Osteo Arthritis KneeNCT07609056
The Role of Rumination and Worry in Pain and Functional Limitation in Knee Osteoarthritis
An observational study of Osteo Arthritis Knee and Worries; Pain or Disability, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteo Arthritis Knee, Worries; Pain or Disability, Rumination
- How many people
- 103 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, Atasehir, 34752
About this study
Official title: The Role of Rumination and Worry in Pain and Functional Limitation in Patients With Knee Osteoarthritis: A Cross-Sectional Study Considering Radiographic Severity
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.
Read the detailed description
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.
- Keywords
- Knee Osteoarthritis, Rumination, Worry, WOMAC, Pain, Kellgren-Lawrence
- Medical subject headings
- Pain, Rumination Syndrome, Osteoarthritis, Knee
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 | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline assessment at study enrollment
Secondary outcomes (4)
Visual Analog Scale (VAS) Pain Score
Pain severity will be assessed using the Visual Analog Scale (VAS), scored from 0 to 10, with higher scores indicating greater pain severity.
Measured: Baseline assessment at study enrollment
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
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.
Measured: Baseline assessment at study enrollment
Penn State Worry Questionnaire Score
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.
Measured: Baseline assessment at study enrollment
Kellgren-Lawrence Radiographic Grade
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.
Measured: Baseline assessment at study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Mar 2026
- Primary completion20 May 2026
- Study completion1 Jun 2026
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 Osteo Arthritis KneeStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olcay Yavuz, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609056
- Sponsor's protocol ID
- W-RUM-OA-2026
- Status last verified
- Aug 2026
- First submitted
- 19 May 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 2076086Nwankwo 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.
PubMed 33933091Panwar 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.
PubMed 41029374
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Rumination and Worry in Pain and Functional Limitation in Patients With Knee Osteoarthritis: A Cross-Sectional Study Considering Radiographic Severity
- ClinicalTrials.gov ID
- NCT07609056
- Acronym / sponsor ID
- W-RUM-OA-2026
- Keywords
- Knee Osteoarthritis, Rumination, Worry, WOMAC, Pain, Kellgren-Lawrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 27 May 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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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
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.
4 secondary outcomes
Visual Analog Scale (VAS) Pain Score
Time frame: Baseline assessment at study enrollment
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
Time frame: Baseline assessment at study enrollment
Penn State Worry Questionnaire Score
Time frame: Baseline assessment at study enrollment
Kellgren-Lawrence Radiographic Grade
Time frame: Baseline assessment at study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 2076086Meyer 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.
- Background: PubMed 33933091Nwankwo 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.
- Background: PubMed 41029374Panwar 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.
- Karatepe HT, Yavuz FK, Turkcan A. Validity and reliability of the Turkish version of the Ruminative Thought Style Questionnaire. Psychiatry Clin Psychopharmacol. \[Internet\]. 2021 Feb. 22 \[cited 2026 May 20\];23(3):231-4.Link provided by the sponsor.
- Boysan M, Keskin S, Beşiroğlu L. Assessment of hierarchical factor structure, reliability and validity of penn state worry questionnaire turkish version. Psychiatry Clin Psychopharmacol. \[Internet\]. 2021 Mar. 4 \[cited 2026 May 20\];18(3):174-82.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteo Arthritis Knee and Worries; Pain or Disability, run by Fatih Sultan Mehmet Training and Research Hospital 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 1 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ruminative Thought Style Questionnaire Score in Patients with Knee Osteoarthritis (time frame: Baseline assessment at study enrollment). 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 NCT07609056, 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 1 Sep 2026.