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创伤性骨科损伤和手术后慢性疼痛的情绪意识与表达疗法(EAET):单臂可行性临床试验的研究方案

Emotional awareness and expression therapy (EAET) for chronic pain following traumatic orthopaedic injury and surgery: study protocol for a single-arm feasibility clinical trial.

作者信息

Ravyts Scott G, Carnahan Nicolette, Campbell Claudia, Castillo Renan, Wegener Stephen, Rassu Fenan S, Lumley Mark A, Aaron Rachel

机构信息

Department of Psychological Science, University of North Carolina at Charlotte, Charlotte, North Carolina, USA.

Department of Physical Medicine and Rehabilitation, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.

出版信息

BMJ Open. 2025 Mar 15;15(3):e093102. doi: 10.1136/bmjopen-2024-093102.

DOI:10.1136/bmjopen-2024-093102
PMID:40090682
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11911693/
Abstract

BACKGROUND

Nearly half of individuals who sustain orthopaedic trauma develop chronic pain and experience significant levels of depression and anxiety. Emotional awareness and expression therapy (EAET) is a newly developed psychological intervention designed to treat chronic pain by helping patients process psychological trauma and conflict to reduce pain. The purpose of this study is to examine the feasibility of delivering EAET to individuals who sustained traumatic orthopaedic injuries requiring surgery and who have chronic pain 6 months after hospital discharge.

METHODS AND ANALYSIS

The study will consist of a single-arm design. Thirty individuals who sustained traumatic orthopaedic injuries requiring surgery and who reported chronic pain 6 months after hospital discharge will be recruited. Participants will receive eight sessions of individually administered EAET delivered via telehealth and complete self-report questionnaires at three timepoints (pretreatment, post-treatment and 3-month follow-up). Quantitative sensory testing will also be done before and after treatment. The primary outcome of the study is feasibility (eg, per cent of eligible patients recruited and per cent of study completers) and acceptability as reported by responses to a self-report questionnaire.

ETHICS AND DISSEMINATION

This study has been approved by the Johns Hopkins Institutional Review Board. All data are expected to be collected by 2026, with results of this study to be disseminated via relevant peer-reviewed journals and scientific conferences.

TRIAL REGISTRATION NUMBER

ClinicalTrials.gov NCT05989230. Registered on 14 August 2023.

摘要

背景

近一半遭受骨科创伤的患者会出现慢性疼痛,并伴有显著程度的抑郁和焦虑。情绪觉察与表达疗法(EAET)是一种新开发的心理干预方法,旨在通过帮助患者处理心理创伤和冲突来减轻疼痛,从而治疗慢性疼痛。本研究的目的是检验对因创伤性骨科损伤接受手术且出院6个月后仍有慢性疼痛的个体实施情绪觉察与表达疗法的可行性。

方法与分析

本研究将采用单臂设计。将招募30名因创伤性骨科损伤接受手术且出院6个月后报告有慢性疼痛的个体。参与者将通过远程医疗接受八次单独实施的情绪觉察与表达疗法,并在三个时间点(治疗前、治疗后和3个月随访)完成自我报告问卷。治疗前后还将进行定量感觉测试。本研究的主要结果是可行性(例如,招募的符合条件患者的百分比和研究完成者的百分比)以及自我报告问卷反馈所显示的可接受性。

伦理与传播

本研究已获得约翰霍普金斯机构审查委员会的批准。所有数据预计在2026年前收集完成,本研究结果将通过相关同行评审期刊和科学会议进行传播。

试验注册号

ClinicalTrials.gov NCT05989230。于2023年8月14日注册。

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本文引用的文献

1
Emotional Awareness and Expression Therapy vs Cognitive Behavioral Therapy for Chronic Pain in Older Veterans: A Randomized Clinical Trial.老年退伍军人慢性疼痛的情绪意识与表达疗法与认知行为疗法对比:一项随机临床试验
JAMA Netw Open. 2024 Jun 3;7(6):e2415842. doi: 10.1001/jamanetworkopen.2024.15842.
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Psychological treatments for the management of pain after musculoskeletal injury: a systematic review and meta-analysis.肌肉骨骼损伤后疼痛管理的心理治疗:系统评价与荟萃分析
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Emotional Awareness and Expression Therapy Achieves Greater Pain Reduction than Cognitive Behavioral Therapy in Older Adults with Chronic Musculoskeletal Pain: A Preliminary Randomized Comparison Trial.
情绪觉察与表达疗法在患有慢性肌肉骨骼疼痛的老年人中比认知行为疗法能更有效地减轻疼痛:一项初步随机对照试验。
Pain Med. 2020 Nov 1;21(11):2811-2822. doi: 10.1093/pm/pnaa145.
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Current illicit drug use profile of orthopaedic trauma patients and its effect on hospital length of stay.骨科创伤患者当前的非法药物使用情况及其对住院时间的影响。
Injury. 2020 Apr;51(4):887-891. doi: 10.1016/j.injury.2020.02.077. Epub 2020 Feb 17.
5
Early Effects of the Trauma Collaborative Care Intervention: Results From a Prospective Multicenter Cluster Clinical Trial.创伤协作护理干预的早期效果:一项前瞻性多中心集群临床试验的结果。
J Orthop Trauma. 2019 Nov;33(11):538-546. doi: 10.1097/BOT.0000000000001581.
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Pain, Anxiety, and Depression in the First Two Years Following Transport-Related Major Trauma: A Population-Based, Prospective Registry Cohort Study.创伤后两年内与交通相关的重大创伤后的疼痛、焦虑和抑郁:一项基于人群的前瞻性登记队列研究。
Pain Med. 2020 Feb 1;21(2):291-307. doi: 10.1093/pm/pnz209.
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Emotional Awareness and Expression Therapy for Chronic Pain: Rationale, Principles and Techniques, Evidence, and Critical Review.慢性疼痛的情绪意识与表达疗法:基本原理、原则与技术、证据与批判性评价。
Curr Rheumatol Rep. 2019 May 23;21(7):30. doi: 10.1007/s11926-019-0829-6.
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Feasibility of a Hybrid Web-Based and In-Person Self-management Intervention Aimed at Preventing Acute to Chronic Pain Transition After Major Lower Extremity Trauma (iPACT-E-Trauma): A Pilot Randomized Controlled Trial.基于网络和线下混合模式的自我管理干预预防下肢大创伤后急慢性疼痛转变的可行性研究(iPACT-E-Trauma):一项先导随机对照试验
Pain Med. 2019 Oct 1;20(10):2018-2032. doi: 10.1093/pm/pnz008.
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Results of a feasibility randomized controlled trial (RCT) of the Toolkit for Optimal Recovery (TOR): a live video program to prevent chronic pain in at-risk adults with orthopedic injuries.最佳康复工具包(TOR)可行性随机对照试验(RCT)的结果:一个预防骨科损伤高危成年人慢性疼痛的直播视频项目。
Pilot Feasibility Stud. 2019 Feb 20;5:30. doi: 10.1186/s40814-019-0416-7. eCollection 2019.
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The IASP classification of chronic pain for ICD-11: chronic postsurgical or posttraumatic pain.国际疼痛学会(IASP)ICD-11 慢性疼痛分类:慢性手术后或创伤后疼痛。
Pain. 2019 Jan;160(1):45-52. doi: 10.1097/j.pain.0000000000001413.