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临床试验/NCT02701218
NCT02701218Unknown不适用

Comparison of the Treatment Outcomes of Posterior Canal Benign Paroxysmal Positional Vertigo (BPPV) With Canalith Repositioning Procedure (CRP): Single Versus Multiple Cycles

Chiang Mai University2 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2016年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
114
试验地点
2
主要终点
Dix-Hallpike test (DHT)

研究概览

简要总结

Unilateral posterior canal benign paroxysmal positional vertigo (BPPV) cases will be randomized to treat with single or multiple cycles of canalith repositioning procedure.The treatment outcomes will be assessed at 7th and 28th days.

详细描述

Patients present with brief episodes of vertigo will be evaluated by Dix-Hallpike test. Cases with positive Dix-Hallpike test, unilateral, posterior canal, will be randomized with block of four. Either single or multiple cycles of canalith repositioning procedure will be performed. Four treatment outcomes will be blindly assessed at 7 and 28 days.

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
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Recurrent episodes of vertigo
  • 15 years of age or older
  • Positive Dix-Hallpike test: unilateral, posterior canal

排除标准

  • Received vestibular suppressant within 6 hours
  • With other diseases or conditions cause of vertigo or central nervous system disease
  • With diseases or conditions contraindicate for Dix-Hallpike test or CRP eg: cervical spine disease, back/ neck stiffness, retinal detachment
  • Positive Dix-Hallpike test: bilateral, other canals
  • Complications from CRP eg: nausea, vomiting, canalith jam
  • Cannot read the questionaire

研究组 & 干预措施

Single cycle

Experimental

single cycle of canalith repositioning procedure

干预措施: Canalith repositioning procedure (Procedure)

multiple cycles of CRP

Experimental

multiple cycles of canalith repositioning procedure CRP will be stopped if 1) no nystagmus and vertigo in all positions 2) complications exited 3) stable nystagmus in the 2 last cycles

干预措施: Canalith repositioning procedure (Procedure)

结局指标

主要结局

Dix-Hallpike test (DHT)

时间窗: At 7th day

percentage of negative DHT between single and multiple cycles

次要结局

  • Dizziness handicap inventory (DHI)(compare to the first visit at 28th day between single and multiple cycles)
  • Loss of balance(compare to the first visit at 28th day between single and multiple cycles)
  • Dix-Hallpike test (DHT)(At 28th day)
  • Subjective symptoms(Improvement of the symptoms compare to the first visit at 28th day between single and multiple cycles)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suwicha Isaradisaikul Kaewsiri

Principal Investigator, Clinical Professor

Chiang Mai University

研究点 (2)

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