- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Omar M Elbastawesy, Bachelor
- Telefonní číslo: 01274284008
- E-mail: omarmouness@gmail.com
Studijní záloha kontaktů
- Jméno: Karima S Mohamed, PHD
- Telefonní číslo: 01140306696
- E-mail: Karimasalah33@yahoo.com
Studijní místa
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Cairo, Egypt
- Cairo University
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Kontakt:
- Omar M Elbastawesy, Bachlor
- Telefonní číslo: 01274284008
- E-mail: omarmouness@gmail.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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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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Žádný zásah
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Content validity
Časové okno: 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
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Internal consistency
Časové okno: 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
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Haytham M Elhafez, Cairo University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- P.T.REC/012/006554
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