The Long-term Effect of Perineural Injection Therapy in Patients With Carpal Tunnel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline of pain on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
研究概览
简要总结
Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration. Recently, the ultrasound-guided perineural injection with 5% dextrose was widely used for entrapment neuropathy with positive benefit. However, current studies have not entirely proved the effects of perineural injection on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided perineural injection with 5% dextrose in patients with CTS.
详细描述
After obtaining written informed consent, patients of clinically diagnosed with CTS were randomized into intervention and control group. Participants in intervention group received one-session ultrasound-guided perineural injection with 5% dextrose and control group received one-session ultrasound-guided perineural injection with normal saline. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd, 4th, 8th, 12th, 16th and 24th week after the treatment.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20-85 year-old.
- •Diagnosis was confirmed using an electrophysiological study and ultrasonography
排除标准
- •Coagulopathy
- •Pregnancy
- •Inflammation status
- •Cervical radiculopathy
- •Polyneuropathy, brachial plexopathy
- •Thoracic outlet syndrome
- •Previously undergone wrist surgery or steroid injection for CTS
研究组 & 干预措施
Perineural injection with 5% dextrose
Ultrasound-guided perineural injection with 5% Dextrose (3cc) between proximal carpal tunnel and median nerve.
干预措施: Ultrasound-guided perineural injection with 5% dextrose (Procedure)
Perineural injection with 5% dextrose
Ultrasound-guided perineural injection with 5% Dextrose (3cc) between proximal carpal tunnel and median nerve.
干预措施: 5% Dextrose (Drug)
Perineural injection with normal saline
Ultrasound-guided perineural injection with normal saline (3cc) between proximal carpal tunnel and median nerve.
干预措施: Ultrasound-guided perineural injection with normal saline (Procedure)
Perineural injection with normal saline
Ultrasound-guided perineural injection with normal saline (3cc) between proximal carpal tunnel and median nerve.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Change from baseline of pain on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
时间窗: Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
次要结局
- Change from baseline in severity of symptoms and functional status on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.(Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment)
- Change from baseline in cross-sectional area of the median nerve on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.(Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment)
研究者
Yung-Tsan Wu
Attending physician of physical medicine and rehabilitation
Tri-Service General Hospital