Clinical trial NCT05013879: Kinesiotape for Edema After Bilateral Total Knee Arthroplasty
Official title: Effect of Kinesiotaping on Edema Management, Pain and Function on Patients With Bilateral Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty Complications
Arthroplasty, Replacement, Knee
Keywords: edema
arthroplasty, knee, bilateral
kinesiotaping
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Burke Rehabilitation Hospital
First posted: 2021-08-19
Enrollment: 65
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Repeated measures with two within-subjects factors: time and taped/untaped leg
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if kinesiotaping for edema management will decrease post-operative edema in patients with bilateral total knee arthroplasty. The leg receiving kinesiotaping during inpatient rehabilitation may have decreased edema and pain and improved movement and function when compared to the leg not receiving kinesiotape.

Detailed description: After being informed about the study and potential risk, all patients undergoing inpatient rehabilitation after bilateral total knee arthroplasty will have Kinesio(R)Tape applied to one randomly selected leg while the other leg serves as a control. Measurement of bilateral leg circumference, knee range of motion, numerical rating scale for pain, and selected questions from the Knee Injury and Osteoarthritis Outcome Score will occur at regular intervals throughout the rehabilitation stay. Patients will receive standard rehabilitation.

Eligibility criteria: Inclusion Criteria:

* admitted to Burke Rehabilitation Hospital for inpatient rehabilitation within 5 days after same-day or staged bilateral total knee arthroplasty;
* 50-85 years of age;
* able to read and understand English or a hospital-provided translator when consenting for the study;
* free from contraindications for kinesiotaping (see below); and,
* able to tolerate an active rehabilitation program.

Exclusion Criteria:

* stage III or IV heart failure, stage III or IV renal failure;
* fragile, very hairy or sensitive skin;
* anesthesia or paraesthesia of any area of the lower extremity, except the surgical sites
* active skin rashes or infections or skin lesions in the lower extremity;
* prior history of allergic reactions to skin taping, bandaids, surgical tape; athletic tape or other skin-adhering electrode adhesives;
* prior history of lower extremity lymphedema;3
* prior history of lower extremity venous or arterial disease;
* post-operative complications in the surgical sites;4
* partial joint arthroplasty or revision arthroplasty of one or both knees;1,5
* inability to give informed consent offered in English or through a hospital-provided translator
* age less than 50 years or over 85 years;
* inability to tolerate an active rehabilitation program.

Primary outcomes:
measure: Change from baseline and during 1-2-day time intervals of circumferences of both knees and lower extremities
timeFrame: During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8
Secondary outcomes:
measure: Change from baseline and day-to-day changes of bilateral knee pain on numerical pain rating scale
timeFrame: During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8
measure: Change from baseline and during 1-2-day time intervals for bilateral knee range of motion
timeFrame: During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8
measure: Change from baseline to Day 4 to Discharge Day for selected parts of the Knee Injury and Osteoarthritis Outcome Score (KOOS) self-report
timeFrame: At start of study, 4 days after start of study, and day 8
measure: Change from baseline and during 1-2-day time intervals for Timed Up-and-Go Test
timeFrame: During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Burke Rehabilitation Hospital
state: New York
Study officials:
affiliation: Burke Rehabilitation Hospital
name: Suzanne Babyar, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tornatore L, De Luca ML, Ciccarello M, Benedetti MG. Effects of combining manual lymphatic drainage and Kinesiotaping on pain, edema, and range of motion in patients with total knee replacement: a randomized clinical trial. Int J Rehabil Res. 2020 Sep;43(3):240-246. doi: 10.1097/MRR.0000000000000417.
citation: Guney Deniz H, Kinikli GI, Onal S, Sevinc C, Caglar O, Yuksei I. Comparison of Kinesio Tape application and manual lymphatic drainage on lower extremity oedema and functions after total knee arthroplasty. [Abstract]. Ann Rheum Dis. 2018; 77: 1791.
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.
citation: Sulman M, Riaz S, Khan RR, Faisal Z, Rajput R, Noor M. Effectiveness of Kinesio Taping on pain and function after total knee arthroplasty. Pak J Med Health Sci. 2020;14:1267-1270.
citation: Oktas B, Vergili O. The effect of intensive exercise program and kinesiotaping following total knee arthroplasty on functional recovery of patients. J Orthop Surg Res. 2018 Sep 12;13(1):233. doi: 10.1186/s13018-018-0924-9.
citation: Alghadir A, Anwer S, Brismee JM. The reliability and minimal detectable change of Timed Up and Go test in individuals with grade 1-3 knee osteoarthritis. BMC Musculoskelet Disord. 2015 Jul 30;16:174. doi: 10.1186/s12891-015-0637-8.
citation: Hancock GE, Hepworth T, Wembridge K. Accuracy and reliability of knee goniometry methods. J Exp Orthop. 2018 Oct 19;5(1):46. doi: 10.1186/s40634-018-0161-5.
citation: Unver B, Ertekin O, Karatosun V. Pain, fear of falling and stair climbing ability in patients with knee osteoarthritis before and after knee replacement: 6 month follow-up study. J Back Musculoskelet Rehabil. 2014;27(1):77-84. doi: 10.3233/BMR-130422.
citation: Bakar Y, Ozdemir OC, Sevim S, Duygu E, Tugral A, Surmeli M. Intra-observer and inter-observer reliability of leg circumference measurement among six observers: a single blinded randomized trial. J Med Life. 2017 Jul-Sep;10(3):176-181.
citation: Collins NJ, Roos EM. Patient-reported outcomes for total hip and knee arthroplasty: commonly used instruments and attributes of a "good" measure. Clin Geriatr Med. 2012 Aug;28(3):367-94. doi: 10.1016/j.cger.2012.05.007. Epub 2012 Jun 22.