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

NCT03328806 | Completed DMC

• 1 other identifier: Ay7au712017
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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. 1.Face validity which will be evaluated subjectively based on judgment of expert committee and patients' feedback.
2. 2.Concurrent validity is assessed by testing correlation between the COMI and VAS, ODI, RMDQ and SF-36
3. 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.

Conditions

Low Back Pain

Keywords

low back pain; outcome measures; cross culture adaptation; Core Outcome Measure Index

Outcome Measures

Primary Outcomes (1)

• Correlation between the COMI and Ronald Morris Disability Questionnaire (RMDQ)

  This will be done to assess the construct validity. RMDQ evaluates the disability associated with LBP. It consists of 24 yes/no items related specifically to physical functions including walking, bending over, sitting, lying down, dressing sleeping, self-care and daily activities. Patients are asked whether the statements apply to them that day (i.e. the last 24 h). One point is given for each item. The total score ranges from 0 (no disability) to 24 (severe disability).

  1 day

Secondary Outcomes (6)

• Correlation between the COMI and Visual Analogue Scale (VAS)

  1 day

• Correlation between the COMI and Oswestry Disability Index (ODI)

  1 day

• Correlation between the COMI and Short Form 36 (SF-36)

  1 day

• Perceived changes in back and/or leg pain

  1 day

• Reliability of COMI

  7-14 days

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study will be delimited to: 1-140 Egyptian patients diagnosed clinically with LBP with or without leg pain. 2- Patients' age ranging from 21 years to 50

You may qualify if:

• Adults male and females with age ranging from 21 to 50 years.
• Referred with a diagnosis of low back pain described as pain and discomfort, localized below the costal margin and above the inferior gluteal folds, with or without referred leg pain (Airaksinen et al., 2006).
• Arabic speaking in the Egyptian dialect.

You may not qualify if:

• Back pain secondary to known specific pathology (e.g. infection, tumor, Osteoporosis, fracture, structural deformity, inflammatory disorder (e.g. ankylosing spondylitis), radicular syndrome or cauda equine syndrome) (Mannion et al., 2012).
• Pregnant women
• Post-operative patients
• Patients who had traumatic injury in the lower quadrant within the past 6 months.

Sponsors & Collaborators

• Aliaa Rehan Youssef: lead

Study Sites (1)

Cairo University, Faculty of Physical Therapy

Cairo, 11391, Egypt

Location

Related Publications (48)

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MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aliaa Rehan Youssef, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor at The Department of Musculoskeletal Disorder and Its Surgery

Study Record Dates

• First Submitted: September 24, 2017
• First Posted: November 1, 2017
• Study Start: July 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: October 15, 2019

Record last verified: 2019-10

Locations

EG (1)