Biomechanical Treatment of CTS Via Carpal Arch Space Augmentation: A Pilot Clinical Trial

摘要 腕管综合征是一种常见的手部疾病，通常通过手术治疗。 切断腕横韧带以减轻正中神经的压力并缓解症状。 尽管已知的手术并发症，包括手功能下降和症状复发， 外科技术自世纪早期以来基本上保持不变。非手术 已经开发了治疗性地操纵手腕的干预，但是这些方式 由于缺乏有效性的科学和临床证据，未获得广泛接受。我们以前的 研究已经确定了正中神经减压的新机制，其核心概念是， 桡尺腕部压迫导致腕弓间隙增大（CASA），随后， 正中神经减压术与目前可用的治疗方法相比，其目的是增加患者的免疫功能。 腕弓的宽度，我们的方法缩小了弓的宽度，以增加弓的高度和交叉， 截面积这种新的生物力学干预得到了我们广泛研究的支持，包括体外研究 尸体实验、几何建模、有限元分析、体内人体实验，以及 临床前可行性研究。在这些科学和临床前提的基础上，我们计划进行一项 一项临床试验机构、双盲、随机对照临床试验初步研究，旨在证明 CASA治疗腕管综合征，并与假器械的治疗效果进行比较。具体 该项目的目的是（1）证明非手术CASA干预改善症状和手 腕管综合征患者的功能;（2）比较CASA干预的临床结局 与假干预;和（3）证明的可行性和可扩展性的多站点，随机 对照，全面的临床试验比较CASA干预和假干预。我们假设（i） 为期四周的CASA干预将缓解腕管综合征症状并改善手功能 而且，干预期结束后，有益效果将持续存在;（ii）CASA干预将导致 症状和功能比假干预有更大的改善;和（iii）招募是可行的， 保留率和依从性将是可接受的，并且治疗将是安全的。临床试验结果 试验将使我们能够了解CASA干预的预期治疗效果，细化样本量， 患者依从性和脱落率的预期，并为更大规模的多中心设计提供信息 CASA干预的随机对照临床试验。这项试点试验是我们准备 有效地启动了一个全面的多地点临床试验，最终将我们的科学价值 CASA的生物力学原理及非手术治疗腕管综合征的研究结果 综合征

ABSTRACT Carpal tunnel syndrome is a commonly diagnosed hand disorder that is routinely treated by surgically transecting the transverse carpal ligament to reduce pressure on the median nerve and to alleviate symptoms. Despite known complications of surgery, including reduced hand function and symptom recurrence, the surgical technique has remained fundamentally unchanged since the early twentieth century. Non-surgical interventions where the wrist is therapeutically manipulated have been developed, but these modalities have not gained widespread acceptance due to a lack of scientific and clinical evidence of efficacy. Our previous investigations have identified a novel mechanism for median nerve decompression, the core concept of which is that radioulnar wrist compression leads to carpal arch space augmentation (CASA) and, subsequently, to median nerve decompression. In contrast to currently available therapeutic methods which aim to increase the width of the carpal arch, our approach narrows the arch width in order to increase the arch height and cross- sectional area. This novel biomechanical intervention is supported by our extensive research including in vitro cadaveric experiments, geometric modeling, finite element analysis, in vivo human experimentation, and preclinical feasibility studies. Building upon these scientific and clinical premises, we plan to carry out a single site, double-blinded, randomized controlled clinical trial pilot study to demonstrate the treatment efficacy of CASA for carpal tunnel syndrome and compare the therapeutic effects with a sham device. The Specific Aims of the project are (1) to demonstrate that non-surgical CASA intervention improves symptoms and hand function in patients with carpal tunnel syndrome; (2) to compare the clinical outcomes of CASA intervention with a sham intervention; and (3) to demonstrate the feasibility and scalability of a multisite, randomized controlled, full-scale clinical trial comparing CASA intervention and sham intervention. We hypothesize that (i) four-weeks of CASA intervention will alleviate carpal tunnel syndrome symptoms and improve hand function and that the beneficial effects will persist beyond the intervention period; (ii) CASA intervention will result in greater improvement of symptoms and function than the sham intervention; and (iii) recruitment will be feasible, retention rates and compliance will be acceptable, and the treatment will be safe. Results of this pilot clinical trial will allow us to understand the expected treatment effects of CASA intervention, refine sample size, set expectations for patient compliance and dropout rates, and inform the design of a larger scale multisite randomized controlled clinical trial of CASA intervention. This pilot trial is a crucial step in our preparation to effectively launch a full-scale multisite clinical trial, eventually translating our scientifically meritorious biomechanical principle of CASA and research findings into a novel non-surgical treatment of carpal tunnel syndrome.