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

March 3, 2021 updated by: M. Gilliaux, Hopital La Musse
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Saint-Sébastien-de-Morsent, France, 27180
        • Recruiting
        • Hôpital La Musse
        • Contact:
          • Maxime Gilliaux, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Two groups

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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;
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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amplitude
Time Frame: 5 minutes
shoulder amplitude (in °) computed with inertial sensors
5 minutes
Speed
Time Frame: 5 minutes
shoulder speed (in °/seconde) computed with inertial sensors
5 minutes
Smoothness
Time Frame: 5 minutes
shoulder smoothness (peak speed/mean speed) computed with inertial sensors
5 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital La Musse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2020

Primary Completion (Actual)

November 17, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

March 19, 2019

First Submitted That Met QC Criteria

March 20, 2019

First Posted (Actual)

March 22, 2019

Study Record Updates

Last Update Posted (Actual)

March 4, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AWMSD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data collected will be anonymized, computerized and stored by Maxime GILLIAUX. Only the investigators (Mr GILLIAUX and Mrs Julie VAN NIEUWENHOVE) will have access to the anonymized data in order to carry out the statistical work of this research.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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