Knee Osteoarthritis Clinical Trial
Official title:
Efficacy of Kinesio® Tex Taping on Edema and Early Functional Outcome of Post Total Knee Replacement Patients: a Randomized-controlled Trial
Verified date | March 2021 |
Source | Istituto Ortopedico Galeazzi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 71 |
Est. completion date | February 18, 2020 |
Est. primary completion date | February 18, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 85 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Istituto Ortopedico Galeazzi | Milan |
Lead Sponsor | Collaborator |
---|---|
Istituto Ortopedico Galeazzi |
Italy,
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. Review. — View Citation
Donec V, Krišciunas A. The effectiveness of Kinesio Taping® 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. — View Citation
Morris D, Jones D, Ryan H, Ryan CG. The clinical effects of Kinesio® Tex taping: A systematic review. Physiother Theory Pract. 2013 May;29(4):259-70. doi: 10.3109/09593985.2012.731675. Epub 2012 Oct 22. Review. — View 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. Review. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Timed Up and Go test | Functional test | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day | |
Secondary | 10 meters walking test | Functional test | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day | |
Secondary | Barthel Index | Autonomy outcome | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day | |
Secondary | Functional Independence Measure | Autonomy outcome | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day | |
Secondary | 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 | |
Secondary | Thigh circumference | Thigh circumference expressed in cm | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day | |
Secondary | Leg circumference | Leg circumference expressed in cm | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day | |
Secondary | Ankle circumference | Ankle circumference expressed in cm | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day | |
Secondary | 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 | |
Secondary | R0 measured using bioimpedance | body impedance | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04651673 -
Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
|
||
Completed |
NCT05677399 -
Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise.
|
N/A | |
Active, not recruiting |
NCT04043819 -
Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis
|
Phase 1 | |
Recruiting |
NCT06000410 -
A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee
|
Phase 3 | |
Completed |
NCT05014542 -
Needling Techniques for Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05892133 -
Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty
|
N/A | |
Recruiting |
NCT05528965 -
Parallel Versus Perpendicular Technique for Genicular Radiofrequency
|
N/A | |
Active, not recruiting |
NCT03472300 -
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
|
||
Active, not recruiting |
NCT02003976 -
A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone
|
N/A | |
Active, not recruiting |
NCT04017533 -
Stability of Uncemented Medially Stabilized TKA
|
N/A | |
Completed |
NCT04779164 -
The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT04006314 -
Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05423587 -
Genicular Artery Embolisation for Knee Osteoarthritis II
|
N/A | |
Enrolling by invitation |
NCT04145401 -
Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
|
||
Active, not recruiting |
NCT03781843 -
Effects of Genicular Nerve Block in Knee Osteoarthritis
|
N/A | |
Completed |
NCT05974501 -
Pre vs Post Block in Total Knee Arthroplasty (TKA)
|
Phase 4 | |
Completed |
NCT05324163 -
Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis
|
Phase 3 | |
Completed |
NCT05529914 -
Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05693493 -
Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA?
|
N/A | |
Not yet recruiting |
NCT05510648 -
Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis
|
N/A |