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Completed

NCT Number: NCT06760338

Factors Associated With Quality of Life in Knee Osteoarthritis

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kutahya Health Science University

Kütahya, Turkey (Türkiye)

About this study

Participants aged between 40-65 years, willing to participate in the study and diagnosed with knee osteoarthritis will be included in the study. Necessary demographic information will be obtained with the prepared data form. Numerical Rating Scale (NRS), Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC Osteoarthritis Index), Knee Injury and Osteoarthritis Outcome Score (KOOS), Lower Extremity Functional Scale (LEFS), Beck Depression Scale, Short Form - 36 (Quality of Life Questionnaire) will be used for evaluation. The data obtained in the study will be entered into SPSS 17 package programme (Greasley, 2007). Minimum-maximum values, arithmetic mean and standard deviation will be used to evaluate numerical data, and frequency distributions and percentages will be used to summarise categorical data. The data of the study will be analysed using Analysis of Moment Structures (AMOS) statistical package programmes. In all analyses, p<0.05 will be considered statistically significant.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Numerical Rating Scale - NRS

    Time frame: 1 minute

    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.

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

    Time frame: 3 minute

    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. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 5 minute

    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).

  4. Lower Extremity Functional Scale (LEFS)

    Time frame: 2 minute

    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.

  5. Beck Depression Scale

    Time frame: 5 minute

    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.

  6. Short Form - 36 Quality of Life Questionnaire (SF-36)

    Time frame: 7 minute

    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.

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

Factors Associated With Quality of Life in Patients With Knee Osteoarthritis

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2025
Registry last updated
Aug 12, 2025

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.

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