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

This study is currently recruiting participants.

Verified June 2011 by Kovacs Foundation

Sponsor:

Information provided by:

Kovacs Foundation

ClinicalTrials.gov Identifier:

NCT00667316

First received: April 24, 2008

Last updated: June 26, 2011

Last verified: June 2011

History of Changes

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 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:	March 2013
Estimated Primary Completion Date:	November 2012 (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

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:

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. 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. 2007 Jul 15;32(16):1761-6.

Responsible Party:	Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation
ClinicalTrials.gov Identifier:	NCT00667316 History of Changes
Other Study ID Numbers:	FK-I-25
Study First Received:	April 24, 2008
Last Updated:	June 26, 2011
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
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013

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