Early Knee OsteoarthritisNCT06388811
Validity and Reliability Study of the Turkish Version of the Early Osteoarthritis Questionnaire
An observational study of Early Knee Osteoarthritis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The symptoms of early osteoarthritis (OA) are quite similar to established knee OA, they differ, particularly in frequency, intensity, and severity. For this reason, in 2023, the International Symposium of intra-articular treatment (ISIAT) technical experts panel (TEP-technical experts panel) published for the first… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Early Knee Osteoarthritis
- What is being tested?
- Early Osteoarthritis Questionnaire
- How many people
- 220 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Feb 2025to 19 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with early knee osteoarthritis and population without knee pain for control gorup
Who may be able to join
- -
- For the patient group :
- Meeting the diagnostic criteria for early symptomatic knee OA
- In the absence of risk factors, two mandatory symptoms (pain when climbing up and down stairs and increased pain with overload) are present
- In the presence of 1 or 2 risk factors, at least pain when climbing up and down stairs is present among the two mandatory symptoms
- Presence of at least 1 mandatory symptom in the presence of 3 or more risk factors
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- Over 40 years of age
- Signing the informed consent form
- Being able to read and write Turkish
- To be able to come to the follow-ups required by the study
- For the control group:
- Absence of knee pain
- Over 40 years of age
- Signing the informed consent form
- Being able to read and write Turkish
- To be able to come to the follow-ups required by the study
Who cannot join
- For the patient group:
- Active inflammatory arthritis
- The presence of widespread pain
- Being under 40 years of age
- Having stage 1-4 knee OA according to Kellgren and Lawrence
- Recent trauma or injury
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- Symptom duration of more than 6 months
- Having a mental capacity, cognition level that prevents understanding and completing the questionnaire
- For the control group:
- Having knee pain
- Being under 40 years of age
- Having a mental capacity, cognition level that prevents understanding and completing the questionnaire
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University Istanbul Faculty of Medicine
Istanbul
Fatma Merih Akpınar
About this study
Official title: Validity and Reliability Study of the Turkish Version of the Early Osteoarthritis
The symptoms of early osteoarthritis (OA) are quite similar to established knee OA, they differ, particularly in frequency, intensity, and severity. For this reason, in 2023, the International Symposium of intra-articular treatment (ISIAT) technical experts panel (TEP-technical experts panel) published for the first time a questionnaire designed to assess and monitor the follow-up and clinical progression of patients affected by early knee OA. Early management of knee OA is recommended by various guidelines because this approach may alter the course and clinical features of the disease, especially when considering disease-modifying agents that may delay disease progression.
Therefore, the assessment of early knee OA with a questionnaire may facilitate the follow-up of OA in the early stages of the disease when treatment is likely to be more effective. This approach will allow to reduce disability and improve patients' quality of life. While creating the Early Osteoarthritis Questionnaire (EOAQ), it was aimed to have a complete, short and easy-to-understand questionnaire and to ensure that the respondents could complete the questionnaire easily and in a short time. The EOAQ consists of 11 questions. The questions were divided into two different groups. While the first two questions were related with clinical characteristics, the other nine questions aimed to investigate the results reported by the patient. For each question, there are three responses depending on the number of episodes: Never, rarely (between one and three episodes) and frequently (more than three episodes) within a 6-month period. Turkish validity and reliability study of the EOAQ has not been conducted yet.
For the translation of the questionnaire, the guide recommended by Beaton et al. for the cultural adaptation of questionnaires will be used. According to this guideline the original EOAQ will be translated into Turkish by two experts independently of each other, and then a single Turkish version will be created by two experts working together. This Turkish version will then be translated back into English by an expert who can speak both languages at an advanced level. The experts will then evaluate the translation and adapt the questionnaire accordingly. After the completion of the translated form, 110 patients and 110 control group participants who applied to Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation and met the inclusion criteria will be included. The participants will be informed verbally and in writing about the purpose, duration and method of the study and will be asked to sign an "Informed Voluntary Consent Form" after their consent is obtained. Participants will fill in the Turkish version of the questionnaire. Along with the questionnaire, knee pain will be questioned with the Numeric Rating Scale (0=no pain, 10=the most severe pain you experience) and disability will be questioned with the WOMAC Questionnaire, whose Turkish validity and reliability study has been conducted. Test-retest method will be applied for reliability analyses; therefore, at least 30 patients among the patients included in the study will complete the questionnaire twice (the second evaluation will be 2 weeks after the first evaluation).
- Conditions
- Early Knee Osteoarthritis
- Being tested
- Early Osteoarthritis Questionnaire
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Osteoarthritis QuestionnaireOther
Self administered questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Early Knee Osteoarthritis Patients | Not described Receives: Other: Early Osteoarthritis Questionnaire | |
| Population Without Knee Pain | Not described Receives: Other: Early Osteoarthritis Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
Patients rate their level of pain between 0-10 during movement, rest and night, 0 indicates no pain, 10 indicates the worst imaginable pain
Measured: Baseline, second week
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
WOMAC consists of 24 items consisting of 3 subgroups that the patients answer themselves. These subgroups include; pain intensity during various positions or movements, severity of joint stiffness and difficulty in performing daily functional activities. It has 3 forms: 5-point Likert, 100 mm visual analogue scale and 11-box numerical evaluation scale. The 5 point likert form will be filled in this study. Higher scores indicate worse pain, stiffness, or physical function.
