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

Lumbar Disc Herniation Clinical Trial

Official title:

WHODAS-II for Patients With Symptomatic Lumbar Disc Herniation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00480038
• Other study ID #: FK-R-18
• 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 Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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).

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 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation

Intervention

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

Locations

Country	Name	City	State
Spain	Fundación Kovacs	Palma de Mallorca	Balearic Islands
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 herniated disc		At baseline and at 7 days	No