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: 10318650
• 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 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10318650
• 关键词: Address; Adherence; Affect; Area; Attention; Awareness; Back; Behavior; Behavioral; Body Regions; Cellular Phone; Chronic low back pain; Clinical; Clinical Trials; Cognition; Cognitive Therapy; Complex; Ecological momentary assessment; Education; 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 management; Participant; Patients; Persons; Pharmaceutical Preparations; Prediction of Response to Therapy; Prognosis; Protocols documentation; Public Health; Questionnaires; Randomized; Randomized Controlled Trials; Regulation; Sensory; Signal Transduction; Standardization; Stress; Tai Ji; Testing; Thinking; Work; Yoga; acceptability and feasibility; base; 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.

项目摘要/摘要 慢性下腰痛（CLBP）的治疗仍然是一个主要的公共健康问题。药物是 有限的价值。当前的指南建议使用非药物方法用于CLBP，其中包括 瑜伽，太极拳，基于正念的压力减轻（MBSR）和认知行为疗法（CBT）。尽管 这些方法已被证明是有益的，所有当前的方法都有重要的局限性 有效的。我们假设可以加强这些干预措施对CLBP更有效。 对高优先级主题的FOA PAR-18-417的响应，该提案着重于修改MBSR以开发 基于正念的CLBP的优化程序（MBPR）。根据最近的进步 了解疼痛的中心处理，我们计划在三个密切相关且潜在的三个密切相关的修改 协同领域：（1）加强互感意识的技能发展以解决慢性疼痛 通过在特定的疼痛区域中集中注意力； （2）强调由正念运动优化 使用CLBP特异性瑜伽运动； （3）将教学内容的某些重点转移到更好的 了解慢性疼痛及其神经生理学，结合了认知行为疗法的元素 用于疼痛和神经生理疼痛教育。该格式将与MBSR相同：每周2½-的8周 小时小组会议和一整天的静修，但小组的规模较小：每节课10个参与者 更多个性化的支持。关键目标是减少回避，反思，痛苦灾难性和恐惧 移动。 我们已经开发了干预措施的初始概述。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方面具有专业知识的行为和瑜伽治疗师，以获得专家 有关干预优化的建议，并制作MBPR手册的初稿。我们将注册4 x 10 = 40 CLBP的患者连续4个MBPR类迭代地完善手动MBPR方案 每8周的MBPR之后，通过混合方法评估。我们将评估可行性 通过问卷调查，移动技术评估MBPR的房屋使用的MBPR协议的可接受性 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名参与者并将其随机化为标准MBSR（N≈10）或第四个MBPR类（总n≈10）。钥匙 疼痛结果将在基线，8周零6个月时评估。为了准备更大的临床试验，我们将 还可以测试并完善智能手机平台，以获得生态时刻的疼痛评估措施 结果并评估遵守冥想实践。该临床可行性试验将为大型试验做准备 CLBP患者的多中心效率试验与MBPR与MBSR进行了比较。这不仅要承诺 提高了CLBP的综合健康方法，但可以解决其他形式的慢性疼痛。