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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Kovacs Foundation
Sponsor:
Information provided by (Responsible Party):
Francisco M. Kovacs, Kovacs Foundation
ClinicalTrials.gov Identifier:
NCT00667316
First received: April 24, 2008
Last updated: March 11, 2014
Last verified: March 2014
  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:


Further study details as provided by Kovacs Foundation:

Primary Outcome Measures:
  • The influence of different factors on risk of sick leave for low back pain [ Time Frame: 18 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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: 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:
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
Study First Received: April 24, 2008
Last Updated: March 11, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

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

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

ClinicalTrials.gov processed this record on October 20, 2014