Feasibility Trial of a Novel Integrated Mindfulness and Acupuncture Program to Improve Outcomes after Spine Surgery (I-MASS)

旨在改善脊柱手术后效果的新型综合正念和针灸计划的可行性试验（I-MASS）

• 批准号: 10649741
• 负责人: TREVOR LENTZ
• 金额: $ 24.15万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-21 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10649741
• 关键词: Accounting; Acupuncture Therapy; Address; Administrator; Adult; Age; Analgesics; Anxiety; Area; Back; Behavioral; Caring; Clinical; Clinical Practice Guideline; Clinical Trials; Clinical Trials Design; Combined Modality Therapy; Data; Data Collection; Development; Ear Acupuncture; Effectiveness; Electronic Health Record; Goals; Guidelines; Health Personnel; Health Technology; Health system; Healthcare; Image; Incidence; Individual; Integrative Therapy; Intervention; Interview; Knowledge; Laminectomy; Lifting; Medical; Mental Depression; Methods; Mindfulness Training; National Center for Complementary and Integrative Health; Operative Surgical Procedures; Opioid; Outcome; Overdose; Pain; Pain management; Pathway interactions; Patient Education; Patients; Persistent pain; Persons; Physical therapy; Postoperative Pain; Preparation; Procedures; Protocols documentation; Psychological Factors; Questionnaires; Randomized; Randomized Controlled Clinical Trials; Recommendation; Reporting; Research; Research Priority; Research Proposals; Resources; Risk; Risk Factors; Risk Reduction; Site; Spine pain; Spine surgery; Structure; Surgeon; Testing; Therapeutic; United States; United States National Institutes of Health; Vertebral column; Visit; Work; academic standard; acceptability and feasibility; addiction; arm; burden of illness; care delivery; clinical efficacy; comparative effectiveness; comparative effectiveness trial; compare effectiveness; cost; cost effective; design; effectiveness study; efficacy study; epidemiologic data; experience; feasibility testing; feasibility trial; global health; improved; improved outcome; innovation; mHealth; mind/body; mindfulness; mobile application; multi-component intervention; multimodality; novel; opioid misuse; opioid overdose; opioid use; pain reduction; pain relief; pain sensitivity; participant retention; pragmatic trial; preference; programs; protocol development; psychologic; randomized trial; recruit; retention rate; satisfaction; therapeutic target; treatment as usual; trial comparing; usability

ABSTRACT Spine pain consistently ranks first or near the top in global rankings of disease burden, and epidemiological data suggest the burden is worsening. The number of low back surgeries has increased by 300% over the past 2 decades, accounting for approximately 30% of spine-related costs in the US. While it can provide cost- effective pain relief to some patients, up to 25% of those who undergo spine surgery will develop persistent pain requiring additional surgery, imaging, or other invasive interventions. Moreover, many patients will experience persistent opioid use, which carries significant risks of misuse, addiction, and overdose. Clinical practice guidelines strongly recommend the use of multimodal – or ‘mind and body’ – treatments for effective pain management after surgery. This approach combines interventions with analgesic or physical therapeutic inputs alongside interventions with psychological or behavioral inputs to better address the multifaceted risk factors for persistent pain and opioid use following surgery. Integration of Mindfulness delivered via mobile app (mHealth) with auricular Acupuncture (AA) in individuals undergoing Spine Surgery (I-MASS) is a highly promising multimodal treatment approach given the distinct yet complementary mechanisms by which mindfulness and AA influence pain after surgery. Establishing the effectiveness of I-MASS requires a rigorously designed pragmatic trial comparing it to usual medical care in adults who undergo spine surgery. However, trials of this size and scope require careful preparation. This proposed mixed methods R34 project is designed to answer important preparatory questions regarding the feasibility and acceptability of I-MASS through the following Specific Aims: 1) Conduct interviews with patient and care delivery stakeholders to refine and finalize the I-MASS intervention protocol by integrating mHealth mindfulness training and AA for use in patients age 18-80 undergoing spine surgery; 2) Conduct a single-site, exploratory randomized controlled clinical trial to assess the feasibility and acceptability of I-MASS in patients undergoing single-level laminectomy, discectomy or fusion; and 3) Use feasibility trial results to develop and submit a competitive research proposal to NIH for a multi-site, pragmatic, randomized comparative effectiveness clinical trial designed to rigorously evaluate I-MASS compared to mHealth mindfulness, AA, and usual care augmented with standard education. The results of this R34 project will provide the information needed to successfully execute on such a study and create new knowledge regarding the feasibility and acceptability of a highly innovative non-pharmacological multimodal approach designed to improve the lives of patients undergoing spine surgery.

抽象的 脊柱疼痛始终排名第一或接近疾病伯恩的全球排名和流行病学 数据表明伯恩感到遗憾。过去，腰部手术的数量增加了300％ 在美国，约有20年的时间，约占脊柱相关成本的30％。虽然可以提供成本 - 一些患者有效缓解疼痛，接受脊柱手术的患者中有25％会持续发展 需要额外的手术，成像或其他侵入性干预措施。而且，许多患者将 经验持续的阿片类药物使用，它具有很大的小姐，成瘾和过量的风险。临床 实践指南强烈建议使用多模式（或“思想和身体”）治疗以有效 手术后的疼痛管理。这种方法将干预措施与镇痛或物理疗法结合在一起 输入以及具有心理或行为投入的干预措施，以更好地解决多方面的风险 手术后持续性疼痛和阿片类药物使用的因素。通过移动应用程序交付的正念集成 （MHealth）在接受脊柱手术（I-MAS）的个体中具有耳塞针灸（AA）是一个高度 有希望的多模式治疗方法，鉴于具有独特但完整的机制 正念和AA会影响手术后的疼痛。建立i-mas的有效性需要一个 严格设计的务实试验将其与接受脊柱手术的成年人的常规医疗服务进行了比较。 但是，这种大小和范围的试验需要仔细准备。该提出的混合方法R34项目是 旨在回答有关I-Mass的可行性和可接受性的重要准备问题 通过以下特定目的：1）与患者和护理交付利益相关者进行访谈以完善 并通过整合MHealth的正念培训和用于使用 18-80岁的患者接受脊柱手术； 2）进行单点探索性随机控制 临床试验以评估I-MAS在接受单层的患者中的可行性和可接受性 椎板切除术，椎间盘切除术或融合； 3）使用可行性试验结果来开发和提交竞争性 对NIH的研究建议，进行多站点，务实的，随机的比较有效性临床试验 与MHealth的正念，AA和通常的护理相比，旨在严格评估I-Mass 进行标准教育。该R34项目的结果将提供成功的信息 执行此类研究并创建有关高度可行性和可接受性的新知识 创新的非药理学多模式方法，旨在改善正在接受的患者的生活 脊柱手术。