Treatment of Thoracic Outlet Syndrome With Botulinum Toxin Injection: A Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain as measured on Visual Analog Scale (VAS) at 6 weeks, 3 months and 6 months post-intervention
研究概览
简要总结
The purpose of this study is:
- To assess the effect of BOTOX injection to the scalene muscles on the severity of pain from TOS.
- To assess the effect of BOTOX injection on numbness and tingling and quality of life.
详细描述
Background:
Thoracic Outlet Syndrome (TOS) is a symptom complex consisting of pain, paresthesias and often functional impairment caused by compression of the neurovascular supply to the upper limb. Impingement may occur at the interscalene triangle, and both anesthetic blockade and chemodenervation of the scalene muscles have been shown to temporarily improve symptoms of TOS in non-randomized controlled trials.
Objective:
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:
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
- 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 six months
- •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 six 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, 3 months and 6 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
1
To assess the effect of BOTOX injection to the scalene muscles on the severity of pain from TOS.
干预措施: Botulinum Toxin Type A injection (BOTOX) (Drug)
2
To assess the effect of BOTOX injection on numbness and tingling and quality of life.
干预措施: Botulinum Toxin Type A injection (BOTOX) (Drug)
结局指标
主要结局
Pain as measured on Visual Analog Scale (VAS) at 6 weeks, 3 months and 6 months post-intervention
时间窗: 6 monhts
次要结局
- Paresthesias as measured on VAS(6 months)
- Function as measured with Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, SF-36, number of days lost from work(6 months)