CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 85 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03328806
NCT03328806N/ACompleted

Cross Culture Adaptation and Validation of the Arabic Version of the Core Outcome Measure Index in Patients With Low Back Pain

Aliaa Rehan Youssef·observational·Posted Nov 1, 2017·Updated Oct 15, 2019

In Brief

An observational study for Low Back Pain. Completed, enrolled 85 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 1, 2017
Enrollment StartJul 1, 2018
Primary CompletionAug 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.7 years ago