- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05449236
A Reliability and Validity Study of Urdu Version of Western Ontario And MacMaster Osteoarthritis Index
January 13, 2023 updated by: Riphah International University
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
87
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
-
-
Punjab
-
Faisalabad, Punjab, Pakistan, 38000
- Ripah International University
-
-
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
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Pakistani population with primary knee Osteoarthritis will be included in the study.
Description
Inclusion Criteria:
- Male and Female patients
- Age above 40 years
- Participants with primary knee Osteoarthritis
- Patients willing to participate.
Exclusion Criteria:
- History or presence of ;
- Rheumatic diseases,severe articulation inflammation and cardiac disease.
- Participants with secondary knee Osteoarthritis.
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
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1st day
|
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.
|
1st day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 30, 2021
Primary Completion (Actual)
July 10, 2022
Study Completion (Actual)
July 12, 2022
Study Registration Dates
First Submitted
July 4, 2022
First Submitted That Met QC Criteria
July 4, 2022
First Posted (Actual)
July 8, 2022
Study Record Updates
Last Update Posted (Estimate)
January 16, 2023
Last Update Submitted That Met QC Criteria
January 13, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC-FSD-00251
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.
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