OsteoarthritisOANCT05320562
Effect of Kinesio Taping and Sham Taping in Knee Osteoarthritis
A study testing Kinesio taping in people with Osteoarthritis, run by Lithuanian Sports University at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Kinesio taping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteLithuania
- Study dates
- 20 Feb 2021to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- rheumatoid arthritis
- systemic connective tissue disease
- knee joint oedema
- surgery intervention in recent 6 months
- wearing of knee braces
- skin problems
Show all 11Show fewer
- previous total or partial knee replacement surgery
- inability to perform physical examination tests
- oncology
- use of medications, infection
- previous experience of kinesio taping intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Kinesio Taping and Sham Taping on Knee Function in Patients With Knee Osteoarthritis: Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Kinesio taping, Sham taping
- Keywords
- kinesiotaping, functional mobility, physiotherapy, knee pain
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tapingProcedure or surgery
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.
Sham tapingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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. |
| Sham taping | Sham comparator | 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. Receives: Procedure: Sham taping |
| Kinesio taping | Experimental | 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. Receives: Procedure: Kinesio taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and after 7 days
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.
Measured: Baseline and after 7 days
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.
Measured: Baseline and after 7 days
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).
Measured: Baseline and after 7 days
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).
Measured: Baseline and after 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start20 Feb 2021
- Primary completion20 Aug 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian Sports University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320562
- Sponsor's protocol ID
- LithuanianSportsU-8
- Acronym
- OA
- Status last verified
- Apr 2022
- First submitted
- 25 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesio Taping and Sham Taping on Knee Function in Patients With Knee Osteoarthritis: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05320562
- Acronym / sponsor ID
- OA / LithuanianSportsU-8
- Conditions
- Osteoarthritis
- Keywords
- kinesiotaping, functional mobility, physiotherapy, knee pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lithuanian Sports UniversityUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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. |
| Sham taping | Sham comparator | Procedure: Sham tapingParticipants 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. |
| Kinesio taping | Experimental | Procedure: Kinesio tapingParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- rheumatoid arthritis
- systemic connective tissue disease
- knee joint oedema
- surgery intervention in recent 6 months
- wearing of knee braces
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio tapingAdditionally, 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. | Procedure or surgery | Kinesio taping |
| Sham tapingAdditionally, 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. | Procedure or surgery | Sham taping |
Primary outcome
Change from Baseline Knee Pain at 1 week
Time frame: Baseline and after 7 days
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
Time frame: Baseline and after 7 days
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
Time frame: Baseline and after 7 days
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
Time frame: Baseline and after 7 days
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
Time frame: Baseline and after 7 days
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio taping in people with Osteoarthritis, run by Lithuanian Sports University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Knee Pain at 1 week (time frame: Baseline and after 7 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.