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Effect of Kinesio® Taping in Total Knee Replacement Surgery

Primary Purpose

Knee Osteoarthritis, Post-Surgical Complication

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sterile Kinesio Taping
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Kinesiotape, Post-Surgical Functional Outcomes, Total Knee Replacement Surgery

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • to be volunteered to participate in the study.
  • It will be performed in patients who have stage 3-4 osteoarthritis according to the "Kellgren-Lawrence" classification and therefore undergo total knee replacement surgery in a ligament-cutting design in the Department of Orthopedics and Traumatology of Baskent University Ankara Hospital.

Exclusion Criteria:

  • Patients who underwent total knee prosthesis surgery in a hinge-preserving and hinged design
  • Patients who underwent simultaneous bilateral total knee prosthesis surgery
  • Patients with lymphedema
  • Skin lesions at the place where the taping will be applied
  • Local sensitivity in the skin sensitivity test to be performed the day before the application
  • Chronic kidney failure patients
  • Patients with congestive heart failure
  • Patients with a body mass index of 30 and above
  • Patients who underwent surgery for pathological fractures
  • Patients who underwent total knee replacement revision surgery
  • Patients who had previously undergone high tibial osteotomy or unicondylar knee replacement surgery
  • Patients who underwent surgery due to traumatic arthrosis

Sites / Locations

  • Baskent University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group 1: Sterile Kinesio tape application

Group 2: Control group

Arm Description

The standard post-surgical protocol and sterile EDF kinesio-taping will be applied to this group. The clinical evaluation will be made on the 15th, 45th and 90th days; functional measurements will be taken. The follow-up period was determined as 3 months.

The standard post-surgical protocol applied in our clinic will be applied to Group 2. The clinical evaluation will be made on the 15th, 45th and 90th days; functional measurements will be taken. The follow-up period was determined as 3 months.

Outcomes

Primary Outcome Measures

Change from Baseline at 15th, 45th and 90th days in Pain
Visual analogue scale will be used for pain assessment in rest, activity and sleep. The patient will be asked to define the severity of pain in a 10 cm line, from 0 to 10. 0 means no pain and 10 means unbearable pain.
Change from Baseline at 15th, 45th and 90th days in Range of Motion Assessment
range of motion of knee flexion and extension will be measured with digital inclinometer
Change from Baseline at 15th, 45th and 90th days in Edema
edema will be made with measurement of the opposite extremity which will be compared with the tape measure

Secondary Outcome Measures

Change from Baseline at 15th, 45th and 90th days in Complications
Complications such as superficial-deep skin infection or allergic reaction will be evaluated.
Change from Baseline at 15th, 45th and 90th days in Functional Assessment of knee
Functional scores before and after surgery will be assessed with Knee Society Score. The Knee Society Score (KSS) has two components (knee and function scores), each of which is scored separately from 0 to 100, with higher values indicating better outcomes.
Change from Baseline at 15th, 45th and 90th days in Functional Assessment for osteoarthritis.
Functional scores before and after surgery will be assessed with Western Ontario and McMaster Universities Osteoarthritis Index Score. The Western Ontario and McMaster University Osteoarthritis Index (WOMAC) is a disease-specific, self administered, health measure developed to study patients with osteoarthritis in the hip or knee. The domains are pain, stiffness, physical function, social function and emotional function. Every question can be given five alternative answers, which means a total of 0-4 points. The maximum score in the Likert version is 20 points for pain, 8 for stiffness and 68 points for physical function. A maximum score of 100 points occurred when the patient had minimum pain, stiffness and optimal function.
Change from Baseline at 15th, 45th and 90th days in Thermographic measurement
Thermal changes in the skin will be assessed via a thermal camera at the knee region
Change from Baseline at 15th, 45th and 90th days in Inflammatory markers as Interleukin 6 (IL-6)
Inflammatory markers in the blood such as Interleukin 6 (IL-6) will be assessed. The reported values for IL-6 in the blood of healthy people vary between 0 and 43.5 pg/ml.
Change from Baseline at 15th, 45th and 90th days in Inflammatory markers as Sedimentation rate
Inflammatory markers in the blood such as Sedimentation rate, the rate at which they settle is measured as the number of millimeters of clear plasma present at the top of the column after one hour (mm/hr), will be assessed.
Change from Baseline at 15th, 45th and 90th days in Inflammatory markers as C-reactive protein (CRP)
Inflammatory markers in the blood such as C-reactive protein (CRP) will be assessed. CRP concentration is measured in mg/L
Change from Baseline at 15th, 45th and 90th days in Inflammatory markers as Creatine Kinase (CK)
Inflammatory markers in the blood such as Creatine Kinase (CK) will be assessed. Normal range is 22 to 198 U/L (units per liter)

