search
Back to results

The Efficacy of Kinesiotaping on Pain, Edema and Functionality After Total Knee Arthroplasty

Primary Purpose

Knee Arthroplasty, Pain, Edema

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
kinesio tape
Sham taping
Exercise
Sponsored by
Kirsehir Ahi Evran Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthroplasty focused on measuring knee arthroplasty, kinesiotaping

Eligibility Criteria

40 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Performing total knee joint arthroplasty due to stage 4 gonarthrosis
  2. Agree to participate in the study
  3. Having signed the informed consent form

Exclusion Criteria:

  1. Presence of malignancy, infection, rheumatological disease
  2. Having a tape allergy
  3. Having a diagnosis of lymphedema

Sites / Locations

  • Ahievran university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Other

Arm Label

kinesiology group

sham taping group

only physical therapy group(control group)

Arm Description

In the group receiving kinesiology treatment, kinesiotaping is applied to the sub-knee region in accordance with the lymphatic correction technique from the first postoperative day to reduce edema and pain. Accordingly, the proximal part of the tape is placed close to the lymph node. In our study, as stated in the literature, the proximal part of the tape will be adhered to the fibular head area next to the lymph nodes without applying any stretching. Then 5-10% stretching is applied and the distal part is adhered. 2 separate bands are applied so that the strips cross each other (from the medial and lateral of the knee). On the first postoperative day, on the third day, the patients will be taped with kinesio tape and discharged on the fourth day. After discharge, they will be asked to remove the tapes after 3 days as they were taught.

Sham application will be taped with a plaster from the same area on the same days as the kinesio application. No tension will be applied while taping. The difference of the plaster from the kinesiotape is that it does not contain tension and does not allow stretching.

Conservative will be explained on the second day after the operation. Go for a visit with a local cold application 20 times once a day. Ankle pumping exercises, deep breathing exercises, isometric and hip exercises will be planned with a load that can be applied to students who are being applied for bed training. Increased the number and allowance of exercises; isotonic knee and exercises that make you feel It will be added. You will be discharged on the 4th day after the surgery on the 2nd or 3rd day. You will do home exercises after discharge. On the 10th day, you will be called for control.

Outcomes

Primary Outcome Measures

edema
thigh, knee and leg diameter measurements to be measured with a tape measure
edema
thigh, knee and leg diameter measurements to be measured with a tape measure
edema
thigh, knee and leg diameter measurements to be measured with a tape measure
edema
thigh, knee and leg diameter measurements to be measured with a tape measure

Secondary Outcome Measures

Pain Intensity
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Pain Intensity
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Pain Intensity
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Pain Intensity
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.

Full Information

First Posted
July 3, 2022
Last Updated
February 22, 2023
Sponsor
Kirsehir Ahi Evran Universitesi
search

1. Study Identification

Unique Protocol Identification Number
NCT05457686
Brief Title
The Efficacy of Kinesiotaping on Pain, Edema and Functionality After Total Knee Arthroplasty
Official Title
The Efficacy of Kinesiology Taping After Total Knee Arthroplasty Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 14, 2022 (Actual)
Primary Completion Date
February 12, 2023 (Actual)
Study Completion Date
February 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran Universitesi

