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临床试验/NCT07105540
NCT07105540已完成4 期

Comparison of Hydrodissection With 5% Dextrose and Perineural Corticosteroid Injection in Carpal Tunnel Syndrome: A Prospective Study

Ankara Etlik City Hospital1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2025年8月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
53
试验地点
1
主要终点
Boston Carpal Tunnel Questionnaire

研究概览

简要总结

The aim of this study is to compare the effects of ultrasound-guided hydrodissection with 5% dextrose and perineural corticosteroid injection on the clinical parameters of carpal tunnel syndrome, as well as to evaluate the long-term efficacy of these treatments.

详细描述

Carpal tunnel syndrome (CTS), the most prevalent peripheral compressive neuropathy, manifests primarily with sensory disturbances such as pain, numbness, and nocturnal paresthesia. Treatment options for CTS differ considerably depending on the severity of symptoms, and typically include splinting, physiotherapy, local injection therapies, and surgical release. Hydrodissection is an ultrasound-guided technique that has recently gained increased attention for its role in the management of nerve entrapment syndromes. The technique uses fluid injection to separate the nerve from nearby tissues. This may reduce perineural adhesions and improve the patient's symptoms. In hydrodissection, normal saline, 5% dextrose, or platelet-rich plasma (PRP) can be used as injectates. Recently, hydrodissection with 5% dextrose has become the most commonly used approach. Several studies in the literature have demonstrated that perineural hydrodissection with 5% dextrose provides more favorable outcomes than corticosteroid injections in patients with mild to moderate CTS, particularly at 4 to 6 months post-injection. However, it remains unclear whether hydrodissection leads to a reduction in the cross-sectional area of the median nerve. In addition, studies examining the procedural details of hydrodissection are limited. Therefore, further clinical research is needed to better understand and validate the technique.

Ultrasound-guided hydrodissection for CTS is performed using a 12 MHz linear array transducer probe (GE Logiq P9, GE Healthcare, Boston, MA). The median nerve (MN) is visualized at the scaphoid-pisiform level. In the intervention group, 2.5 ml of 5% dextrose is injected via an in-plane ulnar approach to separate the MN from the transverse carpal ligament, followed by an additional 2.5 ml of normal saline (NS) injected to separate the MN from the flexor tendons. In the control group, perineural injection of 1 ml betamethasone is administered around the MN using the same ultrasound device and probe.

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 (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients diagnosed with unilateral moderate carpal tunnel syndrome (CTS) confirmed by an electrophysiological study within the last 6 months
  • •Presence of at least one of the following symptoms lasting more than one month:
  • •Paresthesia/dysesthesia accompanied by weakness and clumsiness in the hand, worsened by repetitive wrist use or sleep, and relieved by postural correction or shaking of the hand
  • •Numbness due to sensory disturbance in the median nerve (MN) distribution
  • •Thenar muscle weakness with atrophy
  • •Positive Tinel's sign or Phalen's test
  • •Pain intensity of ≥4 out of 10 on the Visual Analog Scale (VAS) prior to treatment

排除标准

  • •History of previous wrist surgery, polyneuropathy, brachial plexopathy, or thoracic outlet syndrome
  • •Presence of systemic infection
  • •Pregnancy
  • •Prior corticosteroid injection for CTS

研究组 & 干预措施

Hydrodissection group

Active Comparator

Participants in the hydrodissection group will undergo ultrasound-guided perineural hydrodissection of the median nerve at the scaphoid-pisiform level using a 12 MHz linear transducer (GE Logiq P9, GE Healthcare, Boston, MA). Under sterile conditions, 2.5 ml of 5% dextrose will be injected via an in-plane ulnar approach to mechanically separate the median nerve from the transverse carpal ligament. Subsequently, an additional 2.5 ml of 5% dextrose will be administered to separate the nerve from adjacent flexor tendons. The total injection volume will be 5 ml.

干预措施: 5% Dextrose (Drug)

Corticosteroid group

Active Comparator

Participants in the corticosteroid group will undergo ultrasound-guided perineural injection of the median nerve at the scaphoid-pisiform level using a 12 MHz linear transducer (GE Logiq P9, GE Healthcare, Boston, MA). A perineural injection of 1 ml betamethasone combined with 1 ml 2% lidocaine will be administered around the median nerve.

干预措施: Betamethasone and local anesthetic (Drug)

结局指标

主要结局

Boston Carpal Tunnel Questionnaire

时间窗: At baseline, at Month 1,3,6 (Visit 1,2,3)

The Boston Carpal Tunnel Questionnaire (BCTQ) is a validated disease-specific assessment tool developed in 1993 to provide standardized clinical evaluation of carpal tunnel syndrome (CTS). It comprises 19 items divided into two subscales: the Symptom Severity Scale (BCTQ-SSS) and the Functional Status Scale (BCTQ-FSS). Scores on both subscales range from 1 to 5, with higher scores reflecting increased symptom burden and functional impairment associated with CTS.

次要结局

  • Visual Analog Scale (VAS)(At baseline and at Month 1,3,6 (Visit 1,2,3))
  • Cross-Sectional Area (CSA) of the Median Nerve via Ultrasonography(At baseline and at month 3,6 (Visit 2,3))
  • Hand Grip Strength(At baseline and at Month 3,6 (Visit 2,3))

研究者

发起方
Ankara Etlik City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Gizem Suna Tuncer

Principal Investigator, Physical Medicine and Rehabilitation Specialist

Ankara Etlik City Hospital

研究点 (1)

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