Can Benign Paroxysmal Positional Vertigo (BPPV) be Treated Faster and More Efficiently by Using a Mechanical Rotational Chair Compared to the Traditional Manual Repositioning Maneuvers?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Treatment success after first treatment
研究概览
简要总结
Comparison of treatment efficacy of a mechanical rotational chair (TRV-chair) vs. manual repositioning maneuvers in BPPV
详细描述
Open-label, randomized controlled trial comparing manual repositioning maneuvers with a mechanical rotational chair (TRV-chair) in diagnosing and treating BPPV. Patients with suspected BPPV will be randomized to either manual repositioning maneuvers or the TRV-chair.
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
- 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
- 否
入选标准
- •Characteristic (for BPPV) positional nystagmus
- •Positive Dix-Hallpike
- •Positive supine roll test
- •Medical history compatible with BPPV
排除标准
- •Treatment in TRV-chair within the last 6 months
- •Exclusion of BPPV diagnosis
- •Lack of treatment cooperation
- •Known cerebral aneurism or cerebral hemorrhage
- •Diagnosed and treated for BPPV within the past month
- •Treatment with sedating anti-histamines within the past 7 days
研究组 & 干预措施
Manual repositioning maneuver
Diagnostics and treatment of BPPV with manual repositioning maneuvers. In case of posterior canal involvement, Epley's maneuver will be used. In case of horizontal canal involvement, the log roll maneuver will be used.
干预措施: Manual repositioning maneuver (Procedure)
Treatment in mechanical rotational chair (TRV-chair)
Diagnostics and treatment of BPPV with the use of a TRV chair. In case of posterior canal involvement, Epley's maneuver will be used with the addition of 10 kinetic impulses in each position.
In case of horizontal canal involvement, the log roll maneuver will be used with the addition of 10 kinetic impulses in each position.
干预措施: TRV-chair (Device)
结局指标
主要结局
Treatment success after first treatment
时间窗: 2 years
Number of subjects achieving resolution of vertigo and nystagmus after one treatment
Number of treatments
时间窗: 2 years
Number of treatment necessary to achieve resolution of vertigo and nystagmus
次要结局
- Adverse events(2 years)
- Dizziness Handicap Inventory (DHI) questionnaire(2 years)
研究者
Dan Dupont Hougaard
MD, Associate Professor, Principal Investigator
Aalborg University Hospital