NCT00667316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2008

Completed
13.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

13.3 years

First QC Date

April 24, 2008

Last Update Submit

August 27, 2025

Conditions

Keywords

low back painworkersdisabilitysick leave

Outcome Measures

Primary Outcomes (1)

  • The influence of different factors on risk of sick leave for low back pain

    18 months

Study Arms (1)

A

Workers from companies and workers' health care organizations who go for their periodic medical checkup.

Behavioral: Set of questionnaires (respondent)

Interventions

A set of questionnaires to determine risk factors for sick leave due to low back pain.

A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Workers from companies and workers' health care organizations who are currently active.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kovacs Foundation

Palma de Mallorca, Balearic Islands, 07012, Spain

Location

Related Publications (4)

  • 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. doi: 10.1002/ajim.4700280504.

    PMID: 8561169BACKGROUND
  • 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. doi: 10.1097/01.brs.0000202762.88787.af.

    PMID: 16540874BACKGROUND
  • Kovacs FM, Muriel A, Castillo Sanchez 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. doi: 10.1097/BRS.0b013e3180b9f5f7.

    PMID: 17632397BACKGROUND
  • Seco-Calvo J, Royuela A, Rodriguez-Perez V, Kovacs F. Predicting low back pain-related absenteeism in the Spanish general working population. Occup Environ Med. 2026 Jan 21;82(11):547-555. doi: 10.1136/oemed-2025-110435.

MeSH Terms

Conditions

Low Back Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Francisco M Kovacs, MD, PhD

    Kovacs Foundation, Palma de Mallorca, 07012, Spain

    STUDY DIRECTOR
  • Mario Gestoso, MD

    Kovacs Foundation,Palma de Mallorca, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Scientific Department, Kovacs Foundation

Study Record Dates

First Submitted

April 24, 2008

First Posted

April 28, 2008

Study Start

February 1, 2008

Primary Completion

June 1, 2021

Study Completion

December 1, 2021

Last Updated

September 4, 2025

Record last verified: 2025-08

Locations