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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult (≧ 18 years) employed full-time (minimum of 30 hours per week).

• 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.

• Symptoms persisting for more than 6 weeks.

⁃ Diagnosis-specific criteria:

• 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;

• 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);

• 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.

Locations
Other Locations
Canada
Centre interdisciplinaire de recherche en réadaptation et intégration sociale (Cirris)
RECRUITING
Québec
Contact Information
Primary
Jean-Sébastien Roy Jean-Sébastien Roy, PT, PhD
jean-sebastien.roy@fmed.ulaval.ca
418-529-9141
Backup
Philippe Meidinger PT, PhD student
philippe.meidinger.1@ulaval.ca
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2026-07
Participants
Target number of participants: 42
Treatments
Experimental: Device + Education
Education session at week 2 and feedback from SWL during week 2 and week 3
Active_comparator: Education
Education session at week 2.
Sponsors
Leads: Laval University
Collaborators: The Arthritis Society, Canada

This content was sourced from clinicaltrials.gov