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World Health Organization Disability Assessment Schedule (WHODAS-II) for Patients With Symptomatic Lumbar Disc Herniation
This study is currently recruiting participants.
Verified by Kovacs Foundation, May 2009
First Received: May 28, 2007   Last Updated: May 27, 2009   History of Changes
Sponsored by: Kovacs Foundation
Information provided by: Kovacs Foundation
ClinicalTrials.gov Identifier: NCT00480038
  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: Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2007
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: January 2010 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480038

Contacts
Contact: Francisco M Kovacs, MD, PhD +34 971 720809 kovacs@kovacs.org
Contact: María Teresa Gil del Real, MPH +34 91 3440244 mtgildelreal@kovacs.org

Locations
Spain, Balearic Islands
Fundación Kovacs Recruiting
Palma de Mallorca, Balearic Islands, Spain, 07012
Principal Investigator: Francisco M Kovacs, MD, PhD            
Spain, Cantabria
Hospital Universitario Marqués de Valdecilla Recruiting
Santander, Cantabria, Spain, 39008
Principal Investigator: José Luis Peña, MD            
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: Kovacs Foundation ( Francisco M. Kovacs, Director of Scientific Department )
Study ID Numbers: FK-R-18
Study First Received: May 28, 2007
Last Updated: May 27, 2009
ClinicalTrials.gov Identifier: NCT00480038     History of Changes
Health Authority: Spain: Spanish Agency of Medicines

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

Study placed in the following topic categories:
Spinal Diseases
Pathological Conditions, Anatomical
Musculoskeletal Diseases
Hernia
Quality of Life
Intervertebral Disk Displacement
Bone Diseases

Additional relevant MeSH terms:
Spinal Diseases
Pathological Conditions, Anatomical
Musculoskeletal Diseases
Hernia
Intervertebral Disk Displacement
Bone Diseases

ClinicalTrials.gov processed this record on September 11, 2009