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WHODAS-II for Patients With Nonspecific Low Back Pain

This study has been terminated.
(Recruitment rate, lower than expected. Organizational changes made it impossible for recruiting centers to continue)
Information provided by:
Kovacs Foundation Identifier:
First received: May 25, 2007
Last updated: June 26, 2011
Last verified: June 2011
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).

Condition Intervention
Low Back Pain Other: Set of questionnaires (respondent)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: WHODAS-II for Patients With Nonspecific Low Back Pain

Resource links provided by NLM:

Further study details as provided by Kovacs Foundation:

Primary Outcome Measures:
  • Measurement characteristics of WHODAS-II [ Time Frame: At baseline and at 7 days ]

Secondary Outcome Measures:
  • Correlation between WHODAS-II and VAS, RMQ, FABQ and SF-12 in nonspecific low back pain [ Time Frame: At baseline and at 7 days ]

Estimated Enrollment: 200
Study Start Date: April 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule)
Other: Set of questionnaires (respondent)
To determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule)


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00479245

Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Sponsors and Collaborators
Kovacs Foundation
Study Director: Francisco M Kovacs, MD, PhD Kovacs Foundation, Palma de Mallorca, Spain
Principal Investigator: José Luis Peña, MD Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain
  More Information

Responsible Party: Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation Identifier: NCT00479245     History of Changes
Other Study ID Numbers: FK-R-17
Study First Received: May 25, 2007
Last Updated: June 26, 2011

Keywords provided by Kovacs Foundation:
nonspecific low back pain
fear avoidance beliefs
quality of life

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on August 18, 2017