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Kinesiotaping in Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesiotape
Sham-kinesiotape
Home-based exercise program
Sponsored by
Bozyaka Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Knee osteoarthritis, Kinesiotape, Pain

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pain for a minimum of 3 months
  • Pain intensity within the last week minimum of 3 according to the visual analogue scale (VAS) at the symptomatic knee
  • Grade 2-3 knee OA according to the Kellgren and Lawrence Scale
  • Ability to perform the tests

Exclusion Criteria:

  • Fragile, very sensitive skin, or lesions in the area
  • Inflammatory arthritis
  • Inability to perform functional tests
  • Pregnancy
  • Use of drugs associated with a psychiatric disorder
  • Previous joint replacement surgery for knee/hip joints
  • Diagnosis with balance disorder
  • Disorders that may cause loss of muscle strength in the lower extremities
  • Previous experience with the Kinesiotaping method

Sites / Locations

  • University of Health Sciences Izmir Bozyaka Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Kinesiotape

Sham-kinesiotape

Arm Description

The participants received kinesiotape to the rectus femoris muscle.

Non-specific taping was applied.

Outcomes

Primary Outcome Measures

Change from Baseline Pain intensity-rest at 1st hour, 3rd week, and 7th week
Pain intensity was assessed by using the Visual Analogue Scale (VAS). Each patient was asked to indicate pain intensity during rest at each assessment point (on a 0-10 points numerical pain rating scale; higher scores indicate severe pain).
Change from Baseline Pain intensity-activity at 1st hour, 3rd week, and 7th week
Pain intensity was assessed by using the Visual Analogue Scale (VAS). Each patient was asked to indicate pain intensity during 50-meter walking test at each assessment point (on a 0-10 points numerical pain rating scale; higher scores indicate severe pain).

Secondary Outcome Measures

Change from Baseline Knee-Related Health Status at 1st hour, 3rd week, and 7th week
To determine the baseline and the degree of change in knee-related health status Western Ontario and McMaster Universities Osteoarthritis Index was applied. Western Ontario and McMaster Universities Osteoarthritis Index, is a widely valid and reliable outcome measurement scale in patients with knee osteoarthritis. The scale consists of 24 items and is divided into three dimensions; pain; stiffness, and functionality.
Change from Baseline Pain-free Knee Range of Motion at 1st hour, 3rd week, and 7th week
Active pain-free knee range of motion examination was performed by a 360̊ double-armed universal goniometer. Knee active flexion range of motion angle without pain was measured in the supine position while the axis of the goniometer was on the femur's lateral epicondyle. For active knee extension range of motion, the investigator recorded the angle that which the participant extends the knee as much as possible. If there was an inability to reach the 0-degree starting position, the angle was given a negative value reflecting the angle missing from the full extension. Three assessment was performed and the mean value was recorded as active flexion and extension angle.
Change from Baseline Physical Function at 1st hour, 3rd week, and 7th week
The physical function of the participants enrolled in the study was evaluated by the 50-meter walking test will the subjects walk 2.5 return journeys between two cones placed 10 m apart along a walking course. The participants stood beside the cone. They were instructed to walk to the other when signaled by the investigator, go around it to the outer side, and walk back again as fast as possible. The time taken the task completed assessed by the same chronometer was recorded
Change from Baseline Static Postural Stability at 1st hour, 3rd week, and 7th week
The quantitative measure of the balance and postural stability of participants was performed by the Biodex Balance System (BBS). Participants completed three trial repetitions before static balance tests. For the static balance test, the participants were asked to stand with two legs on the center of the locked platform of the BBS. Three evaluations were performed in each measurement session and a mean score was calculated from the three trials. The device provides three postural stability indices (PSI) obtained by calculating the standard deviations of the degrees of an inclination concerning the zero point: overall static postural stability index (sPSI_O), static anteroposterior postural stability index (sPSI_AP), and static mediolateral postural stability index (sPSI_ML).
Change from Baseline Dynamic Postural Stability at 1st hour, 3rd week, and 7th week
The quantitative measure of the balance and postural stability of participants was performed by the Biodex Balance System (BBS). Participants completed three trial repetitions before dynamic balance tests. During the dynamic balance test, the platform moves simultaneously to the anteroposterior (AP), or mediolateral (ML) directions in 12 different stability levels (level 1 is the least stable; level 12 is the most stable level within a 20-degree range of inclination). Dynamic PSI (dPSI) represents the variance of foot platform displacement in degrees, from level, in all motions during the test. A high number is indicative of a lot of movement during the test. Dynamic balance test was performed on the most stable level with the following parameters: duration: 20 seconds, stability level: 12, and stance: two legs

Full Information

First Posted
April 18, 2022
Last Updated
April 23, 2022
Sponsor
Bozyaka Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05351996
Brief Title
Kinesiotaping in Knee Osteoarthritis
Official Title
Does Kinesiotaping Effective for Knee Osteoarthritis? Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
October 26, 2021 (Actual)
Study Completion Date
October 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bozyaka Training and Research Hospital

