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

Musculoskeletal Disorder Clinical Trial

— AWMSD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03886545
• Other study ID #: AWMSD
• Status: Recruiting
• Start date: November 17, 2020
• Est. completion date: June 2021

Study information

• Verified date: March 2021
• Source: Hopital La Musse
• Contact: Maxime GILLIAUX, PhD
• Phone: 0033
• Email: m.gilliaux[@]iflrs-lamusse.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 2021
• Est. primary completion date: November 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Musculoskeletal Diseases
• Musculoskeletal Disorder

Intervention

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;

Locations

Country	Name	City	State
France	Hopital La Musse	Saint-Sébastien-de-Morsent

Sponsors (1)

Lead Sponsor	Collaborator
Hopital La Musse

Country where clinical trial is conducted

France, 

References & Publications (17)

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ARS Haute-Normandie. Prévenir durablement les Troubles Musculo-Squelettiques. 2013

De Baets L, van der Straaten R, Matheve T, Timmermans A. Shoulder assessment according to the international classification of functioning by means of inertial sensor technologies: A systematic review. Gait Posture. 2017 Sep;57:278-294. doi: 10.1016/j.gaitpost.2017.06.025. Epub 2017 Jun 27. Review. — View Citation

DGAFP. Guide pratique-Démarche de prévention des troubles musculo-squelettiques.2015; 1-65.

DIRECCTE de Normandie. Plan santé au travail 2016-2020 Normandie. oct 2017.

Fayad F, Lefevre-Colau MM, Gautheron V, Macé Y, Fermanian J, Mayoux-Benhamou A, Roren A, Rannou F, Roby-Brami A, Revel M, Poiraudeau S. Reliability, validity and responsiveness of the French version of the questionnaire Quick Disability of the Arm, Shoulder and Hand in shoulder disorders. Man Ther. 2009 Apr;14(2):206-12. doi: 10.1016/j.math.2008.01.013. Epub 2008 Apr 23. — View Citation

Ghasemi MS, Hosseinzadeh P, Zamani F, Ahmadpoor H, Dehghan N. Ergonomic design and evaluation of a diagnostic ultrasound transducer holder. Int J Occup Saf Ergon. 2017 Dec;23(4):519-523. doi: 10.1080/10803548.2016.1216763. Epub 2016 Sep 7. — View Citation

Gutenbrunner C, Meyer T, Melvin J, Stucki G. Towards a conceptual description of Physical and Rehabilitation Medicine. J Rehabil Med. 2011 Sep;43(9):760-4. doi: 10.2340/16501977-0866. — View Citation

Hefford C, Abbott JH, Arnold R, Baxter GD. The patient-specific functional scale: validity, reliability, and responsiveness in patients with upper extremity musculoskeletal problems. J Orthop Sports Phys Ther. 2012 Feb;42(2):56-65. doi: 10.2519/jospt.2012.3953. Epub 2012 Feb 1. — View Citation

INRS. Troubles musculosquelettiques (TMS). INRS; 2015.

Krause DA, Neuger MD, Lambert KA, Johnson AE, DeVinny HA, Hollman JH. Effects of examiner strength on reliability of hip-strength testing using a handheld dynamometer. J Sport Rehabil. 2014 Feb;23(1):56-64. doi: 10.1123/jsr.2012-0070. Epub 2013 Nov 14. — View Citation

Padula RS, Comper MLC, Sparer EH, Dennerlein JT. Job rotation designed to prevent musculoskeletal disorders and control risk in manufacturing industries: A systematic review. Appl Ergon. 2017 Jan;58:386-397. doi: 10.1016/j.apergo.2016.07.018. Epub 2016 Aug 9. Review. — View Citation

Pransky G, Robertson MM, Moon SD. Stress and work-related upper extremity disorders: implications for prevention and management. Am J Ind Med. 2002 May;41(5):443-55. Review. — View Citation

Schneider et al. OSH in figures: Work-related musculoskeletal disorders in the EU. 2010.

Seitz AL, Uhl TL. Reliability and minimal detectable change in scapulothoracic neuromuscular activity. J Electromyogr Kinesiol. 2012 Dec;22(6):968-74. doi: 10.1016/j.jelekin.2012.05.003. Epub 2012 Jun 8. — View Citation

Sivan M, O'Connor RJ, Makower S, Levesley M, Bhakta B. Systematic review of outcome measures used in the evaluation of robot-assisted upper limb exercise in stroke. J Rehabil Med. 2011 Feb;43(3):181-9. doi: 10.2340/16501977-0674. Review. — View Citation

van den Noort JC, Wiertsema SH, Hekman KMC, Schönhuth CP, Dekker J, Harlaar J. Reliability and precision of 3D wireless measurement of scapular kinematics. Med Biol Eng Comput. 2014 Nov;52(11):921-931. doi: 10.1007/s11517-014-1186-2. Epub 2014 Sep 6. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amplitude	shoulder amplitude (in °) computed with inertial sensors	5 minutes
Primary	Speed	shoulder speed (in °/seconde) computed with inertial sensors	5 minutes
Primary	Smoothness	shoulder smoothness (peak speed/mean speed) computed with inertial sensors	5 minutes
Secondary	surface electromyographs	fatigability of shoulder muscles assessed using surface electromyographs	15 minutes
Secondary	global dexterity	global manual dexterity quantified using the Box and Block Test	5 minutes
Secondary	fine manual dexterity	fine manual dexterity quantified using Purdue Pegboard Test	5 minutes
Secondary	activity limitations	activity limitations assessed using the "Patient-Specific Functional Scale" questionnaire	5 minutes
Secondary	participation restrictions	participation restrictions assessed using the "Quick Dash" questionnaire	5 min