Knee OsteoarthritisNCT07869680
Functional Capacity Differences in Knee Osteoarthritis With Similar Pain Severity
An observational study of Knee Osteoarthritis, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
Trial summary
People with knee osteoarthritis may have similar levels of pain but very different abilities to walk, rise from a chair, and perform daily activities. This study aims to examine the factors associated with these differences in functional capacity among patients with similar knee pain severity. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 1 May 2027
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adults attending the Physical Medicine and Rehabilitation outpatient clinic of Mardin Training and Research Hospital with clinical and radiographic knee osteoarthritis. Only patients with Kellgren-Lawrence grade 2 or 3 disease and similar moderate knee pain severity will be included. No healthy control group will be enrolled.
Who may be able to join
- Age 40-75 years
- Clinical and radiographic diagnosis of knee osteoarthritis
- Kellgren-Lawrence grade 2 or 3 knee osteoarthritis
- Knee pain lasting at least 3 months
- Average knee pain intensity during the previous week between 4 and 6 on a 0-10 visual analog scale
- Ability to provide written informed consent
Who cannot join
- Kellgren-Lawrence grade 1 or 4 knee osteoarthritis
- Inflammatory rheumatic disease
- History of knee surgery or intra-articular knee injection within the previous 6 months
- Neurological disease that substantially affects knee function
- Severe cardiopulmonary disease that prevents walking or performance testing
- Cognitive impairment that prevents participation in the assessment procedures
- For participants with bilateral knee osteoarthritis, assessments will be performed on the more painful knee.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mardin Training and Research Hospital
Mardin, 47100
Taha Yasin YILDIRIM, M.D., +90 534 220 77 17, tyasinyildirim.ftr@gmail.com
About this study
Official title: Evaluation of Functional Capacity Heterogeneity in Patients With Knee Osteoarthritis and Similar Pain Severity
People with knee osteoarthritis may have similar levels of pain but very different abilities to walk, rise from a chair, and perform daily activities. This study aims to examine the factors associated with these differences in functional capacity among patients with similar knee pain severity.
Adults with radiographic knee osteoarthritis and an average knee pain level of 4-6 on a 0-10 scale will be included. During a single study visit, participants will complete questionnaires about physical function, central sensitization-related symptoms, and physical activity. They will also perform a 10-meter walk test, a 30-second chair stand test, and the Timed Up and Go test.
Self-reported physical function will be assessed using the function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index. Participants with better and poorer function will be compared, and the clinical factors independently associated with functional capacity will be examined. No treatment or intervention will be assigned as part of this study.
Read the detailed description
Pain severity does not fully explain functional limitation in knee osteoarthritis. Patients with similar levels of knee pain may differ substantially in their ability to perform daily activities and physical tasks. This study will examine functional capacity within a group of patients whose pain severity is restricted to a similar moderate range.
In this study, "functional reserve" refers to the relative preservation of function among patients with comparable pain intensity. It is a study-specific operational concept rather than a separate validated measurement scale. Functional capacity will be evaluated using the function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index. Higher scores indicate greater functional limitation.
The primary analysis will use the function score as a continuous variable in the full study sample. Multivariable linear regression will be used to examine whether demographic and clinical characteristics, radiographic disease severity, central sensitization-related symptom burden, and physical activity are independently associated with functional capacity.
An additional group-based analysis will compare participants in the lowest 25% and highest 25% of the function score distribution. The lowest quartile, representing less functional limitation, will be defined as the higher functional reserve group. The highest quartile, representing greater functional limitation, will be defined as the lower functional reserve group. These groups will be compared in terms of objective physical performance and relevant clinical characteristics. This approach will be used to explore why patients with similar pain severity may have markedly different levels of function.
- Conditions
- Knee Osteoarthritis
- Keywords
- Functional Capacity, Central Sensitization, Physical Activity, Western Ontario and McMaster Universities Osteoarthritis Index, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
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 |
|---|---|---|
| Patients With Knee Osteoarthritis | Adults aged 40-75 years with clinical and radiographic knee osteoarthritis of Kellgren-Lawrence grade 2 or 3 and an average knee pain intensity of 4-6 on a 0-10 visual analog scale during the previous week.d. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Physical Function Assessed by the WOMAC Function Subscale
Self-reported functional limitation will be assessed using the 17-item function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Each item is scored from 0 to 4, producing a total score ranging from 0 to 68. Higher scores indicate greater functional limitation and worse physical function.
