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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00667316
Other study ID # FK-I-25
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 2008
Est. completion date December 2021

Study information

Verified date February 2021
Source Kovacs Foundation
Contact Francisco M Kovacs, MD, PhD
Phone 34-971-720-809
Email kovacs@kovacs.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 7300
Est. completion date December 2021
Est. primary completion date June 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Set of questionnaires (respondent)
A set of questionnaires to determine risk factors for sick leave due to low back pain.

Locations

Country Name City State
Spain Kovacs Foundation Palma de Mallorca Balearic Islands

Sponsors (1)

Lead Sponsor Collaborator
Kovacs Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The influence of different factors on risk of sick leave for low back pain 18 months
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