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Effect of Kinesio Taping and Sham Taping in Knee Osteoarthritis (OA)

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Kinesio taping
Sham taping
Sponsored by
Lithuanian Sports University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring kinesiotaping, functional mobility, physiotherapy, knee pain

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinical and radiography diagnosis of osteoarthritis of the knee joint
  • patients with different degrees of severity of the knee osteoarthritis
  • consent to participate in the study.

Exclusion Criteria:

  • rheumatoid arthritis
  • systemic connective tissue disease
  • knee joint oedema
  • surgery intervention in recent 6 months
  • wearing of knee braces
  • skin problems
  • previous total or partial knee replacement surgery
  • inability to perform physical examination tests
  • oncology
  • use of medications, infection
  • previous experience of kinesio taping intervention.

Sites / Locations

  • Lithuanian Sports University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Sham Comparator

Experimental

Arm Label

Control group

Sham taping

Kinesio taping

Arm Description

Participants underwent 3 exercise sessions for 60 minutes each. Exercise program was created to improve range of motion and muscle strength. Participants executed active exercise in lying, sitting, and standing positions, isometric exercise, exercise with resistance band. All exercises were repeated 12 times in 3 sets and depending on the capacity of the subject. Breaks between sets 10 sec.

Participants underwent 3 exercise sessions for 60 minutes each. Exercise program was created to improve range of motion and muscle strength. Participants executed active exercise in lying, sitting, and standing positions, isometric exercise, exercise with resistance band. All exercises were repeated 12 times in 3 sets and depending on the capacity of the subject. Breaks between sets 10 sec.

Participants underwent 3 exercise sessions for 60 minutes each. Exercise program was created to improve range of motion and muscle strength. Participants executed active exercise in lying, sitting, and standing positions, isometric exercise, exercise with resistance band. All exercises were repeated 12 times in 3 sets, 10 s breaks between sets.

Outcomes

Primary Outcome Measures

Change from Baseline Knee Pain at 1 week
was evaluated using the Visual Analogue Pain Scale (VAS). Participants were asked to report "current" pain intensity. A higher score indicates greater pain intensity: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).
Change from Baseline Range of Motions at 1 week
A goniometer was used to measure the flexion and extension of the knee joint. The initial position of the subject is prone lying, the axis of goniometer is placed on the lateral femoral epicondyle. The stationary part of goniometer is placed along the lateral midline of the thigh, the reference point being the greater trochanter of femur. The moving part of goniometer is placed along the midline of the lower leg, the reference point being the lateral ankle.
Change from Baseline Muscle Strength at 1 week
Manual muscle strength testing. The strength of knee flexion and extension was evaluated (Cuthbert, & Goodheart, 2007). The classic 5-point manual muscle strength assessment system is used to determine muscle strength. If for some reason participant could not perform the full range of motion, then the muscle strength test is performed at the possible amplitude.
Change from Baseline Walking Speed at 1 week
A 10-meter straight line was marked in the start and finish points. The subject had to stand 2 meters in front of the start line, after the signal participant was told to walk at his/her own speed until he/she was 2 meters behind the finish line. The timer was turned on when the patient crossed the start line and stopped when he/she crossed the finish line. The test was performed 5 times and the average calculated. Time was recorded in seconds and converted to meters per second (Master et al., 2021).
Change from Baseline Functional Mobility at 1 week
Initial position was participant sitting on the chair. The patient had to get up from the chair, walk three meters to the marked line, turn around 180 degrees, and return to the chair, and sit down on the chair. During the test, the person must wear normal footwear and use all means of movement normally required. The test was performed 5 times and the average of 5 tests was calculated. The height of the chair used was 46 cm and the test time was recorded in seconds (Alghadir et al., 2015).

Secondary Outcome Measures

Full Information

First Posted
March 25, 2022
Last Updated
April 2, 2022
Sponsor
Lithuanian Sports University
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1. Study Identification

Unique Protocol Identification Number
NCT05320562
Brief Title
Effect of Kinesio Taping and Sham Taping in Knee Osteoarthritis
Acronym
OA
Official Title
Effect of Kinesio Taping and Sham Taping on Knee Function in Patients With Knee Osteoarthritis: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 20, 2021 (Actual)
Primary Completion Date
August 20, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lithuanian Sports University

