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临床试验/NCT03391336
NCT03391336已完成不适用

Median Nerve Injury in US-guided Carpal Tunnel Injections

yi-chih HSU1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2017年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
126
试验地点
1
主要终点
The observation of median nerve injury

研究概览

简要总结

Carpal tunnel syndrome (CTS) is the most common nerve compression disorder in the upper extremity. It can be treated with surgical or nonsurgical methods. When nonsurgical treatment is indicated, local corticosteroid injection into the carpal tunnel can be used to reduce pain and tingling sensation.

Currently, the most widely used ultrasound (US)-guided CTS-injection method are transverse and longitudinal approach. Although we can accurately place needle within the carpal tunnel using this approach and this approach is easy to learn, median nerve injury (MNI) is still an inevitable complication and difficult to be treat.

MNI is the most serious complication associated with a local corticosteroid injection for CTS among them. A MNI will be presented with shooting pain at the injection time or transient exacerbation of CTS symptoms following the corticosteroid injection because of the pain which often masked by anesthetic during injection. Permanent damage of MN should be considered if the symptoms persist and exacerbate for more than 48 hours. A surgical intervention such as neurolysis, resection or graft repair or a gentle debridement of the crystal from the nerve may be performed in the patients with median nerve damage. Hence, early recognition of MNI before corticosteroid injection may avoid the permanent damage of MN.

Accordingly, the aim of this study is to determine the relationship between the MNI with the possible influencing factors and findings in the US-guided corticosteroid injection for patients with CTS with and to compare the therapeutic efficacy in the patients with and without MNI.

详细描述

Patients:

This study was approved by our institutional review board (Tri-Service General Hospital); however, patient consent was not required for the retrospective review of records and images because patient anonymity was preserved. The patients with clinically suspected CTS evaluated by the referring neurologist (F. C. Y.), and the clinical tests included (1) typical symptoms, eg, hand numbness and pain in the distribution of the median nerve, nocturnal worsening of symptoms, worsening symptoms while driving or gripping, (2) positive Tinel's and/or Phalen's sign, (3) failure of splinting and/or hand rest. Patients with clinically suspected CTS underwent US examination. The diagnoses of CTS in these patients were confirmed by US and/or electrodiagnostic investigations.

Ultrasonography:

The US was provided using a scanner (Xario 100; Toshiba, Tokyo, Japan) with a 7~18 MHz linear transducer (PLU-1204BT). The US examinations were performed by an experienced technician (C.Y. H.) with 6 years of musculoskeletal experience in US. The technician received specialized training on the procedure used to scan the MN regarding the CTS and to record the images and was directly supervised by the attending radiologist (Y.C.H.). The US images after the US-guided hydrodissection were recorded by the attending radiologist (Y.C.H.). The diagnosis of CTS was based on qualitative US criteria, with a cutoff value of ≥12 mm2 regarding the cross-sectional area (CSA) of the MN (CSA-MN) at the inlet of the carpal tunnel. The diagnoses of CTS were confirmed by electrodiagnostic investigations in the patients with US findings of the CSA-MN < 12 mm2 at the inlet of the carpal tunnel. The flowchart illustrating patient selection is shown in Fig. 1. All US images and the measurements of cross sectional area (CSA) of the median nerve at the inlet of carpal tunnel were saved in the picture archiving and communication system (PACS). All the patients with clinically suspected CTS during the study period were examined using a standardized US protocol previously described to assess the MN at the wrist level (Figure. 1). Within 1 month after US-guided corticosteroid injection, we assessed the MN again with this manner.

Ultrasound needle guidance:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The clinical tests included (1) typical symptoms, eg, hand numbness and pain in the distribution of the median nerve, nocturnal worsening of symptoms, worsening symptoms while driving or gripping, (2) positive Tinel's and/or Phalen's sign, (3) failure of splinting and/or hand rest.
  • Patients with clinically suspected CTS underwent US examination.
  • The diagnoses of CTS in these patients were confirmed by US and/or electrodiagnostic investigations.

排除标准

  • prior carpal tunnel release
  • loss of follow-up US examinations
  • previous US-guided carpal tunnel injections
  • US-guided carpal tunnel injections with recurrence on ipsilateral hands

结局指标

主要结局

The observation of median nerve injury

时间窗: July 2017 to September 2017

The investigators observed if patient had symptoms of shooting pain after the corticosteroid injection along with numbness, paresthesia and other sensory deficits and distributions in the median nerve supply area.

次要结局

  • The intra-rater agreement of measurements(July 2017 to September 2017)
  • The relationship between pre-injection factors and MNI(July 2017 to September 2017)
  • The relationship between post-injection factors and MNI(July 2017 to September 2017)
  • The symptoms relief after corticosteroid injection in the groups of MNI or not(July 2017 to September 2017)

研究者

发起方
yi-chih HSU
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

yi-chih HSU

Radiologist

Tri-Service General Hospital

研究点 (1)

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