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TerminatedNCT00479245Updated Jun 28, 2011

WHODAS-II for Patients With Nonspecific Low Back Pain

An interventional study of Set of questionnaires (respondent) in Low Back Pain, sponsored by Kovacs Foundation. Terminated at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-06-28.

Sponsored by Kovacs Foundation · Not applicable, Interventional, and Diagnostic

Why this study was terminated
Recruitment rate, lower than expected. Organizational changes made it impossible for recruiting centers to continue
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
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Study 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 low back pain (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).

02

Conditions studied

  • Low Back Pain

Keywords

  • nonspecific low back pain
  • disability
  • fear avoidance beliefs
  • quality of life
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's planned enrollment of 200 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Kovacs Foundation is the lead sponsor of 20 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients seen for nonspecific low back pain, with or without referred pain
  • Able to read and write
  • Have signed the informed consent form

Exclusion criteria

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 herniated disc or symptomatic spinal stenosis
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Other
    1

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

    Other: Set of questionnaires (respondent)

Interventions

  • OtherSet of questionnaires (respondent)

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

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What researchers measure

Primary outcomes

  1. Measurement characteristics of WHODAS-II

    Time frame: At baseline and at 7 days

Secondary outcomes

  1. Correlation between WHODAS-II and VAS, RMQ, FABQ and SF-12 in nonspecific low back pain

    Time frame: At baseline and at 7 days

07

Study locations

1 site
  • Hospital Universitario Marqués de Valdecilla
    Santander, Cantabria 39008, Spain
08

References and documents

Publications

  • 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. PubMed 11124723 ↗
  • 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. PubMed 12873644 ↗
  • 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. PubMed 12525383 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00479245
Lead sponsor
Kovacs Foundation
First posted
May 28, 2007
Start date
Apr 2007
Primary completion
Apr 2011
Completion
Apr 2011
Last update
Jun 28, 2011

Study contacts

Francisco M Kovacs, MD, PhD
study director · Kovacs Foundation, Palma de Mallorca, Spain
José Luis Peña, MD
principal investigator · Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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