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

• Conditions: Musculoskeletal Disorder
• Interventions: Other: Assessment of physical and functional capacities

• Registration Number: NCT03886545
• Lead Sponsor: Hopital La Musse

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.

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 Timeline

• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-22
• Study Start: 2020-11-17
• Primary Completion: 2020-11-17
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-03
• Last Update Posted: 2021-03-04
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
caregivers with shoulder pain	Assessment of physical and functional capacities	-
Healthy subjects	Assessment of physical and functional capacities	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hopital La Musse; 🇫🇷 Saint-Sébastien-de-Morsent, France