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Diagnostic Value of Workload Analysis Instrument to Detect Occupational Risks of Upper Limb Musculoskeletal Conditions (ACT-ACHS)

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ClinicalTrials.gov Identifier: NCT03108612
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
Asociación Chilena de Seguridad
Information provided by (Responsible Party):
Medwave Estudios Limitada

Brief Summary:
The aim of the study is to evaluate the diagnostic accuracy of an instrument (semi-structured interview) called Workload Analysis Instrument (WAI) (Análisis de Carga de Trabajo ACT), in detecting the presence of occupational risk in patients presenting an upper-limb musculoskeletal disorder. The test instrument was developed by Asociación Chilena de Seguridad (ACHS). This instrument will be applied to the worker when he or she visits the ACHS health care facility. The test administration is performed by an ergonomics specialist previously trained in WAI. WAI is the index test and the gold standard will be the Estudio de Puesto de Trabajo (EPT) resolution. The hypothesis of the study is that WAI is able to correctly label the occupational origin (rule in or rule out) of an upper-limb musculoskeletal disorder. Sensitivity, specificity and positive predictive value will be established.

Condition or disease Intervention/treatment Phase
Musculoskeletal Disease Occupational Exposure Diagnostic Test: Análisis de carga de trabajo (ACT) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Participants are enrolled consecutively in the occupational health care clinic. After signing the informed consent form, the evaluators administer the index diagnostic test (WAI). Subsequently, the study participants are referred to the gold standard (EPT). Study participants, WAI evaluators and EPT evaluators are blinded to the results of the other test.
Masking: None (Open Label)
Masking Description: The care providers that administer the index test and the EPT assessment are not masked. However, the outcomes assesors of the EPT (gold standard) are masked to the results of the WAI (index test). The adminstrators of the WAI are unaware of the EPT result, as this evaluation is conducted after the application of the index test.
Primary Purpose: Diagnostic
Official Title: Exactitud diagnóstica Del Instrumento Análisis de Carga de Trabajo Para Identificar Riesgos Laborales en Trabajadores Con Trastornos músculo esqueléticos de Extremidades Superiores Que se evalúan en la Asociación Chilena de Seguridad.
Actual Study Start Date : August 9, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : August 31, 2018

Arm Intervention/treatment
Experimental: Study group
Intervention: Análisis de carga de trabajo (ACT)
Diagnostic Test: Análisis de carga de trabajo (ACT)
Semi-structured interview for detecting possible occupational etiology of an upper limb musculoskeletal disease that has been reported (by the worker) as possibly of occupational origin. The instrument is called Workload Analysis Instrument (WAI) or Análisis de Carga de Trabajo (ACT).
Other Name: Workload Analysis Instrument (WAI)




Primary Outcome Measures :
  1. Occupational origin of upper limb musculoskeletal disorders [ Time Frame: Participants are only assessed once when they are interviewed with the WAI. Final outcomes are obtained without the participant. ]
    Each patient´s disorder is classified as positive (occupational origin) or negative (non-occupational origin) by the index instrument and then by the gold standard. There are four possible main outcomes: true positive, true negative, false positive, false negative. Both the index instrument and the gold standard may yield a doubtful result.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 18 and in a company affiliated to Asociación Chilena de Seguridad
  • Suspicion of occupational origin of upper limb musculoskeletal disorder and have a registered claim of occupational origin of reported disorder (DIEP form)
  • Disorder must be included in the following CIE-10 list: Trigger Finger ICD-10 code: M65.3; Flexor and extensor wrist tendinitis ICD-10 code: M65.8; Radial styloid tenosynovitis [de Quervain] ICD-10 ICD-10 code: M65.4; Carpal Tunnel Syndrome ICD-10 code: G56.0; Elbow Epitrocleitis ICD-10 code: M77.0; Epicondylitis ICD-10 code: M77.1; Shoulder tendinopathy of rotator cuff ICD-10 code: M75.1; Tendinitis bicipital ICD-10 code: M75.2; Subacromial bursitis ICD-10 code: M75.5

Exclusion Criteria:

  • Not consulting within the study recruitment timetable for a consecutive sample
  • Patients with physical limitations that preclude administering the instrument
  • Patients with prior diagnosis of the included disorder (see above)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108612


Contacts
Contact: Patricio A. Gomolán, RT, MSc 56997899759 pgomolan@gmail.com
Contact: Matías Goyenechea 56222743013 mgoyenechea@medwave.cl

Locations
Chile
Hospital del Trabajador de la Asociación Chilena de Seguridad Recruiting
Santiago, Región Metropolitana, Chile, 7501239
Contact: Sandra Herrera    56226853333    sherrera@achs.cl   
Contact: Patricia Ferreira    56226853333 ext 57469    pferreiraq@achs.cl   
Sponsors and Collaborators
Medwave Estudios Limitada
Asociación Chilena de Seguridad
Investigators
Study Chair: Vivienne C. Bachelet, MD, MSc Medwave Estudios Limitada

Additional Information:
Responsible Party: Medwave Estudios Limitada
ClinicalTrials.gov Identifier: NCT03108612     History of Changes
Other Study ID Numbers: 203-2016
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The IPD will be anonymized in an Excel database. Permission to share with other investigators will be requested to the overseeing regulatory authority (Superintendencia de Seguridad Social). At the present time we cannot commit to sharing data without governmental approval.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medwave Estudios Limitada:
diagnostic accuracy
upper limb

Additional relevant MeSH terms:
Musculoskeletal Diseases