NCT01649011

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Last Updated

July 27, 2012

Status Verified

July 1, 2012

Enrollment Period

8 months

First QC Date

July 18, 2012

Last Update Submit

July 25, 2012

Conditions

Keywords

Oswestry Disability IndexODIRoland Morris Disability QuestionnaireRMDQ

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Low back pain scored by the RMQ spanish version

    Initial evaluation and 2 weeks after

Study Arms (1)

Scores of the ODI and RMQ for low back pain

Behavioral: Application of the initial evaluationBehavioral: Final application of scales

Interventions

Initial evaluation involves the application of the previously spanish validated Rolland Morris Questionnaire and the new spanish Oswestry Disability Index

Scores of the ODI and RMQ for low back pain

Application of the previously spanish validated version of the RMQ and the new spanish translation of the ODI 2 weeks after initial evaluation

Scores of the ODI and RMQ for low back pain

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with low back pain

You may qualify if:

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

You may not qualify if:

  • Visual or mentally impaired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American British Cowdray Medical Center

Mexico City, Mexico City, 05300, Mexico

RECRUITING

Related Publications (3)

  • 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.

    PMID: 11880841BACKGROUND
  • 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.

    PMID: 6450426BACKGROUND
  • 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.

    PMID: 11124727BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ernesto E Galvan Hernandez, MD, MSc

    American British Cowdray Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ernesto E Galvan, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Galvan Ernesto Eduardo MD, MSc, Principal investigator

Study Record Dates

First Submitted

July 18, 2012

First Posted

July 25, 2012

Study Start

July 1, 2012

Primary Completion

March 1, 2013

Last Updated

July 27, 2012

Record last verified: 2012-07

Locations