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The Influence of Different Factors on Workers' Disability Due to Low Back Pain

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ClinicalTrials.gov Identifier: NCT00667316
Recruitment Status : Unknown
Verified March 2014 by Francisco M. Kovacs, Kovacs Foundation.
Recruitment status was:  Recruiting
First Posted : April 28, 2008
Last Update Posted : March 13, 2014
Sponsor:
Information provided by (Responsible Party):
Francisco M. Kovacs, Kovacs Foundation

Study Description
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Brief Summary:
The purpose of this study is to determine, in Spanish workers, the influence of different factors (personal, psychological, work related and clinical) on the risk of being on sick leave during the 18 months after baseline assessment, and on the duration of that sick leave.

Condition or disease Intervention/treatment
Low Back Pain Behavioral: Set of questionnaires (respondent)

Study Design
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Study Type : Observational
Estimated Enrollment : 7200 participants
Time Perspective: Prospective
Official Title: Study to Identify the Influence of Different Factors on Workers' Disability Due to Low Back Pain
Study Start Date : February 2008
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

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

Groups and Cohorts
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Group/Cohort Intervention/treatment
A
Workers from companies and workers' health care organizations who go for their periodic medical checkup.
 Behavioral: Set of questionnaires (respondent)
A set of questionnaires to determine risk factors for sick leave due to low back pain.


Outcome Measures
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Primary Outcome Measures :
  1. The influence of different factors on risk of sick leave for low back pain [ Time Frame: 18 months ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Workers from companies and workers' health care organizations who are currently active.
Criteria

Inclusion Criteria:

  • Subjects who get their checkups at participating health services
  • With a labor contract that won't make it likely that they stop work before the next 18 months, for causes other than their health
  • Who sign the informed consent form

Exclusion Criteria:

  • Don't sign the informed consent form
  • Inability to fill our the questionnaires
  • Bedridden
  • Rheumatologic inflammatory disease, cancer or fibromyalgia
  • Suspicion of fibromyalgia
  • Red flags for systemic disease
  • Criteria for surgery
  • Criteria for urgent referral to surgery
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00667316


Contacts
Contact: Francisco M Kovacs, MD, PhD 34-971-720-809 kovacs@kovacs.org
Contact: María Teresa Gil del Real, MPH 34-913-440-244 mtgildelreal@kovacs.org

Locations
Spain
Kovacs Foundation Recruiting
Palma de Mallorca, Balearic Islands, Spain, 07012
Contact: Francisco M Kovacs, MD, PhD    34-971-720-809    kovacs@kovacs.org   
Contact: María Teresa Gil del Real, MPH    34-913-440-244    mtgildelreal@kovacs.org   
Principal Investigator: Francisco M Kovacs, MD, PhD         
Sub-Investigator: Mario Gestoso, MD         
Sponsors and Collaborators
Kovacs Foundation
Investigators
Study Director: Francisco M Kovacs, MD, PhD Kovacs Foundation, Palma de Mallorca, 07012, Spain
Principal Investigator: Mario Gestoso, MD Kovacs Foundation,Palma de Mallorca, Spain
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation, Kovacs Foundation
ClinicalTrials.gov Identifier: NCT00667316     History of Changes
Other Study ID Numbers: FK-I-25
First Posted: April 28, 2008    Key Record Dates
Last Update Posted: March 13, 2014
Last Verified: March 2014

Keywords provided by Francisco M. Kovacs, Kovacs Foundation:
low back pain
workers
disability
sick leave

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