Feedback Device for Shoulder Pain

Overseen By Philippe Meidinger PT, PhD student

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Disqualifiers: Massive rotator cuff tear, fractures, adhesive capsulitis, shoulder instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 2 weeks

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wearable device, the Shoulder Watch Load (SWL) feedback, which provides real-time feedback to workers with shoulder pain to help them understand and manage their physical workload. Resembling a watch, the device measures shoulder movements and muscle activity, offering insights that could reduce pain and improve workplace conditions. Participants will be divided into two groups: one will use the device and receive education, while the other will receive only education. This trial suits full-time workers who have experienced work-related shoulder pain for more than six weeks, such as those with rotator cuff-related pain or shoulder arthritis. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to improved pain management solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants can continue medication for rheumatoid arthritis (RA) and osteoarthritis (OA).

What prior data suggests that this feedback device is safe for workers with shoulder pain?

Research shows that wearable devices, like smartwatches, have been used safely to track and support physical activities. Studies have found that these devices can monitor movements and provide feedback, helping people adjust their activities effectively. Significant problems have not been reported in these situations.

The shoulder watch load feedback device in this trial is a similar type of wearable technology. It measures shoulder movements and muscle activity in real-time. Although this device is new and untested with workers who have shoulder pain, similar devices have been well-tolerated. They typically do not cause harm because they are non-invasive, sitting on the skin without penetrating the body.

Since the trial is in its early stages and focuses on testing the device's usability and effectiveness, the risk of harm appears low. However, as with any new technology, some uncertainty remains until thorough testing is complete. Participants in the trial will help determine if this new device is safe and useful for people with shoulder pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Feedback Device for Shoulder Pain because it introduces a novel way to manage shoulder discomfort. Unlike traditional treatments that often rely on medication or physical therapy, this approach uses a Shoulder Watch Load (SWL) feedback device, which provides real-time feedback on shoulder activity. This device aims to help patients adjust their movements to prevent overloading the shoulder, potentially reducing pain and speeding up recovery. Additionally, combining this feedback with educational sessions empowers patients with knowledge about their condition, promoting better self-management and adherence to healthy movement patterns.

What evidence suggests that this feedback device is effective for shoulder pain?

This trial will compare the Shoulder Watch Load (SWL) feedback device with education alone for managing shoulder pain. Studies have shown that wearable devices can help manage physical stress on the body. The SWL device tracks shoulder movements and muscle activity, providing real-time information for workers to adjust their movements and reduce strain. Research on similar devices has shown they can help people adhere to exercise routines and improve results. Although the SWL device hasn't been tested specifically on workers with shoulder pain yet, the concept is promising. By using this feedback, workers might better understand and manage the physical demands of their jobs, potentially reducing pain and disability. ^{1 2 6 7 8}

Who Is on the Research Team?

Jean-Sébastien Roy PT, PhD

Principal Investigator

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

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

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for workers experiencing shoulder pain due to conditions like rotator cuff injury, osteoarthritis, or rheumatoid arthritis. Participants should be currently employed and suffering from work-related shoulder disorders. There's no mention of specific inclusion or exclusion criteria provided.

Inclusion Criteria

I have shoulder pain from work, scoring at least 14 on the QuickDASH due to rotator cuff pain, osteoarthritis, or rheumatoid arthritis.

Diagnosis-specific criteria for RCRSP: presence of a painful arc in flexion or abduction, a positive Neer sign or Hawkins-Kennedy Test, and pain with resisted humeral external rotation or abduction, or a positive Jobe Test; for SOA: diagnosis based on clinical and radiologic findings; for RA involving the shoulder: confirmed diagnosis according to the American College of Rheumatology criteria

I am over 18 and work at least 35 hours a week.

Exclusion Criteria

Absenteeism from work

I have a recent shoulder injury or condition like a tear, fracture, or instability.

I experience numbness or pain in my hands or feet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the experimental group use the feedback device for 2 weeks, while the control group continues without intervention

2 weeks

Education session at week 2

Follow-up

Participants are monitored for safety and effectiveness after treatment, including focus groups and questionnaires

8 weeks

Focus groups from 4 weeks to 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Shoulder watch load (SWL) feedback

Trial Overview The study tests a wearable feedback device (SWL) that monitors shoulder movement and muscle activity, providing real-time data to help manage physical demands at work. The trial has two groups: one uses the device for two weeks; the other works as usual without intervention.

How Is the Trial Designed?

Group I: Device + Education Experimental Treatment 2 Interventions

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

Group II: Education Active Control 1 Intervention

Education session at week 2.

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

The Arthritis Society, Canada

Collaborator

Trials

27

Recruited

9,700+

Published Research Related to This Trial

A randomized controlled trial showed that patients with subacromial pain syndrome using the DAid smart shirt experienced significantly better recovery outcomes compared to a reference group, as measured by standardized tests (p < 0.001).

The DAid smart shirt provides real-time feedback on shoulder motion, helping patients perform exercises more accurately, which enhances muscle control and contributes to improved rehabilitation results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the Recovery of Patients with Subacromial Pain Syndrome with the DAid Smart Textile Shirt. Semjonova, G., Vetra, J., Cauce, V., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12180215/

protocol of a mixed methods pilot study To address this, we developed a portable feedback system, the ShoulderWatchLoad (SWL), designed to estimate physical work demands on the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06693479

Could a Feedback Device Help Manage Work-related ... Recently, our team developed a wearable feedback device, similar to a watch worn on the arm, which measures shoulder movements and muscle activity, transforming ...

3. researchgate.net researchgate.net/publication/388565937_Quantifying_the_Relationship_Between_At-Home_Shoulder_Physiotherapy_Participation_and_Outcome_What_can_a_Watch_Tell_Us

Quantifying the Relationship Between At-Home Shoulder ... Objective assessment of at-home exercise is critical to understand its relationship with clinical outcomes. This study uses the Smart ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7381014/

Adherence Tracking With Smart Watches for Shoulder ... The proposed research will (1) validate a smartwatch and machine learning (ML) approach for evaluating adherence to shoulder exercise participation and ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/14/7/e085381

protocol for an open-label randomised controlled trial The primary outcome measure will be the Shoulder Pain and Disability Index, measured at baseline, 3 weeks, 3 months (primary analysis) and 6 months. Secondary ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2468781224003424

Do biopsychosocial factors predict the level of physical ... The objective of this cross-sectional study was to compare the physical activity level between individuals with and without rotator cuff related shoulder ...

7. bmjopensem.bmj.com bmjopensem.bmj.com/content/11/1/e002523

a study protocol of a randomised controlled trial The sample size was determined based on previous studies investigating exercise interventions for shoulder dysfunction in overhead athletes.

8. mdpi.com mdpi.com/2076-3417/13/21/11944

The Role of Pain in the Relationship between Shoulder ... This prospective study aimed to comprehensively assess the relationship between shoulder muscle strength, JPS, and pain in individuals with SIS.