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基于正念的干预与物理疗法相结合(MIND-PT)对腰椎手术后康复的有效性:作为背痛联合会(BACPAC)研究计划的一部分的随机对照试验方案。

The Effectiveness of a Mindfulness-Based Intervention Integrated with Physical Therapy (MIND-PT) for Postsurgical Rehabilitation After Lumbar Surgery: A Protocol for a Randomized Controlled Trial as Part of the Back Pain Consortium (BACPAC) Research Program.

机构信息

Department of Physical Therapy & Athletic Training, The University of Utah, Salt Lake City, Utah.

Department of Rehabilitation Medicine, Brooke Army Medical Center, San Antonio, Texas.

出版信息

Pain Med. 2023 Aug 4;24(Suppl 1):S115-S125. doi: 10.1093/pm/pnac138.

Abstract

BACKGROUND

Improving pain management for persons with chronic low back pain (LBP) undergoing surgery is an important consideration in improving patient-centered outcomes and reducing the risk of persistent opioid use after surgery. Nonpharmacological treatments, including physical therapy and mindfulness, are beneficial for nonsurgical LBP through complementary biopsychosocial mechanisms, but their integration and application for persons undergoing surgery for LBP have not been examined. This study (MIND-PT) is a multisite randomized trial that compares an enriched pain management (EPM) pathway that integrates physical therapy and mindfulness vs usual-care pain management (UC) for persons undergoing surgery for LBP.

DESIGN

Participants from military treatment facilities will be enrolled before surgery and individually randomized to the EPM or UC pain management pathways. Participants assigned to EPM will receive presurgical biopsychosocial education and mindfulness instruction. After surgery, the EPM group will receive 10 sessions of physical therapy with integrated mindfulness techniques. Participants assigned to the UC group will receive usual pain management care after surgery. The primary outcome will be the pain impact, assessed with the Pain, Enjoyment, and General Activity (PEG) scale. Time to opioid discontinuation is the main secondary outcome.

SUMMARY

This trial is part of the National Institutes of Health Helping to End Addiction Long-term (HEAL) initiative, which is focused on providing scientific solutions to the opioid crisis. The MIND-PT study will examine an innovative program combining nonpharmacological treatments designed to improve outcomes and reduce opioid overreliance in persons undergoing lumbar surgery.

摘要

背景

改善接受慢性下腰痛(LBP)手术治疗的患者的疼痛管理,是改善以患者为中心的治疗效果和降低术后持续使用阿片类药物风险的重要考虑因素。非药物治疗,包括物理治疗和正念,通过互补的生物心理社会机制对非手术性 LBP 有益,但尚未对接受 LBP 手术治疗的患者进行整合和应用。这项研究(MIND-PT)是一项多中心随机试验,比较了一种强化疼痛管理(EPM)方案,该方案整合了物理治疗和正念,与接受 LBP 手术治疗的患者的常规疼痛管理(UC)相比。

设计

军事治疗设施的参与者将在手术前招募,并进行个体随机分组,接受 EPM 或 UC 疼痛管理路径。分配到 EPM 组的参与者将接受术前生物心理社会教育和正念指导。手术后,EPM 组将接受 10 次结合正念技术的物理治疗。分配到 UC 组的参与者将在手术后接受常规疼痛管理护理。主要结局是疼痛影响,采用疼痛、享受和一般活动(PEG)量表评估。停药时间是主要次要结局。

总结

该试验是美国国立卫生研究院帮助终结阿片类药物危机的长期(HEAL)计划的一部分,该计划专注于提供解决阿片类药物危机的科学解决方案。MIND-PT 研究将研究一种创新的方案,结合旨在改善接受腰椎手术患者的结果和减少对阿片类药物过度依赖的非药物治疗方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a138/10403309/116c19c652d1/pnac138f1.jpg

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