Using a wearable device to manage work-related shoulder pain

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

This study is testing a wearable device that helps workers with shoulder pain by giving them feedback on their movements to see if it can make their pain and work limitations better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Laval University (Academic / other)
• Locations: 1 site (Québec, Quebec)
• Trial ID: NCT06693479 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the feasibility of a wearable feedback device designed to help workers manage work-related shoulder disorders. The device, worn like a watch, measures shoulder movements and muscle activity, providing real-time feedback to users about their physical demands. The study aims to assess recruitment success, adherence to the intervention, and the technology's acceptability, while also exploring its potential to reduce pain, disability, and work limitations among affected workers. If successful, this approach could lead to a larger randomized clinical trial to further validate its effectiveness.

Who should consider this trial

Good fit: Ideal candidates are adults employed full-time who have been experiencing work-related shoulder disorders for more than six weeks.

Not a fit: Patients with shoulder disorders not related to work or those with acute symptoms lasting less than six weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this device could significantly improve the management of work-related shoulder disorders, enhancing workers' quality of life.

How similar studies have performed: While the use of wearable technology for health monitoring is gaining traction, this specific approach to managing work-related shoulder disorders is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Adult (≧ 18 years) employed full-time (minimum of 30 hours per week).
2. Experiencing work-related shoulder disorders (WRSDs), with minimal score of 14 points on the for the abbreviated version of the Disability of the Arm Shoulder and Hand questionnaire (QuickDASH), stemming from a diagnosis of rotator cuff-related shoulder pain (RCRSP), shoulder osteoarthritis (SOA) or rheumatoid arthritis (RA) involving the shoulder.
3. Symptoms persisting for more than 6 weeks.

Diagnosis-specific criteria:

1. RCRSP: diagnosis requires meeting three positive criteria, including the presence of a painful arc in abduction, a positive Neer sign, Hawkins-Kennedy test, or Jobe Test, pain with resisted humeral external rotation;
2. SOA: diagnosis based on clinical findings (e.g., activity-related pain, reduced range of motion particularly external rotation and function, worsening night/rest pain) and radiologic findings (e.g., osteophytes, joint space narrowing, subchondral sclerosis, cyst formations, and humeral head deformities);
3. RA involving the shoulder: confirmed diagnosis according to the American College of Rheumatology criteria.

Both SOA and RA diagnoses will be confirmed by a physician.

Exclusion Criteria:

1. clinical signs of a massive rotator cuff tear (e.g., pseudoparesis or pseudoparalysis, passive elevation intact but active limited to \<90°, without neurologic deficit);
2. acute traumatic rotator cuff tears, fractures, adhesive capsulitis (characterized by night pain, pain with sudden or unexpected movements, global loss of active and passive range of motion), or shoulder instability (evidenced by a combination of orthopaedic tests such as apprehension and relocation tests, Jerk, Kim and posterior tests, along with and clinical signs like neuromuscular function impairment, history of instability, lesion mechanisms, worries that their shoulder could dislocate during activities);
3. distal neurovascular symptoms (e.g., thoracic outlet syndrome, venous thromboembolism);
4. previous shoulder surgery;
5. corticosteroid injection administered within the past 3 months;
6. symptomatic acromioclavicular joint pathology;
7. currently receiving conservative management for their shoulder pain (excluding medication for RA and OA),
8. absenteeism from work (unable to work at least 30 hours per week or on sick leave).

Where this trial is running

Québec, Quebec

• Centre interdisciplinaire de recherche en réadaptation et intégration sociale (Cirris) — Québec, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Philippe Meidinger, PT, PhD student, PT, PhD student — Centre interdisciplinaire de recherche en réadaptation et intégration sociale (Cirris)
• Study coordinator: Jean-Sébastien Roy Jean-Sébastien Roy, PT, PhD

Conditions Rotator Cuff-related Shoulder Pain; Shoulder Osteoarthritis; Rheumatoid Arthritis; Technology; Shoulder pain; Feasibility; Workers; Feedback