Yoga to Treat Chronic Pain in Persons Receiving Opioid Agonist Therapy

瑜伽可治疗接受阿片类激动剂治疗的患者的慢性疼痛

• 批准号: 9091107
• 负责人: Michael D Stein
• 金额: $ 22.69万
• 依托单位: BUTLER HOSPITAL (PROVIDENCE, RI)
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-01 至 2019-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9091107
• 关键词: Adherence; Affective; Agonist; Alcohol or Other Drugs use; Alcohols; Anxiety; Attention; Behavioral Mechanisms; Benzodiazepines; Buprenorphine; Cognitive; Cognitive Therapy; Complement; Confidence Intervals; Control Groups; Data; Education; Educational Intervention; Enrollment; Feedback; Focus Groups; Fright; Health; Health education; Hyperalgesia; Illicit Drugs; Intervention; Maintenance; Manuals; Meditation; Mental Depression; Naloxone; Opiate Addiction; Opioid; Outcome; Pain; Pain management; Participant; Patients; Personal Satisfaction; Persons; Pharmaceutical Preparations; Phase; Physical activity; Population; Posture; Provider; Randomized Clinical Trials; Relaxation Therapy; Reporting; Research; Safety; Severities; Staging; Students; Training; Yoga; addiction; base; chronic pain; disability; dosage; experience; follow-up; illicit drug use; improved; instructor; methadone maintenance; mindfulness; opiate tolerance; opioid misuse; opioid use disorder; patient population; pranayama; prevent; primary outcome; psychiatric disability; public health relevance; research and development; secondary outcome; substance abuser; therapy development

 DESCRIPTION (provided by applicant): Chronic pain is a significant problem for people receiving opioid agonist therapy (OAT) for opioid dependence - i.e., buprenorphine/ naloxone (BUP) and methadone maintenance treatment (MMT). At least half of patients receiving BUP and MMT have chronic pain. Chronic pain is associated with pain-related disability, psychiatric problems, physical problems, and increased likelihood of misuse of opioids or other illicit drugs in this population, often leading providers to terminate treatment. Pharmacologic pain treatment in OAT patients is complicated by issues such as opioid-induced hyperalgesia, increased tolerance of opioids, other substance use, and patients' own fears about medications and addiction. Hatha yoga may be a beneficial adjunctive approach to treating chronic pain, decreasing pain-related disability, and preventing opioid misuse during OAT. Yoga includes benefits of relaxation training, physical activity, and mindfulness training in a unified practice. Yoga is a promising approach for treating chronic pain in people enrolled in OAT because: 1) yoga has evidence supporting its ability to reduce pain-related disability and pain severity in other populations; 2) there are plausible cognitive/affective and behavioral mechanisms by which yoga may reduce chronic pain, decrease pain-related disability, and reduce opioid misuse; 3) yoga is increasingly available; and 4) yoga can complement other types of pain and substance use treatment. We propose to conduct treatment development research that would prepare us to study whether yoga (vs. a health education control group) might be an effective adjunctive treatment for pain in people enrolled in OAT for opioid use disorders. We hypothesize that, relative to a control group, yoga will: decrease pain-related disability (primary outcome), decrease pain, and decrease opioid misuse. This project will include two phases. In phase 1 (Treatment Development Stage 1A), we will use feedback from patient focus groups (n= 24 patients) and experts to refine our current hatha yoga intervention and health education intervention for specific use in people enrolled in OAT with chronic pain. In phase 2 (Treatment Development Stage 1B), we will conduct a pilot randomized clinical trial (n = 60) of yoga vs. health education groups (attention control) for persons with chronic pain who enrolled in OAT. Participants will be enrolled in the active intervention for 3 months, and then be followed for 6 months. Specifically, we will assess feasibility, acceptability, and safety of both the active intervention and control groups; assess differences between groups on outcomes (within relevant confidence intervals); examine changes on potential mechanisms of action, including mindfulness, pain catastrophizing, depression, and anxiety; and examine whether amount ("dosage") of yoga practice is related to key outcomes. This project will provide us with materials, experience, and pilot data necessary for the next stage of this line of research, namely, a fully powered randomized clinical trial. Hatha yoga has a potential to decrease pain-related disability, pain severity, and opioid misuse in this population of people with difficult-to treat chronic pain.

 描述（由适用提供）：对于接受阿片类药物治疗（OAT）的人来说，慢性疼痛是一个重大问题，即阿片类药物依赖性 - 即丁丙诺啡/纳洛宁（BUP）和Methodone维持治疗（MMT）。至少有一半接受BUP和MMT的患者患有慢性疼痛。慢性疼痛与与疼痛有关的残疾，精神病问题，身体问题以及在该人群中失去杀虫剂或其他非法药物的可能性增加，通常会导致提供者终止治疗。燕麦症患者的药理疼痛治疗使诸如骨细胞诱导的痛觉过敏，卵毒素的耐受性增加，其他药物使用以及患者对药物和成瘾的担忧。 Hatha瑜伽可能是治疗慢性疼痛，减轻疼痛相关的残疾以及防止燕麦症中的休脂蛋白滥用的一种有益的辅助方法。瑜伽包括放松训练，体育锻炼和正念训练的好处。 瑜伽是治疗燕麦症患者慢性疼痛的有希望的方法，因为：1）瑜伽有证据支持其减少其他人群中与疼痛相关的残疾和疼痛严重程度的能力； 2）存在瑜伽可以减轻慢性疼痛，减少与疼痛相关的残疾并减少阿片类药物的疾病的合理认知/情感和行为机制； 3）瑜伽越来越多； 4）瑜伽可以补充其他类型的疼痛和药物治疗。我们建议进行治疗开发研究，使我们能够研究瑜伽（与健康教育控制组）是否可能是对燕麦症患者的疼痛的有效辅助治疗。我们假设相对于对照组，瑜伽将：减少与疼痛相关的残疾（主要结果），减轻疼痛并减少OID滥用。该项目将包括两个阶段。在第1阶段（治疗开发阶段1A）中，我们将使用患者焦点小组（n = 24名患者）和专家的反馈来完善我们当前的Hatha瑜伽干预和健康教育干预措施，以在患有慢性疼痛的燕麦症中进行特定用途。在第2阶段（治疗开发阶段1B）中，我们将对参加燕麦的慢性疼痛患者进行瑜伽与健康教育组（注意力控制）的试验随机临床试验（n = 60）。参与者将参加活跃干预3个月，然后进行6个月。具体而言，我们将评估主动干预组和对照组的可行性，可接受性和安全性；在结果（相关置信区间内）的评估差异；检查潜在作用机制的变化，包括正念，疼痛灾难性，抑郁和焦虑；并检查瑜伽实践的数量（“剂量”）是否与关键结果有关。该项目将为我们提供该研究系列的下一阶段所需的材料，经验和试点数据，即一项全功率的随机临床试验。 Hatha瑜伽有可能减少与疼痛相关的残疾，疼痛严重程度以及在这些困难的人群中 治疗慢性疼痛。