NCT03886545

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

November 17, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

Same day

First QC Date

March 19, 2019

Last Update Submit

March 3, 2021

Conditions

Keywords

Assessment ; work-related musculoskeletal disorders of the shoulder

Outcome Measures

Primary Outcomes (3)

  • Amplitude

    shoulder amplitude (in °) computed with inertial sensors

    5 minutes

  • Speed

    shoulder speed (in °/seconde) computed with inertial sensors

    5 minutes

  • Smoothness

    shoulder smoothness (peak speed/mean speed) computed with inertial sensors

    5 minutes

Secondary Outcomes (5)

  • surface electromyographs

    15 minutes

  • global dexterity

    5 minutes

  • fine manual dexterity

    5 minutes

  • activity limitations

    5 minutes

  • participation restrictions

    5 min

Study Arms (2)

caregivers with shoulder pain

Other: Assessment of physical and functional capacities

Healthy subjects

Other: Assessment of physical and functional capacities

Interventions

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

Healthy subjectscaregivers with shoulder pain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital La Musse

Saint-Sébastien-de-Morsent, 27180, France

RECRUITING

Related Publications (17)

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

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

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

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

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

    BACKGROUND
  • Akkas O, Lee CH, Hu YH, Harris Adamson C, Rempel D, Radwin RG. Measuring exertion time, duty cycle and hand activity level for industrial tasks using computer vision. Ergonomics. 2017 Dec;60(12):1730-1738. doi: 10.1080/00140139.2017.1346208. Epub 2017 Jul 6.

    PMID: 28640656BACKGROUND
  • 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.

    PMID: 27488732BACKGROUND
  • 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.

    PMID: 27633235BACKGROUND
  • 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. doi: 10.1002/ajim.10040.

    PMID: 12071496BACKGROUND
  • 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.

    PMID: 21874211BACKGROUND
  • van den Noort JC, Wiertsema SH, Hekman KMC, Schonhuth 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.

    PMID: 25192921BACKGROUND
  • 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.

    PMID: 24231811BACKGROUND
  • 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.

    PMID: 28683420BACKGROUND
  • 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.

    PMID: 22683057BACKGROUND
  • 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.

    PMID: 21305232BACKGROUND
  • 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.

    PMID: 22333510BACKGROUND
  • Fayad F, Lefevre-Colau MM, Gautheron V, Mace 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.

    PMID: 18436467BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Diseases

Central Study Contacts

Maxime GILLIAUX, PhD

CONTACT

Maxime HOURY, PT

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 19, 2019

First Posted

March 22, 2019

Study Start

November 17, 2020

Primary Completion

November 17, 2020

Study Completion

June 1, 2021

Last Updated

March 4, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

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.

Locations