Comparative analysis of single versus double injection ultrasound-guided perineural hydrodissection of the median nerve in carpal tunnel syndrome: a randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Pain score as measured by numerical pain rating scale (NRS)
研究概览
简要总结
Carpal tunnel syndrome (CTS) is the most prevalent entrapment neuropathy, caused by compression of the median nerve beneath the transverse carpal ligament at the wrist. Thickening and fibrosis of the subsynovial connective tissue (SSCT) contribute to restricted movement of the median nerve within the carpal tunnel. Cadaveric studies have shown that hydrodissection decreases gliding resistance of the median nerve by mechanically releasing these adhesions.
Standard non-surgical management includes wrist splinting, NSAIDs, activity modification, local corticosteroid injections, and physiotherapy. Recently, ultrasound-guided hydrodissection has emerged as a minimally invasive intervention in which targeted fluid injection (normal saline, D5W, platelet-rich plasma, hyaluronic acid) is used to physically separate the median nerve from the SSCT and flexor retinaculum, reducing compression and restoring nerve mobility. The injectate creates a perineural plane, mechanically loosening adhesions and improving nerve gliding.
A 2021 systematic review of randomised trials concluded that ultrasound-guided hydrodissection is safe and potentially effective for CTS but emphasised that optimal parameters like injectate type, volume, and frequency, remain undefined. A 2024 network meta-analysis found that D5W produced the most consistent improvement in symptoms and function at 4, 12, and 24 weeks.
Despite this growing body of research, no high-quality studies have directly compared single-injection with multiple-injection (“double-injection”) hydrodissection protocols. Given that adhesions may reform between sessions, repeated hydrodissection could theoretically yield more durable symptom relief. This evidence gap provides the rationale for the present study, which aims to compare the clinical and functional outcomes of double-injection versus single-injection ultrasound-guided hydrodissection in mild to moderate CTS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinical diagnosis of mild to moderate CTS (based on symptoms, nerve conduction study and median nerve cross-sectional area on ultrasound examination) Symptom duration more than 3 months Able to provide informed consent.
排除标准
- •Previous carpal tunnel surgery Severe CTS (denervation changes on EMG) Other upper limb neuropathies or thoracic outlet syndrome, cervical radiculopathy or brachial plexopathy Coagulopathy or anticoagulant use Previous corticosteroid injection in the affected wrist within 6 months Pregnancy or lactation Systemic diseases such as thyroid disorders, rheumatoid arthritis, diabetes mellitus, chronic renal failure.
结局指标
主要结局
Pain score as measured by numerical pain rating scale (NRS)
时间窗: At baseline, 4, 12, and 24 weeks
次要结局
- Boston carpal tunnel syndrome questionnaire symptom severity score (BCTQ SSS)(At baseline, 4, 12, and 24 weeks)
- Median nerve cross-sectional area at pisiform level on ultrasonography(At baseline, 4, 12, and 24 weeks)
- Patient satisfaction (Likert scale)(At 4, 12, and 24 weeks)
- Nerve conduction study parameters (distal motor latency, sensory latency, sensory conduction velocity)(At baseline and 24 weeks)
研究者
Anjali Kumari
Kalinga institute of medical sciences, Bhubaneshwar