- ICH GCP
- US-Register für klinische Studien
- Klinische 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Omar M Elbastawesy, Bachelor
- Telefonnummer: 01274284008
- E-Mail: omarmouness@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Karima S Mohamed, PHD
- Telefonnummer: 01140306696
- E-Mail: Karimasalah33@yahoo.com
Studienorte
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Cairo, Ägypten
- Cairo University
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Kontakt:
- Omar M Elbastawesy, Bachlor
- Telefonnummer: 01274284008
- E-Mail: omarmouness@gmail.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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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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Kein Eingriff
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Content validity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Internal consistency
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Haytham M Elhafez, Cairo University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- P.T.REC/012/006554
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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