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

NCT00480311 | Terminated DMC

• 1 other identifier: FK-R-19
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to determine the measurement characteristics of WHODAS-II (World Health Organization Disability Assessment Schedule II), as well as to analyze its correlation with symptomatic lumbar spinal stenosis (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

Lumbar Spinal Stenosis

Keywords

symptomatic; lumbar spinal stenosis; disability; fear avoidance beliefs; quality 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 spinal stenosis

  At baseline and at 7 days

Study Arms (1)

1

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

Other: WHODAS II (World Health Organization Disability Assessment Schedule II)

Interventions

WHODAS II (World Health Organization Disability Assessment Schedule II) OTHER

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

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen at Hospital Universitario Marqués de Valdecilla in Santander, Spain - for symptomatic lumbar spinal stenosis.

You may qualify if:

• Patients seen for symptomatic lumbar spinal stenosis
• With signs of neurogenous claudication
• MRI or CAT scan concordant with observed signs
• Able to read and write
• Have 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 disc herniation
• Symptoms suggesting saddle anesthesia, cauda equina, loss of sphincter tone or paraparesis
• Motor deficit that progresses or does not improve in 6 weeks

Sponsors & Collaborators

• Kovacs Foundation: lead

Study Sites (1)

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: 11124723 BACKGROUND

• 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: 12873644 BACKGROUND

• 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: 12525383 BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

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: observational
• Time Perspective: CROSS SECTIONAL
• 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 (1)