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临床试验/NCT07371221
NCT07371221已完成不适用

Ultrasound-Guided Nerve Hydrodissection With 5% Dextrose in Carpal Tunnel Syndrome: A Prospective Study

Dr. Nafiz Korez Sincan State Hospital1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2024年6月17日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
试验地点
1
主要终点
Change in Visual Analog Scale

研究概览

简要总结

The goal of this clinical trial is to evaluate the clinical and ultrasonographic outcomes of ultrasound-guided median nerve hydrodissection with 5% dextrose in patients with mild and moderate carpal tunnel syndrome.

The main questions it aims to answer are:

  • Does ultrasound-guided dextrose hydrodissection improve pain and functional status in patients with carpal tunnel syndrome?
  • Does this procedure lead to changes in ultrasonographic parameters of the median nerve?
  • Is ultrasound-guided dextrose hydrodissection a safe procedure in this patient population?

Participants will:

  • Undergo a single session of ultrasound-guided median nerve hydrodissection with 5% dextrose
  • Be evaluated before the procedure and at 1-month and 3-month follow-up visits using clinical outcome measures and ultrasound assessment
  • Be monitored for any procedure-related adverse events

详细描述

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy of the upper extremity and is caused by compression of the median nerve within the carpal tunnel. Conservative treatment options are commonly preferred in patients with mild to moderate CTS. Ultrasound-guided interventions have gained increasing attention due to their ability to provide real-time visualization of anatomical structures and improve procedural accuracy and safety.

Ultrasound-guided median nerve hydrodissection is a minimally invasive technique that aims to mechanically separate the median nerve from surrounding tissues within the carpal tunnel, potentially reducing nerve compression and improving nerve mobility. The use of 5% dextrose solution has been suggested to provide both mechanical and potential neuromodulatory effects, which may contribute to symptom relief.

In this prospective study, patients diagnosed with mild and moderate CTS undergo ultrasound-guided median nerve hydrodissection using 5% dextrose. All procedures are performed under aseptic conditions by experienced physicians trained in ultrasound-guided interventions. A high-frequency linear ultrasound transducer is used to visualize the median nerve and surrounding anatomical structures at the level of the carpal tunnel. Hydrodissection is performed using an in-plane technique, which allows for continuous visualization of the needle and injectate during the procedure.

Participants receive a single-session ultrasound-guided hydrodissection, during which the injectate is administered to separate the median nerve from adjacent connective tissues. The procedure is conducted according to a standardized protocol to ensure consistency across all participants.

Clinical and ultrasonographic assessments are performed at baseline, and at 1-month and 3-month follow-up visits after the ultrasound-guided injection. Patients are monitored for any procedure-related adverse events throughout the study period. The study aims to evaluate changes in clinical symptoms and ultrasound findings following the intervention, as well as to assess the safety profile of ultrasound-guided dextrose hydrodissection in patients with mild and moderate CTS.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 65 years
  • Electrophysiologically confirmed mild to moderate CTS on electroneuromyography (ENMG)
  • Paresthesia or dysesthesia that worsens at night or with repetitive wrist movement
  • Presence of at least one of the following clinical findings:
  • Numbness in the median nerve distribution
  • Decreased hand strength or thenar muscle weakness
  • Positive Phalen's test and/or Tinel's sign
  • Pain intensity of ≥3 on the Visual Analog Scale (VAS)

排除标准

  • Previous carpal tunnel surgery
  • Severe CTS on ENMG
  • Polyneuropathy
  • Pregnancy
  • Injections in the same area within the last 3 months
  • Peripheral nerve injury, thoracic outlet syndrome, cervical radiculopathy, brachial plexopathy
  • Traumatic hand injury in the last 2 years
  • Inflammatory rheumatological disease
  • Thyroid and autoimmune disease

研究组 & 干预措施

Ultrasound-Guided Dextrose Median Nerve Hydrodissection

Experimental

Participants in this arm undergo a single session of ultrasound-guided median nerve hydrodissection using 5% dextrose solution. The procedure is performed under aseptic conditions with real-time ultrasound guidance to visualize the median nerve and surrounding anatomical structures within the carpal tunnel. The injectate is administered to mechanically separate the median nerve from adjacent tissues.

干预措施: Ultrasound-Guided Median Nerve Hydrodissection with 5% Dextrose (Procedure)

结局指标

主要结局

Change in Visual Analog Scale

时间窗: Baseline, 1 month and 3 months

The severity of pain in the fingers over the past week was measured using a 10-cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).

次要结局

  • Change in Vascularity Index of the Median Nerve(Baseline, 1 month and 3 months)
  • Change in median nerve cross-sectional area(Baseline, 1 month and 3 months)
  • Change in Boston Carpal Tunnel Questionnaire(Baseline, 1 month and 3 months)

研究者

发起方
Dr. Nafiz Korez Sincan State Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sevgi Esra Ozdemir Tekes

Medical Doctor

Dr. Nafiz Korez Sincan State Hospital

研究点 (1)

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