METHODS: This mechanistic, randomised, single-blind, controlled trial will include 78 people with electrodiagnostically confirmed mild or moderate CTS and 30 healthy participants (N = 108). Patients will be randomly assigned into (1) a 6-week progressive home-based neurodynamic exercise intervention (n = 26), (2) a steroid injection (= 26), or (3) advice (n = 26) group. The primary outcome measure is fractional anisotropy of the median nerve at the wrist using advanced magnetic resonance neuroimaging. Secondary outcome measures include neuroimaging markers at the wrist, quantitative sensory testing, electrodiagnostics, and patient reported outcome measures. Exploratory outcomes include neuroimaging markers at the cervical spine, inflammatory and axonal integrity markers in serial blood samples and biopsies of median nerve innervated skin. We will evaluate outcome measures at baseline and at the end of the 6-week intervention period. We will repeat questionnaires at 6-months. Two-way repeated measures ANCOVAs, followed by posthoc testing will be performed to identify differences in outcome measures among groups and over time.
CONCLUSIONS: This study will advance our understanding of the mechanisms of action underpinning neurodynamic exercises, which will ultimately help clinicians to better target these treatments to those patients who may benefit from them. The inclusion of a positive control group (steroid injection) and a negative control group (advice) will strengthen the interpretation of our results.
BACKGROUND: NCT05859412, 20/4/2023.
方法:这种机制,随机化,单盲,对照试验将包括78例电诊断证实为轻度或中度CTS的患者和30例健康参与者(N=108)。患者将被随机分配到(1)为期6周的基于家庭的神经动力运动干预(n=26),(2)类固醇注射液(=26),或(3)建议组(n=26)。主要结果测量是使用先进的磁共振神经成像在腕部的正中神经的部分各向异性。次要结果指标包括腕部的神经影像学标记,定量感官测试,电诊断,和患者报告的结果指标。探索性结果包括颈椎的神经影像学标记,连续血液样本和正中神经支配皮肤活检中的炎症和轴突完整性标志物。我们将在基线和6周干预期结束时评估结果指标。我们将在6个月内重复调查问卷。双向重复措施ANCOVA,随后将进行posthoc测试,以确定组间和随时间的结果测量的差异。
结论:这项研究将促进我们对神经动力运动的作用机制的理解,这将最终帮助临床医生更好地将这些治疗方法针对那些可能从中受益的患者。纳入阳性对照组(类固醇注射)和阴性对照组(建议)将加强对我们结果的解释。
背景:NCT05859412,20/4/2023。