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Search / Trial NCT06693479

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

Launched by LAVAL UNIVERSITY · Nov 14, 2024

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Technology Shoulder Pain Feasibility Workers Feedback Pilot Randomized Controlled Trial Focus Group Device Mixed Methods Study

ClinConnect Summary

This clinical trial is investigating whether a new wearable feedback device can help people who have work-related shoulder pain. This device, which looks similar to a watch, tracks shoulder movements and muscle activity to provide real-time information about the physical demands of their tasks. By using this device, workers might be able to better understand their movements and adjust their activities to reduce pain and improve their quality of life. The study is important because work-related shoulder issues can greatly affect a person's ability to work and enjoy daily activities.

To participate in the trial, individuals must be at least 18 years old, work full-time, and have been experiencing shoulder pain related to their job for at least six weeks. They should also have a specific level of disability related to their shoulder pain. The trial will involve 42 participants divided into two groups: one group will use the feedback device for two weeks, while the other will continue their usual activities without any intervention. Participants can expect to provide feedback about their experience with the device, helping researchers understand how well it works and if it could be helpful in the workplace.

Gender

ALL

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).

About Laval University

Laval University is a prestigious research institution located in Quebec, Canada, renowned for its commitment to advancing knowledge and innovation in various fields, including health sciences. The university actively engages in clinical trials aimed at exploring new therapeutic interventions and improving patient outcomes. With a strong emphasis on ethical standards and rigorous scientific methodologies, Laval University collaborates with multidisciplinary teams of researchers, healthcare professionals, and industry partners to conduct high-quality clinical research. Its state-of-the-art facilities and dedication to fostering a culture of inquiry position Laval University as a leader in clinical research, contributing significantly to the understanding and treatment of diverse medical conditions.

Locations

Québec, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

Philippe Meidinger, PT, PhD student, PT, PhD student

Principal Investigator

Centre interdisciplinaire de recherche en réadaptation et intégration sociale (Cirris)

Jean-Sébastien Roy PT, PhD

Study Director

Centre interdisciplinaire de recherche en réadaptation et intégration sociale (Cirris)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported