跳至主要内容
临床试验/NCT03371589
NCT03371589Unknown不适用

Intratympanic Stereoidal Injections for Facial Nerve Palsy

Hillel Yaffe Medical Center0 个研究点目标入组 30 人开始时间: 2018年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
30
主要终点
House brackman scale

研究概览

简要总结

Bell's palsy is defined as a facial nerve palsy without any other known cause. The common practice for this disease consists of the use of oral steroids. Such treatment can cause harm to people who have disabilities or prior conditions such as pregnancies, diabetes, obesity and/or high blood pressure. While the use of intratympanic injection for sudden sensory hearing loss is well rehearsed in many practices, similar management of facial nerve palsy due to Bell's phenomenon is rare and a few researches have been conducted regarding the subject. In this research we suggest intratympanic injections for these patients as a treatment for Bell's palsy.

详细描述

Bell's palsy is defined as a facial nerve paralysis without any other known diagnosis or cause .Its' estimated occurrence is in 20 to 30 people per 100,000 people per year. The occurence is greater in patients older than 65 years old and lower in children younger than 13 years old. There are many estimated etiologies for Bell's palsy, such as failure of the vasa nervosa, viral infections, ischemic neuropathies and auto immune reactions. Of those, viral hypothesis is the most widely accepted.

The prognosis for recovery for most patients is 80% to 90%. One series showed that only 17 out of 1505 patients demonstrated moderate to severe sequela and none had complete facial nerve paralysis. The common practice for the management of Bell's palsy consists of oral steroids with or without the antiviral medications. A recent study made by the Department of Otorhinolaryngology and Head and Neck surgery in Korea indicated that Intratympanic injections could replace the use of oral steroids . Another recent study by Jong job lee et al. has shown that Intratympanic injections have prolonged uptake in rats, in comparison to Intraperitoneal injections.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Adult patients 18 years old or more, diagnosed with Bell's palsy who cannot receive oral steroid treatment for their condition, due to to pregnancy, diabetes, high blood pressure etc.

排除标准

  • Children under the age of
  • Patients who can receive oral steroid treatment for their condition.
  • Patients with internal ear problems. * Patients who already recieved treatmetn for their condition.

研究组 & 干预措施

no P.O corticosteroids

Experimental

Steroids injection

干预措施: Dexamethasone (Drug)

结局指标

主要结局

House brackman scale

时间窗: change in score 1 month, 3 months and 6 months after end of treatment

grade 1-6

次要结局

  • Nottingham scale for facial palsy(change in score 1 month, 3 months and 6 months after end of treatment)

研究者

申办方类型
Other Gov
责任方
Sponsor

相似试验