NCT07811414

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Sep 2026Dec 2026

Study Start

First participant enrolled

September 1, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 3, 2026

Last Update Submit

September 3, 2026

Conditions

Keywords

Translationcross-cultural adaptationvalidityreliabilityMaine-Seattle Back Questionnaire

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    7 days

Secondary Outcomes (3)

  • Internal consistency

    7 days

  • Test-retest reliability

    7 days

  • Feasibility of the Arabic Version of the Maine-Seattle Back Questionnaire (MSBQ)

    7 days

Study Arms (1)

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.

Other: No intervention

Interventions

No intervention

Low back pain and sciatica group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, Egypt

Location

Study Officials

  • Haytham M Elhafez

    Cairo University

    STUDY CHAIR

Central Study Contacts

Omar M Elbastawesy, Bachelor

CONTACT

Karima S Mohamed, PHD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 3, 2026

First Posted

September 10, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

September 10, 2026

Record last verified: 2026-09

Locations