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

身心综合疗法治疗慢性腰痛的可行性临床试验

• 批准号: 10520055
• 负责人: Frederick M Hecht
• 金额: $ 24.23万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-15 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10520055
• 关键词: Address; Adherence; Affect; Area; Attention; Awareness; Behavior; Behavioral; Body Regions; Cellular Phone; Chronic low back pain; Clinical; Clinical Trials; Cognition; Cognitive Therapy; Complex; Ecological momentary assessment; Education; Educational process of instructing; Elements; Emotional; Enrollment; Ensure; Esthesia; Evaluation; Exercise; Feedback; Fright; Goals; Guidelines; Home; Hour; Integrative Medicine; International; Interoception; Intervention; Interview; Learning; Location; Low Back Pain; Manuals; Measures; Mediating; Meditation; Mental Depression; Methods; Mind-Body Intervention; Mindfulness Training; Modification; Movement; Outcome; Pain; Pain Measurement; Pain management; Participant; Patients; Persons; Pharmaceutical Preparations; Prediction of Response to Therapy; Prognosis; Protocols documentation; Public Health; Questionnaires; Randomized; Randomized, Controlled Trials; Recommendation; Regulation; Sensory; Signal Transduction; Standardization; Stress; Tai Ji; Testing; Thinking; Work; Yoga; acceptability and feasibility; chronic pain; chronic pain management; comorbidity; disability; disability-adjusted life years; distraction; efficacy trial; evidence base; experience; feasibility trial; follow-up; improved; mindfulness; mindfulness based cognitive therapy; mindfulness intervention; mindfulness-based stress reduction; mobile application; mobile computing; neurophysiology; pain catastrophizing; pain outcome; pain patient; pain processing; pain reduction; pain sensation; programs; protocol development; recruit; response; rumination; skill acquisition; tool; trial comparing; years of life lost

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.

项目概要/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 价值有限。目前的指南建议使用非药物方法治疗 cLBP，其中包括 瑜伽、太极拳、正念减压 (MBSR) 和认知行为疗法 (CBT)。尽管 这些方法已被证明是有益的，但所有当前方法在以下方面都存在重要局限性： 功效。我们假设这些干预措施可以得到加强，从而对 cLBP 更有效。在 为了响应 FOA PAR-18-417 的高优先级主题，该提案侧重于修改 MBSR 以开发 针对 cLBP（基于正念的疼痛减轻 (MBPR)）的优化程序。基于最近的进展 为了了解疼痛的中央处理，我们计划对三个密切相关且潜在的方面进行修改 协同领域：(1) 加强内感受意识的技能发展，以解决慢性疼痛 通过集中注意力于特定的疼痛区域； (2) 强调正念运动，通过以下方式优化 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，结合认知行为治疗的要素 用于疼痛和神经生理学疼痛教育。格式与 MBSR 相同：8 周，每周 2½- 小时的小组课程和为期一天的静修，但小组规模较小：每班 10 名参与者，以允许 更加个性化的支持。主要目标是减少回避、沉思、痛苦灾难化和恐惧 移动。 我们已经制定了干预措施的初步纲要。为了完善它，我们将召集一个国际小组 具有慢性疼痛教育和管理专业知识的行为和瑜伽治疗师以获得专家 关于干预优化的建议并制定 MBPR 手册的初稿。我们将报名 4 x 10 = 40 将 cLBP 患者分为 4 个连续的 MBPR 类别，以迭代完善手动 MBPR 方案 在每轮 8 周的 MBPR 后通过混合方法评估。我们将评估可行性并 通过问卷调查和移动技术评估 MBPR 协议的可接受性，以评估 MBPR 的家庭使用情况 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，并将他们随机分配到标准 MBSR（n ≈10）或第四个 MBPR 类别（总 n ≈10）。钥匙 将在基线、8 周和 6 个月时评估疼痛结果。为了准备更大规模的临床试验，我们将 还测试和完善智能手机平台以获得疼痛的生态瞬时评估指标 结果并评估对冥想练习的坚持程度。该临床可行性试验将为大规模 在 cLBP 患者中进行的多中心疗效试验，比较 MBPR 与 MBSR。这不仅有希望 推进针对 cLBP 以及其他形式的慢性疼痛的综合健康方法。