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临床试验/NCT03180125
NCT03180125已完成1 期

Use of Hyaluronic Acid Injection in Treatment of Idiopathic Carpal Tunnel Syndrome Versus Corticosteroid Injection Sonographically Guided

Assiut University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年8月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
80
试验地点
1
主要终点
neuropathic pain VAS

研究概览

简要总结

carpal tunnel syndrome (CTS) is the most common compression syndrome in the upper extremities, CTS is characterized by typical anatomic changes, the most probable swelling of the median nerve in the proximal part of the CT.

Local infiltration of corticosteroids easily leads to atrophy of the median nerve, subcutaneous fat, and systematic complications, surgical treatment decision is always taken by the patient who sometimes wants to delay or avoid the surgery because of psychological or medical concerns, It would be interesting if low molecular weight sodium hyaluorinate injection is used as an alternative conservative treatment of CTS. This study aims to investigate if, and to what extent, hydro-dissection using 1% lidocain followed by injection of Sodium hyaluronate versus 1% lidocain followed by injection of 40 mg of triamcinolone acetonide, under ultrasound guidance.

详细描述

60 CT patients, blindly divided into two groups. Both will underwent median nerve hydro-dissection using 1% lidocain followed by group I injection of Sodium hyaluronate and group II injection of 40 mg of triamcinolone acetonide, under ultrasound guidance. Baseline VAS pain and nerve conduction study, patient satisfaction, and therapeutic duration, will be determined in 2nd week, 3rd and 6th month after the procedure. US measurements of the median nerve cross-sectional area (CSA) in the CT inlet will be compared pre and post procedure in 6th month and use NCS results as the gold standard diagnostic test.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

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

入选标准

  • patients with mild or moderate carpal tunnel diagnosed by nerve conduction study

排除标准

  • secondary carpal tunnel to any other disease and peripheral neuropathy patients

研究组 & 干预措施

corticosteroid with ultrasound guided

Placebo Comparator

median nerve hydro-dissection using 1% lidocain followed by injection of corticosteroid Ultrasonographically guided

干预措施: ultrasound (Device)

sodium hyaluorinate ultrasound guided

Experimental

median nerve hydro-dissection using 1% lidocain followed by low molecular weight sodium hyaluronate (Hyalgan) injection ultrasonographically guided

干预措施: Sodium Hyaluronate (Drug)

sodium hyaluorinate ultrasound guided

Experimental

median nerve hydro-dissection using 1% lidocain followed by low molecular weight sodium hyaluronate (Hyalgan) injection ultrasonographically guided

干预措施: ultrasound (Device)

sodium hyaluorinate ultrasound guided

Experimental

median nerve hydro-dissection using 1% lidocain followed by low molecular weight sodium hyaluronate (Hyalgan) injection ultrasonographically guided

干预措施: Sodium Hyaluronate and 1% lidocain (Drug)

corticosteroid with ultrasound guided

Placebo Comparator

median nerve hydro-dissection using 1% lidocain followed by injection of corticosteroid Ultrasonographically guided

干预措施: Sodium Hyaluronate and 1% lidocain (Drug)

corticosteroid with ultrasound guided

Placebo Comparator

median nerve hydro-dissection using 1% lidocain followed by injection of corticosteroid Ultrasonographically guided

干预措施: Corticosteroid and 1%lidocain (Drug)

结局指标

主要结局

neuropathic pain VAS

时间窗: 2 weeks

0-10 VAS scale in the 2nd week after injection

次要结局

  • nerve conduction study(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manal Hassanien

Principal Investigator

Assiut University

研究点 (1)

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