Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07609056

The Role of Rumination and Worry in Pain and Functional Limitation in Knee Osteoarthritis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

About this study

Knee osteoarthritis is one of the most common degenerative joint diseases and represents a major cause of pain, disability, and reduced quality of life in older adults. Although radiographic severity is commonly used to evaluate disease progression, clinical symptoms often show substantial variability among patients with similar structural findings. This discrepancy suggests that factors beyond structural joint degeneration may contribute to pain perception and functional impairment in osteoarthritis.

Rumination is a repetitive and difficult-to-control cognitive process characterized by persistent focus on negative thoughts, bodily symptoms, or distressing experiences. Similarly, worry reflects excessive and uncontrollable concern about potential threats or adverse outcomes. Both cognitive processes may increase attentional focus on pain-related sensations and contribute to heightened pain perception, emotional distress, and functional limitation. Previous studies have demonstrated associations between psychological factors and chronic pain outcomes; however, the simultaneous effects of rumination and worry on osteoarthritis-related pain and functional status, while considering radiographic disease severity, remain insufficiently investigated.

The purpose of this observational study is to evaluate the relationships between radiographic osteoarthritis severity, pain severity, functional limitation, rumination, and worry in patients with knee osteoarthritis. Participants presenting with knee pain and diagnosed with osteoarthritis based on radiographic evaluation will be included. Radiographic severity will be graded according to the Kellgren-Lawrence classification system. Psychological and clinical assessments will include 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 primary objective of the study is to determine whether rumination and worry are independently associated with pain severity and functional limitation after accounting for radiographic osteoarthritis severity. Secondary analyses will investigate the relationships between psychological measures and WOMAC subscales, as well as the extent to which psychological factors may contribute to symptom severity disproportionate to structural disease burden.

The findings of this study may contribute to a better understanding of the biopsychosocial mechanisms underlying pain in knee osteoarthritis and may support the development of multidisciplinary treatment strategies that integrate psychological assessment into routine clinical care.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Ruminative Thought Style Questionnaire Score in Patients with Knee Osteoarthritis

    Time frame: Baseline assessment at study enrollment

    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.

Secondary outcomes

  1. Visual Analog Scale (VAS) Pain Score

    Time frame: Baseline assessment at study enrollment

    Pain severity will be assessed using the Visual Analog Scale (VAS), scored from 0 to 10, with higher scores indicating greater pain severity.

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

    Time frame: Baseline assessment at study enrollment

    Functional limitation and symptom severity will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a 24-item self-report questionnaire evaluating pain (5 items), stiffness (2 items), and physical function (17 items) in patients with osteoarthritis. Items are scored on a 0-4 Likert scale, with higher scores indicating greater symptom severity and functional limitation.

  3. Penn State Worry Questionnaire Score

    Time frame: Baseline assessment at study enrollment

    Worry severity will be assessed using the Penn State Worry Questionnaire, a 16-item self-report scale scored on a 1-5 Likert scale. Total scores range from 16 to 80, with higher scores indicating greater worry severity.

  4. Kellgren-Lawrence Radiographic Grade

    Time frame: Baseline assessment at study enrollment

    Radiographic osteoarthritis severity will be assessed using the Kellgren-Lawrence grading system, ranging from Grade 0 to Grade 4, with higher grades indicating more severe radiographic osteoarthritis. Grade 1 indicates doubtful or minimal osteophyte formation; Grade 2 indicates definite osteophytes with mild joint space narrowing; Grade 3 indicates definite joint space narrowing, osteophytes, and subchondral sclerosis; and Grade 4 indicates severe joint space loss, marked bony deformity, and cystic changes.

Sponsors and collaborators

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Other

Registry information

Official study title

The Role of Rumination and Worry in Pain and Functional Limitation in Patients With Knee Osteoarthritis: A Cross-Sectional Study Considering Radiographic Severity

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 27, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.