Kinesiotape for Edema After Bilateral Total Knee Arthroplasty

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

Effect of Kinesiotaping on Edema Management, Pain and Function on Patients With Bilateral Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05013879
• Other study ID #: 2021-13203
• Status: Completed
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: November 24, 2023

Study information

• Verified date: February 2024
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 24, 2023
• Est. primary completion date: November 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty Complications
• Arthroplasty, Replacement, Knee
• Edema

Intervention

Device:
• Kinesio(R)Tape for edema control
Kinesio(R)Tape is an elastic, cotton tape with an adhesive backing. When applied for edema management, strips of Kinesio(R)Tape are applied to the lower leg in a criss-cross fashion by a physical therapist who is a Certified Kinesiotape Practitioner.

Locations

Country	Name	City	State
United States	Burke Rehabilitation Hospital	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	Burke Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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.

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. — View 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. — View 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.

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline and during 1-2-day time intervals of circumferences of both knees and lower extremities	Bilateral circumferences, in centimeters, at the following points: 10 cm above the superior pole of the patella; middle of the knee joint; calf circumference at the broadest part of the calf and at 3 inches below the fibular head landmark; figure of eight method for foot and ankle circumference - a measurement from the lateral malleolus to the navicular tuberosity, under the plantar aspect of the foot towards the tuberosity of the fifth metatarsal, around to the medial malleolus, and posterior to the leg to return to the lateral malleolus.	During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8
Secondary	Change from baseline and day-to-day changes of bilateral knee pain on numerical pain rating scale	Patient self-report: Pain rating for each leg on a integer scale of 0 (no pain) to 10 (worst pain imaginable)	During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8
Secondary	Change from baseline and during 1-2-day time intervals for bilateral knee range of motion	Physical therapist's measurement of active and active assistive knee range of motion (degrees) for flexion and extension using a standard goniometer	During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8
Secondary	Change from baseline to Day 4 to Discharge Day for selected parts of the Knee Injury and Osteoarthritis Outcome Score (KOOS) self-report	Patient self-report using the KOOS sections relating to pain, stiffness, activities of daily living	At start of study, 4 days after start of study, and day 8
Secondary	Change from baseline and during 1-2-day time intervals for Timed Up-and-Go Test	Time (sec) to rise from a seated position, walk 10 m, turn, walk back to seat, and sit down. Patient will use appropriate assistive device and have appropriate guarding by a physical therapist.	During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8