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

• Sponsor: Kovacs Foundation (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT00667316
• Collaborator: (none)
• Enrollment: 7,300
• Location: 1
• Duration (Months): 166
• Patients Per Site Per Month: 44

Study Details

Study Description

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	Phase
Low Back Pain	Behavioral: Set of questionnaires (respondent)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 7300 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Study to Identify the Influence of Different Factors on Workers' Disability Due to Low Back Pain
• Study Start Date: Feb 1, 2008
• Anticipated Primary Completion Date: Jun 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	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

Primary Outcome Measures

1. The influence of different factors on risk of sick leave for low back pain [18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Kovacs Foundation	Palma de Mallorca	Balearic Islands	Spain	07012

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

Study Documents (Full-Text)

None provided.

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.
• 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.
• 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.

• Responsible Party: Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation, Kovacs Foundation
• ClinicalTrials.gov Identifier: NCT00667316
• Other Study ID Numbers: FK-I-25
• First Posted: Apr 28, 2008
• Last Update Posted: Feb 23, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation, Kovacs Foundation: low back pain; workers; disability; sick leave
• Additional relevant MeSH terms: Back Pain; Low Back Pain

Study Results

No Results Posted as of Feb 23, 2021