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

项目总结/摘要 慢性腰痛（cLBP）的治疗仍然是一个主要的公共卫生问题。药物是 有限的价值。目前的指南建议使用非药物方法治疗cLBP，包括 瑜伽、太极、正念减压（MBSR）和认知行为疗法（CBT）。而 尽管这些方法已经被证明是有益的，但是所有当前的方法都具有重要的局限性， 功效我们假设这些干预措施可以加强，以更有效地治疗cLBP。在 作为对FOA PAR-18-417高优先级主题的回应，本提案的重点是修改MBSR， 针对cLBP的优化程序，基于正念的疼痛减轻（MBPR）。根据最近的进展 了解疼痛的中枢处理，我们计划在三个密切相关的，潜在的修改， 协同领域：（1）加强内感受意识的技能发展，以解决慢性疼痛 通过集中注意力在疼痛的特定区域;（2）强调通过以下方式优化的正念运动 使用cLBP特定的瑜伽动作;（3）将教学内容中的一些重点转向更好的 了解慢性疼痛及其神经生理学，结合认知行为治疗的元素 疼痛和神经生理学疼痛教育。格式将与MBSR相同：8周，每周2½- 小时的小组会议和为期一天的务虚会，但小组规模较小：每班10名参与者， 更多个性化支持关键目标是减少回避，反刍，痛苦灾难化，和恐惧， 运动 我们已经制定了干预的初步纲要。为了完善它，我们将召集一个国际小组 在慢性疼痛教育和管理方面具有专业知识的行为和瑜伽治疗师， 就干预措施的优化提供咨询意见，并编写MBPR手册初稿。我们将招募4 x 10 = 40人 将cLBP患者分为4个连续MBPR类别，以迭代优化手动MBPR方案 在每8周的MBPR后通过混合方法进行评估。我们将评估可行性， 通过问卷调查、移动的技术评估家庭使用MBPR的MBPR方案可接受性 实践和定性访谈。我们将通过招募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类（共n = 10）。关键 将在基线、8周和6个月时评估疼痛结局。为了准备更大规模的临床试验，我们将 我还测试和完善了智能手机平台，以获得对疼痛的生态瞬时评估措施 结果和评估坚持冥想练习。这项临床可行性试验将为大规模的 在cLBP患者中比较MBPR与MBSR的多中心疗效试验。这不仅保证了 推进cLBP的综合健康方法，但其他形式的慢性疼痛。

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.