NCT00480038

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

June 28, 2011

Status Verified

June 1, 2011

Enrollment Period

4 years

First QC Date

May 28, 2007

Last Update Submit

June 26, 2011

Conditions

Lumbar Disc Herniation

Keywords

symptomaticlumbar disc herniationdisabilityfear avoidance beliefsquality of life

Outcome Measures

Primary Outcomes (1)

  • Measurement characteristics of WHODAS-II

    At baseline and at 7 days

Secondary Outcomes (1)

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

    At baseline and at 7 days

Study Arms (1)

1

OTHER

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

Other: WHODAS II

Interventions

WHODAS IIOTHER

To determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule)

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fundación Kovacs

Palma de Mallorca, Balearic Islands, 07012, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Related Publications (3)

  • 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.

    PMID: 11124723BACKGROUND

  • 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.

    PMID: 12873644BACKGROUND

  • 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.

    PMID: 12525383BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Francisco M Kovacs, MD, PhD

    Kovacs Foundation, Palma de Mallorca, Spain

    STUDY DIRECTOR

  • José Luis Peña, MD

    Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2007

First Posted

May 30, 2007

Study Start

April 1, 2007

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

June 28, 2011

Record last verified: 2011-06

Locations

ES(2)