Measured: Baseline
Secondary outcomes (5)
Walking Speed Assessed by the 10-Meter Walk Test
Participants will walk a 10-meter distance at their usual walking pace. Completion time will be recorded in seconds, and walking speed will be calculated in meters per second. Higher walking speed indicates better physical performance.
Measured: Baseline
Chair Stand Performance Assessed by the 30-Second Chair Stand Test
The number of complete sit-to-stand repetitions performed within 30 seconds will be recorded. The score has a minimum of 0 repetitions and no predefined maximum. A higher number of repetitions indicates better lower-extremity functional performance.
Measured: Baseline
Functional Mobility Assessed by the Timed Up and Go Test
The time required to stand up from a chair, walk 3 meters, turn, return to the chair, and sit down will be recorded in seconds. The measure has a minimum of 0 seconds and no predefined maximum. A longer completion time indicates poorer functional mobility.
Measured: Baseline
Central Sensitization-Related Symptom Burden Assessed by the Central Sensitization Inventory
Central sensitization-related symptom burden will be assessed using Part A of the 25-item Central Sensitization Inventory. Each item is scored from 0 to 4, producing a total score ranging from 0 to 100. Higher scores indicate a greater burden of central sensitization-related symptoms.
Measured: Baseline
Weekly Physical Activity Duration
The total duration of walking and/or moderate-intensity physical activity performed during the previous week will be recorded in minutes per week. Higher values indicate a longer duration of physical activity. Participants will also be categorized as performing less than 150 minutes or at least 150 minutes of physical activity per week.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Aug 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
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 Knee 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Collaborators
- Mardin Training and Research Hospital
- Responsible party
- Principal investigator, Taha Yasin YILDIRIM, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869680
- Sponsor's protocol ID
- MEAH-PMR-TYY1
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 9 Oct 2026
- 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 15639634White DK, Tudor-Locke C, Zhang Y, Fielding R, LaValley M, Felson DT, Gross KD, Nevitt MC, Lewis CE, Torner J, Neogi T. Daily walking and the risk of incident functional limitation in knee osteoarthritis: an observational study. Arthritis Care Res (Hoboken). 2014 Sep;66(9):1328-36. doi: 10.1002/acr.22362.
PubMed 24923633Neogi T. The epidemiology and impact of pain in osteoarthritis. Osteoarthritis Cartilage. 2013 Sep;21(9):1145-53. doi: 10.1016/j.joca.2013.03.018.
PubMed 23973124
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Functional Capacity Heterogeneity in Patients With Knee Osteoarthritis and Similar Pain Severity
- ClinicalTrials.gov ID
- NCT07869680
- Acronym / sponsor ID
- MEAH-PMR-TYY1
- Conditions
- Knee Osteoarthritis
- Keywords
- Functional Capacity, Central Sensitization, Physical Activity, Western Ontario and McMaster Universities Osteoarthritis Index, Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Collaborators
- Mardin Training and Research Hospital
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 9 Oct 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.
People with knee osteoarthritis may have similar levels of pain but very different abilities to walk, rise from a chair, and perform daily activities. This study aims to examine the factors associated with these differences in functional capacity among patients with similar knee pain severity.
Adults with radiographic knee osteoarthritis and an average knee pain level of 4-6 on a 0-10 scale will be included. During a single study visit, participants will complete questionnaires about physical function, central sensitization-related symptoms, and physical activity. They will also perform a 10-meter walk test, a 30-second chair stand test, and the Timed Up and Go test.
Self-reported physical function will be assessed using the function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index. Participants with better and poorer function will be compared, and the clinical factors independently associated with functional capacity will be examined. No treatment or intervention will be assigned as part of this study.
