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

椎板切除减压术（DL）是老年人最常见的脊柱手术， 腰椎管狭窄症（LSS）并减少行走时的相关疼痛、感觉异常和/或虚弱（即， 间歇性神经源性跛行- INC）。我们最近对193名老年退伍军人进行了前瞻性队列研究， DL后12个月的研究显示，超过50%的参与者没有出现显著的功能障碍， 改进.在非退伍军人人群中也报告了类似的手术失败率。由于绝 大多数DLs是选择性进行的，建议将非手术治疗作为初始步骤。两项临床 临床试验已经证明，手动治疗和运动（MTE）对INC患者的疗效适中， 在一次审判中成立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初步研究数据， 电针（特别是肌内电针[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增加初始响应的鲁棒性和B）通过 助推器该两个研究中心的可行性研究将在波士顿医疗中心和奥兰多VA进行 医疗中心，因为他们的社会人口多样性和多个患者的患病率而选择 合并症，最终将促进研究结果广泛推广的特征。我们将 评估招募、随机分配和保留参与者的可行性;干预措施交付的准确性; 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.五十六例受试者（每个研究中心28例）患有影像学确定的LSS和INC，未接受腰椎 手术，将随机接受1）MTE 3个月（12周内10次），随后接受6- 3个月观察期; 2）MTE 3个月，随后每月MTE加强治疗6个月;或 3)MTE + IMEA持续3个月，随后每月MTE + IMEA持续6个月。主要结局（Brigham 将在基线、3个月（主要终点）、6个月和9个月时进行测量。我们 还将测量社区流动性（生活空间），情绪功能（PHQ 8和GAD 7），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、医学合并症）。 富达将通过提供标准化的供应商培训，定期审查参与者， 提供商干预会议和文档，以及每月所有站点的秘密会议。我们还将监测 参与者出勤率和家庭锻炼依从性。如果我们证明我们提出的方法的可行性， 我们将定位于测试一种新的护理模式，用于LSS和INC患者，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.