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Completed

NCT Number: NCT05013879

Kinesiotape for Edema After Bilateral Total Knee Arthroplasty

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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Burke Rehabilitation Hospital

White Plains, New York, 10605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: kinesiotaping or kinesiological taping

Primary outcomes

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

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

    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 outcomes

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

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

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

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

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

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

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

    Time frame: At start of study, 4 days after start of study, and day 8

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

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

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

    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.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Burke Rehabilitation Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 19, 2021
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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