NCT07869680

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Aug 2026May 2027

Study Start

First participant enrolled

August 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

9 months

First QC Date

October 6, 2026

Last Update Submit

October 6, 2026

Conditions

Keywords

Functional CapacityCentral SensitizationPhysical ActivityWestern Ontario and McMaster Universities Osteoarthritis IndexKnee Osteoarthritis

Outcome Measures

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.

    Baseline

Secondary Outcomes (5)

  • Walking Speed Assessed by the 10-Meter Walk Test

    Baseline

  • Chair Stand Performance Assessed by the 30-Second Chair Stand Test

    Baseline

  • Functional Mobility Assessed by the Timed Up and Go Test

    Baseline

  • Central Sensitization-Related Symptom Burden Assessed by the Central Sensitization Inventory

    Baseline

  • Weekly Physical Activity Duration

    Baseline

Study Arms (1)

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.

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mardin Training and Research Hospital

Mardin, 47100, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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.

    PMID: 15639634BACKGROUND
  • 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.

    PMID: 24923633BACKGROUND
  • 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.

    PMID: 23973124BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeMotor Activity

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Central Study Contacts

Taha Yasin YILDIRIM, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

October 6, 2026

First Posted

October 9, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations