- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06760338
Factors Associated With Quality of Life in Knee Osteoarthritis
August 11, 2025 updated by: Emrah Afsar, Kutahya Health Sciences University
Factors Associated With Quality of Life in Patients With 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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
174
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kutahya, Turkey
- Kutahya Health Science University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability 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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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5 minute
|
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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.
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7 minute
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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.
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1 minute
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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.
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3 minute
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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).
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5 minute
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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.
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2 minute
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Emrah Afsar, Phd, Kutahya Health Science University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 6, 2025
Primary Completion (Actual)
July 25, 2025
Study Completion (Actual)
July 25, 2025
Study Registration Dates
First Submitted
December 30, 2024
First Submitted That Met QC Criteria
December 30, 2024
First Posted (Actual)
January 6, 2025
Study Record Updates
Last Update Posted (Actual)
August 12, 2025
Last Update Submitted That Met QC Criteria
August 11, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-e
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Knee Osteoarthritis
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Istanbul University - CerrahpasaCompletedKnee Osteoarthritis | Knee Osteoarthritis (Knee OA)Turkey (Türkiye)
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Edin MešanovićCompletedOsteoarthritis | Osteoarthritis of the Knee | Osteoarthritis of Knee | Osteoarthritis of the Knees | Osteoarthritis (OA) of the Knee | Osteoarthritis Knee | Osteoarthritis in the Knee | Osteoarthritis of Knee JointBosnia and Herzegovina
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Golden Jubilee National HospitalJohnson & Johnson; DePuy OrthopaedicsNot yet recruitingOsteoarthritis | Knee Osteoarthritis | Osteoarthritis (OA) | Osteo Arthritis | Osteoarthritis in the Knee | Osteoarthritis (Knee) | Osteo Arthritis of the KneeUnited Kingdom
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Dr. David WassersteinSunnybrook Research InstituteRecruitingKnee Osteoarthritis (Knee OA) | Knee Osteoarthritis (OA)Canada
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LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
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Lucas R. Cusumano, MDNot yet recruitingKnee Osteoarthritis | Knee Discomfort | Knee Pain Chronic | Knee Swelling PainUnited States
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Emory UniversityVertex Pharmaceuticals IncorporatedNot yet recruitingKnee Osteoarthritis | Knee ArthritisUnited States
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VA Office of Research and DevelopmentNot yet recruitingKnee Osteoarthritis (Knee OA)United States
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The Hong Kong Polytechnic UniversityChinese University of Hong Kong; Zhujiang HospitalNot yet recruitingKnee Osteoarthritis (Knee OA)
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University of MiamiNot yet recruiting