Surgery or Clinical Follow-up in Patients With Bell's Palsy. A Prospective, Parallell, Single Center, Randomized , Open Surgery Clinical Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Sunny Brook (SB) score > 70
研究概览
简要总结
The purpose of this study is to investigate if an early surgical intervention on patienst with Bell´s Palsy has a better impact on their facial muscular function and their quality of life as compared to conventional therapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Bell´s Palsy
- •Men and women aged 18-55 y
- •Score < 70 according to Sunny Brook scale (SB)
- •Signed informed consent
排除标准
- •High bloodpressure
- •Currently on immunodepressive treatment
- •Psychiatric disorder
- •Cor incomp, according to NYHA grade: IV, kidney or liver disorder, that greatly influence patienst ability to receive surgery
研究组 & 干预措施
Early surgery
Patienst with Bell´s Palsy with an early surgical intervention (< 3month), according to 'baby-sitter' method
干预措施: Baby-sitter surgery N. fascialis (Procedure)
Conventional treatment and follow-up
Patienst with Bell´s Palsy treated with conventional treatment and standardized physiotherapy according to Jaqueline Diels model.
干预措施: Conventional treatment and follow-up (Other)
结局指标
主要结局
Sunny Brook (SB) score > 70
时间窗: 1 year
Patients with Bell´s Palsy that has been randomized to conventional treatment or early surgical intervention are scored according to SB after 12 month of study participation.
次要结局
- Facial Disability Index(15 month)
- FaCe(15 month)
研究者
Malou Hultcrantz
M.D. Professor
Karolinska Institutet