NCT06760338

Brief Summary

The aim of this study was to investigate the relationship between quality of life and factors that may affect quality of life (pain, stiffness, functional status and depression) in knee osteoarthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
174

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 30, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 6, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2025

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

December 30, 2024

Last Update Submit

August 11, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Numerical Rating Scale - NRS

    It is an 11-point scale with numbers from 0 to 10, with 0 indicating 'no pain' and 10 indicating 'the worst pain imaginable'. Patients are asked to choose a single number from the scale that best represents their level of pain.

    1 minute

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    WOMAC is a valid and reliable questionnaire that is frequently used in clinics and research in patients with knee OA. WOMAC is a self-administered assessment tool. It consists of 24 questions and three subcategories (pain, stiffness and physical function). Pain is assessed with 5 questions, stiffness with 2 questions and physical function with 17 questions. Each question is scored between 0-4 (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = extreme). Subcategories are evaluated within themselves. The maximum score is: 20 points for pain, 8 points for stiffness and 68 points for physical function. High WOMAC scores indicate an increase in pain and stiffness and deterioration in physical function.

    3 minute

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)

    It is a scale used to evaluate symptoms and functional status related to knee osteoarthritis. It consists of a total of 42 items and 5 subscales including pain, patient's views on other symptoms, activities of daily living, sports and recreational activities and knee-related quality of life. Each question is scored between 0 and 4 points. Each subscale is scored between 0-100 (0 indicates a serious problem and 100 indicates no problem).

    5 minute

  • Lower Extremity Functional Scale (LEFS)

    It is used to classify the functional status of individuals. LEFS is a 5-point Likert scale consisting of 20 questions with options (graded between 0 and 4 points). The total score ranges from 0-80. Higher scores represent a better functional status.

    2 minute

  • Beck Depression Scale

    The Beck Depression Scale is a self-report questionnaire that assesses the presence and severity of depressive symptoms. It consists of 21 items. Each item is scored on a four-point scale ranging from 0 (none) to 3 (severe). Total scores can vary between 0 and 63. The reliability and validity findings of the questionnaire adapted to Turkish have been obtained.

    5 minute

  • Short Form - 36 Quality of Life Questionnaire (SF-36)

    The Short Form - 36 Quality of Life Questionnaire (SF-36) is a general measure of health status, rather than measuring the outcomes of specific conditions. There is evidence that the SF-36 can be used to monitor musculoskeletal conditions. The SF-36 is a health-related quality of life questionnaire consisting of 8 scales (physical functioning, role limitations due to physical health problems, pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, mental health). Responses to items are converted into scale scores from 0 (worst health) to 100 (best health). One physical and one mental summary health measure are derived from the 8 scales.

    7 minute

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study will include people aged between 40-65 years, who volunteered to participate in the study and diagnosed with knee osteoarthritis.

You may qualify if:

  • Volunteering to participate in the study
  • Being diagnosed with knee osteoarthritis
  • In studies between the ages of 40 and 65

You may not qualify if:

  • Other orthopaedic surgery in the lower extremity
  • Cognitive impairment at a level that prevents understanding and answering the questionnaire
  • Presence of neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Science University

Kütahya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Emrah Afsar, Phd

    Kutahya Health Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

December 30, 2024

First Posted

January 6, 2025

Study Start

January 6, 2025

Primary Completion

July 25, 2025

Study Completion

July 25, 2025

Last Updated

August 12, 2025

Record last verified: 2025-08

Locations