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
Kinesiotape is one of the treatment choices for the patients with knee osteoarthritis. Unlike the brace, it seems to be an important advantage in kinesiotape application in that it permits the movement of the joint. However, kinesiotape is conditionally recommended for knee osteoarthritis in the 2019 American College of Rheumatology treatment recommendations due to limiting the quality of evidence, using various application methods, and the lack of blindness concerning its use is not possible. The aim of the study is to determine the effects of kinesiotaping on pain, physical performance, knee range of motion, and postural stability in knee osteoarthritis.
Detailed Description
Non-pharmacological treatments are recommended as first-line management in knee osteoarthritis. Kinesiotape was regarded as a supplementary intervention for patients with knee osteoarthritis. Although the results are conflicting, regarding knee osteoarthritis, recently published studies indicate beneficial effects of kinesiotape on knee-related health status, pain, quadriceps muscle strength, and range of motion. On the other hand, the measurements were performed immediately following taping or within a short-term period. The inconsistency of the study data still indicates that the efficacy of kinesiotape in knee osteoarthritis should be evaluated in randomized controlled trials. Therefore a study that investigates both short and long-term follow-up results are warranted. This study aimed to determine the immediate and long-term effects of the single and repetitive application of kinesiotape on pain, knee joint range of motion, postural stability, and physical performance in participants with knee osteoarthritis. The results of this study will support evidence-based reports based on the effectiveness of kinesiotape in knee osteoarthritis and recommendations for future studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Knee osteoarthritis, Kinesiotape, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesiotape
Arm Type
Active Comparator
Arm Description
The participants received kinesiotape to the rectus femoris muscle.
Arm Title
Sham-kinesiotape
Arm Type
Sham Comparator
Arm Description
Non-specific taping was applied.
Intervention Type
Device
Intervention Name(s)
Kinesiotape
Intervention Description
The participants received kinesiotape application three times with one-week intervals. Y strip tape was used. The interventionist applied the band to the rectus femoris muscle with facilitation technique.
Intervention Type
Device
Intervention Name(s)
Sham-kinesiotape
Intervention Description
The participants received sham-kinesiotape application three times with one-week intervals. In the sham group, the interventionist adhered KT to the rectus femoris transversely, without stretching.
Intervention Type
Other
Intervention Name(s)
Home-based exercise program
Intervention Description
Participants were taught exercise program training. The exercise intervention was based on quadriceps and knee flexor muscle group strengthening, and knee joint range of motion exercises, in their home.
Primary Outcome Measure Information:
Title
Change from Baseline Pain intensity-rest at 1st hour, 3rd week, and 7th week
Description
Pain intensity was assessed by using the Visual Analogue Scale (VAS). Each patient was asked to indicate pain intensity during rest at each assessment point (on a 0-10 points numerical pain rating scale; higher scores indicate severe pain).
Time Frame
Baseline (week 0), 1st hour, 3rd week, 7th week
Title
Change from Baseline Pain intensity-activity at 1st hour, 3rd week, and 7th week
Description
Pain intensity was assessed by using the Visual Analogue Scale (VAS). Each patient was asked to indicate pain intensity during 50-meter walking test at each assessment point (on a 0-10 points numerical pain rating scale; higher scores indicate severe pain).
Time Frame
Baseline (week 0), 1st hour, 3rd week , 7th week
Secondary Outcome Measure Information:
Title
Change from Baseline Knee-Related Health Status at 1st hour, 3rd week, and 7th week
Description
To determine the baseline and the degree of change in knee-related health status Western Ontario and McMaster Universities Osteoarthritis Index was applied. Western Ontario and McMaster Universities Osteoarthritis Index, is a widely valid and reliable outcome measurement scale in patients with knee osteoarthritis. The scale consists of 24 items and is divided into three dimensions; pain; stiffness, and functionality.
Time Frame
Baseline (week 0), 1st hour, 3rd week , 7th week
Title
Change from Baseline Pain-free Knee Range of Motion at 1st hour, 3rd week, and 7th week
Description
Active pain-free knee range of motion examination was performed by a 360̊ double-armed universal goniometer. Knee active flexion range of motion angle without pain was measured in the supine position while the axis of the goniometer was on the femur's lateral epicondyle. For active knee extension range of motion, the investigator recorded the angle that which the participant extends the knee as much as possible. If there was an inability to reach the 0-degree starting position, the angle was given a negative value reflecting the angle missing from the full extension. Three assessment was performed and the mean value was recorded as active flexion and extension angle.
Time Frame
Baseline (week 0), 1st hour, 3rd week , 7th week
Title
Change from Baseline Physical Function at 1st hour, 3rd week, and 7th week
Description
The physical function of the participants enrolled in the study was evaluated by the 50-meter walking test will the subjects walk 2.5 return journeys between two cones placed 10 m apart along a walking course. The participants stood beside the cone. They were instructed to walk to the other when signaled by the investigator, go around it to the outer side, and walk back again as fast as possible. The time taken the task completed assessed by the same chronometer was recorded
Time Frame
Baseline (week 0), 1st hour, 3rd week , 7th week
Title
Change from Baseline Static Postural Stability at 1st hour, 3rd week, and 7th week
Description
The quantitative measure of the balance and postural stability of participants was performed by the Biodex Balance System (BBS). Participants completed three trial repetitions before static balance tests. For the static balance test, the participants were asked to stand with two legs on the center of the locked platform of the BBS. Three evaluations were performed in each measurement session and a mean score was calculated from the three trials. The device provides three postural stability indices (PSI) obtained by calculating the standard deviations of the degrees of an inclination concerning the zero point: overall static postural stability index (sPSI_O), static anteroposterior postural stability index (sPSI_AP), and static mediolateral postural stability index (sPSI_ML).
Time Frame
Baseline (week 0), 1st hour, 3rd week , 7th week
Title
Change from Baseline Dynamic Postural Stability at 1st hour, 3rd week, and 7th week
Description
The quantitative measure of the balance and postural stability of participants was performed by the Biodex Balance System (BBS). Participants completed three trial repetitions before dynamic balance tests. During the dynamic balance test, the platform moves simultaneously to the anteroposterior (AP), or mediolateral (ML) directions in 12 different stability levels (level 1 is the least stable; level 12 is the most stable level within a 20-degree range of inclination). Dynamic PSI (dPSI) represents the variance of foot platform displacement in degrees, from level, in all motions during the test. A high number is indicative of a lot of movement during the test. Dynamic balance test was performed on the most stable level with the following parameters: duration: 20 seconds, stability level: 12, and stance: two legs
Time Frame
Baseline (week 0), 1st hour, 3rd week , 7th week

