- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00667316
The Influence of Different Factors on Workers' Disability Due to Low Back Pain
August 27, 2025 updated by: Francisco M. Kovacs, Kovacs Foundation
Study to Identify the Influence of Different Factors on Workers' Disability Due to Low Back Pain
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
7300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Balearic Islands
-
Palma de Mallorca, Balearic Islands, Spain, 07012
- Kovacs Foundation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Workers from companies and workers' health care organizations who are currently active.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
A
Workers from companies and workers' health care organizations who go for their periodic medical checkup.
|
A set of questionnaires to determine risk factors for sick leave due to low back pain.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The influence of different factors on risk of sick leave for low back pain
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1002/ajim.4700280504.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
June 1, 2021
Study Completion (Actual)
December 1, 2021
Study Registration Dates
First Submitted
April 24, 2008
First Submitted That Met QC Criteria
April 25, 2008
First Posted (Estimated)
April 28, 2008
Study Record Updates
Last Update Posted (Estimated)
September 4, 2025
Last Update Submitted That Met QC Criteria
August 27, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Back Pain
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Low Back Pain
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- FK-I-25
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.