Faculty of Nursing, Laval University, Quebec City, Quebec, Canada.
Research Center of the CHU de Québec, Quebec City, Quebec, Canada.
Pain Med. 2019 Oct 1;20(10):2018-2032. doi: 10.1093/pm/pnz008.
Objective 1) To assess the feasibility of research methods to test a self-management intervention aimed at preventing acute to chronic pain transition in patients with major lower extremity trauma (iPACT-E-Trauma) and 2) to evaluate its potential effects at three and six months postinjury. Design A pilot randomized controlled trial (RCT) with two parallel groups. Setting A supraregional level 1 trauma center. Methods Fifty-six adult patients were randomized. Participants received the intervention or an educational pamphlet. Several parameters were evaluated to determine the feasibility of the research methods. The potential efficacy of iPACT-E-Trauma was evaluated with measures of pain intensity and pain interference with activities. Results More than 80% of eligible patients agreed to participate, and an attrition rate of ≤18% was found. Less than 40% of screened patients were eligible, and obtaining baseline data took 48 hours postadmission on average. Mean scores of mild pain intensity and pain interference with daily activities (<4/10) on average were obtained in both groups at three and six months postinjury. Between 20% and 30% of participants reported moderate to high mean scores (≥4/10) on these outcomes at the two follow-up time measures. The experimental group perceived greater considerable improvement in pain (60% in the experimental group vs 46% in the control group) at three months postinjury. Low mean scores of pain catastrophizing (Pain Catastrophizing Scale score < 30) and anxiety and depression (Hospital Anxiety and Depression Scale scores ≤ 10) were obtained through the end of the study. Conclusions Some challenges that need to be addressed in a future RCT include the small proportion of screened patients who were eligible and the selection of appropriate tools to measure the development of chronic pain. Studies will need to be conducted with patients presenting more serious injuries and psychological vulnerability or using a stepped screening approach.
目的 1）评估旨在预防下肢主要创伤患者急性向慢性疼痛转变的自我管理干预（iPACT-E-Trauma）的研究方法的可行性，并 2）评估其在受伤后 3 个月和 6 个月的潜在效果。 设计 一项平行组、随机对照试验（RCT）的初步研究。 地点 一家超区域 1 级创伤中心。 方法 56 名成年患者被随机分组。参与者接受干预或教育小册子。评估了多个参数以确定研究方法的可行性。使用疼痛强度和活动干扰的测量来评估 iPACT-E-Trauma 的潜在疗效。 结果 超过 80%的合格患者同意参加，失访率≤18%。不到 40%的筛查患者符合条件，平均在入院后 48 小时获得基线数据。两组患者在受伤后 3 个月和 6 个月的平均轻度疼痛强度和日常活动干扰评分（<4/10）均较低。在两个随访时间点，约 20%至 30%的参与者报告这些结果的中度至高度平均评分（≥4/10）。实验组在受伤后 3 个月时报告疼痛有较大的明显改善（实验组为 60%，对照组为 46%）。研究结束时，疼痛灾难化量表评分（<30）和焦虑抑郁量表评分（医院焦虑抑郁量表评分≤10）的平均得分较低。 结论 在未来的 RCT 中，需要解决一些挑战，包括符合条件的筛查患者比例较小，以及选择适当的工具来测量慢性疼痛的发展。需要对受伤更严重和心理脆弱的患者进行研究，或采用分步筛查方法。