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
In this prospective, randomized controlled trial; To evaluate the effect of kinesiology taping applied for edema on pain, edema and functions in the early period after total knee replacement.Patients who underwent total knee replacement will be included in the 10-day follow-up study.Patients will be divided into three groups by randomization. A conservative postoperative physiotherapy program, which is routinely applied to all groups, will be applied. Thus, no patient will be left without treatment. The first group will be considered as the control group, which will be given only a conservative physiotherapy program. In addition to the conservative postoperative physiotherapy program, the 2nd group will be taped without applying tension with a plaster and will be considered as the sham group. In the third group, in addition to the conservative postoperative physiotherapy program, kinesiotaping for payment will be applied.
Detailed Description
Patients will be divided into three groups by randomization. A conservative postoperative physiotherapy program, which is routinely applied to all groups, will be applied. Thus, no patient will be left without treatment. The first group will be considered as the control group, which will be given only a conservative physiotherapy program. In addition to the conservative postoperative physiotherapy program, the 2nd group will be taped without applying tension with a plaster and will be considered as the sham group. In the third group, in addition to the conservative postoperative physiotherapy program, kinesiotaping for payment will be applied. It is planned to prevent bias between the groups by giving standard analgesic treatment to all three groups in the postoperative period. In the postoperative period, Paracetamol 10 mg/ml Infusion 3*1, 100 mg tramadol hydrochloride tablet 2*1 and celecoxib capsule 100 mg 2*1 will be routinely administered until the discharge period. Conservative postoperative physiotherapy program: Conservative exercise program will be started on the second day after the surgery. All patients will receive an exercise program combined with a 20-minute local cold application once a day. Ankle pumping exercises, deep breathing exercises, isometric knee and hip circumference strengthening exercises, sitting by the bed, timed walking with a tolerable load on the prosthetic side will be recommended. The number and frequency of exercises were gradually increased; isotonic knee and hip circumference strengthening exercises It will be added. After the drainage of the surgical wound is removed on the 2nd or 3rd day, the patients will be discharged on the 4th postoperative day. All patients will be informed about the conditions and activities that need attention. Patients who continue their home exercise program after discharge will be called for control on the 10th day. Kinesio taping: In addition to its use in regional pain syndromes in recent years, KT application has also been reported in the literature after various non-orthopedic surgical procedures . Today, after KT application, which is widely used in orthopedics, especially in arthroscopic interventions, no negative effects have been observed on patients, and positive results have been reported, especially in the early period. The investigators aimed to compare this treatment method, which has been shown to be effective in studies performed after total knee arthroplasty, with SHAM taping and conservative postoperative physiotherapy program control group in a prospective randomized comparison. Kinesiotaping is applied to the sub-knee region in accordance with the lymphatic correction technique in order to reduce edema and pain from the first postoperative day in the group receiving KT treatment.Accordingly, the proximal part of the tape will be placed close to the lymph node.In our study, as stated in the literature, the proximal part of the tape will be adhered to the fibular head area next to the lymph nodes without applying any stretching.Then 5-10% stretching is applied and the distal part is adhered. The strips are applied as 2 separate bands crossing each other (from the medial and lateral of the knee).The patients will be taped with kinesio tape on the first day and the third day postoperatively, and they will be discharged on the fourth day. After discharge, participant will be asked to remove the bands after 3 days as instructed. SHAM taping: Sham application will be taped with a plaster from the same area on the same days as the kinesio application. No tension will be applied while taping. The difference of the plaster from the kinesiotape is that it does not contain tension and does not allow stretching. Kinesiotaping application; It will be done by a physical therapist who has a kinesiology taping course certificate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthroplasty, Pain, Edema
Keywords
knee arthroplasty, kinesiotaping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled study
Masking
ParticipantOutcomes Assessor
Masking Description
This study was designed as blinded, randomized and controlled.the person who evaluates the patients before and after the treatment is blind.In other words,the person evaluating the patients and the person giving the treatment are different.
Allocation
Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
kinesiology group
Arm Type
Experimental
Arm Description
In the group receiving kinesiology treatment, kinesiotaping is applied to the sub-knee region in accordance with the lymphatic correction technique from the first postoperative day to reduce edema and pain. Accordingly, the proximal part of the tape is placed close to the lymph node. In our study, as stated in the literature, the proximal part of the tape will be adhered to the fibular head area next to the lymph nodes without applying any stretching. Then 5-10% stretching is applied and the distal part is adhered. 2 separate bands are applied so that the strips cross each other (from the medial and lateral of the knee). On the first postoperative day, on the third day, the patients will be taped with kinesio tape and discharged on the fourth day. After discharge, they will be asked to remove the tapes after 3 days as they were taught.
Arm Title
sham taping group
Arm Type
Sham Comparator
Arm Description
Sham application will be taped with a plaster from the same area on the same days as the kinesio application. No tension will be applied while taping. The difference of the plaster from the kinesiotape is that it does not contain tension and does not allow stretching.
