The Effect of Two Short Education Programs for Nonspecific Low Back Pain in a Workers' Health Care Organization - Full Text View

Sponsors and Collaborators:	Kovacs Foundation Hospital Laboral SOLIMAT
Information provided by:	Kovacs Foundation
ClinicalTrials.gov Identifier:	NCT00665821

Purpose

The purpose of this study is to assess the effect of two different types of health education programs on the disability, beliefs related to low back pain and duration of sick leave in patients seen at a workers' health care organization

Condition	Intervention
Low Back Pain	Behavioral: Classic back pain prevention education, and cognitive behavioral management. Behavioral: General health education

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Study of the Effect of Two Short Education Programs for the Treatment of Nonspecific Low Back Pain in Patients Seen at a Workers' Health Care Organization

Further study details as provided by Kovacs Foundation:

Primary Outcome Measures:

A reduction in low back pain related disability and sick leave. [ Time Frame: 365 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

A reduction in catastrophizing beliefs related to low back pain. [ Time Frame: 365 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	657
Study Start Date:	September 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Classic education: postural hygiene, Back Guide. Cognitive behavioral management: active management, Back Book.

General health education: a booklet describing general norms for maintaining good health

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

low back pain patients, with or without referred or radiated pain
no systemic disease or criteria for referral to surgery

Exclusion Criteria:

inability to fill out the questionnaires and scales
bedridden
rheumatologic inflammatory disease, cancer or fibromyalgia
suspicion of fibromyalgia
spinal fracture

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665821

Contacts

Contact: Francisco M Kovacs, MD, PhD	+34 971 720809	kovacs@kovacs.org
Contact: María Teresa Gil del Real, MPH	+34 91 3440244	mtgildelreal@kovacs.org

Locations

Spain, Balearic Islands
Kovacs Foundation	Recruiting
Palma de Mallorca, Balearic Islands, Spain, 07012
Contact: Francisco M Kovacs, MD, PhD +34 971 720809 kovacs@kovacs.org
Contact: María Teresa Gil del Real, MPH +34 91 3440244 mtgildelreal@kovacs.org
Principal Investigator: Francisco M Kovacs, MD, PhD
Spain, Castilla la Mancha
Hospital Laboral SOLIMAT	Recruiting
Toledo, Castilla la Mancha, Spain, 45004
Contact: Andrés Barriga, MD +34 925 269200 docbarriga@gmail.es
Principal Investigator: Andrés Barriga, MD

Sponsors and Collaborators

Kovacs Foundation

Hospital Laboral SOLIMAT

Investigators

Study Director:	Francisco M Kovacs, MD, PhD	Kovacs Foundation, Palma de Mallorca, 07012, Spain
Principal Investigator:	Andrés Barriga, MD	Hospital Laboral Solimat, Toledo, Spain

More Information

Publications:

Burton AK, Waddell G, Tillotson KM, Summerton N. Information and advice to patients with back pain can have a positive effect. A randomized controlled trial of a novel educational booklet in primary care. Spine. 1999 Dec 1;24(23):2484-91.

Frost H, Lamb SE, Doll HA, Carver PT, Stewart-Brown S. Randomised controlled trial of physiotherapy compared with advice for low back pain. BMJ. 2004 Sep 25;329(7468):708. Epub 2004 Sep 17.

Kovacs F, Abraira V, Santos S, Díaz E, Gestoso M, Muriel A, Gil del Real MT, Mufraggi N, Noguera J, Zamora J; Spanish Back Pain Research Network. A comparison of two short education programs for improving low back pain-related disability in the elderly: a cluster randomized controlled trial. Spine. 2007 May 1;32(10):1053-9.

Responsible Party:	Kovacs Foundation ( Francisco M. Kovacs, Director of Scientific Department )
Study ID Numbers:	FK-S-24
Study First Received:	April 23, 2008
Last Updated:	November 28, 2008
ClinicalTrials.gov Identifier:	NCT00665821
Health Authority:	Spain: Comité Etico de Investigación Clínica

Keywords provided by Kovacs Foundation:

nonspecific low back pain
disability
sick leave
catastrophizing
workers

Study placed in the following topic categories:

Signs and Symptoms
Neurologic Manifestations
Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009