Factors Associated With Quality of Life in Knee Osteoarthritis

Recruiting

• Conditions: Knee Osteoarthritis

• Registration Number: NCT06760338
• Lead Sponsor: Kutahya Health Sciences University

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2024-12-30
• Status Verified: 2025-01
• Study Start: 2025-01-06
• Study First Posted: 2025-01-06
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-06-27
• Study Completion: 2025-06-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale - NRS	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.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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.
Lower Extremity Functional Scale (LEFS)	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.
Knee Injury and Osteoarthritis Outcome Score (KOOS)	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).
Beck Depression Scale	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.
Short Form - 36 Quality of Life Questionnaire (SF-36)	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.

Trial Locations

Locations (1)

Kutahya Health Science University; 🇹🇷 Kutahya, Turkey