Measured: Baseline, second week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start19 Feb 2025
- Primary completion19 Mar 2025 (estimated)
- Study completion19 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Merih Akpınar, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388811
- Sponsor's protocol ID
- 2023/1162
- Status last verified
- Feb 2025
- First submitted
- 25 Apr 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability Study of the Turkish Version of the Early Osteoarthritis
- ClinicalTrials.gov ID
- NCT06388811
- Acronym / sponsor ID
- 2023/1162
- Conditions
- Early Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 19 Mar 2025 (estimated)
- Study completion
- 19 Mar 2025 (estimated)
- First posted
- 29 Apr 2024 (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 symptoms of early osteoarthritis (OA) are quite similar to established knee OA, they differ, particularly in frequency, intensity, and severity. For this reason, in 2023, the International Symposium of intra-articular treatment (ISIAT) technical experts panel (TEP-technical experts panel) published for the first time a questionnaire designed to assess and monitor the follow-up and clinical progression of patients affected by early knee OA. Early management of knee OA is recommended by various guidelines because this approach may alter the course and clinical features of the disease, especially when considering disease-modifying agents that may delay disease progression.
Therefore, the assessment of early knee OA with a questionnaire may facilitate the follow-up of OA in the early stages of the disease when treatment is likely to be more effective. This approach will allow to reduce disability and improve patients' quality of life. While creating the Early Osteoarthritis Questionnaire (EOAQ), it was aimed to have a complete, short and easy-to-understand questionnaire and to ensure that the respondents could complete the questionnaire easily and in a short time. The EOAQ consists of 11 questions. The questions were divided into two different groups. While the first two questions were related with clinical characteristics, the other nine questions aimed to investigate the results reported by the patient. For each question, there are three responses depending on the number of episodes: Never, rarely (between one and three episodes) and frequently (more than three episodes) within a 6-month period. Turkish validity and reliability study of the EOAQ has not been conducted yet.
For the translation of the questionnaire, the guide recommended by Beaton et al. for the cultural adaptation of questionnaires will be used. According to this guideline the original EOAQ will be translated into Turkish by two experts independently of each other, and then a single Turkish version will be created by two experts working together. This Turkish version will then be translated back into English by an expert who can speak both languages at an advanced level. The experts will then evaluate the translation and adapt the questionnaire accordingly. After the completion of the translated form, 110 patients and 110 control group participants who applied to Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation and met the inclusion criteria will be included. The participants will be informed verbally and in writing about the purpose, duration and method of the study and will be asked to sign an "Informed Voluntary Consent Form" after their consent is obtained. Participants will fill in the Turkish version of the questionnaire. Along with the questionnaire, knee pain will be questioned with the Numeric Rating Scale (0=no pain, 10=the most severe pain you experience) and disability will be questioned with the WOMAC Questionnaire, whose Turkish validity and reliability study has been conducted. Test-retest method will be applied for reliability analyses; therefore, at least 30 patients among the patients included in the study will complete the questionnaire twice (the second evaluation will be 2 weeks after the first evaluation).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Knee Osteoarthritis Patients | – | Other: Early Osteoarthritis Questionnaire |
| Population Without Knee Pain | – | Other: Early Osteoarthritis Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with early knee osteoarthritis and population without knee pain for control gorup
Key inclusion criteria (16 listed)
- -
- Meeting the diagnostic criteria for early symptomatic knee OA
- Over 40 years of age
- Signing the informed consent form
- Being able to read and write Turkish
Key exclusion criteria (12 listed)
- For the patient group:
- Having knee pain
- Being under 40 years of age
- Having a mental capacity, cognition level that prevents understanding and completing the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Osteoarthritis QuestionnaireSelf administered questionnaire | Other | Early Knee Osteoarthritis Patients, Population Without Knee Pain |
Primary outcome
Numeric Rating Scale
Time frame: Baseline, second week
Patients rate their level of pain between 0-10 during movement, rest and night, 0 indicates no pain, 10 indicates the worst imaginable pain
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline, second week
WOMAC consists of 24 items consisting of 3 subgroups that the patients answer themselves. These subgroups include; pain intensity during various positions or movements, severity of joint stiffness and difficulty in performing daily functional activities. It has 3 forms: 5-point Likert, 100 mm visual analogue scale and 11-box numerical evaluation scale. The 5 point likert form will be filled in this study. Higher scores indicate worse pain, stiffness, or physical function.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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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.
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 Early Knee Osteoarthritis, run by Istanbul 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 16 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 19 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma Merih Akpınar (+905333558843, merihcaliskan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (time frame: Baseline, second week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2025.