Efficacy of Combined Ultrasound Guided Steroid Injection and Splinting in Patients With Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- Change from Baseline in the scores on the Boston Carpal Tunnel Questionnaire (BQ).
研究概览
简要总结
To compare the effectiveness of ultrasound guided-steroid injection plus splinting to that of steroid injection alone using clinical and electrophysiological parameters in patients with carpal tunnel syndrome
详细描述
This is a prospective, single-blinded randomized controlled study. Patient with CTS were randomly assigned to group receiving ultrasound guided steroid injection and group receiving ultrasound guided corticosteroid injection and splinting. The steroid injection was using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine). The inclusion criteria included an age of more than 18 years and typical signs of CTS according to American Academy of Neurology criteria lasting for at least 3 months. The diagnosis of CTS was confirmed by electrophysiological tests.The exclusion criteria included the following: presence of thenar atrophy; existence of disorders such as hypothyroidism, diabetes mellitus, chronic renal failure, or rheumatoid arthritis; any accompanying orthopedic or neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome; prior steroid injection into the affected carpal tunnel or carpal tunnel surgery; history of distal radius fracture; pregnancy or lactation; regular use of systemic NSAIDs or corticosteroids; and known allergy to corticosteroids and local anesthetics.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of CTS
- •The diagnosis of CTS was confirmed by electrophysiological tests.
排除标准
- •presence of thenar atrophy
- •existence of disorders such as hypothyroidism, diabetes mellitus, chronic renal failure, or rheumatoid arthritis; any accompanying orthopedic or neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome
- •prior steroid injection into the affected carpal tunnel or carpal tunnel surgery
- •history of distal radius fracture
- •pregnancy or lactation
- •regular use of systemic NSAIDs or corticosteroids
- •known allergy to corticosteroids and local anesthetics.
研究组 & 干预措施
experimental: steroid injection and splinting
ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine) and a customized volar thermoplastic wrist splint
干预措施: Triamcinolone Acetonide (Drug)
experimental: steroid injection and splinting
ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine) and a customized volar thermoplastic wrist splint
干预措施: thermoplastic wrist splint (Device)
experimental: steroid injection and splinting
ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine) and a customized volar thermoplastic wrist splint
干预措施: lidocaine hydrochloride (Drug)
steroid injection
ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine)
干预措施: Triamcinolone Acetonide (Drug)
steroid injection
ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine)
干预措施: lidocaine hydrochloride (Drug)
结局指标
主要结局
Change from Baseline in the scores on the Boston Carpal Tunnel Questionnaire (BQ).
时间窗: at 2, 6, 12 weeks
The BQ was interviewed-administered to assess the severity of symptoms and functional status.
次要结局
- Change from Baseline in Median nerve distal motor latency(at 2, 6, 12 weeks)
- Change from Baseline in sensory nerve conduction velocity(at 2, 6, 12 weeks)
- Change from Baseline in compound muscle action potential amplitude (CMAP)(at 2, 6, 12 weeks)
- Change from Baseline in sensory nerve action potential amplitudes.(at 2, 6, 12 weeks)
- Change from Baseline in self-reported pain intensity(at 2, 6, 12 weeks)
- change from Baseline in Cross sectional area(at 2, 6, 12 weeks)
- change from Baseline in flattening ratio(at 2, 6, 12 weeks)
