WHODAS-II for Patients With Nonspecific Low Back Pain - Full Text View

Sponsored by:	Kovacs Foundation
Information provided by:	Kovacs Foundation
ClinicalTrials.gov Identifier:	NCT00479245

Purpose

The main purpose of this study is to determine the measurement characteristics of WHODAS-II (World Health Organization Disability Assessment Schedule), as well as to analyze its correlation with low back pain (Visual Analog Scale, VAS), disability (Spanish version of the Roland Morris Questionnaire, RMQ), fear avoidance beliefs and attitudes (Spanish version of the FAB Questionnaire, FABQ) and quality of life (SF-12). Measurements will be taken at baseline and 6 days later (day 7).

Condition	Intervention
Low Back Pain	Other: Set of questionnaires (respondent)

MedlinePlus related topics: Back Pain International Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	WHODAS-II for Patients With Nonspecific Low Back Pain

Further study details as provided by Kovacs Foundation:

Primary Outcome Measures:

Measurement characteristics of WHODAS-II [ Time Frame: At baseline and at 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Correlation between WHODAS-II and VAS, RMQ, FABQ and SF-12 in nonspecific low back pain [ Time Frame: At baseline and at 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	April 2007
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule)	Other: Set of questionnaires (respondent) To determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule)

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients seen for nonspecific low back pain, with or without referred pain
Able to read and write
Have signed the informed consent form

Exclusion Criteria:

Central nervous system pathology (with or without treatment)
Diagnosis of rheumatic inflammatory disease or fibromyalgia
Red flags for underlying systemic disease
Criteria for diagnosis of symptomatic herniated disc or symptomatic spinal stenosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479245

Contacts

Contact: Francisco M Kovacs, MD, PhD	+34 971 720809	kovacs@kovacs.org
Contact: María Teresa Gil del Real, MPH	+34 91 3440244	mtgildelreal@kovacs.org

Locations

Spain, Cantabria
Hospital Universitario Marqués de Valdecilla	Recruiting
Santander, Cantabria, Spain, 39008
Contact: Francisco M Kovacs, MD, PhD +34 971 720809 kovacs@kovacs.org
Contact: María Teresa Gil del Real, MPH +34 91 3440244 mtgildelreal@kovacs.org
Principal Investigator: Francisco M Kovacs, MD, PhD
Principal Investigator: José Luis Peña, MD

Sponsors and Collaborators

Kovacs Foundation

Investigators

Study Director:	Francisco M Kovacs, MD, PhD	Kovacs Foundation, Palma de Mallorca, Spain
Principal Investigator:	José Luis Peña, MD	Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain

More Information

Publications:

Bombardier C. Outcome assessments in the evaluation of treatment of spinal disorders. Introduction. Spine. 2000 Dec 15;25(24):3097-9. Review. No abstract available.

Chwastiak LA, Von Korff M. Disability in depression and back pain: evaluation of the World Health Organization Disability Assessment Schedule (WHO DAS II) in a primary care setting. J Clin Epidemiol. 2003 Jun;56(6):507-14.

van Tubergen A, Landewe R, Heuft-Dorenbosch L, Spoorenberg A, van der Heijde D, van der Tempel H, van der Linden S. Assessment of disability with the World Health Organisation Disability Assessment Schedule II in patients with ankylosing spondylitis. Ann Rheum Dis. 2003 Feb;62(2):140-5.

Responsible Party:	Kovacs Foundation ( Francisco M. Kovacs, Director of Scientific Department )
Study ID Numbers:	FK-R-17
Study First Received:	May 25, 2007
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00479245 History of Changes
Health Authority:	Spain: Spanish Back Pain Research Network (REIDE)

Keywords provided by Kovacs Foundation:

nonspecific low back pain
disability
fear avoidance beliefs
quality of life

Study placed in the following topic categories:

Signs and Symptoms
Quality of Life
Neurologic Manifestations

Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:

Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations

Low Back Pain
Pain
Back Pain

ClinicalTrials.gov processed this record on May 07, 2009