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

通过腕弓间隙增大治疗 CTS 的生物力学治疗：初步临床试验

• 批准号: 10725257
• 负责人: C KENT KWOH
• 金额: $ 54.03万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10725257
• 关键词: Affect; Anatomy; Area; Basic Science; Biomechanics; Cadaver; Carpal Tunnel Syndrome; Clinic; Clinical; Clinical Research; Clinical Trials; Data; Devices; Diagnosis; Disease; Double-Blind Method; Dropout; Feasibility Studies; Finite Element Analysis; Future; Goals; Hand; Hand functions; Health Care Costs; Healthcare Systems; Height; High Prevalence; Human; Human Experimentation; In Vitro; Intervention; Intervention Studies; Investigation; Laboratory Study; Ligaments; Methods; Modality; Modeling; Multi-Institutional Clinical Trial; Nerve compression syndrome; Neural Conduction; Neuropathy; Numbness; Operative Surgical Procedures; Outcome; Pain; Patient Dropouts; Patient Outcomes Assessments; Patients; Physiological; Pilot Projects; Population; Preparation; Public Health; Quality of life; Randomized; Randomized Controlled Clinical Trials; Recovery; Recurrence; Reporting; Research; Research Project Grants; Sample Size; Site; Surgical complication; Symptoms; Techniques; Therapeutic; Therapeutic Effect; Translating; Translations; Treatment Efficacy; Treatment outcome; Width; Wrist; arm; clinical translation; compliance behavior; design; evidence base; experimental study; follow-up; hand rehabilitation; improved; in vivo; innovation; median nerve; nerve decompression; novel; pain symptom; pathomechanics; patient expectation; pilot trial; pre-clinical; pressure; recruit; reduce symptoms; retention rate; symptom management; symptomatic improvement; therapy design; treatment effect; trial comparing

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.

抽象的 腕管综合症是一种常见的手部疾病，通常通过手术治疗 横断腕横韧带以减轻正中神经的压力并缓解症状。 尽管已知手术并发症，包括手功能下降和症状复发， 自二十世纪初以来，手术技术基本上没有变化。非手术 已经开发出对手腕进行治疗操作的干预措施，但这些方式已经 由于缺乏有效性的科学和临床证据，尚未获得广泛接受。我们之前的 研究发现了一种新的正中神经减压机制，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。与目前可用的旨在增加 腕弓的宽度，我们的方法是缩小腕弓的宽度，以增加腕弓的高度和交叉 截面积。这种新颖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、人体体内实验，以及 临床前可行性研究。基于这些科学和临床前提，我们计划开展一项单一的研究 现场、双盲、随机对照临床试验先导研究，以证明治疗效果 CASA 治疗腕管综合症并与假装置比较治疗效果。具体 该项目的目标是 (1) 证明非手术 CASA 干预可改善症状和手部症状 腕管综合征患者的功能； (2)比较CASA干预的临床结果 进行假干预； (3) 证明多站点、随机的可行性和可扩展性 比较 CASA 干预和假干预的对照、全面临床试验。我们假设 (i) 为期四个星期的 CASA 干预将缓解腕管综合症症状并改善手部功能 并且有益效果将在干预期结束后持续存在； (ii) CASA 干预将导致 与假干预相比，症状和功能有更大的改善； (iii) 招募是可行的， 保留率和依从性是可以接受的，并且治疗是安全的。本次试点临床结果 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、设定 对患者依从性和退出率的期望，并为更大规模的多站点设计提供信息 CASA干预的随机对照临床试验。此次试点是我们准备的关键一步 有效地开展全面的多中心临床试验，最终转化我们的科学成果 CASA的生物力学原理和腕管新型非手术治疗的研究成果 综合症。