Kinesiotape for Edema After Bilateral Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Arthroplasty Complications, Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Device: Kinesio(R)Tape for edema control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Repeated measures with two within-subjects factors: time and taped/untaped leg
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kinesiotape leg plus standard rehabilitation<br>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<br>* 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.<br>* Other names: kinesiotaping or kinesiological taping;|
| No Intervention: Control leg with standard rehabilitation alone<br>Control leg receiving standard inpatient rehabilitation alone. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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edema, arthroplasty, knee, bilateral, kinesiotaping