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

Terminated

• Conditions: Lumbar Spinal Stenosis
• Interventions: Other: WHODAS II (World Health Organization Disability Assessment Schedule II)

• Registration Number: NCT00480311
• Lead Sponsor: Kovacs Foundation

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-05-28
• Study First Submitted QC: 2007-05-28
• Study First Posted: 2007-05-30
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-26
• Last Update Posted: 2011-06-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	WHODAS II (World Health Organization Disability Assessment Schedule II)	Measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule).

Primary Outcome Measures

Name	Time	Method
Measurement characteristics of WHODAS-II	At baseline and at 7 days

Secondary Outcome Measures

Name	Time	Method
Correlation between WHODAS-II and VAS, RMQ, FABQ and SF-12 in symptomatic lumbar spinal stenosis	At baseline and at 7 days

Trial Locations

Locations (1)

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Cantabria, Spain