- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05847725
Effects of Bandaging and Kinesiotaping® in Patients With Total Knee Arthroplasty
May 7, 2023 updated by: Gursoy Coskun, Hacettepe University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Elastic bandaging
Patients who have undergone TKA for primary knee OA
|
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.
|
|
Experimental: Short stretch bandaging
Patients who have undergone TKA for primary knee OA
|
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.
|
|
Experimental: Kinesio taping
Patients who have undergone TKA for primary knee OA
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: up to sixth weeks
|
Pain intensity, Minumum score 0: no pain, maximum score 10: worst pain
|
up to sixth weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measuring Tape Measure
Time Frame: up to sixth weeks
|
Edema
|
up to sixth weeks
|
|
The Knee Society Clinical Scoring System
Time Frame: up to sixth weeks
|
Functional level assessment, maximum score 100, <60 poor, 60-69 average, 70-84 good, 85-100 excellent
|
up to sixth weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gürsoy Coşkun, Assoc. Prof, Hacettepe University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2015
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
April 1, 2023
First Submitted That Met QC Criteria
April 27, 2023
First Posted (Actual)
May 8, 2023
Study Record Updates
Last Update Posted (Actual)
May 9, 2023
Last Update Submitted That Met QC Criteria
May 7, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HU-15/666-21
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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