Knee OsteoarthritisNCT05449236
A Reliability and Validity Study of Urdu Version of Western Ontario And MacMaster Osteoarthritis Index
An observational study of Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of the study is to translate and culturally adapt Western Ontario And MacMaster Osteoarthritis Index into Urdu language and to investigate its reliability and validity Pakistani population with primary knee osteoarthritis while assessing its correlation with Lequesne Index. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 87 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 12 Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pakistani population with primary knee Osteoarthritis will be included in the study.
Who may be able to join
- Male and Female patients
- Age above 40 years
- Participants with primary knee Osteoarthritis
- Patients willing to participate.
Who cannot join
- History or presence of ;
- Rheumatic diseases,severe articulation inflammation and cardiac disease.
- Participants with secondary knee Osteoarthritis.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: A Reliability and Validity Study of Urdu Version of Western Ontario And MacMaster Osteoarthritis Index Among Pakistani Primary Knee Osteoarthritis Patients
The aim of the study is to translate and culturally adapt Western Ontario And MacMaster Osteoarthritis Index into Urdu language and to investigate its reliability and validity Pakistani population with primary knee osteoarthritis while assessing its correlation with Lequesne Index.
Read the detailed description
As per preceding commendation, Western Ontario And MacMaster Osteoarthritis Index will be translated into Urdu language from its English version and adapted culturally in Pakistan. Among primary knee osteoarthritis population, Western Ontario And MacMaster Osteoarthritis Index will be distributed among 87 patients recruited by convenience sampling technique under the pre-defined inclusion and exclusion criteria after signing consents forms. For testing inter-observer reliability and intra-observer reliability of Western Ontario And MacMaster Osteoarthritis Index and Lequesne Index will be administrated by two observers, on the same day, with a time interval of 2 hours between 1st and 2nd conduction. As for the 3rd conduction, it will be carried out after seven days by the first observer, for intra-observer assessment. Statistical Package of Social Sciences software version 24 will be used for the purpose of data entry and analysis. Internal consistency will be assessed by using an intra-class correlation coefficient. The Western Ontario And MacMaster Osteoarthritis Index will be evaluated for content validity, construct validity, criterion validity and responsiveness
- Conditions
- Knee Osteoarthritis
- Keywords
- Western Ontario And MacMaster Osteoarthritis Index, Urdu Version, Reliability, Validity, Knee Osteoarthritis, Lequesne Index
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario And MacMaster Osteoarthritis Index
Western Ontario And MacMaster Osteoarthritis Index is an instrument which used to check the results of treatment. Western Ontario And MacMaster Osteoarthritis Index is valid and reliable Outcome measure for Pain and Activity of Daily Livings.
Measured: 1st day
Lequesne Index
The Lequesne Index is a 10-question survey given to patients with osteoarthritis of the knee. It has five questions pertaining to pain or discomfort, one question dealing with maximum distance walked, and four questions about activities of daily living.
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start30 May 2021
- Primary completion10 Jul 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449236
- Sponsor's protocol ID
- REC-FSD-00251
- Status last verified
- Jan 2023
- First submitted
- 4 Jul 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Reliability and Validity Study of Urdu Version of Western Ontario And MacMaster Osteoarthritis Index Among Pakistani Primary Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT05449236
- Acronym / sponsor ID
- REC-FSD-00251
- Conditions
- Knee Osteoarthritis
- Keywords
- Western Ontario And MacMaster Osteoarthritis Index, Urdu Version, Reliability, Validity, Knee Osteoarthritis, Lequesne Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 10 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 8 Jul 2022 (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 the study is to translate and culturally adapt Western Ontario And MacMaster Osteoarthritis Index into Urdu language and to investigate its reliability and validity Pakistani population with primary knee osteoarthritis while assessing its correlation with Lequesne Index.
Detailed description
As per preceding commendation, Western Ontario And MacMaster Osteoarthritis Index will be translated into Urdu language from its English version and adapted culturally in Pakistan. Among primary knee osteoarthritis population, Western Ontario And MacMaster Osteoarthritis Index will be distributed among 87 patients recruited by convenience sampling technique under the pre-defined inclusion and exclusion criteria after signing consents forms. For testing inter-observer reliability and intra-observer reliability of Western Ontario And MacMaster Osteoarthritis Index and Lequesne Index will be administrated by two observers, on the same day, with a time interval of 2 hours between 1st and 2nd conduction. As for the 3rd conduction, it will be carried out after seven days by the first observer, for intra-observer assessment. Statistical Package of Social Sciences software version 24 will be used for the purpose of data entry and analysis. Internal consistency will be assessed by using an intra-class correlation coefficient. The Western Ontario And MacMaster Osteoarthritis Index will be evaluated for content validity, construct validity, criterion validity and responsiveness
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pakistani population with primary knee Osteoarthritis will be included in the study.
Key inclusion criteria (4 listed)
- Male and Female patients
- Age above 40 years
- Participants with primary knee Osteoarthritis
- Patients willing to participate.
Key exclusion criteria (3 listed)
- History or presence of ;
- Rheumatic diseases,severe articulation inflammation and cardiac disease.
- Participants with secondary knee Osteoarthritis.
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
Western Ontario And MacMaster Osteoarthritis Index
Time frame: 1st day
Western Ontario And MacMaster Osteoarthritis Index is an instrument which used to check the results of treatment. Western Ontario And MacMaster Osteoarthritis Index is valid and reliable Outcome measure for Pain and Activity of Daily Livings.
Lequesne Index
Time frame: 1st day
The Lequesne Index is a 10-question survey given to patients with osteoarthritis of the knee. It has five questions pertaining to pain or discomfort, one question dealing with maximum distance walked, and four questions about activities of daily living.
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 17 Jan 2023.
- 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. This study is not recruiting at the moment.
Muhammad Kashif study chair
Riphah International 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 Riphah International University at 1 site in Pakistan.
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 4 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 17 Jan 2023. 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 Pakistan. 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?
Western Ontario And MacMaster Osteoarthritis Index (time frame: 1st day). 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 17 Jan 2023; AzTrials last refreshed its copy on 6 Nov 2026.