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NCT03328806
Cross Culture Adaptation and Validation of the Arabic Version of COMI in Patients With Low Back Pain
trial in Low Back Pain in 85 participants. Completed in 1 August 2019.
1 August 2019
Quick facts
| Lead sponsor | Aliaa Rehan Youssef |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 85 |
| Start date | 1 July 2018 |
| Primary completion | 1 August 2019 |
| Estimated completion | 1 August 2019 |
| Sites | 1 location across Egypt |
Conditions studied
- Low Back Pain — all drugs for Low Back Pain →
Sponsor
Aliaa Rehan Youssef
Who can join
Adults 21 to 50, any sex, with Low Back Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims at translating, cross culturally adapting and establishing the psychometric properties of the The Core Outcome Measure Index (COMI) for patients with low back pain (LBP) in Egypt. This study will be conducted at the outpatient clinic of public hospitals in Egypt. This study will be divided into two main stages: (1) Translation and cross culture adaptation, and (2) Validation. In the translation and cross culture adaptation stage, the original English version will be translated into modern Arabic following the guidelines described by Beaton et al. (2000). Then, the translated final version will be tested on a sample of 30-40 participants in a small pilot study to ensure linguistic clarity. For the validation stage, 100 male and female adults with LBP will be recruited from public physiotherapy outpatient clinics. Eligible patients will be asked to complete a questionnaire booklet containing The Arabic versions of Oswestry Disability index (ODI), Ronald Morris Disability Questionnaire (RMDQ), Short-form 36 (SF-36) and the Visual analogy scale (VAS). Further, disability and function will be assessed by Timed Up and Go test (TUG), 50 feet walking and loaded reach test. Outcome measures will include: 1. Face validity which will be evaluated subjectively based on judgment of expert committee and patients' feedback. 2. Concurrent validity is assessed by testing correlation between the COMI and VAS, ODI, RMDQ and SF-36 3. Construct validity will be assessed by testing the correlation between the scores for each item of the COMI and its corresponding valid back specific full-length questionnaire including the ODI, RMDQ, SF-36 and VAS. All testing procedure will be repeated after seven days for testing reliability.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03328806
- Europe PMC full search
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Other Aliaa Rehan Youssef trials
Trials by the same sponsor.
- NCT03970408 — Median Nerve Excursion During Neurodynamic Mobilization · completed
- NCT03658915 — Validity and Reliability of Smartphone Use in Measuring Joint Position Sense in Patients With Knee Osteoarthritis · completed
- NCT03745469 — The Effect of Smartphone Use Duration in Patients With Chronic Mechanical Neck Pain. · completed
- NCT03517410 — Association Between the Duration of Smart Phone Use and Back Dysfunction in Patients With Low Back Pain · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03328806 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aliaa Rehan Youssef
- Last refreshed: 15 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03328806.
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