Cross-Cultural Adaptation, Validity and Reliability Test of the Arabic Version of the Maine-Seattle Back Questionnaire

September 3, 2026 updated by: Omar Mouness Elbastawesy, Cairo University

Translation, Cross-Cultural Adaptation, Validity, and Reliability of the Arabic Version of the Maine-Seattle Back Questionnaire

The purpose of this study is to translate and test face validity, content validity, construct validity, internal consistency reliability, and test-retest reliability of adapted Arabic-language version of MSBQ in patients with low back pain and sciatica.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Detailed Description

The Maine-Seattle Back Questionnaire (MSBQ) is a condition-specific instrument developed to assess functional disability in patients with low back pain (LBP) and sciatica. It was derived from a modified version of the Roland-Morris Disability Questionnaire (RMDQ) and has demonstrated good reliability, validity, and responsiveness in its original development study .The MSBQ is concise and easy to administer, making it suitable for both clinical and research settings.

Despite the high prevalence of low back pain in Arabic-speaking populations, validated Arabic versions of some LBP-specific questionnaires, including the MSBQ, remain limited. Cultural, linguistic, and contextual factors may influence patient responses, highlighting the need for culturally adapted and psychometrically sound instruments. Developing an Arabic version of the MSBQ would facilitate accurate assessment of disability and enable meaningful comparisons in clinical practice and research.

The MSBQ was developed as a 12-item shortened version of the modified RMDQ to reduce respondent burden. It was constructed using qualitative methods and cluster analysis techniques to identify representative and non-redundant items. Its brevity enhances feasibility for self-administration in both home and clinical environments, making it particularly suitable for prospective outcome assessment in routine healthcare settings.

The present study is significant as it aims to address this gap through the development and validation of an Arabic version of the MSBQ. Providing a culturally adapted and psychometrically sound instrument will enhance clinical decision-making, standardize outcome measurement, and support patient-centered care among individuals with low back pain and sciatica in Arabic-speaking populations.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants diagnosed with low back pain and sciatica will participate in the study that aimed to translate and test (face, content, and construct) validity, (internal consistency and test-retest) reliability of the MSBQ questionnaire into the Arabic language.

Description

Inclusion Criteria:

  • Age between 18 - 45 years representing the target population with sciatica.
  • Diagnosed with low back or leg pain, with symptoms present for less than 6 months.
  • Ability to read and write in Arabic - for accurate comprehension and completion of the questionnaire.
  • Patients will be referred by the physician.
  • Provide informed consent - indicating willingness to participate in the study voluntarily.

Exclusion Criteria:

  • Prior lumbar spinal surgery.
  • Presence of serious spinal pathology (fracture, tumor, infection, cauda equina syndrome, inflammatory spinal diseases).
  • Neurological disorders affecting mobility or cognition. Pregnancy.
  • Severe cognitive impairment or psychiatric disorders that may interfere with questionnaire completion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Low back pain and sciatica group
Participants diagnosed with low back or leg pain will participate in the study that aimed to translate and test (face, content, and construct) validity, (internal consistency and test-retest) reliability of the MSBQ questionnaire into the Arabic language.
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Content validity
Time Frame: 7 days
It is the extent to which questions on the instrument and the scores from these questions represent all possible questions that could be asked about the content or skill. It will be measured by item content validity index and scale content validity indices.
7 days
Face validity
Time Frame: 7 days
The ability of an instrument to be understandable and relevant for the targeted population. It is the weakest way to establish the validity of the questionnaire. It motivates the respondents to answer more truthfully. It will be assessed by a panel of bilingual experts (clinicians, linguists, and researchers) who will reviewed the translated items for clarity, relevance, and cultural appropriateness.
7 days
Construct validity
Time Frame: 7 days
It refers to validating your constructs based on their pattern of correlations with other variables assumed to be indicators of or theoretically related to the construct of interest. It will be assessed by factor analysis, convergent and divergent validity.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Internal consistency
Time Frame: 7 days
It indicates how well the items on a tool fit together conceptually. It will be assessed using Cronbach a and the value will be considered excellent above 0.80.
7 days
Test-retest reliability
Time Frame: 7 days
It is estimated by administering the same test to the same group of respondents at different times. The correlation between the two scores, and often between individual questions, indicates the stability of the instrument. It will be evaluated by the two way mixed intra class correlation coefficient with 95% confidence intervals, values of equal or more than 0.8 were considered as a high level of correlation.
7 days
Feasibility of the Arabic Version of the Maine-Seattle Back Questionnaire (MSBQ)
Time Frame: 7 days
The medical committee agreed to judge feasibility using two factors ( time and missing items) regarding translated instruments. It will be evaluated by the assessment of the frequency of missing answers per item and the time needed to fill it out.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Haytham M Elhafez, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

September 3, 2026

First Submitted That Met QC Criteria

September 3, 2026

First Posted (Actual)

September 10, 2026

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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