World Health Organization Disability Assessment Schedule II (WHODAS-II) for Patients With Symptomatic Lumbar Spinal Stenosis
June 26, 2011 updated by: Kovacs Foundation
WHODAS-II for Patients With Symptomatic Lumbar Spinal Stenosis
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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cantabria
-
Santander, Cantabria, Spain, 39008
- Hospital Universitario Marqués de Valdecilla
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients seen at Hospital Universitario Marqués de Valdecilla in Santander, Spain - for symptomatic lumbar spinal stenosis.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
Measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule).
|
To determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Measurement characteristics of WHODAS-II
Time Frame: At baseline and at 7 days
|
At baseline and at 7 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Correlation between WHODAS-II and VAS, RMQ, FABQ and SF-12 in symptomatic lumbar spinal stenosis
Time Frame: At baseline and at 7 days
|
At baseline and at 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bombardier C. Outcome assessments in the evaluation of treatment of spinal disorders. Introduction. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3097-9. doi: 10.1097/00007632-200012150-00002. 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. doi: 10.1016/s0895-4356(03)00051-9.
- 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. doi: 10.1136/ard.62.2.140.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (ACTUAL)
April 1, 2011
Study Completion (ACTUAL)
April 1, 2011
Study Registration Dates
First Submitted
May 28, 2007
First Submitted That Met QC Criteria
May 28, 2007
First Posted (ESTIMATE)
May 30, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
June 28, 2011
Last Update Submitted That Met QC Criteria
June 26, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FK-R-19
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.