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临床试验/NCT01822002
NCT01822002Unknown不适用

Randomized Controlled Trials for Treatment of Benign Paroxysmal Positional Vertigo

Chonbuk National University2 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2013年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,500
试验地点
2
主要终点
efficacy of repositioning maneuvers for treating PC-BPPV

研究概览

简要总结

To determine the immediate therapeutic efficacies of canalith repositioning maneuvers in each type of BPPV (posterior canal type, apogeotropic horizontal canal type and geotropic horizontal canal type).

详细描述

In nationwide 10 Dizziness Clinics of Korea, consecutive patients with each type of BPPV are randomized to each repositioning maneuver.

For posterior canal type of BPPV (PC-BPPV), patinets are randomized into modified Epley maneuver and Semont maneuver.

Subjects Consecutive patients with a diagnosis of PC-BPPV are recruited from nationwide 10 Dizziness Clinics in Korea. The inclusion criteria for this study were (1) a history of positional vertigo, (2) direction-changing positional nystagmus appropriate for each type of BPPV, and (3) absence of identifiable central nervous system disorders that could explain the positional vertigo and nystagmus. To exclude the patients with nystagmus from central pathologies, all patients also will receive neurotological examinations including spontaneous and gaze-evoked (GEN) nystagmus, horizontal and vertical smooth pursuit and saccades, limb ataxia, and balance function in addition to routine neurological examinations. Even in patients with isolated vertigo, those with central ocular motor signs, limb ataxia, and severe imbalance will be arranged for MRIs.

Diagnostic procedure To induce positional nystagmus, the patients lied supine from sitting (lying-down nystagmus) and turned their heads to either side while in supine (head-turning nystagmus). Then the patients were moved from a supine to sitting position and the head was bent down (head-bending nystagmus). Patients were also subjected to right and left Hallpike maneuvers and straight head hanging test to exclude BPPV involving the posterior or anterior canal.

Study design and Randomization The investigators attempt to determine the immediate therapeutic efficacies of Epley maneuver and Semont maneuver for PC-BPPV, repeated barbecue rotation maneuver and Gufoni maneuver after barbecue rotatio maneuver for geotropic HC-BPPV, and repeated Gufoni maneuver and head-shaking maneuvers after Gufoni maneuver in apogeotropic HC-BPPV by adopting a prospective randomized controlled study design.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • a history of positional vertigo
  • upbeating-torsional nystagmus in Dix-Hallpike maneuver
  • absence of identifiable central nervous system disorders that could explain the positional vertigo and nystagmus.

排除标准

  • (1) Patients with positive neurotological examinations including spontaneous and gaze-evoked (GEN) nystagmus, horizontal and vertical smooth pursuit and saccades, limb ataxia, and balance function in addition to routine neurological examinations.

结局指标

主要结局

efficacy of repositioning maneuvers for treating PC-BPPV

时间窗: 2hr

The immediate treatment response will be determined by participating neurologists in each clinic without knowing the maneuver applied to each patient from 30 minutes to one hour after initial maneuver. The absence of both vertigo and nystagmus will be required to determine a resolution.

次要结局

未报告次要终点

研究者

发起方
Chonbuk National University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sun-Young Oh

Professor

Chonbuk National University

研究点 (2)

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