Does Bilateral Botulinum Toxin A in Patients With Hemifacial Spasm Improve Facial Symmetry Unilateral and Bilateral Injection of Botulinum Toxin A in Patients With Hemifacial Spasm? A Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Sunnybrook Facial Grading System
研究概览
简要总结
Hemifacial spasm patients who received botulinum toxin A injection were divided into two groups. Group A received unilateral injection while group B received bilateral injection. Patients completed follow-up A researcher record facial videos and analyzed facial symmetry and completed 3 scales.
详细描述
Hemifacial spasm patients who received botulinum toxin A injection were divided into two groups.Patients of unilateral group were injected to the affected side and the dose of botulinum toxin A was 2.5-3.75 units/per site. Patients of bilateral group were injected to the affected side with dose of 2.5-3.75 units/per site and the normal side was injected with dose of 1.25 units/per site.
3 scales for measurement were used.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of hemifacial spasm
- •Scott grading III to IV
- •hemifacial spasm duration of half or more years
- •last botulinum toxin A application at least 3 months before the start of the study
排除标准
- •history of facial trauma, congenital facial asymmetry, facial nerve microsurgical decompression
- •bilateral hemifacial spasm
- •allergies to botulinum toxin A or to any component of the drug
- •previous treatment with botulinum toxin A fewer than 3 months
- •the use of drugs that could interfere with neuromuscular transmission or spasm
研究组 & 干预措施
unilateral injection group
Patients of unilateral group were injected botulinum toxin type A to the affected hemiface.
干预措施: Botulinum Toxin Type A (Drug)
bilateral injection group
Patients of bilateral group were injected botulinum toxin type A to the affected hemiface and normal hemiface. The intervention of the bilateral group was that the normal side was injected.
干预措施: Botulinum Toxin Type A (Drug)
结局指标
主要结局
Sunnybrook Facial Grading System
时间窗: up to 6 months
Sunnybrook Facial Grading System consists of resting symmetry, symmetry of voluntary movement and synkinesis. Total score = Symmetry of voluntary movement score - Resting symmetry score - Synkinesis score
次要结局
- Symmetry Scale for Hemifacial Spasm(up to 6 months)
- The effective duration of botulinum toxin A(up to 6 months)
- Adverse events(up to 6 months)
- Facial Clinimetric Evaluation Scale(up to 6 months)
研究者
Lingjing Jin
professor
Tongji University