Botulin Toxin Type A Injections for Thoracic Outlet Syndrome: A Double-Blind, Randomized Control Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
Botulinum toxin type A injected into the anterior and middle scalene muscles will reduce the irritation on the neurovascular structures at the interscalene triangle in subjects with TOS. This will lead to reductions in pain and paresthesias, and improvements in function when compared with injection of placebo.
详细描述
To assess the effect of Botulinum Toxin Type A (BTX-A) injections into the scalene muscles on pain, paresthesias and function in subjects with TOS.
Hypothesis:
BTX-A injected into the anterior and middle scalene muscles will reduce the irritation on the neurovascular structures at the interscalene triangle in subjects with TOS. This will lead to reductions in pain and paresthesias, and improvements in function when compared with injection of placebo.
Study design:
Double-blind, randomized, placebo-controlled parallel groups effectiveness trial evaluating changes in pain, paresthesias and function before, at six weeks and four months following injection.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at least 19 years
- •Medically stable
- •Able to give informed consent
- •Meets criteria for clinical diagnosis of TOS
- •Symptoms of TOS present for at least three months and less than two year
- •Have had EMG studies and a CT or MRI scan of the cervical spine
排除标准
- •Prior treatment with BTX-A
- •Allergy to BTX-A
- •History of botulinum toxicity
- •Prior scalenectomy
- •Surgery for TOS planned within four months
- •Use of blood thinners, i.e., warfarin; unfractionated or low molecular weight heparin
- •History of Myasthenia Gravis, Eaton-Lambert Syndrome or Shy-Drager Syndrome
- •Unable to complete follow-up assessments at 6 weeks and 4 months
- •Any abnormalities on EMG, CT or MRI studies suggesting an alternate diagnosis
- •Pregnancy or planned pregnancy within six months
研究组 & 干预措施
Botulinum Toxin Type A injection
Double-blind, randomized, placebo-controlled trial evaluating changes in pain, paresthesias, and function in subjects with TOS before, at six weeks, and four months following injection of BTX-A into the scalene muscles and pectoralis minor muscle under EMG guidance.
干预措施: Botulinum Toxin Type A (Drug)
Normal Saline
Double-blind, randomized, placebo-controlled trial evaluating changes in pain, paresthesias, and function in subjects with TOS before, at six weeks, and four months following injection of placebo into the scalene muscles under EMG guidance.
干预措施: Normal Saline injection (Other)
结局指标
主要结局
Pain
时间窗: Change from baseline at six weeks and four months
The primary outcome measure will be change in baseline pain as measured on a ten point Numeric Scale and will be assessed at six weeks and four months following injection.
次要结局
- Paresthesias on Numeric Rating Scale(Change from baseline at six weeks and four months)
- Function on DASH scale(change from baseline at 6 weeks and 4 monthss)