- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05320562
Effect of Kinesio Taping and Sham Taping in Knee Osteoarthritis (OA)
Effect of Kinesio Taping and Sham Taping on Knee Function in Patients With Knee Osteoarthritis: Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kaunas, Lithuania
- Lithuanian Sports University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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NO_INTERVENTION: Control group
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.
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SHAM_COMPARATOR: Sham taping
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.
|
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.
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EXPERIMENTAL: Kinesio taping
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.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline Knee Pain at 1 week
Time Frame: Baseline and after 7 days
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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).
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Baseline and after 7 days
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Change from Baseline Range of Motions at 1 week
Time Frame: Baseline and after 7 days
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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.
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Baseline and after 7 days
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Change from Baseline Muscle Strength at 1 week
Time Frame: Baseline and after 7 days
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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.
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Baseline and after 7 days
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Change from Baseline Walking Speed at 1 week
Time Frame: Baseline and after 7 days
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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).
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Baseline and after 7 days
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Change from Baseline Functional Mobility at 1 week
Time Frame: Baseline and after 7 days
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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).
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Baseline and after 7 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LithuanianSportsU-8
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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