Could a Feedback Device Help Manage Work-related Shoulder Disorders?
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaval University
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Shoulder watch load (SWL) feedback
DeviceDuring 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.
Education
Other interventionParticipants 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.
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Device + EducationExperimental treatment 2 interventions
Group B: EducationActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Baseline2
Feasibility : quantitative component procedure
Assessing trial recruitment success (Determining recruitment duration) : Evaluate the time required to recruit the target number of participants.
Time frame
From enrollment to the end of recruitment3
Feasibility : quantitative component procedure
Assessing trial recruitment success (Retention rate) : Monitor the number of participants who complete the trial, and document reasons for attrition.
Time frame
From enrollment to the end the trial at 12 weeks4
Feasibility : quantitative component procedure
Completion rate : Report the completion rate for each questionnaire at each time point.
Time frame
From enrollment to the end of the last completion questionnaire at 12 weeksSecondary outcomes
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
Time frame
Baseline, 3 weeks, 6 weeks, 12 weeks2
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.
Time frame
Baseline, 3 weeks, 6 weeks, 12 weeks3
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
Time frame
Baseline, 3 weeks, 6 weeks, 12 weeks4
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.
Time frame
Baseline, 3 weeks, 6 weeks, 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Laval University
Lead sponsor
The Arthritis Society, Canada
Collaborator
Source ClinicalTrials.gov