Osteoarthritis, KneeNCT05741996
Do Taping and Orthosis Affect Pain, Gait, or Functionality in Mild Knee Osteoarthritis?
A study testing Taping in people with Osteoarthritis, Knee, run by Hacettepe University at 2 sites in Turkey (Türkiye).
Trial summary
Objective: The aim of this study was to compare the effects of elastic taping, rigid taping, and braces applied to women with mild knee Osteoartritis(OA) on pain, gait, and knee functionality. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Taping
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 5 Jan 2023to 20 Jan 2023
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- bilateral knee OA according to the criteria of the American College of Rheumatology
- had radiographically phase 2 based on the criteria identified by Kellgren \& Lawrence
- -, had active knee pain
- did not receive any knee treatment in the last year
- could understand test and evaluations
Who cannot join
- experienced lower extremity trauma or underwent surgery
- had phase 3-4 Osteoarthritis
- had any orthopedic or neurologic problem affecting walking
- were allergic to taping
- did not walk independently on their own
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Tezel Yıldırım Şahan
Ankara, 06018
University of Health Science
Ankara, 06018
About this study
Official title: Do Taping and Orthosis Affect Pain, Gait, or Functionality in Mild Knee Osteoarthritis? A Randomized Clinical Trial
Objective: The aim of this study was to compare the effects of elastic taping, rigid taping, and braces applied to women with mild knee Osteoartritis(OA) on pain, gait, and knee functionality.
Methods: This randomised study included 21 female patients (mean age of 53.81±6.20 years) with bilateral grade 2 knee OA according to the Kellgren \& Lawrence Classification. Pain was evaluated with the visual analog scale, functionality was evaluated with the Western Ontario McMaster Osteoarthritis Index, and the kinetic, kinematic, and spatiotemporal parameters were evaluated using a three-dimensional gait analysis system at baseline (no application) and immediately after the application of elastic taping, rigid taping, and orthoses. The dependent variables were measured after 45 minute the application of four different conditions neutral, elastic taping, rigid taping, and knee brace on each participant with 1-day intervals.
Read the detailed description
Objective: The aim of this study was to compare the effects of elastic taping, rigid taping, and braces applied to women with mild knee OA on pain, gait, and knee functionality.
Methods: This randomised study included 21 female patients (mean age of 53.81±6.20 years) with bilateral grade 2 knee OA according to the Kellgren \& Lawrence Classification. Pain was evaluated with the visual analog scale, functionality was evaluated with the Western Ontario McMaster Osteoarthritis Index, and the kinetic, kinematic, and spatiotemporal parameters were evaluated using a three-dimensional gait analysis system at baseline (no application) and immediately after the application of elastic taping, rigid taping, and orthoses. The dependent variables were measured after 45 minute the application of four different conditions neutral, elastic taping, rigid taping, and knee brace on each participant with 1-day intervals.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Taping
- Keywords
- knee osteoarthritis, athletic tape, brace, kinesiotape, gait
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TapingBehavioural
Also called Brace
Taping types and brace acute effects for knee osteoartritis
| Study group | Role | What they receive |
|---|---|---|
| Effetcs of Taping type and Orthosis on Pain, | Experimental | The order of the elastic taping, rigid taping, and braces was randomized using a computer-generated random sequence created before the research (Random.org). Both knees of each participant were taped and braced. The participants were allowed to become accustomed to the applied elastic taping, rigid taping, and braces before the gait analysis and evaluations. All the taping techniques and braces were similar for all the participants. The participants performed four evaluation condition trials at baseline and with the elastic taping, rigid taping, and braces after 45 minutes. Receives: Behavioral: Taping |
| Effetcs of Taping type and Orthosis on Gait and functionality | Experimental | The Western Ontario and McMaster Universities Turkish Version 3.1 (WOMAC) index is a self-administered questionnaire that assesses three aspects of a patient's health status -pain, stiffness, and physical function - in those with lower limb Osteoarthritis.
Gait analysis was conducted using a 3-dimensional VICON gait analysis system (Workstation Version 4.0, Oxford, UK). Each participant was assessed four times before and after the applications. Receives: Behavioral: Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Maasurements
effects of them on pain
Measured: 5 minute
Secondary outcomes (1)
Gait Measurements, Functionality Measurement
effects of them on gait and functionality
Measured: 10 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start5 Jan 2023
- Primary completion10 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tezel Yıldırım Şahan, Hacettepe University
- Investigators
- Tezel Y Şahan, pHD, Principal investigator, University of Health science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741996
- Sponsor's protocol ID
- 2023-01
- Status last verified
- Oct 2023
- First submitted
- 2 Feb 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If they want from corresponding author then can be shaberable.
Publications
Anvar N, Matlabi H, Safaiyan A, Allahverdipour H, Kolahi S. Effectiveness of self-management program on arthritis symptoms among older women: A randomized controlled trial study. Health Care Women Int. 2018 Dec;39(12):1326-1339. doi: 10.1080/07399332.2018.1438438. Epub 2018 Mar 5.
PubMed 29419362DeVita P, Aaboe J, Bartholdy C, Leonardis JM, Bliddal H, Henriksen M. Quadriceps-strengthening exercise and quadriceps and knee biomechanics during walking in knee osteoarthritis: A two-centre randomized controlled trial. Clin Biomech (Bristol). 2018 Nov;59:199-206. doi: 10.1016/j.clinbiomech.2018.09.016. Epub 2018 Sep 15.
PubMed 30273922Teo PL, Hinman RS, Egerton T, Dziedzic KS, Bennell KL. Identifying and Prioritizing Clinical Guideline Recommendations Most Relevant to Physical Therapy Practice for Hip and/or Knee Osteoarthritis. J Orthop Sports Phys Ther. 2019 Jul;49(7):501-512. doi: 10.2519/jospt.2019.8676.
