The Effectiveness Comparison of Three Different Methods for the Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo: Prospective, Double Blinded, Randomized, Multicenter Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Initial Effectiveness of Treatment for the Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo
研究概览
简要总结
The purpose of this study was to compare the treatment effectiveness of three different methods for posterior semicircular canal benign paroxysmal positional vertigo. The included methods are Modified Epley maneuver, Semont maneuver and Sham maneuver.
详细描述
This study was a prospective, double blinded, randomized, multicenter clinical trial. The enrolled posterior semicircular canal benign paroxysmal positional vertigo patients were randomized to one of the three treatment regimens when they are diagnosed with the Dix-Hallpike test. An then the patient was treated with one of the three maneuvers. After 20 minutes, the patient was examined with the Dix-Hallpike test again. The resolution of nystagmus and symptoms were checked. When the nystagmus was sustained, the same treatment was applied once again. And after 20 minutes, the patient was examined with the Dix-Hallpike test too. 1 day after and 7 days after, the patient was re-examined with the Dix-Hallpike test.
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
- Double (Participant, Investigator)
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
- •a symptom of positional vertigo
- •rotational and upbeating nystagmus in Dix-Hallpike test
- •the nystagmus should be disappear within 60 seconds
- •no spontaneous nystagmus
排除标准
- •ages under 18 years
- •suspicious or verified a central nervous system lesion
- •traumatic vertigo patients
- •other otologic disease(acute/chronic otitis media, otosclerosis, etc)
- •other vestibular disease(vestibular neuronitis, Meniere's disease, etc)
- •congenital nystagmus patients
- •the patients with spinal disease
- •the patients with the limitation of cervical movement
研究组 & 干预措施
Epley maneuver
The group using modified Epley maneuver for PSCC BPPV
干预措施: Modified Epley maneuver (Procedure)
Semont maneuver
The group using Semont maneuver for PSCC BPPV
干预措施: Semont maneuver (Procedure)
Sham
The group using Reverse Epley maneuver for PSCC BPPV
干预措施: Reverse Epley maneuver (Procedure)
结局指标
主要结局
Initial Effectiveness of Treatment for the Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo
时间窗: 20 minutes
The immediate effectiveness of treatment was determined by otolaryngologists with the Dix-Hallpike test 20 minutes after initial manerver applied. The investigator had no information of the treatment applied to the patient. The complete resolution means absence of nystagmus and paroxysmal vertigo symptom. If there was a sustained nystagmus, the latency and duration was measured.
次要结局
- Delayed Effectiveness of Treatment for the Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo(1, 7 day)
研究者
Hong Ju Park
Professor
Asan Medical Center