A New Clinical Therapy for Bell's Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 882
- 试验地点
- 1
- 主要终点
- House-Brackmann scale
研究概览
简要总结
The aim of this clinic trial is to testify the efficacy of using new and noninvasive therapy, called simultaneous "Magnetic and Oxygen Treatment along Meridians and Collaterals" (MOMC), to treat Bell's Palsy.
详细描述
Between June 1998 and January 2005, a total of 3002 subjects with BP were evaluated, 882 patients fulfilled the inclusion criteria and entered the study.
Patients were randomly assigned to either the prednisone-valacyclovir group(group 1) or the magnetic-oxygen group(group 2) . Among the 882 patients completing the study,825 patients in group 1 received prednisone, given as a single dose of 40 mg daily for 5 days; the dose will then be reduced by 10 mg per 5 day, with a total treatment time of 20 days.while taking valacyclovir 400 mg in three doses daily for 10 days. 57 patients in group 2 received magnetic-oxygen treatment:MOMC treatment was given as daily 20 min section for 10 days with 2~3 days of intermission between;Oxygen therapy was given simultaneously at a flow rate of 2~3.0 L / min for the same duration during all acupuncture sections.
Clinical evaluation for the severity of paralysis was performed immediately before and after the treatment using the facial nerve grading (FNG) scores of House and Brackmann system.
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
- 10 Years 至 74 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only patients with complete (or nearly complete) non-recurrent facial paralysis (grade 5-6/6) for more than 1 months
- •the first time to onset the disease
- •on one side of the face paralysis
- •willing to finish the whole observation period
- •with written consent form signed by themselves.
排除标准
- •facial palsy caused by other disease, such as infectivity multiple radiculitis, tumor which offend temporal bone, cerebral trauma
- •facial palsy combine diabetes, the severe disease of heart vessel, cerebral vessel, liver, kidney, lung, and psychosis
- •patient with Hunt's syndrome
- •pregnant women or women in lactation
- •patients are participating other clinical research
研究组 & 干预措施
Magnetic - Oxygen
Magnetic and Oxygen Treatment for Bell's Palsy
干预措施: Magnetic and Oxygen Treatment (Device)
prednisone - valacyclovir
prednisone and valacyclovir treatments for bell palsy
干预措施: prednisone and valacyclovir treatments (Drug)
结局指标
主要结局
House-Brackmann scale
时间窗: the 20th day of completion of the treatment
次要结局
未报告次要终点
研究者
wang yanliang
principal investigator
Wenzhou Medical University