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

Primary Purpose

Lumbar Disc Herniation

Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
WHODAS II
Sponsored by
Kovacs Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lumbar Disc Herniation focused on measuring symptomatic, lumbar disc herniation, disability, fear avoidance beliefs, quality of life

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fundación Kovacs
  • Hospital Universitario Marqués de Valdecilla

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule)

Outcomes

Primary Outcome Measures

Measurement characteristics of WHODAS-II

Secondary Outcome Measures

Correlation between WHODAS-II and VAS, RMQ, FABQ and SF-12 in symptomatic lumbar herniated disc

Full Information

First Posted
May 28, 2007
Last Updated
June 26, 2011
Sponsor
Kovacs Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00480038
Brief Title
World Health Organization Disability Assessment Schedule (WHODAS-II) for Patients With Symptomatic Lumbar Disc Herniation
Official Title
WHODAS-II for Patients With Symptomatic Lumbar Disc Herniation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Terminated
Why Stopped
Recruitment was so slow, that it made the study impossible. Organizational changes made it impossible for recruiting centers to continue recruitment
Study Start Date
April 2007 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kovacs Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
symptomatic, lumbar disc herniation, disability, fear avoidance beliefs, quality of life

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule)
Intervention Type
Other
Intervention Name(s)
WHODAS II
Intervention Description
To determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule)
Primary Outcome Measure Information:
Title
Measurement characteristics of WHODAS-II
Time Frame
At baseline and at 7 days
Secondary Outcome Measure Information:
Title
Correlation between WHODAS-II and VAS, RMQ, FABQ and SF-12 in symptomatic lumbar herniated disc
Time Frame
At baseline and at 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco M Kovacs, MD, PhD
Organizational Affiliation
Kovacs Foundation, Palma de Mallorca, Spain
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
José Luis Peña, MD
Organizational Affiliation
Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundación Kovacs
City
Palma de Mallorca
State/Province
Balearic Islands
ZIP/Postal Code
07012
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
11124723
Citation
Bombardier C. Outcome assessments in the evaluation of treatment of spinal disorders. Introduction. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3097-9. doi: 10.1097/00007632-200012150-00002. No abstract available.
Results Reference
background
PubMed Identifier
12873644
Citation
Chwastiak LA, Von Korff M. Disability in depression and back pain: evaluation of the World Health Organization Disability Assessment Schedule (WHO DAS II) in a primary care setting. J Clin Epidemiol. 2003 Jun;56(6):507-14. doi: 10.1016/s0895-4356(03)00051-9.
Results Reference
background
PubMed Identifier
12525383
Citation
van Tubergen A, Landewe R, Heuft-Dorenbosch L, Spoorenberg A, van der Heijde D, van der Tempel H, van der Linden S. Assessment of disability with the World Health Organisation Disability Assessment Schedule II in patients with ankylosing spondylitis. Ann Rheum Dis. 2003 Feb;62(2):140-5. doi: 10.1136/ard.62.2.140.
Results Reference
background

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

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