PubMed 31258044
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Taping and Orthosis Affect Pain, Gait, or Functionality in Mild Knee Osteoarthritis? A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05741996
- Acronym / sponsor ID
- 2023-01
- Conditions
- Osteoarthritis, Knee
- Keywords
- knee osteoarthritis, athletic tape, brace, kinesiotape, gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 23 Feb 2023 (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.
Objective: The aim of this study was to compare the effects of elastic taping, rigid taping, and braces applied to women with mild knee Osteoartritis(OA) on pain, gait, and knee functionality.
Methods: This randomised study included 21 female patients (mean age of 53.81±6.20 years) with bilateral grade 2 knee OA according to the Kellgren \& Lawrence Classification. Pain was evaluated with the visual analog scale, functionality was evaluated with the Western Ontario McMaster Osteoarthritis Index, and the kinetic, kinematic, and spatiotemporal parameters were evaluated using a three-dimensional gait analysis system at baseline (no application) and immediately after the application of elastic taping, rigid taping, and orthoses. The dependent variables were measured after 45 minute the application of four different conditions neutral, elastic taping, rigid taping, and knee brace on each participant with 1-day intervals.
Detailed description
Objective: The aim of this study was to compare the effects of elastic taping, rigid taping, and braces applied to women with mild knee OA on pain, gait, and knee functionality.
Methods: This randomised study included 21 female patients (mean age of 53.81±6.20 years) with bilateral grade 2 knee OA according to the Kellgren \& Lawrence Classification. Pain was evaluated with the visual analog scale, functionality was evaluated with the Western Ontario McMaster Osteoarthritis Index, and the kinetic, kinematic, and spatiotemporal parameters were evaluated using a three-dimensional gait analysis system at baseline (no application) and immediately after the application of elastic taping, rigid taping, and orthoses. The dependent variables were measured after 45 minute the application of four different conditions neutral, elastic taping, rigid taping, and knee brace on each participant with 1-day intervals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effetcs of Taping type and Orthosis on Pain, | Experimental | Behavioral: TapingThe order of the elastic taping, rigid taping, and braces was randomized using a computer-generated random sequence created before the research (Random.org). Both knees of each participant were taped and braced. The participants were allowed to become accustomed to the applied elastic taping, rigid taping, and braces before the gait analysis and evaluations. All the taping techniques and braces were similar for all the participants. The participants performed four evaluation condition trials at baseline and with the elastic taping, rigid taping, and braces after 45 minutes. |
| Effetcs of Taping type and Orthosis on Gait and functionality | Experimental | Behavioral: TapingThe Western Ontario and McMaster Universities Turkish Version 3.1 (WOMAC) index is a self-administered questionnaire that assesses three aspects of a patient's health status -pain, stiffness, and physical function - in those with lower limb Osteoarthritis. Gait analysis was conducted using a 3-dimensional VICON gait analysis system (Workstation Version 4.0, Oxford, UK). Each participant was assessed four times before and after the applications. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- bilateral knee OA according to the criteria of the American College of Rheumatology
- had radiographically phase 2 based on the criteria identified by Kellgren \& Lawrence
- -, had active knee pain
- did not receive any knee treatment in the last year
- could understand test and evaluations
Key exclusion criteria (5 listed)
- experienced lower extremity trauma or underwent surgery
- had phase 3-4 Osteoarthritis
- had any orthopedic or neurologic problem affecting walking
- were allergic to taping
- did not walk independently on their own
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 |
|---|---|---|
| TapingAlso: BraceTaping types and brace acute effects for knee osteoartritis | Behavioural | Effetcs of Taping type and Orthosis on Gait and functionality, Effetcs of Taping type and Orthosis on Pain, |
Primary outcome
Pain Maasurements
Time frame: 5 minute
effects of them on pain
1 secondary outcome
Gait Measurements, Functionality Measurement
Time frame: 10 minute
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 13 Oct 2023.
- Results publication: PubMed 29419362Anvar N, Matlabi H, Safaiyan A, Allahverdipour H, Kolahi S. Effectiveness of self-management program on arthritis symptoms among older women: A randomized controlled trial study. Health Care Women Int. 2018 Dec;39(12):1326-1339. doi: 10.1080/07399332.2018.1438438. Epub 2018 Mar 5.
- Results publication: PubMed 30273922DeVita P, Aaboe J, Bartholdy C, Leonardis JM, Bliddal H, Henriksen M. Quadriceps-strengthening exercise and quadriceps and knee biomechanics during walking in knee osteoarthritis: A two-centre randomized controlled trial. Clin Biomech (Bristol). 2018 Nov;59:199-206. doi: 10.1016/j.clinbiomech.2018.09.016. Epub 2018 Sep 15.
- Results publication: PubMed 31258044Teo PL, Hinman RS, Egerton T, Dziedzic KS, Bennell KL. Identifying and Prioritizing Clinical Guideline Recommendations Most Relevant to Physical Therapy Practice for Hip and/or Knee Osteoarthritis. J Orthop Sports Phys Ther. 2019 Jul;49(7):501-512. doi: 10.2519/jospt.2019.8676.
- Individual participant dataSharing planned: No. If they want from corresponding author then can be shaberable.
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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.
Tezel Y Şahan, pHD principal investigator
University of Health science
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taping in people with Osteoarthritis, Knee, run by Hacettepe University at 2 sites 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 5 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 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Pain Maasurements (time frame: 5 minute). 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 NCT05741996, which also lists 3 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 13 Oct 2023.