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

NCT ID: NCT06693479

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-07-31

Brief 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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Device + Education

Education session at week 2 and feedback from SWL during week 2 and week 3

Group Type: EXPERIMENTAL

Shoulder watch load (SWL) feedback

Intervention Type: DEVICE

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.

Education

Intervention Type: OTHER

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.

Education

Education session at week 2.

Group Type: ACTIVE_COMPARATOR

Education

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Arthritis Society, Canada

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Jean-Sébastien Roy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

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

Jean-Sébastien Roy PT, PhD

Role: STUDY_DIRECTOR

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

Locations

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

Québec, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jean-Sébastien Roy Jean-Sébastien Roy, PT, PhD

Role: CONTACT

jean-sebastien.roy@fmed.ulaval.ca

418-529-9141 ext. 46005

Philippe Meidinger PT, PhD student

Role: CONTACT

philippe.meidinger.1@ulaval.ca

Facility Contacts

Jean-Sébastien Roy, Ph.D.

Role: primary

jean-sebastien.roy@fmed.ulaval.ca

418-529-9141 ext. 46005

Jean Tittley, pht, MSc

Role: backup

jean.tittley@cirris.ulaval.ca

418-529-0324

References

Meidinger P, Hong QN, Tittley J, Campeau-Lecours A, Roy JS. Could a feedback device help manage work-related shoulder disorders?: protocol of a mixed methods pilot study. Pilot Feasibility Stud. 2025 Jun 20;11(1):84. doi: 10.1186/s40814-025-01646-0.

Reference Type: DERIVED

PMID: 40542393 (View on PubMed)

Related Links

https://www.researchsquare.com/article/rs-5183538/v1

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

Other Identifiers

MP-13-2023-2784

Identifier Type: -

Identifier Source: org_study_id