4. Oversight

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

5. Study Description

Brief Summary
The prevalence of knee osteoarthritis has been increasing in recent decades as the number of obese people has increased. Various interventions are used to improve the functional condition of patients, but it is still not clear which one is most effective. The primary aim of this study was to determine and compare the effects of kinesio taping and sham taping on the knee functional mobility.
Detailed Description
The investigators assigned 30 adult participants (26 women, 4 men; mean age 58,1±3,9 yrs) from Lithuania. Participants were assigned to one of three groups: control group (CON) (n = 10), sham taping + exercise (STE) (n = 10), and kinesio taping + exercise (KTE) group (n = 10). Participants performed all necessary tests according to the study protocol one week before the intervention. A second set of tests was performed one week after the intervention. The intervention duration was 1 week. Exercise, sham and kinesio taping were applied by Physical Therapist. All the study groups did exercise training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
kinesiotaping, functional mobility, physiotherapy, knee pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants underwent 3 exercise sessions for 60 minutes each. Exercise program was created to improve range of motion and muscle strength. Participants executed active exercise in lying, sitting, and standing positions, isometric exercise, exercise with resistance band. All exercises were repeated 12 times in 3 sets and depending on the capacity of the subject. Breaks between sets 10 sec.
Arm Title
Sham taping
Arm Type
Sham Comparator
Arm Description
Participants underwent 3 exercise sessions for 60 minutes each. Exercise program was created to improve range of motion and muscle strength. Participants executed active exercise in lying, sitting, and standing positions, isometric exercise, exercise with resistance band. All exercises were repeated 12 times in 3 sets and depending on the capacity of the subject. Breaks between sets 10 sec.
Arm Title
Kinesio taping
Arm Type
Experimental
Arm Description
Participants underwent 3 exercise sessions for 60 minutes each. Exercise program was created to improve range of motion and muscle strength. Participants executed active exercise in lying, sitting, and standing positions, isometric exercise, exercise with resistance band. All exercises were repeated 12 times in 3 sets, 10 s breaks between sets.
Intervention Type
Procedure
Intervention Name(s)
Kinesio taping
Intervention Description
Additionally, they received kinesio taping application for 7 days. Blue color kinesio tape (manufactured by "Theraband®", USA) was used. Kinesio taping was done by experienced physiotherapist with 5 years of experience. Two Y shape bands were applied for lymphatic taping and to improve anterior upper leg muscle function (lymphatic correction and muscle correction techniques were integrated together). Then two I shape bands (75-100% tension) were applied above the patella tendon and medial/lateral collateral ligaments in order to improve mechanoreceptor stimulation, proprioception and knee stability.
Intervention Type
Procedure
Intervention Name(s)
Sham taping
Intervention Description
Additionally, they received sham (placebo) taping: usual white patch was applied to the painful knee for 7 days. The technique of taping used was the same as in kinesiotaping group, but without stretching.
Primary Outcome Measure Information:
Title
Change from Baseline Knee Pain at 1 week
Description
was evaluated using the Visual Analogue Pain Scale (VAS). Participants were asked to report "current" pain intensity. A higher score indicates greater pain intensity: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).
Time Frame
Baseline and after 7 days
Title
Change from Baseline Range of Motions at 1 week
Description
A goniometer was used to measure the flexion and extension of the knee joint. The initial position of the subject is prone lying, the axis of goniometer is placed on the lateral femoral epicondyle. The stationary part of goniometer is placed along the lateral midline of the thigh, the reference point being the greater trochanter of femur. The moving part of goniometer is placed along the midline of the lower leg, the reference point being the lateral ankle.
Time Frame
Baseline and after 7 days
Title
Change from Baseline Muscle Strength at 1 week
Description
Manual muscle strength testing. The strength of knee flexion and extension was evaluated (Cuthbert, & Goodheart, 2007). The classic 5-point manual muscle strength assessment system is used to determine muscle strength. If for some reason participant could not perform the full range of motion, then the muscle strength test is performed at the possible amplitude.
Time Frame
Baseline and after 7 days
Title
Change from Baseline Walking Speed at 1 week
Description
A 10-meter straight line was marked in the start and finish points. The subject had to stand 2 meters in front of the start line, after the signal participant was told to walk at his/her own speed until he/she was 2 meters behind the finish line. The timer was turned on when the patient crossed the start line and stopped when he/she crossed the finish line. The test was performed 5 times and the average calculated. Time was recorded in seconds and converted to meters per second (Master et al., 2021).
Time Frame
Baseline and after 7 days
Title
Change from Baseline Functional Mobility at 1 week
Description
Initial position was participant sitting on the chair. The patient had to get up from the chair, walk three meters to the marked line, turn around 180 degrees, and return to the chair, and sit down on the chair. During the test, the person must wear normal footwear and use all means of movement normally required. The test was performed 5 times and the average of 5 tests was calculated. The height of the chair used was 46 cm and the test time was recorded in seconds (Alghadir et al., 2015).
Time Frame
Baseline and after 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinical and radiography diagnosis of osteoarthritis of the knee joint patients with different degrees of severity of the knee osteoarthritis consent to participate in the study. Exclusion Criteria: rheumatoid arthritis systemic connective tissue disease knee joint oedema surgery intervention in recent 6 months wearing of knee braces skin problems previous total or partial knee replacement surgery inability to perform physical examination tests oncology use of medications, infection previous experience of kinesio taping intervention.
Facility Information:
Facility Name
Lithuanian Sports University
City
Kaunas
Country
Lithuania

12. IPD Sharing Statement

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Effect of Kinesio Taping and Sham Taping in Knee Osteoarthritis

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