Validation of a Translation Into Spanish of the Oswestry Disability Index

This study is currently recruiting participants.
Verified July 2012 by American British Cowdray Medical Center
Sponsor:
Information provided by (Responsible Party):
Galvan Ernesto Eduardo, American British Cowdray Medical Center
ClinicalTrials.gov Identifier:
NCT01649011
First received: July 18, 2012
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Low Back Pain
Behavioral: Application of the initial evaluation
Behavioral: Final application of scales

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of a Translation Into Spanish of the Oswestry Disability Index

Resource links provided by NLM:


Further study details as provided by American British Cowdray Medical Center:

Primary Outcome Measures:
  • Low back pain scored by the translated and proposed version of the ODI [ Time Frame: Initial evaluation and 2 weeks after ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Low back pain scored by the RMQ spanish version [ Time Frame: Initial evaluation and 2 weeks after ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: July 2012
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with low back pain

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Visual or mentally impaired
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649011

Contacts
Contact: Ernesto E Galvan, MD 52 5516647205 egalh@yahoo.com

Locations
Mexico
American British Cowdray Medical Center Recruiting
Mexico City, Mexico, 05300
Contact: Ernesto Eduardo Galvan, MD    52 5516647205    egalh@yahoo.com   
Principal Investigator: Ernesto E Galvan Hernandez, MD, MSc         
Sub-Investigator: Roberto De Leo, MD         
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         
Sponsors and Collaborators
American British Cowdray Medical Center
Investigators
Principal Investigator: Ernesto E Galvan Hernandez, MD, MSc American British Cowdray Medical Center
  More Information

Publications:
Responsible Party: Galvan Ernesto Eduardo, Galvan Ernesto Eduardo MD, MSc, Principal investigator, American British Cowdray Medical Center
ClinicalTrials.gov Identifier: NCT01649011     History of Changes
Other Study ID Numbers: ABC-ODI-12-2012
Study First Received: July 18, 2012
Last Updated: July 25, 2012
Health Authority: Mexico: Ethics Committee

Keywords provided by American British Cowdray Medical Center:
Oswestry Disability Index
ODI
Roland Morris Disability Questionnaire
RMDQ

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014