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

This study has been terminated.
(From Sept./08 to April/09 only 30 subjects were recruited. It has proved extremely difficult to recruit subjects.)
Sponsor:
Collaborator:
Hospital Laboral SOLIMAT
Information provided by:
Kovacs Foundation
ClinicalTrials.gov Identifier:
NCT00665821
First received: April 23, 2008
Last updated: May 14, 2009
Last verified: May 2009
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
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

Resource links provided by NLM:


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:
    Behavioral: Classic back pain prevention education, and cognitive behavioral management.
    Classic education: postural hygiene, Back Guide. Cognitive behavioral management: active management, Back Book.
    Behavioral: General health education
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Spain
Kovacs Foundation
Palma de Mallorca, Balearic Islands, Spain, 07012
Hospital Laboral SOLIMAT
Toledo, Castilla la Mancha, Spain, 45004
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:
Responsible Party: Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation
ClinicalTrials.gov Identifier: NCT00665821     History of Changes
Other Study ID Numbers: FK-S-24
Study First Received: April 23, 2008
Last Updated: May 14, 2009
Health Authority: Spain: Comité Etico de Investigación Clínica

Keywords provided by Kovacs Foundation:
nonspecific low back pain
disability
sick leave
catastrophizing
workers

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 23, 2014