为期一天的接受和承诺治疗研讨会，预防脊柱手术后慢性术后疼痛和长期阿片类药物使用：一项试点可行性随机对照试验方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-01 DOI:10.1016/j.cct.2024.107785

Jolin B. Yamin , Bethany D. Pester , Ramya Kommu , Caroline Allen , Diya Dharmendran , Kylie Steinhilber , Madelyn Crago , Savannah Kazemipour , Angelina Franqueiro , Delia Fentazi , Kristin L. Schreiber , Robert R. Edwards , Robert N. Jamison , Samantha M. Meints

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引用次数: 0

摘要

背景：背部疼痛越来越普遍，导致更多的脊柱手术。虽然大多数人在手术后经历疼痛缓解和功能改善，但许多人继续遭受慢性术后疼痛（CPSP），功能改善有限。CPSP通常用阿片类药物治疗，这引起了人们对滥用、不良功能结局和更广泛的公共卫生影响的担忧。因此，围手术期干预是必要的，以提高预后，降低术后阿片类药物滥用的风险。目的：本文概述了一项研究方案，评估了一种简短的围手术期接受和承诺治疗（ACT）干预的可行性、可接受性和初步疗效，旨在改善脊柱手术后疼痛和减少阿片类药物的使用。设计：在这项试点随机对照试验中，计划进行脊柱手术的参与者（预期N = 100）被分配到ACT干预组或常规治疗组。干预：ACT干预是一个5小时的单次虚拟研讨会，在研讨会后或手术后两周（以较晚者为准）进行一次强化电话会议。结果测量：主要结果是干预后患者报告的治疗效果。次要结局包括干预后患者报告的治疗可信度和期望，手术后1 个月的治疗帮助，以及手术后1、3和6 个月的疼痛干扰、疼痛强度和阿片类药物使用。结论：这项试点试验研究了一种新的、短暂的ACT干预措施，旨在预防CPSP和减少阿片类药物依赖。如果成功，可行性和初步疗效结果将用于该干预措施的未来全面随机试验。

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A one-day acceptance and commitment therapy workshop for the prevention of chronic post-surgical pain and long-term opioid use following spine surgery: Protocol for a pilot feasibility randomized controlled trial

Background

Back pain is increasingly common, leading to more spine surgeries. While most people experience pain relief and improved function after surgery, many continue to suffer from chronic post-surgical pain (CPSP) with limited functional improvement. CPSP is often treated with opioids, raising concerns about misuse, poor functional outcomes, and broader public health impacts. Therefore, perioperative interventions are needed to enhance outcomes and reduce the risk of opioid misuse after surgery.

Objective

This article outlines a study protocol evaluating the feasibility, acceptability, and preliminary efficacy of a brief, perioperative Acceptance and Commitment Therapy (ACT) intervention aimed at improving pain and reducing opioid use after spine surgery.

Design

In this pilot randomized controlled trial, participants scheduled for spine surgery (anticipated N = 100) are assigned to the ACT intervention or a treatment-as-usual group.

Intervention

The ACT intervention is a 5-h, single-session, virtual workshop with a booster call two weeks post-workshop or post-surgery, whichever is later.

Outcome measures

The primary outcome is patient-reported treatment helpfulness immediately after the intervention. Secondary outcomes include patient-reported treatment credibility and expectancy post-intervention, treatment helpfulness at 1 month post-surgery, and pain interference, pain intensity and opioid use at 1, 3, and 6 months post-surgery.

Conclusion

This pilot trial examines a novel, brief ACT intervention aimed at preventing CPSP and reducing opioid dependence. If successful, feasibility and preliminary efficacy results will be utilized to inform a future, full-scale randomized trial of this intervention.

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.