Optimizing Impact of Manual Therapy and Exercise on Lumbar Spinal Stenosis with Neurogenic Claudication: A Multi-Site Feasibility Study

减压椎板切除术(DL)是老年人最常见的脊柱手术，其目的是减轻 腰椎管狭窄(LSS)并减少行走时的相关疼痛、感觉异常和/或虚弱(即， 间歇性神经性跛行(Inc.)。我们最近对193名老年退伍军人进行了前瞻性队列研究，以下是 在接下来的12个月中，超过50%的参与者没有明显的功能障碍 进步。据报道，非退伍军人中也有类似的手术失败率。既然广袤无边 大多数DLS是择期进行的，建议作为初始步骤进行非手术治疗。两个临床病例 试验表明，手动治疗和锻炼(MTE)对患有Inc.的患者疗效不大 在一次审判中持续，但在另一次审判中没有。最近的临床实践指南建议增加针灸 作为非手术疼痛管理策略，并强调需要高质量的证据来支持这一点 推荐。我们的临床经验和有关疗效的初步研究数据 电针(具体地说，肌肉电针[IMEA])在这些患者中是有希望的。 最终，我们希望进行一项随机对照临床试验，以优化和维持MTE的疗效 通过潜在地a)通过添加IMEA来增加初始响应的稳健性，以及b)通过 助推器。这项两个地点的可行性研究将在波士顿医疗中心和奥兰多弗吉尼亚州进行 选择医疗中心，是因为他们的社会人口多样性和多发性硬化症患者的患病率 合并症，这一特征最终将促进研究结果的广泛推广。我们会 评估招募、随机和留住参与者的可行性；干预提供的保真度； 参与者遵守规定的干预措施；以及数据收集的准确性和完整性 程序。56名参与者(每个站点28名)接受了影像识别的LSS和Inc.，他们没有接受过腰椎检查 手术后，将随机接受1)为期3个月的MTE(12周内10次治疗)，然后接受6- 3个月观察期；2)为期3个月的MTE，之后每月为期6个月的MTE助推会；或 3)MTE+IMEA 3个月，然后每月MTE+IMEA 6个月。主要结果(布里格姆) 将在基线、3个月(主要终点)、6个月和9个月进行测量。我们 还将衡量社区流动性(生活空间)、情绪功能(PHQ8和GAD7)、止痛药、 以及与患有LSS和Inc.的老年人相关的其他关键参数(例如，吸烟、BMI、医疗合并症)。 Fidelity将通过提供标准化的提供商培训、定期审查参与者- 提供商干预会议和文档，以及每月全站点会议。我们还将监控 参与者出席率和家庭锻炼依从性。如果我们证明我们提出的方法是可行的， 我们将测试为LSS和Inc.患者提供的新护理模式，旨在优化他们的 功能和生活质量，并节省大量的发病率和医疗保健资源。

Decompressive laminectomy (DL), the most common spinal surgery in older adults, is performed to alleviate lumbar spinal stenosis (LSS) and reduce associated pain, paresthesias, and/or weakness when walking (i.e., intermittent neurogenic claudication - INC). Our recent prospective cohort study of 193 older veterans followed for 12 months following DL revealed that over 50% of participants did not experience significant functional improvement. Similar rates of failed surgery have been reported in non-veteran populations. Since the vast majority of DLs are performed electively, non-surgical treatment is recommended as an initial step. Two clinical trials have demonstrated modest efficacy of manual therapy and exercise (MTE) for people with INC that was sustained in one trial, but not in the other. Recent clinical practice guidelines recommend adding acupuncture as a non-surgical pain management strategy and highlight the need for high quality evidence to support this recommendation. Our clinical experience and preliminary research data regarding the efficacy of electroacupuncture (specifically, intramuscular electroacupuncture [IMEA]) in these patients are promising. Ultimately, we wish to conduct a randomized controlled clinical trial to optimize and sustain the efficacy of MTE by potentially a) increasing the robustness of the initial response via addition of IMEA and b) its durability via boosters. This two-site feasibility study will be conducted at Boston Medical Center and the Orlando VA Medical Center, chosen because of their sociodemographic diversity and prevalence of patients with multiple comorbidities, characteristics that will ultimately facilitate broad generalizability of study findings. We will evaluate the feasibility of recruiting, randomizing and retaining participants; fidelity of intervention delivery; participant adherence to prescribed interventions; and the accuracy and completeness of data collection procedures. Fifty-six participants (28 per site) with imaging-identified LSS and INC who have not had lumbar surgery, will be randomized to receive 1) MTE for 3 months (10 sessions over 12 weeks) followed by a 6- months observation period; 2) MTE for 3 months followed by monthly MTE booster sessions for 6-months; OR 3) MTE + IMEA for 3 months followed by monthly MTE + IMEA for 6-months. The primary outcome (Brigham Spinal Stenosis questionnaire) will be measured at baseline, 3 months (primary endpoint), 6 and 9 months. We also will measure community mobility (life space), emotional functioning (PHQ8 and GAD7), pain medications, and other key parameters relevant to older adults with LSS and INC (e.g., smoking, BMI, medical comorbidity). Fidelity will be optimized by delivering standardized provider training, conducting regular review of participant- provider intervention sessions and documentation, and monthly all-site huddles. We also will monitor participant attendance and home exercise compliance. If we demonstrate feasibility of our proposed methods, we will be positioned to test a new model of care for patients with LSS and INC designed to optimize their function and quality of life and save substantial morbidity and healthcare resources.