World Health Organization Disability Assessment Schedule II (WHODAS-II) for Patients With Symptomatic Lumbar Spinal Stenosis

This study is currently recruiting participants.

Verified by Kovacs Foundation, March 2009

First Received: May 28, 2007 Last Updated: March 13, 2009 History of Changes

Sponsored by:	Kovacs Foundation
Information provided by:	Kovacs Foundation
ClinicalTrials.gov Identifier:	NCT00480311

Purpose

The main purpose of this study is to determine the measurement characteristics of WHODAS-II (World Health Organization Disability Assessment Schedule II), as well as to analyze its correlation with symptomatic lumbar spinal stenosis (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
Lumbar Spinal Stenosis	Other: WHODAS II (World Health Organization Disability Assessment Schedule II)

MedlinePlus related topics: International Health Spinal Stenosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cross-Sectional
Official Title:	WHODAS-II for Patients With Symptomatic Lumbar Spinal Stenosis

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 symptomatic lumbar spinal stenosis [ Time Frame: At baseline and at 7 days ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	April 2007
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule).	Other: WHODAS II (World Health Organization Disability Assessment Schedule II) 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
Sampling Method:	Non-Probability Sample

Study Population

Patients seen at Hospital Universitario Marqués de Valdecilla in Santander, Spain - for symptomatic lumbar spinal stenosis.

Criteria

Inclusion Criteria:

Patients seen for symptomatic lumbar spinal stenosis
With signs of neurogenous claudication
MRI or CAT scan concordant with observed signs
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 disc herniation
Symptoms suggesting saddle anesthesia, cauda equina, loss of sphincter tone or paraparesis
Motor deficit that progresses or does not improve in 6 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480311

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-19
Study First Received:	May 28, 2007
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00480311 History of Changes
Health Authority:	Spain: Spanish Back Pain Research Network (REIDE)

Keywords provided by Kovacs Foundation:

symptomatic
lumbar spinal stenosis
disability
fear avoidance beliefs
quality of life

Study placed in the following topic categories:

Spinal Diseases
Pathological Conditions, Anatomical
Musculoskeletal Diseases
Quality of Life

Constriction, Pathologic
Bone Diseases
Spinal Stenosis

Additional relevant MeSH terms:

Spinal Diseases
Pathological Conditions, Anatomical
Musculoskeletal Diseases

Constriction, Pathologic
Bone Diseases
Spinal Stenosis

ClinicalTrials.gov processed this record on May 07, 2009