Clinical trial NCT06693479: Could a Feedback Device Help Manage Work-related Shoulder Disorders?
Official title: Could a Feedback Device Help Manage Work-related Shoulder Disorders? - Protocol of a Mixed Methods Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff-related Shoulder Pain
Shoulder Osteoarthritis
Rheumatoid Arthritis (RA)
Keywords: Technology
Shoulder pain
Feasibility
Workers
Feedback
Pilot
Randomized controlled trial
Focus group
Device
Mixed methods study
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: The Arthritis Society, Canada
First posted: 2024-11-18
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Adult (≧ 18 years) employed full-time (minimum of 30 hours per week).
2. 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.
3. Symptoms persisting for more than 6 weeks.

Diagnosis-specific criteria:

1. 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;
2. 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);
3. 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.

Exclusion Criteria:

1. clinical signs of a massive rotator cuff tear (e.g., pseudoparesis or pseudoparalysis, passive elevation intact but active limited to \<90°, without neurologic deficit);
2. 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);
3. distal neurovascular symptoms (e.g., thoracic outlet syndrome, venous thromboembolism);
4. previous shoulder surgery;
5. corticosteroid injection administered within the past 3 months;
6. symptomatic acromioclavicular joint pathology;
7. currently receiving conservative management for their shoulder pain (excluding medication for RA and OA),
8. absenteeism from work (unable to work at least 30 hours per week or on sick leave).

Primary outcomes:
measure: Feasibility : quantitative component procedure
timeFrame: Baseline
measure: Feasibility : quantitative component procedure
timeFrame: From enrollment to the end of recruitment
measure: Feasibility : quantitative component procedure
timeFrame: From enrollment to the end the trial at 12 weeks
measure: Feasibility : quantitative component procedure
timeFrame: From enrollment to the end of the last completion questionnaire at 12 weeks
measure: Feasibility : quantitative component procedure
timeFrame: From 2 weeks to 4 weeks of the intervention period
measure: Feasibility : qualitative component procedure
timeFrame: From 4 weeks to 12 weeks
Secondary outcomes:
measure: Abbreviated version of the Disability of the Arm Shoulder and Hand questionnaire-Work Module (QuickDASH-Work Module)
timeFrame: Baseline, 3 weeks, 6 weeks, 12 weeks
measure: Abbreviated version of the Disability of the Arm Shoulder and Hand questionnaire (QuickDASH)
timeFrame: Baseline, 3 weeks, 6 weeks, 12 weeks
measure: Work Limitations Questionnaire (WLQ-25).
timeFrame: Baseline, 3 weeks, 6 weeks, 12 weeks
measure: Pain severity subscale of the Brief Pain Inventory Short Form (BPI-SF)
timeFrame: Baseline, 3 weeks, 6 weeks, 12 weeks
measure: Pain Self-Efficacy Questionnaire (PSEQ).
timeFrame: Baseline, 3 weeks, 6 weeks, 12 weeks
measure: Western Ontario Rotator Cuff Index (WORC)
timeFrame: Baseline, 3 weeks, 6 weeks, 12 weeks
measure: Physical work demands
timeFrame: At 1 week and 4 weeks
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre interdisciplinaire de recherche en réadaptation et intégration sociale (Cirris)
state: Quebec
Study officials:
affiliation: Centre interdisciplinaire de recherche en réadaptation et intégration sociale (Cirris)
name: Philippe Meidinger, PT, PhD student, PT, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre interdisciplinaire de recherche en réadaptation et intégration sociale (Cirris)
name: Jean-Sébastien Roy PT, PhD
role: STUDY_DIRECTOR
References: