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:
Information provided by:
Kovacs Foundation
ClinicalTrials.gov Identifier:
NCT00480038
First received: May 28, 2007
Last updated: June 26, 2011
Last verified: June 2011
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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
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

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
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 ClinicalTrials.gov identifier: 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
Study First Received: May 28, 2007
Last Updated: June 26, 2011
Health Authority: Spain: Spanish Agency of Medicines

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

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

ClinicalTrials.gov processed this record on October 23, 2014