NCT00479245TerminatedNot Applicable
WHODAS-II for Patients With Nonspecific Low Back Pain
Kovacs Foundation2 sites in 1 country200 target enrollmentStarted: April 1, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Measurement characteristics of WHODAS-II
Study Overview
Brief 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 low back pain (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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients seen for nonspecific low back pain, with or without referred pain
- •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 symptomatic herniated disc or symptomatic spinal stenosis
Outcomes
Primary Outcomes
Measurement characteristics of WHODAS-II
Time Frame: At baseline and at 7 days
Secondary Outcomes
- Correlation between WHODAS-II and VAS, RMQ, FABQ and SF-12 in nonspecific low back pain(At baseline and at 7 days)
Investigators
Study Sites (2)
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