Kinesiotape for Edema After Bilateral Total Knee Arthroplasty

NCT05013879 | Completed

• 1 other identifier: 2021-13203
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty Complications; Arthroplasty, Replacement, Knee

Keywords

edema; arthroplasty, knee, bilateral; kinesiotaping

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from baseline and day-to-day changes of bilateral knee pain on numerical pain rating scale

  During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8

• Change from baseline and during 1-2-day time intervals for bilateral knee range of motion

  During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8

• Change from baseline to Day 4 to Discharge Day for selected parts of the Knee Injury and Osteoarthritis Outcome Score (KOOS) self-report

  At start of study, 4 days after start of study, and day 8

• Change from baseline and during 1-2-day time intervals for Timed Up-and-Go Test

  During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8

Study Arms (2)

Kinesiotape leg plus standard rehabilitation

EXPERIMENTAL

Kinesio(R)Tape for edema management applied to a randomly selected lower extremity plus standard inpatient rehabilitation after bilateral total knee arthroplasty

Device: Kinesio(R)Tape for edema control

Control leg with standard rehabilitation alone

NO INTERVENTION

Control leg receiving standard inpatient rehabilitation alone.

Interventions

Kinesio(R)Tape for edema control DEVICE

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.

Also known as: kinesiotaping or kinesiological taping

Kinesiotape leg plus standard rehabilitation

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• admitted to Burke Rehabilitation Hospital for inpatient rehabilitation within 5 days after same-day or staged bilateral total knee arthroplasty;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Burke Rehabilitation Hospital: collaborator

Study Sites (1)

Burke Rehabilitation Hospital

White Plains, New York, 10605, United States

Location

Related Publications (11)

• 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.

  PMID: 32459670 BACKGROUND

• 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.

  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.

  PMID: 24819349 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 30208939 BACKGROUND

• 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.

  PMID: 26223312 BACKGROUND

• 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.

  PMID: 30341552 BACKGROUND

• 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.

  PMID: 23948839 BACKGROUND

• 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.

  PMID: 29075347 BACKGROUND

• 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.

  PMID: 22840304 BACKGROUND

• DalCeredo C, LaCava J, Young R, Conklin K, Herbold J, Simsuangco C, Inostroza Millas F, Sokolow Z, Babyar S. Effectiveness of kinesiotaping for lymphatic drainage after bilateral total knee arthroplasty: A randomized controlled trial. Medicine (Baltimore). 2025 Apr 11;104(15):e41971. doi: 10.1097/MD.0000000000041971.

  PMID: 40228285 DERIVED

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Suzanne Babyar, PT, PhD

  Burke Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Repeated measures with two within-subjects factors: time and taped/untaped leg

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 19, 2021
• Study Start: October 18, 2021
• Primary Completion: November 24, 2023
• Study Completion: November 24, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)