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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)
Sponsor:
Information provided by:
Kovacs Foundation
ClinicalTrials.gov Identifier:
NCT00479245
First received: May 25, 2007
Last updated: June 26, 2011
Last verified: June 2011
History of Changes
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: WHODAS-II for Patients With Nonspecific Low Back Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kovacs Foundation:

Primary Outcome Measures:
  • Measurement characteristics of WHODAS-II [ Time Frame: At baseline and at 7 days ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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
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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation
ClinicalTrials.gov Identifier: NCT00479245     History of Changes
Other Study ID Numbers: FK-R-17
Study First Received: May 25, 2007
Last Updated: June 26, 2011
Health Authority: Spain: Spanish Back Pain Research Network (REIDE)

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

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013