Cross-cultural AdaptationNCT07811414
Cross-Cultural Adaptation, Validity and Reliability Test of the Arabic Version of the Maine-Seattle Back Questionnaire
An observational study of Cross-cultural Adaptation and Validity, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cross-cultural Adaptation, Validity, Reliability
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2026to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants diagnosed with low back pain and sciatica 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Cairo university
Cairo
Omar M Elbastawesy, Bachlor, 01274284008, omarmouness@gmail.com
About this study
Official title: Translation, Cross-Cultural Adaptation, Validity, and Reliability 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.
Read the detailed description
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.
- Conditions
- Cross-cultural Adaptation, Validity, Reliability
- Being tested
- No intervention
- Keywords
- Translation, cross-cultural adaptation, validity, reliability, Maine-Seattle Back Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Content validity
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.
Measured: 7 days
Face validity
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.
Measured: 7 days
Construct validity
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.
Measured: 7 days
Secondary outcomes (3)
Internal consistency
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.
Measured: 7 days
Test-retest reliability
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.
Measured: 7 days
Feasibility of the Arabic Version of the Maine-Seattle Back Questionnaire (MSBQ)
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startSep 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cross-cultural AdaptationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mouness Elbastawesy, Cairo University
- Investigators
- Haytham M Elhafez, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811414
- Sponsor's protocol ID
- P.T.REC/012/006554
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation, Cross-Cultural Adaptation, Validity, and Reliability of the Arabic Version of the Maine-Seattle Back Questionnaire
- ClinicalTrials.gov ID
- NCT07811414
- Acronym / sponsor ID
- P.T.REC/012/006554
- Conditions
- Cross-cultural Adaptation, Validity, Reliability
- Keywords
- Translation, cross-cultural adaptation, validity, reliability, Maine-Seattle Back Questionnaire
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low back pain and sciatica group | – | Other: No interventionParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants diagnosed with low back pain and sciatica 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Low back pain and sciatica group |
Primary outcome
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.
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.
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.
3 secondary outcomes
Internal consistency
Time frame: 7 days
Test-retest reliability
Time frame: 7 days
Feasibility of the Arabic Version of the Maine-Seattle Back Questionnaire (MSBQ)
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haytham M Elhafez study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cross-cultural Adaptation and Validity, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar M Elbastawesy, Bachelor (01274284008, omarmouness@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Content validity (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.