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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by Francisco M. Kovacs, Kovacs Foundation.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00667316
First Posted: April 28, 2008
Last Update Posted: March 13, 2014
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.
Information provided by (Responsible Party):
Francisco M. Kovacs, Kovacs Foundation
  Purpose
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 Intervention
Low Back Pain Behavioral: Set of questionnaires (respondent)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Study to Identify the Influence of Different Factors on Workers' Disability Due to Low Back Pain

Resource links provided by NLM:

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

Further study details as provided by Francisco M. Kovacs, Kovacs Foundation:

Primary Outcome Measures:
  • The influence of different factors on risk of sick leave for low back pain [ Time Frame: 18 months ]
Estimated Enrollment: 7200
Study Start Date: February 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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

Publications:
Guo HR, Tanaka S, Cameron LL, Seligman PJ, Behrens VJ, Ger J, Wild DK, Putz-Anderson V. Back pain among workers in the United States: national estimates and workers at high risk. Am J Ind Med. 1995 Nov;28(5):591-602.
Turner JA, Franklin G, Fulton-Kehoe D, Sheppard L, Wickizer TM, Wu R, Gluck JV, Egan K. Worker recovery expectations and fear-avoidance predict work disability in a population-based workers' compensation back pain sample. Spine (Phila Pa 1976). 2006 Mar 15;31(6):682-9.
Kovacs FM, Muriel A, Castillo Sánchez MD, Medina JM, Royuela A; Spanish Back Pain Research Network. Fear avoidance beliefs influence duration of sick leave in Spanish low back pain patients. Spine (Phila Pa 1976). 2007 Jul 15;32(16):1761-6.

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 Submitted: April 24, 2008
First Posted: April 28, 2008
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


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