Philippe Meidinger, Quan Nha Hong, Jean Tittley, Alexandre Campeau-Lecours, Jean-Sébastien Roy
{"title":"Could a feedback device help manage work-related shoulder disorders?: protocol of a mixed methods pilot study.","authors":"Philippe Meidinger, Quan Nha Hong, Jean Tittley, Alexandre Campeau-Lecours, Jean-Sébastien Roy","doi":"10.1186/s40814-025-01646-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Work-related shoulder disorders (WRSDs) significantly impact workers' health and well-being. Various factors contribute to WRSDs, including work environment, physical workload, psychological stressors, and an aging workforce. Despite numerous interventions proposed to address WRSDs, finding high-quality evidence to support any of them remains challenging. One potential reason is the lack of valid tools to measure physical workload and customize interventions. To address this, we developed a portable feedback system, the ShoulderWatchLoad (SWL), designed to estimate physical work demands on the shoulder. 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, usability of the technology, and 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.</p><p><strong>Methods/design: </strong>A convergent mixed methods pilot study will be conducted. The quantitative component will consist of a two-arm parallel group external pilot RCT involving 42 participants with WRSDs who will be randomized into one of the two study groups. Following baseline evaluation, all participants will attend an education session in the workplace. Following this session, participants of the experimental group will receive a 2-week workplace intervention using feedback from the SWL, while participants in the control group will not receive this intervention. All participants will undergo four evaluations over a 12-week period (baseline, 3rd, 6th, and 12th weeks). The qualitative component will be a interpretative descriptive qualitative study involving three focus groups with 21 participants from the experimental group. An innovative joint display will be used to represent the integration of qualitative and quantitative data, along with progression criteria, to draw meta-inferences about the feasibility of implementing the SWL in the workplace and conducting a full-scale RCT in the future.</p><p><strong>Discussion: </strong>A holistic approach combining qualitative and quantitative elements will enable us to determine the SWL usability and whether the conduct of a full RCT is feasible.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06693479.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"84"},"PeriodicalIF":1.5000,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12180215/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pilot and Feasibility Studies","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s40814-025-01646-0","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Work-related shoulder disorders (WRSDs) significantly impact workers' health and well-being. Various factors contribute to WRSDs, including work environment, physical workload, psychological stressors, and an aging workforce. Despite numerous interventions proposed to address WRSDs, finding high-quality evidence to support any of them remains challenging. One potential reason is the lack of valid tools to measure physical workload and customize interventions. To address this, we developed a portable feedback system, the ShoulderWatchLoad (SWL), designed to estimate physical work demands on the shoulder. 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, usability of the technology, and 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.
Methods/design: A convergent mixed methods pilot study will be conducted. The quantitative component will consist of a two-arm parallel group external pilot RCT involving 42 participants with WRSDs who will be randomized into one of the two study groups. Following baseline evaluation, all participants will attend an education session in the workplace. Following this session, participants of the experimental group will receive a 2-week workplace intervention using feedback from the SWL, while participants in the control group will not receive this intervention. All participants will undergo four evaluations over a 12-week period (baseline, 3rd, 6th, and 12th weeks). The qualitative component will be a interpretative descriptive qualitative study involving three focus groups with 21 participants from the experimental group. An innovative joint display will be used to represent the integration of qualitative and quantitative data, along with progression criteria, to draw meta-inferences about the feasibility of implementing the SWL in the workplace and conducting a full-scale RCT in the future.
Discussion: A holistic approach combining qualitative and quantitative elements will enable us to determine the SWL usability and whether the conduct of a full RCT is feasible.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
