- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Omar M Elbastawesy, Bachelor
- Numer telefonu: 01274284008
- E-mail: omarmouness@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Karima S Mohamed, PHD
- Numer telefonu: 01140306696
- E-mail: Karimasalah33@yahoo.com
Lokalizacje studiów
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Cairo, Egipt
- Cairo University
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Kontakt:
- Omar M Elbastawesy, Bachlor
- Numer telefonu: 01274284008
- E-mail: omarmouness@gmail.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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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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Brak interwencji
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Content validity
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Internal consistency
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: Haytham M Elhafez, Cairo University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- P.T.REC/012/006554
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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