WHODAS-II for Patients With Nonspecific Low Back Pain

NCT ID: NCT00479245

Last Updated: 2011-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2011-04-30

Brief Summary

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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).

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

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

Group Type OTHER

Set of questionnaires (respondent)

Intervention Type OTHER

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

Interventions

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Set of questionnaires (respondent)

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

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kovacs Foundation

OTHER

Sponsor Role lead

Responsible Party

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Kovacs Foundation

Principal Investigators

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Francisco M Kovacs, MD, PhD

Role: STUDY_DIRECTOR

Kovacs Foundation, Palma de Mallorca, Spain

José Luis Peña, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain

Locations

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Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 11124723 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12873644 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12525383 (View on PubMed)

Other Identifiers

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FK-R-17

Identifier Type: -

Identifier Source: org_study_id

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