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NCT Number: NCT07811414

Cross-Cultural Adaptation, Validity and Reliability Test 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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Karima S Mohamed, PHD

CONTACT

[email protected]

01140306696

Omar M Elbastawesy, Bachelor

CONTACT

[email protected]

01274284008

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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