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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05449236
Other study ID # REC-FSD-00251
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 30, 2021
Est. completion date July 12, 2022

Study information

Verified date January 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 87
Est. completion date July 12, 2022
Est. primary completion date July 10, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Pakistan Ripah International University Faisalabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1st day
Primary 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. 1st day
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