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

摘要 在全球疾病负担排行榜和流行病学排行榜上，脊柱疼痛始终位居第一或接近第一 数据显示，这一负担正在恶化。腰部手术的数量比过去增加了300% 20年，约占美国脊柱相关成本的30%。虽然它可以提供成本- 有效缓解一些患者的疼痛，高达25%的脊柱手术患者会出现持续性疼痛 需要额外的手术、成像或其他侵入性干预的疼痛。此外，许多患者会 经历持续的阿片类药物使用，这会带来滥用、成瘾和过量的巨大风险。临床 实践指南强烈建议使用多模式--或“身心”--治疗有效 术后疼痛管理。这种方法将干预措施与止痛药或理疗相结合。 投入加上心理或行为投入的干预措施，以更好地应对多方面的风险 手术后持续性疼痛和阿片类药物使用的因素。通过移动应用提供的专注集成 (MHealth)配合耳针(AA)在脊柱手术(I-MASS)患者中的应用是一种高度 有希望的多模式治疗方法给出了不同但互补的机制，通过 正念和AA会影响手术后的疼痛。建立I-MASS的有效性需要 设计严谨、务实的试验，将其与接受脊柱手术的成年人的常规医疗护理进行比较。 然而，这种规模和范围的试验需要仔细的准备。这个建议的混合方法R34项目是 旨在回答有关I-MASS可行性和可接受性的重要预备问题 通过以下具体目标：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正念训练和AA最终敲定I-MASS干预方案，用于 18-80岁接受脊柱手术的患者；2)进行单部位、探索性随机对照研究 评估I-MASS在单节段手术患者中的可行性和可接受性的临床试验 椎板切除、椎间盘切除或融合术；以及3)利用可行性试验结果开发并提交具有竞争力的 向美国国立卫生研究院提出的多点、务实、随机比较有效性临床试验的研究建议 旨在与mHealth正念、AA和常规护理相比较，严格评估I-MASS 受过标准的教育。R34项目的结果将提供成功所需的信息 执行这样的研究并创造关于高度可接受的 创新的非药理学多模式方法，旨在改善接受手术的患者的生活 脊椎手术。

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.