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临床试验/CTRI/2023/08/056503
CTRI/2023/08/056503尚未招募2/3 期

Effect of head shaking maneuver on subjective and objective treatment outcomes in patients treated with epley maneuver for Benign Paroxysmal Positional Vertigo -Randomized control trial

PIMS1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年8月22日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
To measure the effect of head shaking maneuver on subjective treatment outcomes (measured by dizziness handicap inventory, Berg balance scale) among the patients with Benign Paroxysmal Positional Vertigo undergoing treatment with epley maneuver.

研究概览

简要总结

Benign paroxysmal positional vertigo (BPPV), which was first identified by Barany, is the most common peripheral vestibular pathologic condition. BPPV is defined as an abnormal sensation of movement, usually evoked by sudden head movements.The specific cause of BPPV is still unknown, however it may be associated with various disorders of the inner ear or head trauma(1)

Otoliths called autoconial debris that pass from the utricular macula to the semicircular canal are responsible for the pathogenesis of BPPV. This can happen in two different ways: canalolithiasis and cupulolithiasis. Canalolithiasis occurs when otoliths enter the canal from the non-bulbous end and move freely in the canal. Cupulolithiasis occurs by the adhesion of otoliths in the cupule of the crista ampullaris. The most commonly involved canal is the posterior semicircular canal and the form of posterior canal canalolithiasis is mostly observed. Epley maneuver is done in posterior canal Benign paroxysmal positional vertigo to reposition these otolith into original position

The diagnosis of BPPV is performed by using the Dix---Hallpike Maneuver The success rate of Epley Manuever is ranged between 75%---89%Epley maneuver In patients with posterior canal canalolithiasis may increase the success of Epley Maneuver. In this study, the results of Berg Balance Scale (BBS) and Dizziness Handicap Index (DHI) and VEMP are evaluated in patients who underwent head-shaking maneuver before Epley Maneuver and who underwent Epley Maneuver without head-shaking maneuver before treatment and at the 1st week after treatment.(1)

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients with BPPV 2)Age above 18yrs and below 60 years.

排除标准

  • Patients on vestibular sedatives in last 72 hours 2)Patients with central causes and other peripheral causes of giddiness 3)Pregnant women and mentally challenged persons 4)Orthostatic Hypotension 5)Alcoholic withdrawal Syndrome 6)Middle ear pathology 7)Uncontrolled Diabetic mellitus 8)Uncontrolled Hypertension 9)Severe Cervical spondylosis.

结局指标

主要结局

To measure the effect of head shaking maneuver on subjective treatment outcomes (measured by dizziness handicap inventory, Berg balance scale) among the patients with Benign Paroxysmal Positional Vertigo undergoing treatment with epley maneuver.

时间窗: 7-10 days

次要结局

  • To measure the effect of head shaking maneuver on objective treatment outcome (measured by Vestibular evoked myogenic potential) among the patients with Benign Paroxysmal Positional Vertigo undergoing treatment with epley maneuver(3 to 5 days)

研究者

发起方
PIMS
申办方类型
Private medical college

研究点 (1)

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