Validation of a Translation Into Spanish of the Oswestry Disability Index
NCT ID: NCT01649011
Last Updated: 2012-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2012-07-31
Brief Summary
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Internal consistency, reproducibility and reliability will be addressed scoring the results of the translated version at two time frames. A previously spanish validated translation of the of the Roland Morris Disability Questionnaire (RMDQ) will be used to compare and evaluate both versions.
Detailed Description
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The development of the ODI was initiated by John O'Brien in 1976. The index was designed as a measure for both assessment and outcome on patients with low back pain. The questionnaire can be completed in less than 5 minutes and scored in less than 1 minute. Version 1.0 of the questionnaire was published in 1980 and widely disseminated after the 1981 meeting of the International Society for The Study of the Lumbar Spine (ISSLS) in Paris. A new ODI version was adapted in 1989 by the Chiropractic College in England. The American Academy of Orthopedic Surgeons and other spine associations adapted the ODI 1.0 version in 1996 omitting categories 1, 8 and 9. This version is included in the assessment protocol proposed by the Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS), which brings together the main international spine associations. Version 2.0 was modified by the Medical Research Council Group in the UK in 1996 (16) and they omitted the word "painkillers" in the first category. Version 2.1a is the most recent and recommended by its author. In this version a section called previous treatment appears, which is not taken into account for scoring. The score can be obtained for its clinical use after permission at: http://www.mapi-trust.org/.
The RMDQ is a health status measure designed to be completed by patients to assess physical disability due to low back pain. It was designed for use in research (e.g., as an outcome measure for clinical trials) but has also been found useful for monitoring patients in clinical practice. Was derived from the Sickness Impact Profile (SIP), which is a 136 item health status measure covering all aspects of physical and mental function. Twenty four items were selected from the SIP by the original authors. It is simple, fast, and can be filled out by the patient. The patient must mark each item that applies to his or her current LBP. Scoring is also simple and fast; each checked item receives a score of 1, so scores range between 0 (no disability caused by LBP) and 24 (the maximum possible disability). To date only one version has been translated to Spanish and was published in 2002 by Kovacks FM, et al.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Scores of the ODI and RMQ for low back pain
Application of the initial evaluation
Initial evaluation involves the application of the previously spanish validated Rolland Morris Questionnaire and the new spanish Oswestry Disability Index
Final application of scales
Application of the previously spanish validated version of the RMQ and the new spanish translation of the ODI 2 weeks after initial evaluation
Interventions
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Application of the initial evaluation
Initial evaluation involves the application of the previously spanish validated Rolland Morris Questionnaire and the new spanish Oswestry Disability Index
Final application of scales
Application of the previously spanish validated version of the RMQ and the new spanish translation of the ODI 2 weeks after initial evaluation
Eligibility Criteria
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Inclusion Criteria
* With or without previous back surgery
Exclusion Criteria
18 Years
70 Years
ALL
Yes
Sponsors
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American British Cowdray Medical Center
OTHER
Responsible Party
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Galvan Ernesto Eduardo
Galvan Ernesto Eduardo MD, MSc, Principal investigator
Principal Investigators
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Ernesto E Galvan Hernandez, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
American British Cowdray Medical Center
Locations
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American British Cowdray Medical Center
Mexico City, Mexico City, Mexico
Countries
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Central Contacts
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Facility Contacts
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Ernesto Eduardo Galvan, MD
Role: primary
References
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Kovacs FM, Llobera J, Gil Del Real MT, Abraira V, Gestoso M, Fernandez C, Primaria Group KA. Validation of the spanish version of the Roland-Morris questionnaire. Spine (Phila Pa 1976). 2002 Mar 1;27(5):538-42. doi: 10.1097/00007632-200203010-00016.
Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.
Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3115-24. doi: 10.1097/00007632-200012150-00006. No abstract available.
Other Identifiers
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ABC-ODI-12-2012
Identifier Type: -
Identifier Source: org_study_id