Could a feedback device help manage work-related shoulder disorders?: protocol of a mixed methods pilot study.
Philippe Meidinger, Quan Nha Hong, Jean Tittley...
https://pubmed.ncbi.nlm.nih.gov/40542393Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06693479
Could a Feedback Device Help Manage Work-related Shoulder Disorders? - Protocol of a Mixed Methods Pilot Study
Led by Laval University · Updated on 2025-05-08
42
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
L
Laval University
Lead Sponsor
T
The Arthritis Society, Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
Work-related shoulder pain is a common issue that causes significant pain, disability, and reduced quality of life among workers. This research aims to evaluate a new wearable feedback device called the Shoulder Watch Load (SWL), which measures shoulder movements and muscle activity to provide real-time feedback. The study assesses the device's feasibility and its potential to reduce physical work demands and improve pain and disability in workers with shoulder disorders such as rotator cuff-related pain, shoulder osteoarthritis, or rheumatoid arthritis. The study involves 42 workers with shoulder pain divided into two groups. One group will use the SWL device for two weeks along with an education session, receiving feedback and support to adjust physical work demands. The other group will receive only the education session. The device collects real-time data during work and is adjusted by a physiotherapist to help workers adapt their tasks. The study includes a pilot clinical trial followed by an analysis of user experiences. Participants will attend an education session delivered by a physiotherapist at the workplace after two weeks. Various assessments, including questionnaires about disability, pain, work limitations, and physical work demands, will be conducted at baseline, during the intervention, and up to 12 weeks. Researchers will measure feasibility outcomes such as recruitment, adherence, and technology acceptability, along with clinical outcomes like pain severity and work limitations. The total study duration includes baseline, intervention weeks, and follow-up assessments to monitor changes over time.
CONDITIONS
Brief Title
Could a Feedback Device Help Manage Work-related Shoulder Disorders?
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older employed full-time (at least 30 hours per week)
- Experiencing work-related shoulder disorders with a minimum score of 14 on the QuickDASH questionnaire
- Diagnosed with rotator cuff-related shoulder pain, shoulder osteoarthritis, or rheumatoid arthritis involving the shoulder
- Symptoms lasting more than 6 weeks
- Rotator cuff-related shoulder pain diagnosed by specific clinical tests
- Shoulder osteoarthritis diagnosed by clinical and radiologic findings confirmed by a physician
- Rheumatoid arthritis diagnosis confirmed by American College of Rheumatology criteria
You will not qualify if you...
- Signs of massive rotator cuff tear or limited active shoulder elevation below 90 degrees
- Acute traumatic rotator cuff tears, fractures, adhesive capsulitis, or shoulder instability
- Distal neurovascular symptoms like thoracic outlet syndrome or venous thromboembolism
- Previous shoulder surgery
- Corticosteroid injection within the past 3 months
- Symptomatic acromioclavicular joint problems
- Currently receiving conservative shoulder pain management (excluding RA and OA medication)
- Absenteeism from work or unable to work at least 30 hours per week or on sick leave
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Education
Duration - 1 session lasting 30 to 45 minutes during week 2 post-randomization
Participants receive a personalized education intervention delivered by a physiotherapist at their workplace. This session covers shoulder anatomy, pain management, movement variability, work environment adjustments, and psychological factors affecting pain. Participants receive a booklet summarizing key points.
1 visit (in-person) at week 2
Implementation
Duration - 2 weeks during weeks 2 and 3 post-randomization
Participants in the experimental group use the Shoulder Watch Load (SWL) device during weeks 2 and 3 post-randomization. The device provides real-time feedback on physical work demands. A physiotherapist visits the workplace in week 2 to set and adjust feedback thresholds, with a possible remote session in week 3 to assist with threshold modifications.
1 workplace visit and 1 possible remote meeting
Follow-up Monitoring
Duration - Up to 12 weeks post-enrollment
Participants complete questionnaires and assessments measuring disability, pain, work limitations, pain self-efficacy, and physical work demands up to 12 weeks post-enrollment to evaluate intervention effects and feasibility.
Assessments at baseline, 1 week, 3 weeks, 4 weeks, 6 weeks, and 12 weeks
Trial Site Locations
Total: 1 location
1
Centre interdisciplinaire de recherche en réadaptation et intégration sociale (Cirris)
Québec, Quebec, Canada, G1M 2S8
Actively Recruiting
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Research Team
J
Jean-Sébastien Roy Jean-Sébastien Roy, PT, PhD
P
Philippe Meidinger PT, PhD student
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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