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WHODAS-II for Patients With Nonspecific Low Back Pain

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ClinicalTrials.gov Identifier: NCT00479245
Recruitment Status : Terminated (Recruitment rate, lower than expected. Organizational changes made it impossible for recruiting centers to continue)
First Posted : May 28, 2007
Last Update Posted : June 28, 2011
Sponsor:
Information provided by:
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), 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 or disease Intervention/treatment
Low Back Pain Other: Set of questionnaires (respondent)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: WHODAS-II for Patients With Nonspecific Low Back Pain
Study Start Date : April 2007
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arm Intervention/treatment
1
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)



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479245


Locations
Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Sponsors and Collaborators
Kovacs Foundation
Investigators
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