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

This study has been terminated.

(Recruitment was so slow, that it made the study impossible. Organizational changes made it impossible for recruiting centers to continue recruitment)

Sponsor:

Information provided by:

Kovacs Foundation

ClinicalTrials.gov Identifier:

NCT00480038

First received: May 28, 2007

Last updated: June 26, 2011

Last verified: June 2011

History of Changes

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 symptomatic lumbar disc herniation (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 Disc Herniation	Other: WHODAS II

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	WHODAS-II for Patients With Symptomatic Lumbar Disc Herniation

Resource links provided by NLM:

MedlinePlus related topics: Hernia International Health

U.S. FDA Resources

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 herniated disc [ Time Frame: At baseline and at 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	April 2007
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule)	Other: WHODAS 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

Criteria

Inclusion Criteria:

Patients seen for symptomatic lumbar disc herniation
Radiated pain concordant with nerve root
With or without motor restriction
Able to read and write
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 spinal stenosis
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: NCT00480038

Locations

Spain
Fundación Kovacs
Palma de Mallorca, Balearic Islands, Spain, 07012
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008

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:	Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation
ClinicalTrials.gov Identifier:	NCT00480038 History of Changes
Other Study ID Numbers:	FK-R-18
Study First Received:	May 28, 2007
Last Updated:	June 26, 2011
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Kovacs Foundation:

symptomatic
lumbar disc herniation
disability
fear avoidance beliefs
quality of life

Additional relevant MeSH terms:

Hernia
Intervertebral Disk Displacement
Pathological Conditions, Anatomical

Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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