Hospital Virgen Macarena, Sevilla, Spain.
Hospital Virgen de Valme, Sevilla, Spain.
PLoS One. 2023 Nov 10;18(11):e0281221. doi: 10.1371/journal.pone.0281221. eCollection 2023.
Carpal Tunnel Syndrome (CTS) is the most common compressive neuropathy, accounting for 90% of all neuropathies. Its prevalence ranges from 3.8%-7.8% in the population. The gold standard for its diagnosis is the neurophysiological study (85% sensitivity and 95% specificity), with the disadvantage of being invasive, complex and expensive, which means an increase in cost and time for the diagnosis of the disease. The main objective of this diagnostic test evaluation study is to investigate the value of ultrasound in the diagnosis of CTS, and among the secondary objectives, to establish the ultrasound parameters that are predictors of CTS in comparison with neurophysiological studies, attempting to standardize a protocol and reference values that determine the presence or absence of CTS.
Prospective, cross-sectional study. The reference test with which we compared the ultrasound is the neurophysiological test (NPT). Patients will come consecutively from the Neurophysiology Department of the Virgen Macarena Hospital, with clinical suspicion of CTS and fulfilling the inclusion/exclusion criteria. To calculate the sample size (EPIDAT program) we proposed a sensitivity of 78% and specificity of 87% with a confidence level of 95%, requiring 438 patients (264 NPT positive, 174 NPT negative). We followed an ultrasound study protocol that included the ultrasound variables: cross-sectional area at the entrance and exit of the tunnel, range of nerve thinning, wrist-forearm index, flexor retinaculum bulging, power Doppler uptake and the existence of adjacent wrists or masses. We propose a timeline for the study to be performed between 2020 and 2023. Finally, we propose a cost-effectiveness analysis.
Ultrasound not only allows to objectify the alterations of the median nerve but also the underlying pathological mechanisms in CTS. A multitude of ultrasound parameters have been described that should be regarded in syndrome's study, among which we included the cross-sectional area, the range of nerve thinning, the wrist-forearm index, flexor retinaculum bulging, power Doppler uptake and assessment of anatomical alterations. The use of ultrasound as a diagnostic tool in CTS has many advantages for both doctors and the patients, as it is a non-invasive, convenient, and fast tool increasingly accessible to professionals.
Trials registry number: NCT05556278.
腕管综合征（CTS）是最常见的压迫性神经病变，占所有神经病变的 90%。其在人群中的患病率为 3.8%-7.8%。其诊断的金标准是神经生理学研究（85%的敏感性和 95%的特异性），但具有侵入性、复杂性和昂贵性，这意味着疾病诊断的成本和时间都会增加。本诊断测试评估研究的主要目的是研究超声在 CTS 诊断中的价值，次要目标是确定与神经生理学研究相比，哪些超声参数可预测 CTS，并尝试标准化可确定 CTS 是否存在的协议和参考值。
前瞻性、横断面研究。我们将神经生理学测试（NPT）作为参考测试进行比较。患者将连续从 Virgen Macarena 医院神经生理学科就诊，这些患者均有 CTS 的临床疑似症状且符合纳入/排除标准。为了计算样本量（EPIDAT 程序），我们提出了 78%的敏感性和 87%的特异性，置信水平为 95%，需要 438 名患者（264 名 NPT 阳性，174 名 NPT 阴性）。我们遵循超声研究方案，其中包括超声变量：隧道入口和出口处的横截面积、神经变薄范围、腕-前臂指数、屈肌支持带隆起、功率多普勒摄取以及相邻手腕或肿块的存在。我们提出了在 2020 年至 2023 年之间进行研究的时间表。最后，我们提出了一项成本效益分析。
超声不仅可以客观化正中神经的改变，还可以客观化 CTS 中的潜在病理机制。已经描述了许多超声参数，这些参数应在综合征研究中考虑，其中包括横截面积、神经变薄范围、腕-前臂指数、屈肌支持带隆起、功率多普勒摄取以及解剖结构改变的评估。将超声作为 CTS 的诊断工具对医生和患者都有很多优势，因为它是一种非侵入性、方便、快捷的工具，越来越容易被专业人员获得。
试验注册号：NCT05556278。
