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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
42
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.
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.
Centre interdisciplinaire de recherche en réadaptation et intégration sociale (Cirris)
Québec, Quebec, Canada
RECRUITINGFeasibility : 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: Baseline
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 recruitment
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 weeks
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 weeks
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.
Time frame: From 2 weeks to 4 weeks of the intervention period
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.
Time frame: From 4 weeks to 12 weeks
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 weeks
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 weeks
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 weeks
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 weeks
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).
Time frame: Baseline, 3 weeks, 6 weeks, 12 weeks
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.
Time frame: Baseline, 3 weeks, 6 weeks, 12 weeks
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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.
Time frame: At 1 week and 4 weeks