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Effects of Bandaging and Kinesiotaping® in Patients With Total Knee Arthroplasty

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Elastic bandaging
Short stretch bandaging
Kinesio taping
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Knee Osteoarthritis focused on measuring knee arthroplasty, edema, elastic bandages, short stretch bandages, kinesio tape

Eligibility Criteria

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

Inclusion Criteria: 60 years or older patients who had undergone unilateral TKA surgery for primary knee osteoarthritis, rheumatoid arthritis, and posttraumatic arthritis. Exclusion Criteria: Body mass index greater than or equal to 35 kg/m2, Having a neurological or peripheral vascular disease, Having a contraindication condition for compression application (e.g., acute cellulitis, arterial insufficiency, unstable heart disease, acute deep vein thrombosis), and kinesio taping application (e.g., presence of active infectious, lymphedema and/ or cancer history)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Elastic bandaging

    Short stretch bandaging

    Kinesio taping

    Arm Description

    Patients who have undergone TKA for primary knee OA

    Patients who have undergone TKA for primary knee OA

    Patients who have undergone TKA for primary knee OA

    Outcomes

    Primary Outcome Measures

    Visual Analogue Scale
    Pain intensity, Minumum score 0: no pain, maximum score 10: worst pain

    Secondary Outcome Measures

    Measuring Tape Measure
    Edema
    The Knee Society Clinical Scoring System
    Functional level assessment, maximum score 100, <60 poor, 60-69 average, 70-84 good, 85-100 excellent

    Full Information

    First Posted
    April 1, 2023
    Last Updated
    May 7, 2023
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05847725
    Brief Title
    Effects of Bandaging and Kinesiotaping® in Patients With Total Knee Arthroplasty
    Official Title
    Effects of Bandaging and Kinesiotaping® on Pain, Edema, and Functional Level in Patients With Total Knee Arthroplasty in the Early Postoperative Period: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (Actual)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hacettepe University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study aimed to compare the effectiveness of elastic bandaging, Kinesio taping, and short stretch bandaging techniques on postoperative pain, edema, and functional level in the early stage after total knee arthroplasty.
    Detailed Description
    The study was conducted on 30 volunteer subjects who underwent unilateral total knee arthroplasty surgery. Thirty participants who underwent unilateral total knee arthroplasty were divided into the Elastic Bandage Group (n=10), Kinesio Tape group (n=10), and Short Stretch Bandage group (n=10). All treatments were stopped on the eighth day. All measurements taken preoperatively were repeated postoperative 1st, 3rd, 5th, 8th, 14th, 28th days, 6th week, and 3rd month. The functional level was measured in the sixth week and third month.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    knee arthroplasty, edema, elastic bandages, short stretch bandages, kinesio tape

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The study included a three parallel group of blinded evaluators. These cases were followed up with a planned follow-up program between preoperative and postoperative three months.
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Elastic bandaging
    Arm Type
    Experimental
    Arm Description
    Patients who have undergone TKA for primary knee OA
    Arm Title
    Short stretch bandaging
    Arm Type
    Experimental
    Arm Description
    Patients who have undergone TKA for primary knee OA
    Arm Title
    Kinesio taping
    Arm Type
    Experimental
    Arm Description
    Patients who have undergone TKA for primary knee OA
    Intervention Type
    Other
    Intervention Name(s)
    Elastic bandaging
    Intervention Description
    The bandages were wrapped circularly along the extremity from the toes to the groin, drawing an "8" at the ankle with a 50% overlap rate, starting with 80% tension and decreasing the pressure proximally.
    Intervention Type
    Other
    Intervention Name(s)
    Short stretch bandaging
    Intervention Description
    Short tension bandage application was started on postoperative day 1 following the removal of the drains. According to the width of the extremity, using short tension bandages of 6, 8 and 10 cm width, starting from the sole of the foot, the first layer was wrapped circularly with 50% overlapping rate, 80% tension, and wrapped from the sole of the foot to the groin.
    Intervention Type
    Other
    Intervention Name(s)
    Kinesio taping
    Intervention Description
    Kinesio taping was applied in the form of a fan by cutting into 4 longitudinal pieces using the lymphatic correction technique with 15-20% tension, starting from the periphery of the inguinal lymph nodes on the medial, anterior and lateral of the leg, following the removal of the drains from the 1st post-op day.
    Primary Outcome Measure Information:
    Title
    Visual Analogue Scale
    Description
    Pain intensity, Minumum score 0: no pain, maximum score 10: worst pain
    Time Frame
    up to sixth weeks
    Secondary Outcome Measure Information:
    Title
    Measuring Tape Measure
    Description
    Edema
    Time Frame
    up to sixth weeks
    Title
    The Knee Society Clinical Scoring System
    Description
    Functional level assessment, maximum score 100, <60 poor, 60-69 average, 70-84 good, 85-100 excellent
    Time Frame
    up to sixth weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 60 years or older patients who had undergone unilateral TKA surgery for primary knee osteoarthritis, rheumatoid arthritis, and posttraumatic arthritis. Exclusion Criteria: Body mass index greater than or equal to 35 kg/m2, Having a neurological or peripheral vascular disease, Having a contraindication condition for compression application (e.g., acute cellulitis, arterial insufficiency, unstable heart disease, acute deep vein thrombosis), and kinesio taping application (e.g., presence of active infectious, lymphedema and/ or cancer history)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gürsoy Coşkun, Assoc. Prof
    Organizational Affiliation
    Hacettepe University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of Bandaging and Kinesiotaping® in Patients With Total Knee Arthroplasty

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