Full Information

First Posted
January 13, 2022
Last Updated
July 26, 2023
Sponsor
Baskent University
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1. Study Identification

Unique Protocol Identification Number
NCT05226195
Brief Title
Effect of Kinesio® Taping in Total Knee Replacement Surgery
Official Title
The Effect of Kinesio® Taping on Post-Surgical Functional Outcomes in Patients Undergoing Total Knee Replacement Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 13, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent 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
Total knee replacement, which is the gold standard surgical treatment method applied in today's conditions, in order to maintain the patient's daily life without pain, to provide the knee joint range of motion, to eliminate the deformity and instability in the knee joint in advanced stage (Stage 3-4) knee osteoarthritis (OA) that does not benefit from conservative treatment. Obtaining the best clinical outcome for the patient after surgery is only possible with the implementation of post-surgical physical therapy and rehabilitation programs. Edema and pain occurring in the early post-surgical period prevent patients from moving freely, and as a result, the psychological state of the patients is also affected. With effective physiotherapy, besides relieving pain and edema, patients' sensorimotor performances, proprioceptive senses and body balances are restored, and thus the brain is taught how to maintain joint functions. For this reason, new physiotherapy methods are being developed every day for this purpose. "Kinesio Taping" (KT) is one of the modern physiotherapy methods that has been widely used in sports orthopedics in recent years. It was developed by Kenzo Kase in 1973 and is used clinically to relieve pain and edema, and to increase motor function in musculoskeletal diseases. In this method, an adhesive cotton-based tape called kinesio tape is used. The elastic structure of this band, which allows it to extend 130-140% of its original length, similar to the skin, together with its three-dimensional "fingerprint" texture specific to the band, causes the formation of microfolds on the skin. The formation of these folds; It is known that it increases the proprioceptive perception of the related joint by stimulating skin mechanoreceptors. It also reduces the pressure under the skin and helps relieve pain by increasing lymphatic drainage. The Epidermis-Dermis-Fascia (EDF) taping method is a KB method that has been developed in recent years. It provides less tension and is more easily applied to painful areas. The narrow strips of the applied tape provide more stimulation in the most superficial tissues5. Although studies on the effect of other application methods on rehabilitation after knee replacement surgery are available in the literature, there is no study in the literature showing the effects of the EDF technique. In this study, it is aimed to evaluate the effect of KT applied with EDF technique on clinical results in the early postoperative period in patients who have undergone total knee replacement surgery. The hypothesis of this study is; It was determined that "pain and edema decrease and functional gain increases in patients who underwent KT after total knee prosthesis surgery".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Post-Surgical Complication
Keywords
Kinesiotape, Post-Surgical Functional Outcomes, Total Knee Replacement Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized controlled clinical trial
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Sterile Kinesio tape application
Arm Type
Experimental
Arm Description
The standard post-surgical protocol and sterile EDF kinesio-taping will be applied to this group. The clinical evaluation will be made on the 15th, 45th and 90th days; functional measurements will be taken. The follow-up period was determined as 3 months.
Arm Title
Group 2: Control group
Arm Type
No Intervention
Arm Description
The standard post-surgical protocol applied in our clinic will be applied to Group 2. The clinical evaluation will be made on the 15th, 45th and 90th days; functional measurements will be taken. The follow-up period was determined as 3 months.
Intervention Type
Other
Intervention Name(s)
Sterile Kinesio Taping
Intervention Description
The standard post-surgical protocol and sterile EDF kinesio-taping will be applied to this group in the operating room at the end of the surgery in a sterile manner according to the epidermis-dermis-fascia (EDF) technique previously described in the literature (without tension). Original KinesioTex® Tape will be used in the study. The day of taping will be considered as Day 0 and the tapes will be changed on the 4th day, the 7th day.
Primary Outcome Measure Information:
Title
Change from Baseline at 15th, 45th and 90th days in Pain
Description
Visual analogue scale will be used for pain assessment in rest, activity and sleep. The patient will be asked to define the severity of pain in a 10 cm line, from 0 to 10. 0 means no pain and 10 means unbearable pain.
Time Frame
The clinical evaluation will be made on the 15th, 45th and 90th days
