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

NCT03328806 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 85

Last updated 2019-10-15

No results posted yet for this study

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.

Conditions

  • Low Back Pain

Sponsors & Collaborators

  • Aliaa Rehan Youssef

    lead OTHER

Principal Investigators

  • Aliaa Rehan Youssef, PhD · Cairo University

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2019-08-01
Completion
2019-08-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03328806 on ClinicalTrials.gov