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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kinesiotape | Experimental | Kinesio Tex taping treatment for 10 days + usual care |
|
| Control | No Intervention | usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kinesio Tex | Device | Kinesio Tex tape on the operated limb |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Timed Up and Go test | Functional test | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day |
| 10 meters walking test | Functional test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Negrini, MD | IRCCS Istituto Ortopedico Galeazzi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto Ortopedico Galeazzi | Milan | 20161 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22124445 | Background | 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. | |
| 23088702 | Background | 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. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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.
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| pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day |
| Barthel Index | Autonomy outcome | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day |
| Functional Independence Measure | Autonomy outcome | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day |
| Knee range of motion | 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 | Thigh circumference expressed in cm | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day |
| Leg circumference | Leg circumference expressed in cm | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day |
| Ankle circumference | Ankle circumference expressed in cm | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day |
| 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. | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day |
| R0 measured using bioimpedance | body impedance | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day |
| 22249349 | Background | 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. |
| 29154230 | Background | 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. |
| 24819349 | Background | 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. |
| D012216 |
| Rheumatic Diseases |