Title
Change from Baseline at 15th, 45th and 90th days in Range of Motion Assessment
Description
range of motion of knee flexion and extension will be measured with digital inclinometer
Time Frame
The evaluation will be made on the 15th, 45th and 90th days
Title
Change from Baseline at 15th, 45th and 90th days in Edema
Description
edema will be made with measurement of the opposite extremity which will be compared with the tape measure
Time Frame
The evaluation will be made on the 15th, 45th and 90th days
Secondary Outcome Measure Information:
Title
Change from Baseline at 15th, 45th and 90th days in Complications
Description
Complications such as superficial-deep skin infection or allergic reaction will be evaluated.
Time Frame
The evaluation will be made on the 15th, 45th and 90th days
Title
Change from Baseline at 15th, 45th and 90th days in Functional Assessment of knee
Description
Functional scores before and after surgery will be assessed with Knee Society Score. The Knee Society Score (KSS) has two components (knee and function scores), each of which is scored separately from 0 to 100, with higher values indicating better outcomes.
Time Frame
The evaluation will be made on the 15th, 45th and 90th days
Title
Change from Baseline at 15th, 45th and 90th days in Functional Assessment for osteoarthritis.
Description
Functional scores before and after surgery will be assessed with Western Ontario and McMaster Universities Osteoarthritis Index Score. The Western Ontario and McMaster University Osteoarthritis Index (WOMAC) is a disease-specific, self administered, health measure developed to study patients with osteoarthritis in the hip or knee. The domains are pain, stiffness, physical function, social function and emotional function. Every question can be given five alternative answers, which means a total of 0-4 points. The maximum score in the Likert version is 20 points for pain, 8 for stiffness and 68 points for physical function. A maximum score of 100 points occurred when the patient had minimum pain, stiffness and optimal function.
Time Frame
The evaluation will be made on the 15th, 45th and 90th days
Title
Change from Baseline at 15th, 45th and 90th days in Thermographic measurement
Description
Thermal changes in the skin will be assessed via a thermal camera at the knee region
Time Frame
The evaluation will be made on the 15th, 45th and 90th days
Title
Change from Baseline at 15th, 45th and 90th days in Inflammatory markers as Interleukin 6 (IL-6)
Description
Inflammatory markers in the blood such as Interleukin 6 (IL-6) will be assessed. The reported values for IL-6 in the blood of healthy people vary between 0 and 43.5 pg/ml.
Time Frame
The evaluation will be made on the 15th, 45th and 90th days
Title
Change from Baseline at 15th, 45th and 90th days in Inflammatory markers as Sedimentation rate
Description
Inflammatory markers in the blood such as Sedimentation rate, the rate at which they settle is measured as the number of millimeters of clear plasma present at the top of the column after one hour (mm/hr), will be assessed.
Time Frame
The evaluation will be made on the 15th, 45th and 90th days
Title
Change from Baseline at 15th, 45th and 90th days in Inflammatory markers as C-reactive protein (CRP)
Description
Inflammatory markers in the blood such as C-reactive protein (CRP) will be assessed. CRP concentration is measured in mg/L
Time Frame
The evaluation will be made on the 15th, 45th and 90th days
Title
Change from Baseline at 15th, 45th and 90th days in Inflammatory markers as Creatine Kinase (CK)
Description
Inflammatory markers in the blood such as Creatine Kinase (CK) will be assessed. Normal range is 22 to 198 U/L (units per liter)
Time Frame
The evaluation will be made on the 15th, 45th and 90th days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: to be volunteered to participate in the study. It will be performed in patients who have stage 3-4 osteoarthritis according to the "Kellgren-Lawrence" classification and therefore undergo total knee replacement surgery in a ligament-cutting design in the Department of Orthopedics and Traumatology of Baskent University Ankara Hospital. Exclusion Criteria: Patients who underwent total knee prosthesis surgery in a hinge-preserving and hinged design Patients who underwent simultaneous bilateral total knee prosthesis surgery Patients with lymphedema Skin lesions at the place where the taping will be applied Local sensitivity in the skin sensitivity test to be performed the day before the application Chronic kidney failure patients Patients with congestive heart failure Patients with a body mass index of 30 and above Patients who underwent surgery for pathological fractures Patients who underwent total knee replacement revision surgery Patients who had previously undergone high tibial osteotomy or unicondylar knee replacement surgery Patients who underwent surgery due to traumatic arthrosis
Facility Information:
Facility Name
Baskent University
City
Ankara
ZIP/Postal Code
06810
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effect of Kinesio® Taping in Total Knee Replacement Surgery

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