Arm Title
only physical therapy group(control group)
Arm Type
Other
Arm Description
Conservative will be explained on the second day after the operation. Go for a visit with a local cold application 20 times once a day. Ankle pumping exercises, deep breathing exercises, isometric and hip exercises will be planned with a load that can be applied to students who are being applied for bed training. Increased the number and allowance of exercises; isotonic knee and exercises that make you feel It will be added. You will be discharged on the 4th day after the surgery on the 2nd or 3rd day. You will do home exercises after discharge. On the 10th day, you will be called for control.
Intervention Type
Other
Intervention Name(s)
kinesio tape
Intervention Description
According to this, the proximal part of the band is located close to the lymph node. In our study, as stated in the literature, the proximal part of the tape will be adhered to the fibular head area next to the lymph nodes without applying any stretching. Then 5-10% stretching is applied and the distal part is adhered. 2 separate tapes are applied so that the strips cross each other
Intervention Type
Other
Intervention Name(s)
Sham taping
Intervention Description
In the same procedure and time as kinesiotaping, inelastic tape will be used instead of kinesiotape.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Routine exercise and physiotherapy program applied after knee arthroplasty surgery will be applied
Primary Outcome Measure Information:
Title
edema
Description
thigh, knee and leg diameter measurements to be measured with a tape measure
Time Frame
1 day before surgery
Title
edema
Description
thigh, knee and leg diameter measurements to be measured with a tape measure
Time Frame
1 days after surgery
Title
edema
Description
thigh, knee and leg diameter measurements to be measured with a tape measure
Time Frame
3 days after surgery
Title
edema
Description
thigh, knee and leg diameter measurements to be measured with a tape measure
Time Frame
10 days after surgery
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Time Frame
1 day before surgery
Title
Pain Intensity
Description
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Time Frame
1 day after surgery
Title
Pain Intensity
Description
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Time Frame
3 days after surgery
Title
Pain Intensity
Description
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Time Frame
10 days after surgery
Other Pre-specified Outcome Measures:
Title
Functionality
Description
Functional assessment: Knee functional assessment will be made using the Oxford Knee Score. The Oxford Knee Score (OKS) was specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is a patient-reported 12-item scale. Each question is scored between 1-5 points from best to severe disability. Turkish validity and reliability has been established.
Time Frame
1 day before surgery
Title
Functionality
Description
Functional assessment: Knee functional assessment will be made using the Oxford Knee Score. The Oxford Knee Score (OKS) was specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is a patient-reported 12-item scale. Each question is scored between 1-5 points from best to severe disability. Turkish validity and reliability has been established.
Time Frame
1 day after surgery
Title
Functionality
Description
Functional assessment: Knee functional assessment will be made using the Oxford Knee Score. The Oxford Knee Score (OKS) was specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is a patient-reported 12-item scale. Each question is scored between 1-5 points from best to severe disability. Turkish validity and reliability has been established.
Time Frame
3 days after surgery
Title
Functionality
Description
Functional assessment: Knee functional assessment will be made using the Oxford Knee Score. The Oxford Knee Score (OKS) was specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is a patient-reported 12-item scale. Each question is scored between 1-5 points from best to severe disability. Turkish validity and reliability has been established.
Time Frame
10 days after surgery
Title
Measuring knee Joint Range of Motion
Description
Knee joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, knee ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.
Time Frame
1 day before surgery
Title
Measuring knee Joint Range of Motion
Description
Knee joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, knee ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.
Time Frame
1 daysafter surgery
Title
Measuring knee Joint Range of Motion
Description
Knee joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, knee ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.
Time Frame
3 days after surgery
Title
Measuring knee Joint Range of Motion
Description
Knee joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, knee ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.
Time Frame
10 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Performing total knee joint arthroplasty due to stage 4 gonarthrosis Agree to participate in the study Having signed the informed consent form Exclusion Criteria: Presence of malignancy, infection, rheumatological disease Having a tape allergy Having a diagnosis of lymphedema
Facility Information:
Facility Name
Ahievran university
City
Kirşehi̇r
ZIP/Postal Code
40100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24431257
Citation
Boguszewski D, Tomaszewska I, Adamczyk JG, Bialoszewski D. Evaluation of effectiveness of kinesiology taping as an adjunct to rehabilitation following anterior cruciate ligament reconstruction. Preliminary report. Ortop Traumatol Rehabil. 2013 Oct 31;15(5):469-78. doi: 10.5604/15093492.1084361.
Results Reference
background
PubMed Identifier
26390398
Citation
Jongbloed L, van Twist D, Swart N. Kinesio Taping Improves Pain, Range of Motion, and Proprioception in Older Patients With Knee Osteoarthritis. Am J Phys Med Rehabil. 2016 Jan;95(1):e7. doi: 10.1097/PHM.0000000000000393. No abstract available.
Results Reference
background
Citation
Guney Deniz H, Kinikli G, Onal S, et al THU0727-HPR Comparison of kinesio tape application and manual lymphatic drainage on lower extremity oedema and functions after total knee arthroplasty Annals of the Rheumatic Diseases 2018;77:1791.
Results Reference
background

Learn more about this trial

The Efficacy of Kinesiotaping on Pain, Edema and Functionality After Total Knee Arthroplasty

We'll reach out to this number within 24 hrs