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Clinical Trials/CTRI/2023/08/056503
CTRI/2023/08/056503Not yet recruitingPhase 2/3

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 site in 1 country90 target enrollmentStarted: August 22, 2023Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
90
Locations
1
Primary Endpoint
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.

Study Overview

Brief Summary

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)

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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.

Time Frame: 7-10 days

Secondary Outcomes

  • 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)

Investigators

Sponsor
PIMS
Sponsor Class
Private medical college

Study Sites (1)

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