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RecruitingNCT07869680Updated Oct 9, 2026

Functional Capacity Differences in Knee Osteoarthritis With Similar Pain Severity

An observational study in Knee Osteoarthritis, sponsored by Mardin Artuklu University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Mardin Artuklu University · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Oct 9, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
120
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • Functional Capacity
  • Central Sensitization
  • Physical Activity
  • Western Ontario and McMaster Universities Osteoarthritis Index
  • Knee Osteoarthritis
03

In context

Osteoarthritis, Knee

3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.

This study's planned enrollment of 120 is above the median of 100 across 484 observational studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Mardin Artuklu University is the lead sponsor of 32 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

  4. 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.

    Time frame: Baseline

  5. 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.

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • Mardin Training and Research Hospital
    Mardin, 47100, Turkey (Türkiye)
    Recruiting
08

References and documents

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 15639634 ↗
  • White 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 24923633 ↗
  • Neogi 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 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2026 (actual). Primary completion is estimated for May 2027, 9 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2026
First posted
Oct 9, 2026
StartActual
Aug 1, 2026
Primary completionEst.
May 1, 2027
CompletionEst.
May 1, 2027
Last update
Oct 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07869680
Lead sponsor
Mardin Artuklu University
Collaborators
Mardin Training and Research Hospital
Responsible party
Taha Yasin YILDIRIM (M.D., Mardin Artuklu University) — Principal investigator
First posted
Oct 9, 2026
Start date
Aug 1, 2026
Primary completion
May 1, 2027 (estimated)
Completion
May 1, 2027 (estimated)
Last update
Oct 9, 2026

Study contacts

Taha Yasin YILDIRIM, M.D.
Contact
tyasinyildirim.ftr@gmail.com
+90 534 220 77 17

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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