Ultrasound-Guided Injection of Mild to Moderate Carpal Tunnel Syndrome Using Hyaluronic Acid vs Corticosteroid vs 5% Glucose: Comparative Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in median nerve cross-sectional area (CSA)
研究概览
简要总结
Carpal tunnel syndrome (CTS) is a common peripheral nerve entrapment disorder caused by compression of the median nerve at the wrist. This study is a comparative study designed to evaluate the efficacy of three ultrasound-guided injection treatments for patients with mild to moderate CTS: hyaluronic acid (HA), corticosteroid, and 5% glucose (D5W).
A total of 60 adult patients with clinically and electrophysiologically confirmed mild to moderate CTS will be enrolled and divided into three groups of 20 patients each. Participants will receive a single ultrasound-guided injection using one of the three study interventions. Clinical assessment will include Phalen's test and Tinel's sign. Electrophysiological assessment will include median nerve sensory and motor nerve conduction parameters, while ultrasonographic assessment will include measurement of the median nerve cross-sectional area.
Participants will be reassessed three months after the intervention using the same clinical, electrophysiological, and ultrasonographic measures. The study will compare changes in these outcomes among the three treatment groups to evaluate their relative efficacy in the management of mild to moderate CTS.
详细描述
Detailed Description
Carpal tunnel syndrome (CTS) is the most common peripheral nerve entrapment syndrome and results from compression of the median nerve as it passes through the carpal tunnel at the wrist. The carpal tunnel is a relatively narrow osteofibrous canal containing the median nerve and nine flexor tendons. Any condition that decreases the available space within the tunnel or increases the volume of its contents may increase intracarpal pressure and compromise median nerve function.
The clinical severity of CTS can range from mild to severe. Mild CTS is generally characterized by intermittent sensory symptoms and sensory conduction abnormalities, whereas moderate CTS may involve both sensory and motor nerve conduction abnormalities. Severe disease may be associated with persistent numbness, weakness, thenar muscle atrophy, and evidence of more advanced nerve damage. The present study will focus on patients with mild to moderate CTS, confirmed clinically and electrophysiologically.
Conservative management of CTS includes wrist splinting, physiotherapy, and local injections. Corticosteroid injection is an established treatment option that can provide short-term symptomatic relief. More recently, other injectates have been investigated. Hyaluronic acid (HA) has been proposed as a treatment that may reduce perineural adhesions and improve median nerve gliding. In addition, perineural injection and hydrodissection using 5% glucose (D5W) have shown promising results in patients with neuropathic pain conditions, including CTS.
Ultrasound guidance will be used for all injections. Ultrasound guidance allows visualization of the median nerve and surrounding anatomical structures during the procedure and facilitates accurate placement of the injectate while avoiding direct injury to the median nerve. Ultrasonography will also be used to measure the median nerve cross-sectional area (CSA), providing an objective structural parameter for assessment and follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-70 years. Clinical symptoms of carpal tunnel syndrome for ≥6 weeks. Electrophysiological confirmation of mild to moderate carpal tunnel syndrome. Ability to provide informed consent.
排除标准
- •Prior injection into the same wrist within the previous 6 months. Previous carpal tunnel surgery. Severe carpal tunnel syndrome, defined by absent sensory potentials or electromyographic evidence of denervation.
- •Local infection or coagulopathy.
研究组 & 干预措施
Hyaluronic Acid
articipants will receive 2-3 mL of high-molecular-weight hyaluronic acid by ultrasound-guided perineural injection around the median nerve to create a gliding plane and reduce perineural adhesions.
干预措施: Hyaluronic Acid- corticosteroid- 5% glucose (Drug)
Corticosteroid
Participants will receive triamcinolone acetonide 40 mg mixed with 1 mL lidocaine by ultrasound-guided injection into the carpal tunnel.
干预措施: Hyaluronic Acid- corticosteroid- 5% glucose (Drug)
5% Glucose
Participants will receive 5 mL of 5% glucose (D5W) by ultrasound-guided hydrodissection around the median nerve.
干预措施: Hyaluronic Acid- corticosteroid- 5% glucose (Drug)
结局指标
主要结局
Change in median nerve cross-sectional area (CSA)
时间窗: Baseline to 3 months after injection
Median nerve cross-sectional area measured by ultrasound at baseline and 3 months after treatment, comparing the change among the three treatment groups.
次要结局
未报告次要终点
研究者
Nahla Magdy Elsayed Mahfouz Badran
DOCTOR
Tanta University