Feasibility Clinical Trial of Integrated Mind-Body Therapy for Chronic Low Back Pain

项目摘要/摘要 慢性下腰痛(CLBP)的治疗仍然是一个主要的公共卫生问题。药物治疗是一种 价值有限。目前的指南建议使用非药理学方法治疗cLBP，包括 瑜伽、太极、正念减压(MBSR)和认知-行为疗法(CBT)。而当 这些方法已被证明是有益的，所有当前的方法在 功效。我们假设，这些干预措施可以加强，以更有效地治疗慢性下腰痛。在……里面 响应FOA PAR-18-417针对高优先级主题，本提案侧重于修改MBSR以开发 CLBP的优化程序，基于正念的疼痛减少(MBPR)。基于该领域的最新进展 了解疼痛的中央处理，我们计划在三个密切相关和潜在的修改 协同领域：(1)加强相互感觉意识的技能发展，以应对慢性疼痛 通过集中注意力在特定的疼痛区域；(2)强调通过以下方式优化的专注运动 使用cLBP特定的瑜伽动作；(3)将教学内容的一些重点转向更好的 了解慢性疼痛及其神经生理学，结合认知-行为疗法的元素 用于疼痛和神经生理学疼痛教育。形式将与MBSR相同：8周，每周2/5- 一小时的小组会议和一天的静修，但小组规模较小：每节课允许10人参加 更个性化的支持。主要目标是减少回避、沉思、痛苦灾难和对 有动静。 我们已经制定了干预的初步大纲。为了完善它，我们将召集一个国际小组 拥有慢性疼痛教育和管理专业知识的行为和瑜伽治疗师获取专家 就干预措施的优化提供建议，并编写一份MBPR手册初稿。我们将招收4x10=40 CLBP患者分为4个连续的MBPR类别，以迭代完善手动MBPR方案 在每一轮为期8周的MBPR后进行混合方法评估。我们将评估可行性和 通过问卷调查MBPR协议的可接受性，移动技术评估家庭使用MBPR 实践和定性访谈。我们将通过招聘来评估随机化的可行性和可接受性 20名参与者，并将他们随机分为标准MBSR(n≈10)或第四MBPR班(总计n≈10)。钥匙 疼痛结果将在基线、8周和6个月时进行评估。为了准备更大规模的临床试验，我们将 还测试和完善了智能手机平台，获得了对疼痛的生态瞬时评估措施 结果并评估对冥想练习的遵守情况。这项临床可行性试验将为大规模的 慢性下腰痛患者的多中心疗效试验比较MBPR和MBSR。这不仅保证了 对慢性腰痛，但对其他形式的慢性疼痛，推进综合健康方法。

PROJECT SUMMARY/ABSTRACT The treatment of chronic low back pain (cLBP) remains a major public health concern. Medication is of limited value. Current guidelines recommend using non-pharmacologic approaches for cLBP, which include yoga, tai chi, Mindfulness-Based Stress Reduction (MBSR), and Cognitive-Behavioral Therapy (CBT). While these approaches have been shown to be beneficial, all current approaches have important limitations in efficacy. We hypothesize that these interventions can be strengthened to be more effective for cLBP. In response to the FOA PAR-18-417 for high-priority topics, this proposal focuses on modifying MBSR to develop an optimized program for cLBP, Mindfulness-Based Pain Reduction (MBPR). Based on recent advances in the understanding of the central processing of pain, we plan modifications in three closely related and potentially synergistic areas: (1) strengthening the skill development of interoceptive awareness to address chronic pain through focused attention in the specific region of pain; (2) emphasizing mindful movement that is optimized by using cLBP-specific yoga movements; (3) shifting some of the emphasis in didactic content toward a better understanding of chronic pain and its neurophysiology, incorporating elements of cognitive-behavioral therapy for pain and neurophysiological pain education. The format will be the same as MBSR: 8 weeks of weekly 2½- hour group sessions and a daylong retreat, but with a smaller group size: 10 participants per class to allow for more individualized support. Key goals are to reduce avoidance, rumination, pain catastrophizing, and fear of movement. We have developed an initial outline of the intervention. To refine it, we will convene an international panel of behavioral and yoga therapists with expertise in chronic pain education and management to obtain expert advice on intervention optimization and produce a first draft of a MBPR manual. We will enroll 4 x 10 = 40 patients with cLBP into 4 consecutive MBPR classes to iteratively refine the manualized MBPR protocol through mixed-methods evaluations after each 8-week round of MBPR. We will assess feasibility and acceptability of the MBPR protocol by questionnaires, mobile technology to assess home use of MBPR practices, and qualitative interviews. We will assess feasibility and acceptability of randomization by recruiting 20 participants and randomizing them to standard MBSR (n ≈10) or to the fourth MBPR class (total n ≈10). Key pain outcomes will be assessed at baseline, 8 weeks and 6 months. To prepare for a larger clinical trial, we will also test and refine a smartphone platform to obtain an ecological momentary assessment measure of pain outcomes and assess adherence to meditation practices. This clinical feasibility trial will prepare for a large multi-center efficacy trial in cLBP patients comparing MBPR with MBSR. This holds promise not only to advance integrative health approaches to cLBP, but to other forms of chronic pain.