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

Lumbar Spinal Stenosis Clinical Trial

Official title:

WHODAS-II for Patients With Symptomatic Lumbar Spinal Stenosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00480311
• Other study ID #: FK-R-19
• Status: Terminated
• Phase: N/A
• First received: May 28, 2007
• Last updated: June 26, 2011
• Start date: April 2007
• Est. completion date: April 2011

Study information

• Verified date: June 2011
• Source: Kovacs Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Back Pain Research Network (REIDE)
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Other:
• WHODAS II (World Health Organization Disability Assessment Schedule II)
To determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule).

Locations

Country	Name	City	State
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria

Sponsors (1)

Lead Sponsor	Collaborator
Kovacs Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Bombardier C. Outcome assessments in the evaluation of treatment of spinal disorders. Introduction. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3097-9. Review. — View Citation

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. — View Citation

van Tubergen A, Landewé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement characteristics of WHODAS-II		At baseline and at 7 days	No
Secondary	Correlation between WHODAS-II and VAS, RMQ, FABQ and SF-12 in symptomatic lumbar spinal stenosis		At baseline and at 7 days	No