Spasmodic Dysphonia Pain Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pain Experienced
研究概览
简要总结
This study aims to identify adjuvant methods to improve patient comfort during in-office laryngology procedures.
详细描述
Hypothesis:
The use of local anesthetic or vibrating instrument will decrease overall pain experienced by a patient with spasmodic dysphonia undergoing Botox injections.
Aims, purpose, or objectives:
To identify adjuvant methods to improve patient comfort during in-office laryngology procedures. Results demonstrated here should be transferrable to other transcutaneous in-office procedures in laryngology.
Background:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Spasmodic dysphonia with or without tremor
- •Receiving botox as treatment via a transcricothyroid approach
排除标准
- •Allergy to lidocaine
研究组 & 干预措施
Lidocaine
Patients will receive standard of care laryngeal injection of Botox via a transcricothyroid approach following subcutaneous injection of lidocaine (approximately 2 minutes before Botox injection).
干预措施: Lidocaine (Drug)
Vibrating Wand
Patients will receive standard of care laryngeal injection of Botox via a transcricothyroid approach while using the vibrating wand.
干预措施: Vibrating wand (Device)
结局指标
主要结局
Pain Experienced
时间窗: 6 months
Measured on a Visual Analogue Scale where 0 = no pain and 10 = worst pain
次要结局
- Subject Preference(6 months)
研究者
David G. Lott, M.D.
Principal Investigator
Mayo Clinic