Clinical trial NCT03886545: Objective Assessment for Caregivers With Work-related Musculoskeletal Disorders of the Shoulder
Official title: Objective Assessment for Caregivers With Work-related Musculoskeletal Disorders of the Shoulder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Musculoskeletal Disorder
Keywords: Assessment ; work-related musculoskeletal disorders of the shoulder
Lead sponsor: Hopital La Musse
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two groups

* experimental group, caregivers with shoulder pain
* control group, healthy subjects without shoulder pain

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Amplitude
timeFrame: 5 minutes
measure: Speed
timeFrame: 5 minutes
measure: Smoothness
timeFrame: 5 minutes
Secondary outcomes:
measure: surface electromyographs
timeFrame: 15 minutes
measure: global dexterity
timeFrame: 5 minutes
measure: fine manual dexterity
timeFrame: 5 minutes
measure: activity limitations
timeFrame: 5 minutes
measure: participation restrictions
timeFrame: 5 min
Other outcomes:
Locations:
city: Saint-Sébastien-de-Morsent
country: France
facility: Hopital La Musse
Study officials:
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