Validation of a Translation Into Spanish of the Oswestry Disability Index

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.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain
• Intervention / Treatment: Behavioral: Application of the initial evaluation; Behavioral: Final application of scales

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Ernesto E Galvan, MD; Phone Number: 52 5516647205; Email: egalh@yahoo.com

Study Locations

• Mexico
  • Mexico City, Mexico, 05300
    • Recruiting
    • American British Cowdray Medical Center
    • Contact: Ernesto Eduardo Galvan, MD; Phone Number: 52 5516647205; Email: egalh@yahoo.com
    • Sub-Investigator: Adriana Cervantes, MD
    • Sub-Investigator: Ildefonso Munoz Romero, MD
    • Sub-Investigator: Roberto Rincón Velazquez
    • Sub-Investigator: Victor Pérez Avila
    • Sub-Investigator: Paul Lamote, PhD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with low back pain

Description

Inclusion Criteria:

• Patients with acute or chronic low back pain
• With or without previous back surgery

Exclusion Criteria:

• Visual or mentally impaired

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Scores of the ODI and RMQ for low back pain	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; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: American British Cowdray Medical Center
• Investigators: Principal Investigator: Ernesto E Galvan Hernandez, MD, MSc, American British Cowdray Medical Center

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Spine 2001 Apr 1;26(7):847.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: July 18, 2012
• First Submitted That Met QC Criteria: July 21, 2012
• First Posted (Estimate): July 25, 2012

Study Record Updates

• Last Update Posted (Estimate): July 27, 2012
• Last Update Submitted That Met QC Criteria: July 25, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Oswestry Disability Index; Roland Morris Disability Questionnaire; ODI; RMDQ
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: ABC-ODI-12-2012