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临床试验/CTRI/2024/10/075028
CTRI/2024/10/075028已完成不适用

Comparison of ultrasound guided hydrodissection with dextrose versus normal saline for treatment of carpal tunnel syndrome: A Randomized Controlled Trial

未提供1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年10月19日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Comparison of improvement in BCTQ(SSS), BCTQ (FSS), VAS and CSA of median nerve from pre procedure to post procedure in both groups.

研究概览

简要总结

Carpal tunnel syndrome is most common peripheral neuropathy.Traditionally, conservative management with drugs and splinting is the mainstay of treatment. With encouraging outcomes, there has been a change in recent years towards minimally invasive and image guided procedure ie Hydrodissection.NS has shown good results in mild to moderate CTS by causing adhesiolysis around median nerve and is superior to steroid injection, hence it has been routinely used for treatment in several institutions. Several injectates have been studied after this out of which dextrose was found to be superior due to its proposed additional effects on certain receptors like nociceptive C-fibres, AMPK enzyme, TNF alpha, TRPV-1 receptors. However no consensus in literature about optimal injectate to be used is available so far .Thus, this study was planned to compare the efficacy of hydrodissection with dextrose and normal saline.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Adult patients having NCS proven carpal tunnel syndrome with persistent symptoms not resolving after 6-8 weeks of medications or splinting referred from orthopaedics department for hydrodissection.

排除标准

  • : Patients with other neurological causes like polyneuropathies, thoracic outlet syndrome, cervical radiculopathy; secondary causes like ganglion cysts, accessory muscles; received prior steroid injection / carpal tunnel release surgery ; thenar atrophy; local site infection , history of Colles’ fracture; uncontrolled diabetes / diabetic neuropathy , uncontrolled hypothyroidism or bleeding diathesis.

结局指标

主要结局

Comparison of improvement in BCTQ(SSS), BCTQ (FSS), VAS and CSA of median nerve from pre procedure to post procedure in both groups.

时间窗: At 1 month , 3 month and wherever possible 6 months

次要结局

  • 1. Change from baseline of BCTQ (SSS), BCTQ (FSS) and VAS after ultrasound guided hydrodissection with 5% dextrose .(2. Change from baseline of BCTQ (SSS), BCTQ (FSS) and VAS after ultrasound guided hydrodissection with normal saline .)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Akanksha Saini

Department of Radiodiagnosis, UCMS and GTB Hospital, Dilshad Garden, Delhi

研究点 (1)

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