Scientific Institute for Quality of Healthcare, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
Trials. 2013 Aug 16;14:258. doi: 10.1186/1745-6215-14-258.
Complaints of the arm, neck, or shoulder (CANS) have a multifactorial origin and cause considerable work problems, including decreased work productivity, sickness absence, and, ultimately, job loss. There is a need for intervention programs for people with CANS. Self-management is an approach used in chronic disease care to improve self-efficacy and wellness behaviors to facilitate participants to make informed choices and carry them out. This study will evaluate the effectiveness of a self-management program (including ehealth) and compare it to usual care among employees with chronic CANS (lasting >3 months).
METHODS/DESIGN: This is a randomized controlled trial in which 142 participants will be recruited and randomized (with pre-stratification) to either the intervention group (IG) or control group (CG). The IG will participate in a self-management program consisting of six group sessions and an ehealth module. The CG is allowed to use all usual care available. The primary outcome of the study is the self-reported disability of arm, shoulder, and hand, measured with the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH). Secondary outcomes include: absenteeism, pain in the previous week, quality of life, catastrophizing pain, self-efficacy, workstyle, presenteeism, fatigue, the use of usual care, and limitations experienced on the job. Data are collected at baseline and at 3, 6, and 12 months follow-up.
Following the process of intervention mapping we developed a self-management program to suit and alleviate the problems and needs of employees with CANS. A strength of the study is that our intervention is specifically tailored to match the needs of employees with CANS. The study also has some potential weaknesses (for example, use of co-interventions, combination of group sessions and ehealth, self-reporting of data and possible contamination, Hawthorne effect, and recall or information bias) which are discussed.
The trial is registered with the Dutch Trial Register (http://www.trialregister.nlNTR3816): (January 2013). The first participant was randomized in September 2012.
手臂、颈部或肩部的不适（CANS）有多种原因，会导致严重的工作问题，包括工作效率降低、缺勤以及最终失业。需要为 CANS 患者提供干预计划。自我管理是一种用于慢性病护理的方法，旨在提高自我效能和健康行为，以促进参与者做出明智的选择并实施这些选择。本研究将评估针对慢性 CANS（持续>3 个月）患者的自我管理计划（包括电子健康）的有效性，并将其与常规护理进行比较。
方法/设计：这是一项随机对照试验，将招募 142 名参与者，并进行随机分组（预分层），分为干预组（IG）或对照组（CG）。IG 将参加一个由六次小组会议和一个电子健康模块组成的自我管理计划。CG 可以使用所有可用的常规护理。该研究的主要结果是使用手臂、肩部和手残疾问卷（DASH）自我报告的手臂、肩部和手残疾。次要结果包括：缺勤、上周疼痛、生活质量、灾难性疼痛、自我效能、工作方式、出勤、疲劳、常规护理的使用以及工作中的限制。数据在基线和 3、6 和 12 个月随访时收集。
根据我们制定的干预映射过程，我们开发了一种自我管理计划，以适应和缓解 CANS 患者的问题和需求。该研究的一个优势是我们的干预措施专门针对 CANS 患者的需求进行了定制。该研究还存在一些潜在的弱点（例如，使用共同干预措施、小组会议和电子健康相结合、数据的自我报告以及可能的污染、霍桑效应以及回忆或信息偏差），这些弱点将在讨论中进行讨论。
该试验在荷兰试验注册处（http://www.trialregister.nlNTR3816）注册：（2013 年 1 月）。第一位参与者于 2012 年 9 月随机分组。
