TerminatedNCT00480038Updated Jun 28, 2011

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

An interventional study of WHODAS II in Lumbar Disc Herniation, sponsored by Kovacs Foundation. Terminated at 2 sites 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 was so slow, that it made the study impossible. Organizational changes made it impossible for recruiting centers to continue recruitment

Phase: Not applicable
Study type: Interventional
Enrollment: 200
Allocation: Not applicable
Ages: 18 Years to 80 Years
Sex: All

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 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).

Conditions studied

Lumbar Disc Herniation

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Keywords

symptomatic
lumbar disc herniation
disability
fear avoidance beliefs
quality of life

In context

Intervertebral Disc Displacement

478 studies on the registry are indexed under Intervertebral Disc Displacement; 104 are open to participants now.

This study's planned enrollment of 200 is above the median of 63 across 344 interventional studies indexed under Intervertebral Disc Displacement.

Browse Intervertebral Disc Displacement 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.

Who can participate

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

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

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

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: WHODAS II

Interventions

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

What researchers measure

Primary outcomes

Measurement characteristics of WHODAS-II
Time frame: At baseline and at 7 days

Secondary outcomes

Correlation between WHODAS-II and VAS, RMQ, FABQ and SF-12 in symptomatic lumbar herniated disc
Time frame: At baseline and at 7 days

Study locations

2 sites

Fundación Kovacs
Palma de Mallorca, Balearic Islands 07012, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria 39008, Spain

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 ↗

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 ↗

Registry details

Key details

Study ID: NCT00480038
Lead sponsor: Kovacs Foundation
First posted: May 30, 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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Discussion

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