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

NCT06693479 | Recruiting

• 1 other identifier: MP-13-2023-2784
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Technology; Shoulder pain; Feasibility; Workers; Feedback; Pilot; Randomized controlled trial; Focus group; Device; Mixed methods study

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• Abbreviated version of the Disability of the Arm Shoulder and Hand questionnaire-Work Module (QuickDASH-Work Module)

  Baseline, 3 weeks, 6 weeks, 12 weeks

• Abbreviated version of the Disability of the Arm Shoulder and Hand questionnaire (QuickDASH)

  Baseline, 3 weeks, 6 weeks, 12 weeks

• Work Limitations Questionnaire (WLQ-25).

  Baseline, 3 weeks, 6 weeks, 12 weeks

• Pain severity subscale of the Brief Pain Inventory Short Form (BPI-SF)

  Baseline, 3 weeks, 6 weeks, 12 weeks

• Pain Self-Efficacy Questionnaire (PSEQ).

  Baseline, 3 weeks, 6 weeks, 12 weeks

Study Arms (2)

Device + Education

EXPERIMENTAL

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

Device: Shoulder watch load (SWL) feedback; Other: Education

Education

ACTIVE COMPARATOR

Education session at week 2.

Other: Education

Interventions

Shoulder watch load (SWL) feedback 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.

Device + Education

Education 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.

Device + Education; Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• clinical signs of a massive rotator cuff tear (e.g., pseudoparesis or pseudoparalysis, passive elevation intact but active limited to \<90°, without neurologic deficit);
• 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);
• distal neurovascular symptoms (e.g., thoracic outlet syndrome, venous thromboembolism);
• previous shoulder surgery;
• corticosteroid injection administered within the past 3 months;
• symptomatic acromioclavicular joint pathology;
• currently receiving conservative management for their shoulder pain (excluding medication for RA and OA),
• absenteeism from work (unable to work at least 30 hours per week or on sick leave).

Sponsors & Collaborators

• Laval University: lead
• The Arthritis Society, Canada: collaborator

Study Sites (1)

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

Québec, Quebec, G1M 2S8, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 40542393 DERIVED

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid; Shoulder Pain

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

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

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

  PRINCIPAL INVESTIGATOR

• Jean-Sébastien Roy PT, PhD

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

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

418-529-9141; jean-sebastien.roy@fmed.ulaval.ca

Philippe Meidinger PT, PhD student

CONTACT

philippe.meidinger.1@ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, neither the treating physiotherapist nor the participants can be blinded. Blinding of the evaluator is irrelevant as outcome data will either be collected online with self-reported questionnaires or by the device measuring physical work demands. The investigator and statistician will remain unaware of group assignments throughout.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 18, 2024
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: All data will be available starting after 6 months after publication (with anonymized data).
• Access Criteria: For further information, please contact the authors

Locations

CA (1)