Back to resultsWHODAS-II for Patients With Nonspecific Low Back Pain
Primary Purpose
Low Back Pain
Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Set of questionnaires (respondent)
Sponsored by
About this trial
This is an interventional diagnostic trial for Low Back Pain focused on measuring nonspecific low back pain, disability, fear avoidance beliefs, quality of life
Eligibility Criteria
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
Sites / Locations
- Hospital Universitario Marqués de Valdecilla
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule)
Outcomes
Primary Outcome Measures
Measurement characteristics of WHODAS-II
Secondary Outcome Measures
Correlation between WHODAS-II and VAS, RMQ, FABQ and SF-12 in nonspecific low back pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00479245
Brief Title
WHODAS-II for Patients With Nonspecific Low Back Pain
Official Title
WHODAS-II for Patients With Nonspecific Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Terminated
Why Stopped
Recruitment rate, lower than expected. Organizational changes made it impossible for recruiting centers to continue
Study Start Date
April 2007 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kovacs Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
nonspecific low back pain, disability, fear avoidance beliefs, quality of life
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule)
Intervention Type
Other
Intervention Name(s)
Set of questionnaires (respondent)
Intervention Description
To determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule)
Primary Outcome Measure Information:
Title
Measurement characteristics of WHODAS-II
Time Frame
At baseline and at 7 days
Secondary Outcome Measure Information:
Title
Correlation between WHODAS-II and VAS, RMQ, FABQ and SF-12 in nonspecific low back pain
Time Frame
At baseline and at 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco M Kovacs, MD, PhD
Organizational Affiliation
Kovacs Foundation, Palma de Mallorca, Spain
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
José Luis Peña, MD
Organizational Affiliation
Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
11124723
Citation
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.
Results Reference
background
PubMed Identifier
12873644
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. doi: 10.1016/s0895-4356(03)00051-9.
Results Reference
background
PubMed Identifier
12525383
Citation
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.
Results Reference
background
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WHODAS-II for Patients With Nonspecific Low Back Pain
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