROUNDBade 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.
PMID: 22249349BACKGROUNDWozniak-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.
PMID: 29154230BACKGROUNDDonec 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.
PMID: 24819349BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Negrini, MD
IRCCS Istituto Ortopedico Galeazzi
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2018
First Posted
September 21, 2018
Study Start
May 14, 2018
Primary Completion
February 18, 2020
Study Completion
February 18, 2020
Last Updated
April 1, 2021
Record last verified: 2021-03