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
As the pain intensity and pain threshold may be effected by the gender differences, the enrolled participants were consisted of females.
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pain for a minimum of 3 months Pain intensity within the last week minimum of 3 according to the visual analogue scale (VAS) at the symptomatic knee Grade 2-3 knee OA according to the Kellgren and Lawrence Scale Ability to perform the tests Exclusion Criteria: Fragile, very sensitive skin, or lesions in the area Inflammatory arthritis Inability to perform functional tests Pregnancy Use of drugs associated with a psychiatric disorder Previous joint replacement surgery for knee/hip joints Diagnosis with balance disorder Disorders that may cause loss of muscle strength in the lower extremities Previous experience with the Kinesiotaping method
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nesibe Doğan, MD
Organizational Affiliation
University of Health Sciences Izmir Bozyaka Training and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hayriye Yılmaz, MSc, PT
Organizational Affiliation
University of Health Sciences Izmir Bozyaka Training and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Buğra İnce, MD
Organizational Affiliation
University of Health Sciences Izmir Bozyaka Training and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Şeniz Akçay, Assoc. Prof.
Organizational Affiliation
University of Health Sciences Izmir Bozyaka Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
University of Health Sciences Izmir Bozyaka Training and Research Hospital
City
İzmir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31908149
Citation
Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care Res (Hoboken). 2020 Feb;72(2):149-162. doi: 10.1002/acr.24131. Epub 2020 Jan 6. Erratum In: Arthritis Care Res (Hoboken). 2021 May;73(5):764.
Results Reference
background
PubMed Identifier
32372651
Citation
Donec V, Kubilius R. The effectiveness of Kinesio Taping(R) for mobility and functioning improvement in knee osteoarthritis: a randomized, double-blind, controlled trial. Clin Rehabil. 2020 Jul;34(7):877-889. doi: 10.1177/0269215520916859. Epub 2020 May 6.
Results Reference
background
PubMed Identifier
27149590
Citation
Kaya Mutlu E, Mustafaoglu R, Birinci T, Razak Ozdincler A. Does Kinesio Taping of the Knee Improve Pain and Functionality in Patients with Knee Osteoarthritis?: A Randomized Controlled Clinical Trial. Am J Phys Med Rehabil. 2017 Jan;96(1):25-33. doi: 10.1097/PHM.0000000000000520.
Results Reference
background
PubMed Identifier
27320828
Citation
Wageck B, Nunes GS, Bohlen NB, Santos GM, de Noronha M. Kinesio Taping does not improve the symptoms or function of older people with knee osteoarthritis: a randomised trial. J Physiother. 2016 Jul;62(3):153-8. doi: 10.1016/j.jphys.2016.05.012. Epub 2016 Jun 16.
Results Reference
background
PubMed Identifier
25706053
Citation
Cho HY, Kim EH, Kim J, Yoon YW. Kinesio taping improves pain, range of motion, and proprioception in older patients with knee osteoarthritis: a randomized controlled trial. Am J Phys Med Rehabil. 2015 Mar;94(3):192-200. doi: 10.1097/PHM.0000000000000148.
Results Reference
background

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Kinesiotaping in Knee Osteoarthritis

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