Detailed description
Pain severity does not fully explain functional limitation in knee osteoarthritis. Patients with similar levels of knee pain may differ substantially in their ability to perform daily activities and physical tasks. This study will examine functional capacity within a group of patients whose pain severity is restricted to a similar moderate range.
In this study, "functional reserve" refers to the relative preservation of function among patients with comparable pain intensity. It is a study-specific operational concept rather than a separate validated measurement scale. Functional capacity will be evaluated using the function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index. Higher scores indicate greater functional limitation.
The primary analysis will use the function score as a continuous variable in the full study sample. Multivariable linear regression will be used to examine whether demographic and clinical characteristics, radiographic disease severity, central sensitization-related symptom burden, and physical activity are independently associated with functional capacity.
An additional group-based analysis will compare participants in the lowest 25% and highest 25% of the function score distribution. The lowest quartile, representing less functional limitation, will be defined as the higher functional reserve group. The highest quartile, representing greater functional limitation, will be defined as the lower functional reserve group. These groups will be compared in terms of objective physical performance and relevant clinical characteristics. This approach will be used to explore why patients with similar pain severity may have markedly different levels of function.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Knee Osteoarthritis | – | –Adults aged 40-75 years with clinical and radiographic knee osteoarthritis of Kellgren-Lawrence grade 2 or 3 and an average knee pain intensity of 4-6 on a 0-10 visual analog scale during the previous week.d. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adults attending the Physical Medicine and Rehabilitation outpatient clinic of Mardin Training and Research Hospital with clinical and radiographic knee osteoarthritis. Only patients with Kellgren-Lawrence grade 2 or 3 disease and similar moderate knee pain severity will be included. No healthy control group will be enrolled.
Key inclusion criteria (6 listed)
- Age 40-75 years
- Clinical and radiographic diagnosis of knee osteoarthritis
- Kellgren-Lawrence grade 2 or 3 knee osteoarthritis
- Knee pain lasting at least 3 months
- Average knee pain intensity during the previous week between 4 and 6 on a 0-10 visual analog scale
Key exclusion criteria (7 listed)
- Kellgren-Lawrence grade 1 or 4 knee osteoarthritis
- Inflammatory rheumatic disease
- History of knee surgery or intra-articular knee injection within the previous 6 months
- Neurological disease that substantially affects knee function
- Severe cardiopulmonary disease that prevents walking or performance testing
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
Self-Reported Physical Function Assessed by the WOMAC Function Subscale
Time frame: Baseline
Self-reported functional limitation will be assessed using the 17-item function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Each item is scored from 0 to 4, producing a total score ranging from 0 to 68. Higher scores indicate greater functional limitation and worse physical function.
5 secondary outcomes
Walking Speed Assessed by the 10-Meter Walk Test
Time frame: Baseline
Chair Stand Performance Assessed by the 30-Second Chair Stand Test
Time frame: Baseline
Functional Mobility Assessed by the Timed Up and Go Test
Time frame: Baseline
Central Sensitization-Related Symptom Burden Assessed by the Central Sensitization Inventory
Time frame: Baseline
Weekly Physical Activity Duration
Time frame: Baseline
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 9 Oct 2026.
- 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 24923633White DK, Tudor-Locke C, Zhang Y, Fielding R, LaValley M, Felson DT, Gross KD, Nevitt MC, Lewis CE, Torner J, Neogi T. Daily walking and the risk of incident functional limitation in knee osteoarthritis: an observational study. Arthritis Care Res (Hoboken). 2014 Sep;66(9):1328-36. doi: 10.1002/acr.22362.
- Background: PubMed 23973124Neogi T. The epidemiology and impact of pain in osteoarthritis. Osteoarthritis Cartilage. 2013 Sep;21(9):1145-53. doi: 10.1016/j.joca.2013.03.018.
- 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.
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 Knee Osteoarthritis, run by Mardin Artuklu 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 9 Oct 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?
Contact Taha Yasin YILDIRIM, M.D. (+90 534 220 77 17, tyasinyildirim.ftr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Physical Function Assessed by the WOMAC Function Subscale (time frame: Baseline). 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 NCT07869680, 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 9 Oct 2026.