Knee OsteoarthritisNCT06760338
Factors Associated With Quality of Life in Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 174 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2025to 25 Jul 2025
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include people aged between 40-65 years, who volunteered to participate in the study and diagnosed with knee osteoarthritis.
Who may be able to join
- Volunteering to participate in the study
- Being diagnosed with knee osteoarthritis
- In studies between the ages of 40 and 65
Who cannot join
- Other orthopaedic surgery in the lower extremity
- Cognitive impairment at a level that prevents understanding and answering the questionnaire
- Presence of neurological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start6 Jan 2025
- Primary completion25 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emrah Afsar, Kutahya Health Sciences University
- Investigators
- Emrah Afsar, Phd, Principal investigator, Kutahya Health Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760338
- Sponsor's protocol ID
- 2024-e
- Status last verified
- Aug 2025
- First submitted
- 30 Dec 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Afsar E, Namaz ZS. Predictors of health-related quality of life in patients with knee osteoarthritis. BMC Musculoskelet Disord. 2026 Aug 1;27(1):928. doi: 10.1186/s12891-026-10306-0.
PubMed 42958540
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Quality of Life in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06760338
- Acronym / sponsor ID
- 2024-e
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 6 Jan 2025 (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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include people aged between 40-65 years, who volunteered to participate in the study and diagnosed with knee osteoarthritis.
Key inclusion criteria (3 listed)
- Volunteering to participate in the study
- Being diagnosed with knee osteoarthritis
- In studies between the ages of 40 and 65
Key exclusion criteria (3 listed)
- Other orthopaedic surgery in the lower extremity
- Cognitive impairment at a level that prevents understanding and answering the questionnaire
- Presence of neurological disease
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
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.
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.
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).
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.
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.
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.
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 12 Aug 2025.
- Derived from this study: PubMed 42958540Afsar E, Namaz ZS. Predictors of health-related quality of life in patients with knee osteoarthritis. BMC Musculoskelet Disord. 2026 Aug 1;27(1):928. doi: 10.1186/s12891-026-10306-0.
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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.
Emrah Afsar, Phd principal investigator
Kutahya Health Science University
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 Knee Osteoarthritis, run by Kutahya Health Sciences University 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 3 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 12 Aug 2025. 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?
Numerical Rating Scale - NRS (time frame: 1 minute). The study lists 6 primary outcomes in all. 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 NCT06760338, which also lists 1 linked publication.
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 12 Aug 2025.