Osteoarthritis, KneeNCT05160246
The Instant Effect of Kinesiology Taping in Patients With Knee OA
A study testing kinesiology tape in people with Osteoarthritis, Knee, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine instant effect of kinesiology taping applied to the rectus femoris on muscle activation, physical performance and proprioception in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- kinesiology tape
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Sep 2021to 27 Jun 2022
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 45-65 years,
- Patients with independent ambulation,
- Patients with Grade II-III knee osteoarthritis according to the Kellgren and Lawrence Classification,
- Patients not using NSAIDs during the study,
- Patients who volunteered to participate in the study
Who cannot join
- Patients with previous surgery on the lower extremities
- Patients with neuromuscular disease
- Patients with vestibular pathology
- Patients with diseases of the cardiopulmonary system,
- Patients with communication difficulties,
- Patients who have received physiotherapy or intra-articular injections in the last 6 months or who exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Instant Effect of Kinesiology Taping on Rectus Femoris Muscle on Muscle Activation, Physical Performance and Proprioception in Knee Osteoarthritis Patients
The aim of this study is to determine instant effect of kinesiology taping applied to the rectus femoris on muscle activation, physical performance and proprioception in patients with knee osteoarthritis.
Read the detailed description
40 patients with knee OA will be included in the study. Intervention group and placebo group will be formed. Facilitation taping will be applied on the rectus femoris of the patients in the taping group. The patients in the placebo group will be placed tape on the rectus femoris without any tension. Muscle activation, physical performance and proprioception will be evaluated before taping and 30 minutes after taping.
- Conditions
- Osteoarthritis, Knee
- Being tested
- kinesiology tape, Placebo tape
- Keywords
- knee osteoarthritis, Kinesiotape, Physical performance, Muscle activation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesiology tapeOther
The tape will be fixed without any tension 10 cm below the origin of the rectus femoris muscle. Then 35-50% tension will be applied to the band and descended to the patella. After this point, the Y-shaped band will be terminated to wrap the patella medially and laterally without any tension.
Placebo tapeOther
The tape will attach to the rectus femoris without any tension.
| Study group | Role | What they receive |
|---|---|---|
| taping group | Experimental | Facilitation taping will be applied to the rectus femoris of patients with knee OA in the taping group. Receives: Other: kinesiology tape |
| placebo group | Placebo comparator | The patients with knee OA in the placebo group will be placed tape on the rectus femoris without any tension. Receives: Other: Placebo tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle activation
The muscular activation of the Rectus Femoris will be measured with the EMG (Euro Track MyoPlus 4) device before and after the taping application. With the patient in the sitting position with the hip and knee flexed to 90 degrees, active electrodes will be placed on the motor point of the muscle, three measurements will be made, and the highest MVIC value will be recorded.
Measured: 5 minutes
Secondary outcomes (4)
timed up and go test
Individuals will be asked to get up while sitting on the chair, walk three meters, return from the marked point at the end of three meters, walk towards the chair again and sit on the chair. The time taken for the individual's performances will be recorded in seconds.
Measured: 5 minutes
5 times sit-to-stand test
Patients will be asked to stand up and sit down fully upright from the chair with armrests as quickly as possible five times, and the elapsed time will be recorded.
Measured: 1 minutes
proprioception
Participants will sit on a chair with 90° knee flexion. The lower extremities of the participants will be passively and randomly moved from 90° knee flexion to each of the 15°, 30° and 45° angles. After holding the lower extremity at each target angle for 10 seconds, return to the starting position. After waiting 10 seconds in the starting position, the participants will bring their knees to the target angle on their own and stop. Accordingly, the absolute value of the participant's deviation from the target angle will be measured three times for each target angle with the help of a goniometer and the average value will be calculated.
Measured: 5 minutes
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
It consists of three parts and 24 questions in which pain, stiffness and physical function are questioned. The maximum scores that can be obtained from the index are 20 for the pain subgroup, 8 for stiffness, and 68 for physical function. High scores indicate increased pain and stiffness and impaired physical function.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start6 Sep 2021
- Primary completion27 Jun 2022
- Study completion27 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin Ataş, Kırıkkale University
- Investigators
- Aylin ATAŞ, Principal investigator, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160246
- Sponsor's protocol ID
- Kinesiotape in Knee OA
- Status last verified
- Aug 2022
- First submitted
- 3 Dec 2021
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramoglu M. Acceptability, reliability, validity and responsiveness of the Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan;13(1):28-33. doi: 10.1016/j.joca.2004.10.010.
