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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Shoulder watch load (SWL) feedback treatment for shoulder pain?

The DAid smart shirt study shows that using a feedback system to monitor and adjust shoulder movements can significantly improve recovery in patients with shoulder pain, suggesting that similar feedback devices like the SWL could be effective. ^{1 2 3 4 5}

Is the Feedback Device for Shoulder Pain safe for humans?

Research on shoulder exoskeletons, which are similar devices, shows they can reduce muscle activity and fatigue during tasks, but some users reported discomfort. Improvements are needed for better comfort and usability, suggesting they are generally safe but may cause discomfort in some cases. ^{2 4 6 7 8}

How is the Shoulder watch load (SWL) feedback treatment different from other treatments for shoulder pain?

The Shoulder watch load (SWL) feedback treatment is unique because it likely involves real-time feedback to help patients manage shoulder load, which can improve sensorimotor control (the body's ability to sense movement and position) and reduce pain. This approach is different from traditional treatments that may not focus on real-time feedback or sensorimotor control. ^{4 9 10 11 12}

Research Team

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

Principal Investigator

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

Jean-Sébastien Roy PT, PhD

Principal Investigator

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

Eligibility Criteria

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

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

Absenteeism from work

I experience numbness or pain in my hands or feet.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Scapular movement training is not superior to standardized exercises in the treatment of individuals with chronic shoulder pain and scapular dyskinesis: randomized controlled trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Subjective Shoulder Value for Sport (SSV-Sport) Is a Simple, Reliable, and Valid Score to Assess Shoulder Function in Athletes. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Reliability by surgical status of self-reported outcomes in patients who have shoulder pathologies. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The immediate effects of soft tissue mobilization with proprioceptive neuromuscular facilitation on glenohumeral external rotation and overhead reach. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Improving the Recovery of Patients with Subacromial Pain Syndrome with the DAid Smart Textile Shirt. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Passive Shoulder Exoskeletons: More Effective in the Lab Than in the Field? [2021]

7. United States pubmed.ncbi.nlm.nih.gov

An Occupational Shoulder Exoskeleton Reduces Muscle Activity and Fatigue During Overhead Work. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Ergonomic evaluation of a wearable assistive device for overhead work. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Prospective study on shoulder symptoms among kitchen workers in relation to self-perceived and observed work load. [2009]

10. United States pubmed.ncbi.nlm.nih.gov

Variation in shoulder position sense at mid and extreme range of motion. [2016]

11. United States pubmed.ncbi.nlm.nih.gov

Sensorimotor control deficiency in recurrent anterior shoulder instability assessed with a stabilometric force platform. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

A brief fatigue inventory of shoulder health developed by quality function deployment technique. [2016]