Diagnostic Value of Workload Analysis Instrument to Detect Occupational Risks of Upper Limb Musculoskeletal Conditions

NCT03108612 | Unknown

• 1 other identifier: 203-2016
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Disease; Occupational Exposure

Keywords

diagnostic accuracy; upper limb

Outcome Measures

Primary Outcomes (1)

• Occupational origin of upper limb musculoskeletal disorders

  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.

  Participants are only assessed once when they are interviewed with the WAI. Final outcomes are obtained without the participant.

Study Arms (1)

Study group

EXPERIMENTAL

Intervention: Análisis de carga de trabajo (ACT)

Diagnostic Test: Análisis de carga de trabajo (ACT)

Interventions

Análisis de carga de trabajo (ACT) DIAGNOSTIC_TEST

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).

Also known as: Workload Analysis Instrument (WAI)

Study group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medwave Estudios Limitada: lead
• Asociación Chilena de Seguridad: collaborator

Study Sites (1)

Hospital del Trabajador de la Asociación Chilena de Seguridad

Santiago, Santiago Metropolitan, 7501239, Chile

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Vivienne C. Bachelet, MD, MSc

  Medwave Estudios Limitada

  STUDY CHAIR

Central Study Contacts

Patricio A. Gomolán, RT, MSc

CONTACT

56997899759; pgomolan@gmail.com

Matías Goyenechea

CONTACT

56222743013; mgoyenechea@medwave.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 11, 2017
• Study Start: August 9, 2017
• Primary Completion: April 30, 2018
• Study Completion: August 31, 2018
• Last Updated: March 22, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)