RecruitingNot ApplicableNCT06693479

Could a Feedback Device Help Manage Work-related Shoulder Disorders?

Could a Feedback Device Help Manage Work-related Shoulder Disorders? - Protocol of a Mixed Methods Pilot Study

Sponsor

Laval University

Enrollment

42 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis (RA)Rotator Cuff-related Shoulder Pain Shoulder Osteoarthritis

Summary

Work-related shoulder pain is a common problem with significant socio-economic repercussions. The impact of these disorders on workers is considerable, particularly in terms of pain, disability and reduced quality of life. Several occupational factors may explain the onset of these disorders, such as changes in the work environment, physical demands, psychosocial factors specific to the occupational context and the age of workers. The lack of quantitative measurement tools to assess the physical demands of work over an extended period of time is sorely felt. Recently, our team developed a wearable feedback device, similar to a watch worn on the arm, which measures shoulder movements and muscle activity, transforming this real-time data into clinical indicators. These indicators provide immediate feedback to workers, enabling them to better understand the physical demands of their tasks and adapt accordingly. If this device proves effective in reducing physical demands, it could become a valuable tool for guiding workplace assessments and interventions. However, this device has not yet been tested on workers with shoulder pain. For this reason, a two-part pilot study is needed to understand user needs, assess ease of use and the feasibility of implementing the device. The first component will consist of a pilot clinical trial involving 42 workers suffering from shoulder pain, divided into two groups: one group will use the feedback device for 2 weeks, while the other group will continue to work without intervention. The second phase will analyze the experience of participants who have used the device.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a wearable feedback device — one that monitors how you use your shoulder at work — can help reduce pain and disability in workers who have shoulder disorders caused by their job. It targets conditions including rotator cuff pain, shoulder arthritis, and rheumatoid arthritis affecting the shoulder. **You may be eligible if...** - You are 18 or older and work full-time (at least 30 hours per week) - You have a work-related shoulder condition (rotator cuff pain, shoulder osteoarthritis, or rheumatoid arthritis involving the shoulder) - Your shoulder symptoms have lasted more than 6 weeks - Your shoulder disability is moderate or above (score of 14 or more on the QuickDASH questionnaire) **You may NOT be eligible if...** - You have signs of a complete rotator cuff tear (unable to raise your arm above 90 degrees without neurological cause) - You have an acute traumatic rotator cuff tear or a frozen shoulder (adhesive capsulitis) - You have a fracture or other acute injury Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEShoulder watch load (SWL) feedback

During week 2 and 3 after randomization, the experimental group will undergo the intervention using the SWL, designed to monitor workers' physical work demands. During this time, the SWL will provide real-time feedback based on parameters set via Ergowatchapp. A workplace visit by a physiotherapist will be conducted to establish and adjust the feedback thresholds in week 2, after the education intervention. If necessary, a second remote meeting will take place in week 3 to explain how participants can modify the thresholds themselves. The initial feedback thresholds will be set based on the physical work demands measured during week 1 and will be adjusted after one week of feedback use. These thresholds will be collaboratively determined by a physiotherapist and the workers. Only the experimental group will receive feedback from the SWL during the study period.

OTHEREducation

Participants will receive an education intervention delivered by a physiotherapist. This intervention will take place preferentially at the participants' workplace at the end of the 2nd week post-randomization. The session will last 30 to 45 minutes, and involve personalized, patient-centered education on their condition. The physiotherapist will use open-ended questions to encourage participants to express their goals and address specific concerns related to their shoulder condition. Given the expected diversity in physical constraints (manual vs. non-manual workers) and individual challenges, the session will be tailored to each worker needs. At the end of the session, workers will receive a booklet summarizing key points, including: understanding shoulder anatomy, function and pain, managing shoulder pain, enhancing movement variability, adjusting work environment, and considering factors such as sleep, stress, coping mechanisms, and psychological factors on pain.