Could a Feedback Device Help Manage Work-related Shoulder Disorders?

Официальное название

Could a Feedback Device Help Manage Work-related Shoulder Disorders? - Protocol of a Mixed Methods Pilot Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Shoulder watch load (SWL) feedback
  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 participan
• Другое Education
  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

Первичные конечные точки

• Feasibility : quantitative component procedure [Срок оценки: Baseline]
• Feasibility : quantitative component procedure [Срок оценки: From enrollment to the end of recruitment]
• Feasibility : quantitative component procedure [Срок оценки: From enrollment to the end the trial at 12 weeks]
• Feasibility : quantitative component procedure [Срок оценки: From enrollment to the end of the last completion questionnaire at 12 weeks]
• Feasibility : quantitative component procedure [Срок оценки: From 2 weeks to 4 weeks of the intervention period]
• Feasibility : qualitative component procedure [Срок оценки: From 4 weeks to 12 weeks]

Вторичные конечные точки (7)

• Abbreviated version of the Disability of the Arm Shoulder and Hand questionnaire-Work Module (QuickDASH-Work Module) [Срок оценки: Baseline, 3 weeks, 6 weeks, 12 weeks]
• Abbreviated version of the Disability of the Arm Shoulder and Hand questionnaire (QuickDASH) [Срок оценки: Baseline, 3 weeks, 6 weeks, 12 weeks]
• Work Limitations Questionnaire (WLQ-25). [Срок оценки: Baseline, 3 weeks, 6 weeks, 12 weeks]
• Pain severity subscale of the Brief Pain Inventory Short Form (BPI-SF) [Срок оценки: Baseline, 3 weeks, 6 weeks, 12 weeks]
• Pain Self-Efficacy Questionnaire (PSEQ). [Срок оценки: Baseline, 3 weeks, 6 weeks, 12 weeks]
• Western Ontario Rotator Cuff Index (WORC) [Срок оценки: Baseline, 3 weeks, 6 weeks, 12 weeks]
• Physical work demands [Срок оценки: At 1 week and 4 weeks]

Критерии участия

Критерии включения

• 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.

Diagnosis-specific criteria:

• 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;
• 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);
• 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.

Критерии исключения

• 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;
• corticosteroid injection administered within the past 3 months;
• symptomatic acromioclavicular joint pathology;
• currently receiving conservative management for their shoulder pain (excluding medication for RA and OA),
• absenteeism from work (unable to work at least 30 hours per week or on sick leave).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Канада · 1 центр

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

Публикации

• Meidinger P, Hong QN, Tittley J, Campeau-Lecours A, Roy JS. Could a feedback device help manage work-related shoulder disorders?: protocol of a mixed methods pilot study. Pilot Feasibility Stud. 2025 Jun 20;11(1):84. doi: 10.1186/s40814-025-01646-0. PMID 40542393

Идентификаторы

NCT: NCT06693479 · MP-13-2023-2784

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