OsteoarthritisNCT07417033
From Perception to Performance: A Comprehensive Evaluation in Knee Osteoarthritis.
An observational study of Osteoarthritis and Pain, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial summary
Knee Osteoarthritis (KOA) is commonly characterized by joint pain, swelling, stiffness, and a reduction in range of motion. These symptoms significantly affect daily activities and overall quality of life. A decrease in physical activity levels may further contribute to the deterioration of joint function over time. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Osteoarthritis, Pain, Function
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2024to 30 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants diagnosed with Knee Osteoarthritis
Who may be able to join
- Diagnosis of knee osteoarthritis at Kellgren-Lawrence Grade 2-3,
- Age between 45 and 75 years,
- A history of chronic knee pain lasting at least 6 months,
- Absence of other diagnosed pathologies that could cause knee joint pain,
- Willingness to participate in the study.
Who cannot join
- Body mass index greater than 35 kg/m²,
- A Lysholm Knee Score above 84,
- A history of physiotherapy treatment or intra-articular injection within the previous 6 months,
- A history of knee joint surgery,
- The presence of a cardiorespiratory condition that would prevent the performance of functional tests,
- The presence of a neuropsychiatric disorder that would interfere with the ability to follow instructions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding Function in Knee Osteoarthritis: Subjective and Objective Perspectives
Knee Osteoarthritis (KOA) is commonly characterized by joint pain, swelling, stiffness, and a reduction in range of motion. These symptoms significantly affect daily activities and overall quality of life. A decrease in physical activity levels may further contribute to the deterioration of joint function over time. Physiotherapy assessment plays a critical role in the management of KOA. Such assessment enables a comprehensive evaluation of parameters including pain intensity, joint range of motion, muscle strength, flexibility, functional status, and quality of life. The use of both subjective and objective assessment methods is essential for developing individualized and effective treatment plans.
Read the detailed description
Osteoarthritis-specific outcome measures such as the KOOS, WOMAC, and the Lequesne Algofunctional Osteoarthritis Index include subscales that question pain and physical function, thereby enabling the subjective assessment of pain. Among these instruments, the KOOS specifically allows the evaluation of sports and recreational activities as well as quality of life, WOMAC provides assessment of joint stiffness, and the Lequesne Algofunctional Osteoarthritis Index evaluates walking distance. Objectively, algometric measurements enable the determination of pain sensitivity. In addition, muscle strength can be assessed using a hand dynamometer and isokinetic devices; joint proprioception can be evaluated with inclinometers and isokinetic systems; and flexibility can be measured through standardized flexibility tests. Among objective functional test methods, the 30-second sit-to-stand test provides information regarding lower extremity strength, whereas the Timed Up and Go test is another objective tool used to assess lower extremity function and balance. For the objective evaluation of walking capacity, tests such as the 2-minute walk test, 6-minute walk test, and 20- and 40-meter walk tests may be employed. Within the scope of our study, knee joint function will be evaluated using the subjective measures WOMAC, the Lequesne Algofunctional Knee Index, and the Lysholm Knee Score, as well as the objective measures including the 2-minute walk test, the 30-second sit-to-stand test, and the 9-step stair test.
- Conditions
- Osteoarthritis, Pain, Function, Knee Joint Arthritis
- Keywords
- Knee OA specific functional outcome measures
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Knee Osteoarthritis | Objective and Subjective Knee Evaluation Methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Evaluation of the Knee Function 1
Knee joint function will be evaluated using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Total score ranges from 0 to 96. Higher scores indicate worse pain and functional limitation..
Measured: All tests will be performed at baseline.
Subjective Evaluation of the Knee Function 2
Knee joint function will be evaluated using the Lequesne Algofunctional Knee Index. The index ranges from 0 to 24 points. Higher scores indicate greater pain and functional disability. The scale evaluates pain, maximum walking distance, and activities of daily living. A higher total score reflects a worse clinical condition.
Measured: All tests will be performed at baseline.
Subjective Evaluation of the Knee Function 3
Knee joint function will be evaluated using the Lysholm Knee Score.The score ranges from 0 to 100 points. Higher scores indicate better knee function and fewer symptoms. The scale assesses limp, support, locking, instability, pain, swelling, stair climbing, and squatting ability.
Measured: All tests will be performed at baseline.
Objective Evaluation of the Knee Function 1
Knee joint function will be evaluated using the 2-minute walk test. The test measures the maximum distance walked in two minutes, expressed in meters. A greater walking distance indicates better functional exercise capacity and mobility. There is no fixed maximum score, as results depend on the individual's performance.
Measured: All tests will be performed at baseline.
Objective Evaluation of the Knee Function 2
Knee joint function will be evaluated using the 30-second sit-to-stand test which is one of the objective measures.The test measures the number of full stands completed from a seated position in 30 seconds. Results are expressed as repetition count. A higher number of repetitions indicates better lower-extremity strength and functional mobility. There is no fixed maximum score, as performance depends on the individual.
Measured: All tests will be performed at baseline.
Objective Evaluation of the Knee Function 3
Knee joint function will be evaluated using the 9-step stair test.which is one of the objective measures.The test measures the time required to ascend and/or descend a flight of nine stairs, expressed in seconds. A shorter completion time indicates better functional mobility, balance, and lower-extremity performance. There is no fixed minimum or maximum score, as results depend on individual performance.
Measured: All tests will be performed at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start28 Feb 2024
- Primary completion28 Feb 2025
- Study completion30 Jul 2026 (estimated)
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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Seda BAKTIR, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417033
- Sponsor's protocol ID
- LHU-FTR-ZSBD-05
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Function in Knee Osteoarthritis: Subjective and Objective Perspectives
- ClinicalTrials.gov ID
- NCT07417033
- Acronym / sponsor ID
- LHU-FTR-ZSBD-05
- Conditions
- Osteoarthritis, Pain, Function, Knee Joint Arthritis
- Keywords
- Knee OA specific functional outcome measures
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 18 Feb 2026 (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.
Knee Osteoarthritis (KOA) is commonly characterized by joint pain, swelling, stiffness, and a reduction in range of motion. These symptoms significantly affect daily activities and overall quality of life. A decrease in physical activity levels may further contribute to the deterioration of joint function over time. Physiotherapy assessment plays a critical role in the management of KOA. Such assessment enables a comprehensive evaluation of parameters including pain intensity, joint range of motion, muscle strength, flexibility, functional status, and quality of life. The use of both subjective and objective assessment methods is essential for developing individualized and effective treatment plans.
Detailed description
Osteoarthritis-specific outcome measures such as the KOOS, WOMAC, and the Lequesne Algofunctional Osteoarthritis Index include subscales that question pain and physical function, thereby enabling the subjective assessment of pain. Among these instruments, the KOOS specifically allows the evaluation of sports and recreational activities as well as quality of life, WOMAC provides assessment of joint stiffness, and the Lequesne Algofunctional Osteoarthritis Index evaluates walking distance. Objectively, algometric measurements enable the determination of pain sensitivity. In addition, muscle strength can be assessed using a hand dynamometer and isokinetic devices; joint proprioception can be evaluated with inclinometers and isokinetic systems; and flexibility can be measured through standardized flexibility tests. Among objective functional test methods, the 30-second sit-to-stand test provides information regarding lower extremity strength, whereas the Timed Up and Go test is another objective tool used to assess lower extremity function and balance. For the objective evaluation of walking capacity, tests such as the 2-minute walk test, 6-minute walk test, and 20- and 40-meter walk tests may be employed. Within the scope of our study, knee joint function will be evaluated using the subjective measures WOMAC, the Lequesne Algofunctional Knee Index, and the Lysholm Knee Score, as well as the objective measures including the 2-minute walk test, the 30-second sit-to-stand test, and the 9-step stair test.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee Osteoarthritis | – | –Objective and Subjective Knee Evaluation Methods |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed with Knee Osteoarthritis
Key inclusion criteria (5 listed)
- Diagnosis of knee osteoarthritis at Kellgren-Lawrence Grade 2-3,
- Age between 45 and 75 years,
- A history of chronic knee pain lasting at least 6 months,
- Absence of other diagnosed pathologies that could cause knee joint pain,
- Willingness to participate in the study.
Key exclusion criteria (6 listed)
- Body mass index greater than 35 kg/m²,
- A Lysholm Knee Score above 84,
- A history of physiotherapy treatment or intra-articular injection within the previous 6 months,
- A history of knee joint surgery,
- The presence of a cardiorespiratory condition that would prevent the performance of functional tests,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subjective Evaluation of the Knee Function 1
Time frame: All tests will be performed at baseline.
Knee joint function will be evaluated using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Total score ranges from 0 to 96. Higher scores indicate worse pain and functional limitation..
Subjective Evaluation of the Knee Function 2
Time frame: All tests will be performed at baseline.
Knee joint function will be evaluated using the Lequesne Algofunctional Knee Index. The index ranges from 0 to 24 points. Higher scores indicate greater pain and functional disability. The scale evaluates pain, maximum walking distance, and activities of daily living. A higher total score reflects a worse clinical condition.
Subjective Evaluation of the Knee Function 3
Time frame: All tests will be performed at baseline.
Knee joint function will be evaluated using the Lysholm Knee Score.The score ranges from 0 to 100 points. Higher scores indicate better knee function and fewer symptoms. The scale assesses limp, support, locking, instability, pain, swelling, stair climbing, and squatting ability.
Objective Evaluation of the Knee Function 1
Time frame: All tests will be performed at baseline.
Knee joint function will be evaluated using the 2-minute walk test. The test measures the maximum distance walked in two minutes, expressed in meters. A greater walking distance indicates better functional exercise capacity and mobility. There is no fixed maximum score, as results depend on the individual's performance.
Objective Evaluation of the Knee Function 2
Time frame: All tests will be performed at baseline.
Knee joint function will be evaluated using the 30-second sit-to-stand test which is one of the objective measures.The test measures the number of full stands completed from a seated position in 30 seconds. Results are expressed as repetition count. A higher number of repetitions indicates better lower-extremity strength and functional mobility. There is no fixed maximum score, as performance depends on the individual.
Objective Evaluation of the Knee Function 3
Time frame: All tests will be performed at baseline.
Knee joint function will be evaluated using the 9-step stair test.which is one of the objective measures.The test measures the time required to ascend and/or descend a flight of nine stairs, expressed in seconds. A shorter completion time indicates better functional mobility, balance, and lower-extremity performance. There is no fixed minimum or maximum score, as results depend on individual performance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- 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.
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?
An observational study of Osteoarthritis and Pain, run by Lokman Hekim 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: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Subjective Evaluation of the Knee Function 1 (time frame: All tests will be performed at baseline.). The study lists 6 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 18 Feb 2026.