Bérubé Mélanie, Gélinas Céline, Martorella Géraldine, Côté José, Feeley Nancy, Laflamme George-Yves, Rouleau Dominique, Choinière Manon
Centre Integré Universitaire du Nord de l'Île de Montréal, Departments of Trauma and Nursing, Hôpital du Sacré-Cœur de Montréal, Montreal, QC, Canada.
Center for Nursing Research, Jewish General Hospital, McGill University, Montreal, QC, Canada.
JMIR Res Protoc. 2017 Jun 26;6(6):e125. doi: 10.2196/resprot.7949.
Acute pain frequently transitions to chronic pain after major lower extremity trauma (ET). Several modifiable psychological risk and protective factors have been found to contribute to, or prevent, chronic pain development. Some empirical evidence has shown that interventions, including cognitive and behavioral strategies that promote pain self-management, could prevent chronic pain. However, the efficacy of such interventions has never been demonstrated in ET patients. We have designed a self-management intervention to prevent acute to chronic pain transition after major lower extremity trauma (iPACT-E-Trauma).
This pilot randomized controlled trial (RCT) aims to evaluate the feasibility and research methods of the intervention, as well as the potential effects of iPACT-E-Trauma, on pain intensity and pain interference with daily activities.
A 2-arm single-blind pilot RCT will be conducted. Participants will receive the iPACT-E-Trauma intervention (experimental group) or an educational pamphlet (control group) combined with usual care. Data will be collected at baseline, during iPACT-E-Trauma delivery, as well as at 3 and 6 months post-injury. Primary outcomes are pain intensity and pain interference with daily living activities at 6 months post-injury. Secondary outcomes are pain self-efficacy, pain acceptance, pain catastrophizing, pain-related fear, anxiety and depression symptoms, health care service utilization, and return to work.
Fifty-three patients were recruited at the time of manuscript preparation. Comprehensive data analyses will be initiated in July 2017. Study results are expected to be available in 2018.
Chronic pain is an important problem after major lower ET. However, no preventive intervention has yet been successfully proven in these patients. This study will focus on developing a feasible intervention to prevent acute to chronic pain transition in the context of ET. Findings will allow for the refinement of iPACT-E-Trauma and methodological parameters in prevision of a full-scale multi-site RCT.
International Standard Randomized Controlled Trial Number (ISRCTN): 91987302; http://www.controlled-trials.com/ISRCTN91987302 (Archived by WebCite at http://www.webcitation.org/6rR8G2vMs).
严重下肢创伤（ET）后，急性疼痛常转变为慢性疼痛。已发现一些可改变的心理风险和保护因素会促成或预防慢性疼痛的发展。一些实证证据表明，包括促进疼痛自我管理的认知和行为策略在内的干预措施可以预防慢性疼痛。然而，此类干预措施在ET患者中的疗效尚未得到证实。我们设计了一种自我管理干预措施，以预防严重下肢创伤后急性疼痛向慢性疼痛的转变（iPACT-E-Trauma）。
这项初步随机对照试验（RCT）旨在评估该干预措施的可行性和研究方法，以及iPACT-E-Trauma对疼痛强度和疼痛对日常活动干扰的潜在影响。
将进行一项双臂单盲初步随机对照试验。参与者将接受iPACT-E-Trauma干预（实验组）或教育手册（对照组）并结合常规护理。将在基线、iPACT-E-Trauma实施期间以及受伤后3个月和6个月收集数据。主要结局是受伤后6个月时的疼痛强度和疼痛对日常生活活动的干扰。次要结局是疼痛自我效能感、疼痛接受度、疼痛灾难化、与疼痛相关的恐惧、焦虑和抑郁症状、医疗服务利用情况以及重返工作岗位。
在撰写本稿件时招募了53名患者。将于2017年7月开始进行全面数据分析。预计研究结果将于2018年公布。
严重下肢ET后，慢性疼痛是一个重要问题。然而，尚未在这些患者中成功证明有预防性干预措施。本研究将专注于开发一种可行的干预措施，以预防ET情况下急性疼痛向慢性疼痛的转变。研究结果将有助于完善iPACT-E-Trauma和方法学参数，为全面的多中心随机对照试验做准备。
国际标准随机对照试验编号（ISRCTN）：91987302；http://www.controlled-trials.com/ISRCTN91987302（由WebCite存档于http://www.webcitation.org/6rR8G2vMs）。
