The Effects of Vitamin B12 and Dextrose on the Ultrasound-guided Median Nerve Hydrodissection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change of Boston Carpal Tunnel Syndrome Questionnaire
研究概览
简要总结
Carpal tunnel syndrome is the most common peripheral entrapment neuropathy of the upper limb. Previous experiments found that ultrasound-guided median nerve hydrodissection with 5% dextrose water could ameliorate the condition of carpal tunnel syndrome. Oral administration of vitamin B 12 had been reported to reduce the discomfort from peripheral neuropathy although the level of evidence is not strong. This prospective, double-blind randomized control trial aims to compare the effects of different kinds of the injection agents on carpal tunnel syndrome.
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, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20-80 year-old.
- •Diagnosis (carpal tunnel syndrome) was confirmed using an electrophysiological study.
排除标准
- •Previously undergone wrist surgery or steroid injection for CTS
- •Thrombocytopenia
- •Coagulopathy
- •Inflammation status
- •Polyneuropathy
- •Brachial plexopathy
- •Cervical radiculopathy
- •Autoimmune disease
- •Malignancy
- •Pregnancy
- •Thoracic outlet syndrome
研究组 & 干预措施
Dextrose
干预措施: Ultrasound-guided nerve hydrodissection (Procedure)
Dextrose + Vitamin B12
干预措施: Ultrasound-guided nerve hydrodissection (Procedure)
Vitamin B12
干预措施: Ultrasound-guided nerve hydrodissection (Procedure)
结局指标
主要结局
Change of Boston Carpal Tunnel Syndrome Questionnaire
时间窗: Pre-treatment, 1st, 3rd, 6th month after injection
Measure the severity of symptoms and functional status before and after treatment
次要结局
- Cross-sectional area of the median nerve(Pre-treatment, 1st, 3rd, 6th month after injection)
- Median nerve conduction velocity and amplitude(Pre-treatment, 1st, 6th month after injection)
- Visual analog scale of pain and tingling(Pre-treatment, 1st, 3rd, 6th month after injection)
- Median nerve elastography(Pre-treatment, 1st, 3rd, 6th month after injection)