NCT07609056

Brief Summary

Knee osteoarthritis is a common degenerative joint disease in which pain severity often does not fully correspond with radiographic disease severity. Psychological processes such as rumination and worry may contribute to differences in pain perception and functional limitation among patients with similar structural disease burden. The purpose of this observational study is to investigate the relationships between radiographic osteoarthritis severity, pain severity, functional limitation, rumination, and worry in patients with knee osteoarthritis. Radiographic severity will be assessed using the Kellgren-Lawrence classification. Participants will complete the Penn State Worry Questionnaire, the Ruminative Thought Style Questionnaire, the Visual Analog Scale (VAS), and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The study aims to determine whether rumination and worry are associated with pain severity and functional impairment independently of radiographic osteoarthritis severity. Findings from this study may improve understanding of the biopsychosocial mechanisms underlying pain perception in knee osteoarthritis and may support the development of multidisciplinary treatment approaches that incorporate psychological factors into patient assessment and management.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2026

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 19, 2026

Last Update Submit

May 27, 2026

Conditions

Keywords

Knee OsteoarthritisRuminationWorryWOMACPainKellgren-Lawrence

Outcome Measures

Primary Outcomes (1)

  • Ruminative Thought Style Questionnaire Score in Patients with Knee Osteoarthritis

    Rumination severity will be assessed using the Ruminative Thought Style Questionnaire, a 20-item self-report scale evaluating repetitive and difficult-to-control negative thinking patterns. Each item is scored on a 1-7 Likert scale, with higher total scores indicating greater rumination severity.

    Baseline assessment at study enrollment

Secondary Outcomes (4)

  • Visual Analog Scale (VAS) Pain Score

    Baseline assessment at study enrollment

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score

    Baseline assessment at study enrollment

  • Penn State Worry Questionnaire Score

    Baseline assessment at study enrollment

  • Kellgren-Lawrence Radiographic Grade

    Baseline assessment at study enrollment

Study Arms (1)

Patients With Knee Osteoarthritis

Participants presenting with knee pain who are diagnosed with knee osteoarthritis based on radiographic evaluation will be included in this observational study. Radiographic severity will be classified according to the Kellgren-Lawrence grading system. Participants will complete questionnaires assessing worry, rumination, pain severity, and functional limitation, including the Penn State Worry Questionnaire, Ruminative Thought Style Questionnaire, Visual Analog Scale (VAS), and WOMAC.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults presenting with knee pain to the orthopedic and traumatology outpatient clinic who are diagnosed with knee osteoarthritis based on radiographic evaluation will be enrolled in this observational study. Participants will undergo assessment of radiographic osteoarthritis severity, pain severity, functional limitation, rumination, and worry using validated clinical and psychological questionnaires.

You may qualify if:

  • Age 18 years or older
  • Diagnosis of knee osteoarthritis confirmed by radiographic evaluation
  • Ability and willingness to provide informed consent
  • Ability to complete study questionnaires

You may not qualify if:

  • Presence of comorbid conditions that may cause knee pain other than osteoarthritis
  • Analgesic medication use within the previous week
  • Cognitive impairment or psychiatric conditions that may interfere with questionnaire completion, including dementia, intellectual disability, or psychotic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Atasehir, 34752, Turkey (Türkiye)

Location

Related Publications (3)

  • Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. doi: 10.1016/0005-7967(90)90135-6.

    PMID: 2076086BACKGROUND
  • Nwankwo VC, Jiranek WA, Green CL, Allen KD, George SZ, Bettger JP. Resilience and pain catastrophizing among patients with total knee arthroplasty: a cohort study to examine psychological constructs as predictors of post-operative outcomes. Health Qual Life Outcomes. 2021 May 1;19(1):136. doi: 10.1186/s12955-021-01772-2.

    PMID: 33933091BACKGROUND
  • Panwar P, Chaurasia S, Gangrade J, Bilandi A. Early diagnosis of knee osteoarthritis severity using vision transformer. BMC Musculoskelet Disord. 2025 Sep 30;26(1):884. doi: 10.1186/s12891-025-09137-2.

    PMID: 41029374BACKGROUND

Related Links

MeSH Terms

Conditions

PainRumination SyndromeOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGastrointestinal DiseasesDigestive System DiseasesFeeding and Eating DisordersMental DisordersOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Olcay Yavuz, MD, Principal Investigator

Study Record Dates

First Submitted

May 19, 2026

First Posted

May 27, 2026

Study Start

March 1, 2026

Primary Completion

May 20, 2026

Study Completion

June 1, 2026

Last Updated

May 29, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data collected during the study will not be shared. Only de-identified aggregate study results may be presented in scientific publications or presentations.

Locations