Osteoarthritis, KneeNCT05351996
Kinesiotaping in Knee Osteoarthritis
A study testing Kinesiotape and Home-based exercise program in people with Osteoarthritis, Knee, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Kinesiotape and Home-based exercise program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2019to 26 Oct 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Diagnosis with balance disorder
- Disorders that may cause loss of muscle strength in the lower extremities
- Previous experience with the Kinesiotaping method
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Izmir Bozyaka Training and Research Hospital
Izmir
About this study
Official title: Does Kinesiotaping Effective for Knee Osteoarthritis? Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Kinesiotape, Sham-kinesiotape, Home-based exercise program
- Keywords
- Knee osteoarthritis, Kinesiotape, Pain
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapeDevice
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.
Sham-kinesiotapeDevice
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.
Home-based exercise programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotape | Active comparator | The participants received kinesiotape to the rectus femoris muscle. Receives: Device: Kinesiotape; Other: Home-based exercise program |
| Sham-kinesiotape | Sham comparator | Non-specific taping was applied. Receives: Device: Sham-kinesiotape; Other: Home-based exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (week 0), 1st hour, 3rd week, 7th week
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).
Measured: Baseline (week 0), 1st hour, 3rd week , 7th week
Secondary outcomes (5)
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.
Measured: Baseline (week 0), 1st hour, 3rd week , 7th week
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.
Measured: Baseline (week 0), 1st hour, 3rd week , 7th week
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
Measured: Baseline (week 0), 1st hour, 3rd week , 7th week
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).
Measured: Baseline (week 0), 1st hour, 3rd week , 7th week
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
Measured: Baseline (week 0), 1st hour, 3rd week , 7th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start20 Nov 2019
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeniz Akçay, Bozyaka Training and Research Hospital
- Investigators
- Nesibe Doğan, MD, Principal investigator, University of Health Sciences Izmir Bozyaka Training and Research HospitalHayriye Yılmaz, MSc, PT, Study chair, University of Health Sciences Izmir Bozyaka Training and Research HospitalBuğra İnce, MD, Study chair, University of Health Sciences Izmir Bozyaka Training and Research HospitalŞeniz Akçay, Assoc. Prof., Study director, University of Health Sciences Izmir Bozyaka Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351996
- Sponsor's protocol ID
- 11/09/2019-06
- Status last verified
- Apr 2022
- First submitted
- 18 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31908149Donec 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.
PubMed 32372651Kaya 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.
PubMed 27149590Wageck 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.
PubMed 27320828Cho 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.
PubMed 25706053
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Kinesiotaping Effective for Knee Osteoarthritis? Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05351996
- Acronym / sponsor ID
- 11/09/2019-06
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee osteoarthritis, Kinesiotape, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 28 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesiotape | Active comparator | Device: Kinesiotape, Other: Home-based exercise programThe participants received kinesiotape to the rectus femoris muscle. |
| Sham-kinesiotape | Sham comparator | Device: Sham-kinesiotape, Other: Home-based exercise programNon-specific taping was applied. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| KinesiotapeThe 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. | Device | Kinesiotape |
| Sham-kinesiotapeThe 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. | Device | Sham-kinesiotape |
| Home-based exercise programParticipants 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. | Other | Kinesiotape, Sham-kinesiotape |
Primary outcome
Change from Baseline Pain intensity-rest at 1st hour, 3rd week, and 7th week
Time frame: Baseline (week 0), 1st hour, 3rd week, 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
Time frame: Baseline (week 0), 1st hour, 3rd week , 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).
5 secondary outcomes
Change from Baseline Knee-Related Health Status at 1st hour, 3rd week, and 7th week
Time frame: Baseline (week 0), 1st hour, 3rd week , 7th week
Change from Baseline Pain-free Knee Range of Motion at 1st hour, 3rd week, and 7th week
Time frame: Baseline (week 0), 1st hour, 3rd week , 7th week
Change from Baseline Physical Function at 1st hour, 3rd week, and 7th week
Time frame: Baseline (week 0), 1st hour, 3rd week , 7th week
Change from Baseline Static Postural Stability at 1st hour, 3rd week, and 7th week
Time frame: Baseline (week 0), 1st hour, 3rd week , 7th week
Change from Baseline Dynamic Postural Stability at 1st hour, 3rd week, and 7th week
Time frame: Baseline (week 0), 1st hour, 3rd week , 7th week
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 28 Apr 2022.
- Background: PubMed 31908149Kolasinski 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.
- Background: PubMed 32372651Donec 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.
- Background: PubMed 27149590Kaya 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.
- Background: PubMed 27320828Wageck 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.
- Background: PubMed 25706053Cho 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.
- 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.
Nesibe Doğan, MD principal investigator
University of Health Sciences Izmir Bozyaka Training and Research Hospital
Hayriye Yılmaz, MSc, PT study chair
University of Health Sciences Izmir Bozyaka Training and Research Hospital
Buğra İnce, MD study chair
University of Health Sciences Izmir Bozyaka Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotape and Home-based exercise program in people with Osteoarthritis, Knee, run by Bozyaka Training and Research Hospital 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 4 inclusion and 9 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 28 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 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?
Change from Baseline Pain intensity-rest at 1st hour, 3rd week, and 7th week (time frame: Baseline (week 0), 1st hour, 3rd week, 7th week). The study lists 2 primary outcomes in all. 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 NCT05351996, which also lists 5 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 28 Apr 2022.