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Rotator Cuff-related Shoulder PainNCT06693479

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

A study testing Shoulder watch load (SWL) feedback and Education in people with Rotator Cuff-related Shoulder Pain and Shoulder Osteoarthritis, run by Laval University at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Shoulder watch load (SWL) feedback and Education
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteCanada
Study dates
1 Mar 2025to Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

418-529-9141 ext. 46005

jean-sebastien.roy@fmed.ulaval.ca

Philippe Meidinger PT, PhD student contact

philippe.meidinger.1@ulaval.ca

Canada1 site, 1 recruiting
  • Centre interdisciplinaire de recherche en réadaptation et intégration sociale (Cirris)

    Québec, Quebec, G1M 2S8

    Jean-Sébastien Roy, Ph.D., 418-529-9141 ext. 46005, jean-sebastien.roy@fmed.ulaval.ca

    Jean Tittley, pht, MSc, 418-529-0324, jean.tittley@cirris.ulaval.ca

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Shoulder watch load (SWL) feedback, Education
Keywords
Technology, Shoulder pain, Feasibility, Workers, Feedback, Pilot, Randomized controlled trial, Focus group, Device, Mixed methods study
Medical subject headings
Arthritis, Rheumatoid, Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shoulder watch load (SWL) feedbackDevice

    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.

  • EducationOther

    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.

Study groups in NCT06693479
Study groupRoleWhat they receive
Device + EducationExperimentalEducation session at week 2 and feedback from SWL during week 2 and week 3
Receives: Device: Shoulder watch load (SWL) feedback; Other: Education
EducationActive comparatorEducation session at week 2.
Receives: Other: Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. Feasibility : quantitative component procedure

    Assessing trial recruitment success (Determining recruitment duration) : Evaluate the time required to recruit the target number of participants.

    Measured: From enrollment to the end of recruitment

  3. Feasibility : quantitative component procedure

    Assessing trial recruitment success (Retention rate) : Monitor the number of participants who complete the trial, and document reasons for attrition.

    Measured: From enrollment to the end the trial at 12 weeks

  4. Feasibility : quantitative component procedure

    Completion rate : Report the completion rate for each questionnaire at each time point.

    Measured: From enrollment to the end of the last completion questionnaire at 12 weeks

  5. 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.

    Measured: From 2 weeks to 4 weeks of the intervention period

  6. 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.

    Measured: From 4 weeks to 12 weeks

Secondary outcomes (7)
  1. 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

    Measured: Baseline, 3 weeks, 6 weeks, 12 weeks

  2. 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.

    Measured: Baseline, 3 weeks, 6 weeks, 12 weeks

  3. 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

    Measured: Baseline, 3 weeks, 6 weeks, 12 weeks

  4. 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.

    Measured: Baseline, 3 weeks, 6 weeks, 12 weeks

  5. 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).

    Measured: Baseline, 3 weeks, 6 weeks, 12 weeks

  6. 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.

    Measured: Baseline, 3 weeks, 6 weeks, 12 weeks

  7. 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.

    Measured: At 1 week and 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2024
  2. Study start1 Mar 2025
  3. Primary completionMar 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06693479
Sponsor's protocol ID
MP-13-2023-2784
Status last verified
May 2025
First submitted
13 Nov 2024
Last updated
8 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication (with anonymized data).

Publications

  • 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.

    PubMed 40542393

Questions about this trial

What is this clinical trial studying?

A study testing Shoulder watch load (SWL) feedback and Education in people with Rotator Cuff-related Shoulder Pain and Shoulder Osteoarthritis, run by Laval University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jean-Sébastien Roy Jean-Sébastien Roy, PT, PhD (418-529-9141 ext. 46005, jean-sebastien.roy@fmed.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility : quantitative component procedure (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06693479, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.

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