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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00665821
Recruitment Status : Terminated (From Sept./08 to April/09 only 30 subjects were recruited. It has proved extremely difficult to recruit subjects.)
First Posted : April 24, 2008
Last Update Posted : May 15, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Low Back Pain Behavioral: Classic back pain prevention education, and cognitive behavioral management. Behavioral: General health education

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 657 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2008
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. A reduction in low back pain related disability and sick leave. [ Time Frame: 365 days ]

Secondary Outcome Measures :
  1. A reduction in catastrophizing beliefs related to low back pain. [ Time Frame: 365 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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