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临床试验/NCT05309538
NCT05309538已完成不适用

Effect of Modified Epley's & Semont's Maneuvers With or Without Beta-histine on Benign Paroxysmal Positional Vertigo: A Randomized Control Trail

Neuro Counsel Hospital, Pakistan2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
EQ-5D-5L

研究概览

简要总结

: Benign Paroxysmal Positional Vertigo is a condition related to vestibular system accompanied by dizziness, tinnitus and balance problems leading to increased fall risk and potential disability. Various treatment options are available including pharmacotherapy and vestibular rehabilitation with varied results

详细描述

Objective

The objective of this study was to compare the efficacy of Modified Epley & Semont's maneuver with and without Betahistine for BPPV Material & Methods: The study was a single blind randomized control trail. Total number of patients were 97 as calculated by Epitool calculator. Duration of the study was of one year from 2 January 2021 to 1st January 2022. Out of a total 97 patients, 90 met the inclusion criteria. These participants were randomized by lottery method into two equal groups. Group A (control group) was receiving both maneuvers only while group B (experimental group) included participants receiving betahistine along with both maneuvers. The impact of dizziness and quality of life was measured through EQ-5D-5L questionnaire and dizziness handicap inventory (DHI) in order to analyze the effectiveness of treatments. Pre and Post treatment results were compared within group by Wilcoxon rank test and for between groups, Mann Whitney U test was performed

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 (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age between 18-60
  • positive modified Dix Hil pike test
  • repetitive vertigo spells affecting activities of daily livings (ADLs)

排除标准

  • any cervical spine problem
  • vertigo due to central disease
  • systemic disease
  • cardiac disease
  • Parkinson disease
  • bed bound patients

结局指标

主要结局

EQ-5D-5L

时间窗: 1 month

quality of life

DHI

时间窗: 1 month

dizziness handicap inventery

次要结局

未报告次要终点

研究者

发起方
Neuro Counsel Hospital, Pakistan
申办方类型
Other
责任方
Sponsor

研究点 (2)

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