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

May 5, 2025 updated by: Jean-Sébastien Roy, Laval University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1M 2S8
        • Recruiting
        • Centre interdisciplinaire de recherche en réadaptation et intégration sociale (Cirris)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Philippe Meidinger, pht, Ph.Ds
        • Sub-Investigator:
          • Jean Tittley, pht, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility : quantitative component procedure
Time Frame: Baseline
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
Time Frame: From enrollment to the end of recruitment
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
Time Frame: From enrollment to the end the trial at 12 weeks
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
Time Frame: From enrollment to the end of the last completion questionnaire at 12 weeks
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
Time Frame: From 2 weeks to 4 weeks of the intervention period
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
Time Frame: From 4 weeks to 12 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Abbreviated version of the Disability of the Arm Shoulder and Hand questionnaire-Work Module (QuickDASH-Work Module)
Time Frame: Baseline, 3 weeks, 6 weeks, 12 weeks
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)
Time Frame: Baseline, 3 weeks, 6 weeks, 12 weeks
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).
Time Frame: Baseline, 3 weeks, 6 weeks, 12 weeks
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)
Time Frame: Baseline, 3 weeks, 6 weeks, 12 weeks
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).
Time Frame: Baseline, 3 weeks, 6 weeks, 12 weeks
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)
Time Frame: Baseline, 3 weeks, 6 weeks, 12 weeks
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
Time Frame: At 1 week and 4 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laval University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Arthritis Society, Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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