- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07811414
Cross-Cultural Adaptation, Validity and Reliability Test of the Arabic Version of the Maine-Seattle Back Questionnaire
Translation, Cross-Cultural Adaptation, Validity, and Reliability of the Arabic Version of the Maine-Seattle Back Questionnaire
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Omar M Elbastawesy, Bachelor
- Numero di telefono: 01274284008
- Email: omarmouness@gmail.com
Backup dei contatti dello studio
- Nome: Karima S Mohamed, PHD
- Numero di telefono: 01140306696
- Email: Karimasalah33@yahoo.com
Luoghi di studio
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Cairo, Egitto
- Cairo University
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Contatto:
- Omar M Elbastawesy, Bachlor
- Numero di telefono: 01274284008
- Email: omarmouness@gmail.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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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.
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Nessun intervento
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Content validity
Lasso di tempo: 7 days
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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.
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7 days
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Face validity
Lasso di tempo: 7 days
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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.
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7 days
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Construct validity
Lasso di tempo: 7 days
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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.
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7 days
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Internal consistency
Lasso di tempo: 7 days
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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.
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7 days
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Test-retest reliability
Lasso di tempo: 7 days
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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.
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7 days
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Feasibility of the Arabic Version of the Maine-Seattle Back Questionnaire (MSBQ)
Lasso di tempo: 7 days
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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.
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7 days
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Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Haytham M Elhafez, Cairo University
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- P.T.REC/012/006554
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