Comparison of Different Dose of Steroid Injection in Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 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 different dose of ultrasound guided steroid injection in patient with carpal tunnel syndrome, by using clinical and electrophysiological parameters in evlauation
详细描述
This is a prospective, single-blinded randomized controlled study to determine the efficacy of low dose corticosteroid in patient with CTS. Patient with CTS were randomly assigned to group receiving ultrasound guided steroid injection with different dosage of triamcinolone acetonide (Shincort) mixed, 1ml 10mg (10mg/ml) or 1ml 40mg (40mg/ml) with 1 ml of 2% lidocaine hydrochloride. The follow up at 6 and 12 weeks includes Boston Carpal Tunnel Questionnaire, nerve conductive study and VAS pain score.
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
- Double (Participant, Outcomes Assessor)
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 within 6 months or ever received carpal tunnel surgery
- •history of distal radius fracture
- •pregnancy or lactation
- •regular use of systemic NSAIDs ,corticosteroids or diuretics
- •known allergy to corticosteroids and local anesthetics.
- •impaired cognitive function
研究组 & 干预措施
low dose steroid
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)
low dose steroid
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)
comparator
ultrasound-guided steroid injection using 1ml of 40 mg (40mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine)
干预措施: Triamcinolone Acetonide (Drug)
comparator
ultrasound-guided steroid injection using 1ml of 40 mg (40mg/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 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 6, 12 weeks)
- Change from Baseline in sensory nerve conduction velocity(at 6, 12 weeks)
- Change from Baseline in compound muscle action potential amplitude (CMAP)(at 6, 12 weeks)
- Change from Baseline in self-reported pain intensity(at 6, 12 weeks)