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World Health Organization Disability Assessment Schedule (WHODAS-II) for Patients With Symptomatic Lumbar Disc Herniation

This study has been terminated.
(Recruitment was so slow, that it made the study impossible. Organizational changes made it impossible for recruiting centers to continue recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00480038
First Posted: May 30, 2007
Last Update Posted: June 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kovacs Foundation
  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 symptomatic lumbar disc herniation (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
Lumbar Disc Herniation Other: WHODAS II

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: WHODAS-II for Patients With Symptomatic Lumbar Disc Herniation

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 symptomatic lumbar herniated disc [ 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
1
Measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule)
Other: WHODAS II
To determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule)

  Eligibility

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 symptomatic lumbar disc herniation
  • Radiated pain concordant with nerve root
  • With or without motor restriction
  • Able to read and write
  • 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 spinal stenosis
  • Symptoms suggesting saddle anesthesia, cauda equina, loss of sphincter tone or paraparesis
  • Motor deficit that progresses or does not improve in 6 weeks
  Contacts and Locations
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): NCT00480038


Locations
Spain
Fundación Kovacs
Palma de Mallorca, Balearic Islands, Spain, 07012
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: NCT00480038     History of Changes
Other Study ID Numbers: FK-R-18
First Submitted: May 28, 2007
First Posted: May 30, 2007
Last Update Posted: June 28, 2011
Last Verified: June 2011

Keywords provided by Kovacs Foundation:
symptomatic
lumbar disc herniation
disability
fear avoidance beliefs
quality of life

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical