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Kinesiotape for Edema After Bilateral Total Knee Arthroplasty

Primary Purpose

Arthroplasty Complications, Arthroplasty, Replacement, Knee

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Kinesio(R)Tape for edema control

About this trial

This is an interventional treatment trial for Arthroplasty Complications focused on measuring edema, arthroplasty, knee, bilateral, kinesiotaping

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 75 years;
inability to tolerate an active rehabilitation program.

Sites / Locations

Burke Rehabilitation HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Kinesiotape leg plus standard rehabilitation

Control leg with standard rehabilitation alone

Arm Description

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

Control leg receiving standard inpatient rehabilitation alone.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

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

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

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.

Full Information

NCT ID

NCT05013879

First Posted

August 2, 2021

Last Updated

October 12, 2023

Sponsor

Montefiore Medical Center

Collaborators

Burke Rehabilitation Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05013879

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 18, 2021 (Actual)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Montefiore Medical Center

Collaborators

Burke Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthroplasty Complications, Arthroplasty, Replacement, Knee

Keywords

edema, arthroplasty, knee, bilateral, kinesiotaping

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Kinesiotape leg plus standard rehabilitation

Arm Type

Experimental

Arm Description

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

Arm Title

Control leg with standard rehabilitation alone

Arm Type

No Intervention

Arm Description

Control leg receiving standard inpatient rehabilitation alone.

Intervention Type

Device

Intervention Name(s)

Kinesio(R)Tape for edema control

Other Intervention Name(s)

kinesiotaping or kinesiological taping

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from baseline and during 1-2-day time intervals of circumferences of both knees and lower extremities

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Patient self-report: Pain rating for each leg on a integer scale of 0 (no pain) to 10 (worst pain imaginable)

Time Frame

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

Title

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

Description

Physical therapist's measurement of active and active assistive knee range of motion (degrees) for flexion and extension using a standard goniometer

Time Frame

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

Title

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

Description

Patient self-report using the KOOS sections relating to pain, stiffness, activities of daily living

Time Frame

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

Title

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

Description

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.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Suzanne Babyar, PT, PhD

Phone

914-597-2839

sbabyar@burke.org

First Name & Middle Initial & Last Name or Official Title & Degree

Janet Herbold, PT, PhD, MPH

Phone

914-597-2357

jherbold@burke.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suzanne Babyar, PT, PhD

Organizational Affiliation

Burke Rehabilitation Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Burke Rehabilitation Hospital

City

White Plains

State/Province

New York

ZIP/Postal Code

10605

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Janet Herbold, PT, PhD, MPH

Phone

914-597-2357

jherbold@burke.org

First Name & Middle Initial & Last Name & Degree

Suzanne Babyar, PT, PhD

Phone

914-597-2839

sbabyar@burke.org

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32459670

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.

Results Reference

background

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.

Results Reference

background

PubMed Identifier

24819349

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.

Results Reference

background

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.

Results Reference

background

PubMed Identifier

30208939

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.

Results Reference

background

PubMed Identifier

26223312

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.

Results Reference

background

PubMed Identifier

30341552

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.

Results Reference

background

PubMed Identifier

23948839

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.

Results Reference

background

PubMed Identifier

29075347

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.

Results Reference

background

PubMed Identifier

22840304

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.

Results Reference

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Kinesiotape for Edema After Bilateral Total Knee Arthroplasty

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