Clinical trial NCT00480038: 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
Overall status: TERMINATED
Phase: NA
Conditions: Lumbar Disc Herniation
Keywords: symptomatic
lumbar disc herniation
disability
fear avoidance beliefs
quality of life
Lead sponsor: Kovacs Foundation
Sponsor class: OTHER
First posted: 2007-05-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


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

Primary outcomes:
measure: Measurement characteristics of WHODAS-II
timeFrame: At baseline and at 7 days
Secondary outcomes:
measure: Correlation between WHODAS-II and VAS, RMQ, FABQ and SF-12 in symptomatic lumbar herniated disc
timeFrame: At baseline and at 7 days
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Fundación Kovacs
state: Balearic Islands
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
Study officials:
affiliation: Kovacs Foundation, Palma de Mallorca, Spain
name: Francisco M Kovacs, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain
name: José Luis Peña, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.