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

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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Osteoarthritis; Rheumatoid Arthritis (RA); Rotator Cuff-related Shoulder Pain
• Intervention / Treatment: Device: Shoulder watch load (SWL) feedback; Other: Education

Detailed Description

The objectives of this pilot study are (a) to evaluate the feasibility of implementing the SWL in the workplace and conducting a large-scale randomized clinical trial (RCT) by assessing recruitment success, intervention adherence, acceptability of the technology, the research team's capacity to refine the SWL, and (b) to explore the SWL capacity to reduce disability, pain, work limitations, and physical work demands while increasing pain self-efficacy among workers with WRSDs.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Sébastien Roy Jean-Sébastien Roy, PT, PhD; Phone Number: 46005 418-529-9141; Email: jean-sebastien.roy@fmed.ulaval.ca
• Study Contact Backup: Name: Philippe Meidinger PT, PhD student; Email: philippe.meidinger.1@ulaval.ca

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1M 2S8
      • Recruiting
      • Centre interdisciplinaire de recherche en réadaptation et intégration sociale (CIRRIS)
      • Contact: Jean-Sébastien Roy, Ph.D.; Phone Number: 46005 418-529-9141; Email: jean-sebastien.roy@fmed.ulaval.ca
      • Contact: Jean Tittley, pht, MSc; Phone Number: 418-529-0324; Email: jean.tittley@cirris.ulaval.ca
      • Principal Investigator: Philippe Meidinger, pht, Ph.Ds
      • Sub-Investigator: Jean Tittley, pht, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device + Education; Education session at week 2 and feedback from SWL during week 2 and week 3	Device: Shoulder 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.; Other: Education; 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.
Active Comparator: Education; Education session at week 2.	Other: Education; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility : quantitative component procedure	Assessing trial recruitment success (Recruitment rate) : Track the rate of screened participants who consent to participate in the trial, using a screening and recruitment log.	Baseline
Feasibility : quantitative component procedure	Assessing trial recruitment success (Determining recruitment duration) : Evaluate the time required to recruit the target number of participants.	From enrollment to the end of recruitment
Feasibility : quantitative component procedure	Assessing trial recruitment success (Retention rate) : Monitor the number of participants who complete the trial, and document reasons for attrition.	From enrollment to the end the trial at 12 weeks
Feasibility : quantitative component procedure	Completion rate : Report the completion rate for each questionnaire at each time point.	From enrollment to the end of the last completion questionnaire at 12 weeks
Feasibility : quantitative component procedure	Evaluating adherence to the intervention : Self-reported SWL devise usage: Participants in the experimental group will complete a self-reported questionnaire at the end of each week during the 2-week intervention period to assess their adherence to using the SWL.	From 2 weeks to 4 weeks of the intervention period
Feasibility : qualitative component procedure	Focus groups : All participants from the experimental group will be invited to participate to a focus group, to explore various aspects of feasibility such as the acceptability of the technology, the experience of wearing the SWL and receiving the feedback, and suggestion for potential improvement of the SWL.	From 4 weeks to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abbreviated version of the Disability of the Arm Shoulder and Hand questionnaire-Work Module (QuickDASH-Work Module)	QuickDASH-Work Module includes 4 items, each scored from 1 to 5. This scale range from 0 to 100, with 0 indicating the best function and 100 indicating the worst possible function	Baseline, 3 weeks, 6 weeks, 12 weeks
Abbreviated version of the Disability of the Arm Shoulder and Hand questionnaire (QuickDASH)	The QuickDASH consists of 11 items, , each scored from 1 to 5. This scale range from 0 to 100, with 0 indicating the best function and 100 indicating the worst possible function.	Baseline, 3 weeks, 6 weeks, 12 weeks
Work Limitations Questionnaire (WLQ-25).	This 25-item questionnaire includes four subscales addressing four dimensions of job demands. The total score ranges from 0 to 100, with 0 indicating no limitation and 100 indicating complete limitation	Baseline, 3 weeks, 6 weeks, 12 weeks
Pain severity subscale of the Brief Pain Inventory Short Form (BPI-SF)	It includes 4 items measuring worst, least and average pain in the past 24 hours, as well as current pain, each scored on an 11-point numeric scale (0-10), where 0 indicates no pain and 10 represents the worst pain imaginable.	Baseline, 3 weeks, 6 weeks, 12 weeks
Pain Self-Efficacy Questionnaire (PSEQ).	This questionnaire includes 10 items, each scored on a 7-point Likert scale (0 = not at all confident and 6 = completely confident).	Baseline, 3 weeks, 6 weeks, 12 weeks
Western Ontario Rotator Cuff Index (WORC)	The WORC contains 21 items in total, each scored from 0 to 100, with 0 indicates best function and 100 indicating the worst possible function.	Baseline, 3 weeks, 6 weeks, 12 weeks
Physical work demands	To evaluate physical work demands, workers in both groups will wear the SWL for three consecutive full working days during the 1st week (before the intervention for the experimental group). Participants will log their physical work demands daily using the Ergowatchapp via a Mycap entry. The following outcomes will be averaged for data analysis: 1) number of arm elevations (>60°) per day, 2) time spent with the arm elevated (>60°) per day.	At 1 week and 4 weeks

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: The Arthritis Society, Canada
• Investigators: Principal Investigator: Philippe Meidinger, PT, PhD student, PT, PhD student, Centre interdisciplinaire de recherche en réadaptation et intégration sociale (CIRRIS); Study Director: Jean-Sébastien Roy PT, PhD, Centre interdisciplinaire de recherche en réadaptation et intégration sociale (CIRRIS)

Publications and helpful links

Helpful Links

• Could a feedback device help manage work-related shoulder disorders? - Protocol of a mixed methods pilot study

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Feasibility; Randomized controlled trial; Device; Technology; Feedback; Shoulder pain; Pilot; Focus group; Workers; Mixed methods study
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Joint Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: MP-13-2023-2784

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication (with anonymized data).
• IPD Sharing Time Frame: All data will be available starting after 6 months after publication (with anonymized data).
• IPD Sharing Access Criteria: For further information, please contact the authors
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No