Validation of a Translation Into Spanish of the Oswestry Disability Index

Low Back Pain Clinical Trial

Official title:

Validation of a Translation Into Spanish of the Oswestry Disability Index

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01649011
• Other study ID #: ABC-ODI-12-2012
• Status: Recruiting
• Phase: N/A
• First received: July 18, 2012
• Last updated: July 25, 2012
• Start date: July 2012

Study information

• Verified date: July 2012
• Source: American British Cowdray Medical Center
• Contact: Ernesto E Galvan, MD
• Phone: 52 5516647205
• Email: egalh[@]yahoo.com
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to validate in Mexico a spanish translation of the 2.1a Oswestry Disability Index (ODI) version in patients with low back pain.

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.

Description:

Low back pain (LBP) is one of the most frequent ailments in industrialized countries, with a lifetime prevalence of more than 70%, and is responsible for a major portion of work absenteeism. Measuring disability is important in LBP. First, as an outcome measure, it is an important indicator of the quality of life of the patient. The Oswestry Disability Index (ODI) and the Roland Morris Disability Questionnaire (RMDQ) have emerged as the most commonly recommended condition specific outcome measures for spinal disorders.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with acute or chronic low back pain

• With or without previous back surgery

Exclusion Criteria:

• Visual or mentally impaired

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Low Back Pain

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Mexico	American British Cowdray Medical Center	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
American British Cowdray Medical Center

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. — View Citation

Kovacs FM, Llobera J, Gil Del Real MT, Abraira V, Gestoso M, Fernández 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. — View Citation

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. Review. Erratum in: Spine 2001 Apr 1;26(7):847. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low back pain scored by the translated and proposed version of the ODI	The objective of this outcome measure is to evaluate the ability of the translated ODI version to measure changes in time on patients with low back pain. The score will be registered 2 times with 3 weeks apart	Initial evaluation and 2 weeks after	No
Secondary	Low back pain scored by the RMQ spanish version	The RMQ will be administered at the same time that the proposed translated ODI version, at the beginning of the study and 3 weeks later. The RMQ was previously translated and validated to spanish, and will work like a reference to evaluate the reproducibility of any change in the score obtained by the ODI spanish version.	Initial evaluation and 2 weeks after	No