PubMed 15639634Ye W, Jia C, Jiang J, Liang Q, He C. Effectiveness of Elastic Taping in Patients With Knee Osteoarthritis: A Systematic Review and Meta-Analysis. Am J Phys Med Rehabil. 2020 Jun;99(6):495-503. doi: 10.1097/PHM.0000000000001361.
PubMed 31851010
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Instant Effect of Kinesiology Taping on Rectus Femoris Muscle on Muscle Activation, Physical Performance and Proprioception in Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT05160246
- Acronym / sponsor ID
- Kinesiotape in Knee OA
- Conditions
- Osteoarthritis, Knee
- Keywords
- knee osteoarthritis, Kinesiotape, Physical performance, Muscle activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 27 Jun 2022 (actual)
- First posted
- 16 Dec 2021 (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 aim of this study is to determine instant effect of kinesiology taping applied to the rectus femoris on muscle activation, physical performance and proprioception in patients with knee osteoarthritis.
Detailed description
40 patients with knee OA will be included in the study. Intervention group and placebo group will be formed. Facilitation taping will be applied on the rectus femoris of the patients in the taping group. The patients in the placebo group will be placed tape on the rectus femoris without any tension. Muscle activation, physical performance and proprioception will be evaluated before taping and 30 minutes after taping.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taping group | Experimental | Other: kinesiology tapeFacilitation taping will be applied to the rectus femoris of patients with knee OA in the taping group. |
| placebo group | Placebo comparator | Other: Placebo tapeThe patients with knee OA in the placebo group will be placed tape on the rectus femoris without any tension. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 45-65 years,
- Patients with independent ambulation,
- Patients with Grade II-III knee osteoarthritis according to the Kellgren and Lawrence Classification,
- Patients not using NSAIDs during the study,
- Patients who volunteered to participate in the study
Key exclusion criteria (6 listed)
- Patients with previous surgery on the lower extremities
- Patients with neuromuscular disease
- Patients with vestibular pathology
- Patients with diseases of the cardiopulmonary system,
- Patients with communication difficulties,
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 |
|---|---|---|
| kinesiology tapeThe tape will be fixed without any tension 10 cm below the origin of the rectus femoris muscle. Then 35-50% tension will be applied to the band and descended to the patella. After this point, the Y-shaped band will be terminated to wrap the patella medially and laterally without any tension. | Other | taping group |
| Placebo tapeThe tape will attach to the rectus femoris without any tension. | Other | placebo group |
Primary outcome
muscle activation
Time frame: 5 minutes
The muscular activation of the Rectus Femoris will be measured with the EMG (Euro Track MyoPlus 4) device before and after the taping application. With the patient in the sitting position with the hip and knee flexed to 90 degrees, active electrodes will be placed on the motor point of the muscle, three measurements will be made, and the highest MVIC value will be recorded.
4 secondary outcomes
timed up and go test
Time frame: 5 minutes
5 times sit-to-stand test
Time frame: 1 minutes
proprioception
Time frame: 5 minutes
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
Time frame: 5 minutes
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 8 Aug 2022.
- Background: PubMed 15639634Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramoglu M. Acceptability, reliability, validity and responsiveness of the Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan;13(1):28-33. doi: 10.1016/j.joca.2004.10.010.
- Background: PubMed 31851010Ye W, Jia C, Jiang J, Liang Q, He C. Effectiveness of Elastic Taping in Patients With Knee Osteoarthritis: A Systematic Review and Meta-Analysis. Am J Phys Med Rehabil. 2020 Jun;99(6):495-503. doi: 10.1097/PHM.0000000000001361.
- Individual participant dataSharing planned: No
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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.
Aylin ATAŞ principal investigator
Kırıkkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kinesiology tape in people with Osteoarthritis, Knee, run by Kırıkkale University at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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 8 Aug 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 Turkey (Türkiye). 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?
muscle activation (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05160246, which also lists 2 linked publications.
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 8 Aug 2022.