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NCT03328806

Cross Culture Adaptation and Validation of the Arabic Version of COMI in Patients With Low Back Pain

Completed Last updated 15 October 2019
What this trial tests

trial in Low Back Pain in 85 participants. Completed in 1 August 2019.

Timeline
1 July 2018
Primary endpoint
1 August 2019
1 August 2019

Quick facts

Lead sponsorAliaa Rehan Youssef
StatusCompleted
Study typeOBSERVATIONAL
Enrollment85
Start date1 July 2018
Primary completion1 August 2019
Estimated completion1 August 2019
Sites1 location across Egypt

Conditions studied

Sponsor

Aliaa Rehan Youssef

Who can join

Adults 21 to 50, any sex, with Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims at translating, cross culturally adapting and establishing the psychometric properties of the The Core Outcome Measure Index (COMI) for patients with low back pain (LBP) in Egypt. This study will be conducted at the outpatient clinic of public hospitals in Egypt. This study will be divided into two main stages: (1) Translation and cross culture adaptation, and (2) Validation. In the translation and cross culture adaptation stage, the original English version will be translated into modern Arabic following the guidelines described by Beaton et al. (2000). Then, the translated final version will be tested on a sample of 30-40 participants in a small pilot study to ensure linguistic clarity. For the validation stage, 100 male and female adults with LBP will be recruited from public physiotherapy outpatient clinics. Eligible patients will be asked to complete a questionnaire booklet containing The Arabic versions of Oswestry Disability index (ODI), Ronald Morris Disability Questionnaire (RMDQ), Short-form 36 (SF-36) and the Visual analogy scale (VAS). Further, disability and function will be assessed by Timed Up and Go test (TUG), 50 feet walking and loaded reach test. Outcome measures will include: 1. Face validity which will be evaluated subjectively based on judgment of expert committee and patients' feedback. 2. Concurrent validity is assessed by testing correlation between the COMI and VAS, ODI, RMDQ and SF-36 3. Construct validity will be assessed by testing the correlation between the scores for each item of the COMI and its corresponding valid back specific full-length questionnaire including the ODI, RMDQ, SF-36 and VAS. All testing procedure will be repeated after seven days for testing reliability.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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