NCT00701233撤回2 期
Evaluation of Intercarpal Botox Versus Steroid Injections for Carpal Tunnel Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Visual Analog Scale
研究概览
简要总结
To compare local steroid injections to local Botulinum toxin A injection in a double-blinded study.
详细描述
To compare local steroid injections to local Botulinum toxin A injection in a double-blinded study. The goal is to investigate if Botulinum toxin A injections are effective for Carpal Tunnel Syndrome compared to steroid injections in terms of pain relief and length of symptom alleviation.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Any individual with symptoms of carpal tunnel syndrome and a diagnosis of CTS either clinically or via EMG will be included into this study. There will be a total of 20 subjects displaying symptoms of CTS. The gender of the subjects will not determine enrollment. There is no requirement of male to female ratio for this study. There is no age cut-off or minimal age requirement to enroll in the study. No specific Racial or ethnic restrictions will be present for this study. Female subjects of childbearing potential (not surgically sterile or postmenopausal for at least 2 years) must have a negative pregnancy test at screening.
排除标准
- •Any individual who has a diagnosis of CTS (by EMG or other means) but no symptoms of CTS will be excluded from this study.
- •Vulnerable subjects as defined as children, pregnant women, those with limited autonomy, decisional incapacity and prisoners will not be enrolled in this study.
- •Individuals with any history of carpal tunnel release surgery and recurrent or persistent symptoms will be excluded form this study.
- •Subject is pregnant or lactating.
研究组 & 干预措施
2
Active Comparator
Corticosteroid injection into Carpal Tunnel
干预措施: Corticosteroid injection into Carpal Tunnel (Drug)
1
Active Comparator
Botulinum toxin injection into Carpal Tunnel
干预措施: Botulinum toxin (Drug)
结局指标
主要结局
Visual Analog Scale
时间窗: one week, one month, three months, six month, nine months, and twelve months
次要结局
- Carpal Tunnel Syndrome Assessment Questionnaire(one week, one month, three months, six month, nine months, and twelve months)
研究者
研究点 (1)
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