Yamin Jolin B, Pester Bethany D, Kommu Ramya, Allen Caroline, Dharmendran Diya, Steinhilber Kylie, Crago Madelyn, Kazemipour Savannah, Franqueiro Angelina, Fentazi Delia, Schreiber Kristin L, Edwards Robert R, Jamison Robert N, Meints Samantha M
Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
Department of Anesthesiology and Pain Medicine, University of Washington Medicine, Seattle, WA, USA.
Contemp Clin Trials. 2025 Feb;149:107785. doi: 10.1016/j.cct.2024.107785. Epub 2024 Dec 22.
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.
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.
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.
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.
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.
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.
背痛日益普遍,导致脊柱手术增多。虽然大多数人术后疼痛缓解且功能改善,但许多人仍患有慢性术后疼痛(CPSP),功能改善有限。CPSP通常用阿片类药物治疗,这引发了对药物滥用、功能预后不佳以及更广泛的公共卫生影响的担忧。因此,需要围手术期干预措施来改善预后并降低术后阿片类药物滥用的风险。
本文概述了一项研究方案,评估一种简短的围手术期接受与承诺疗法(ACT)干预措施的可行性、可接受性和初步疗效,该干预旨在改善脊柱手术后的疼痛并减少阿片类药物的使用。
在这项试点随机对照试验中,计划进行脊柱手术的参与者(预计N = 100)被分配到ACT干预组或常规治疗组。
ACT干预是一个为期5小时的单节虚拟研讨会,在研讨会结束后或手术后两周(以较晚者为准)进行一次强化电话随访。
主要结局是干预后患者报告的治疗帮助程度。次要结局包括干预后患者报告的治疗可信度和预期、术后1个月的治疗帮助程度,以及术后1、3和6个月的疼痛干扰、疼痛强度和阿片类药物使用情况。
这项试点试验研究了一种旨在预防CPSP和减少阿片类药物依赖的新型简短ACT干预措施。如果成功,可行性和初步疗效结果将用于为该干预措施未来的全面随机试验提供信息。