Clinical trial NCT03681106: 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
Overall status: TERMINATED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
Total Knee Arthroplasty
Kinesiotaping
Neuro taping
Rehabilitation
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 71
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Knee circumference
timeFrame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Secondary outcomes:
measure: Timed Up and Go test
timeFrame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
measure: 10 meters walking test
timeFrame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
measure: Barthel Index
timeFrame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
measure: Functional Independence Measure
timeFrame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
measure: Knee range of motion
timeFrame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
measure: Thigh circumference
timeFrame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
measure: Leg circumference
timeFrame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
measure: Ankle circumference
timeFrame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
measure: Pain Visual Analogue Scale
timeFrame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
measure: R0 measured using bioimpedance
timeFrame: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
affiliation: IRCCS Istituto Ortopedico Galeazzi
name: Francesco Negrini, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.