AWMSD: Objective Assessment for Caregivers With Work-related Musculoskeletal Disorders of the Shoulder

Sponsor

Hopital La Musse (Other)

Overall Status

Recruiting

CT.gov ID

NCT03886545

Collaborator

(none)

Enrollment

Location

6.4

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Work-related musculoskeletal disorders (WMSD) are a major public health problem both in France and internationally. Our clinical research project focuses on WMSD of the shoulder (WMSD-S), which account for 32% and 23% of these disorders in France and Europe, respectively. In order to prevent WMSD-S, the assessment and rehabilitation of workers' physical and functional capacities (PFC) (e.g. joint amplitude) may complement current interventions (e.g. ergonomics) in a novel manner. As a result, the objectives of this project would be to conduct a cohort study assessing the PFC of caregivers with WMSD-S compared to those of healthy subjects and a randomised, controlled, single-blind, multicentre clinical study assessing the relevance of a rehabilitation program for caregivers with WMSD-S working in a hospital setting. This project would foster the promotion of evidence-based physiotherapy and lead to the development of a interdisciplinary research team dedicated to rehabilitation.

Condition or Disease	Intervention/Treatment	Phase
Musculoskeletal Disorder	Other: Assessment of physical and functional capacities

Detailed Description

Work-related musculoskeletal disorders (WMSD) are "a set of peri-articular conditions that can affect various structures of the upper limbs, lower limbs and back: tendons, muscles, joints, nerves and the vascular system"(1). WMSD are a major public health problem both in France and internationally. Indeed, these disorders represent 85% of occupational diseases in France (2). Our research project focuses on WMSD-S representing 32% and 23% of these disorders in France (3) and Europe (4), respectively. These shoulder disorders lead to a decrease in the quality of life of workers (2) but also have direct (e.g. 50K € for shoulder tendinitis [ST]) and indirect (e.g. between 100K and 350K € for ST) costs (5).

To prevent WMSD-S, current recommendations encourage regular assessments and interventions at the workers workstation (e.g. biomechanical constraints, ergonomics, etc.) (6,7), their organisation (e. g. "job rotation"...) (8) and psycho-social factors (e. g. stress...) (9) related to work. WMSD-S), which account for 32% and 23% of these disorders in France and Europe, respectively. In order to prevent WMSD-S, the assessment and rehabilitation of workers' physical and functional capacities (PFC) (e.g. joint amplitude) may complement current interventions (e.g. ergonomics) in a novel manner.

It is believed that the assessment of PFC in workers suffering from WMSD-S is essential to better understand the origin of these disorders, and therefore to optimise their care (10) . To our knowledge, no clinical studies have analysed the interest of a protocol for the assessment of WMSD-S in caregivers. From this observation, the first part of this project would consist of a cohort study assessing the PFC of caregivers with WMSD-S, compared to those of healthy subjects matched in age and gender. This study would improve the understanding of the worker's physical and functional impairments; a fundamental aspect for the individualised person-focused interventions (i.e. rehabilitation), in addition to those carried out at the workstation level (i.e. ergonomics).

Study Design

Study Type:

Observational

Anticipated Enrollment :

36 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Objective Assessment for Caregivers With Work-related Musculoskeletal Disorders of the Shoulder

Actual Study Start Date :

Nov 17, 2020

Actual Primary Completion Date :

Nov 17, 2020

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
caregivers with shoulder pain	Other: Assessment of physical and functional capacities Comparaison of physical and functional capacities between caregivers with work-related musculoskeletal disorders of the shoulder healthy subjects matched in age and gender;
Healthy subjects	Other: Assessment of physical and functional capacities Comparaison of physical and functional capacities between caregivers with work-related musculoskeletal disorders of the shoulder healthy subjects matched in age and gender;

Arm

Intervention/Treatment

caregivers with shoulder pain

Other: Assessment of physical and functional capacities

Comparaison of physical and functional capacities between caregivers with work-related musculoskeletal disorders of the shoulder healthy subjects matched in age and gender;

Healthy subjects

Other: Assessment of physical and functional capacities

Comparaison of physical and functional capacities between caregivers with work-related musculoskeletal disorders of the shoulder healthy subjects matched in age and gender;

Outcome Measures

Primary Outcome Measures

Amplitude [5 minutes]
shoulder amplitude (in °) computed with inertial sensors
Speed [5 minutes]
shoulder speed (in °/seconde) computed with inertial sensors
Smoothness [5 minutes]
shoulder smoothness (peak speed/mean speed) computed with inertial sensors

Secondary Outcome Measures

surface electromyographs [15 minutes]
fatigability of shoulder muscles assessed using surface electromyographs
global dexterity [5 minutes]
global manual dexterity quantified using the Box and Block Test
fine manual dexterity [5 minutes]
fine manual dexterity quantified using Purdue Pegboard Test
activity limitations [5 minutes]
activity limitations assessed using the "Patient-Specific Functional Scale" questionnaire
participation restrictions [5 min]
participation restrictions assessed using the "Quick Dash" questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

For caregivers with shoulder pain, the inclusion criteria would be: aged between 18 and 65; being a caregiver in a hospital department and having WMSD-S, objectified by shoulder pain.
For healthy subjects , the inclusion criteria would be : aged between 18 and 65 and no shoulder pain (0/10 on visual analogic scale) in the last 3 months, both at rest and during activity.

Exclusion Criteria:

For caregivers with shoulder pain, The exclusion criterion would be any traumatic event not related to the professional activity that could impair the functionality of the upper limbs.
For healthy subject, the exclusion criterion would be any injury to shoulder muscles or tendons.
For both groups, the exclusion criteria would include smoking, being pregnant, and engaging in traumatic physical activity of the shoulder and any systemic disease or neurological injury.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital La Musse	Saint-Sébastien-de-Morsent		France	27180

Sponsors and Collaborators

Hopital La Musse

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

M. Gilliaux, Principal investigator, Hopital La Musse

ClinicalTrials.gov Identifier:

NCT03886545

Other Study ID Numbers:

AWMSD

First Posted:

Mar 22, 2019

Last Update Posted:

Mar 4, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by M. Gilliaux, Principal investigator, Hopital La Musse

Assessment ; work-related musculoskeletal disorders of the shoulder

Additional relevant MeSH terms:

Musculoskeletal Diseases

Disease

Study Results

No Results Posted as of Mar 4, 2021