Treatment of Geotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

NCT ID: NCT01366430

Last Updated: 2011-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-04-30

Brief Summary

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The purpose of this study was to compare the immediate efficacies of each treatment maneuvers in treatment of geotorpic horizontal canal benign paroxysmal positional vertigo (HC-BPPV).

Detailed Description

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A randomized prospective study of patients with HC-BPPV. Patients with geotropic type of HC-BPPV were randomized to one of each three treatment groups at their first clinic visit. These groups included the barbecue maneuver, Gufoni's maneuver, and sham group in geotropic HC-BPPV. Responsiveness of treatment maneuver was determined by positioning maneuver immediately after each treatment method based on resolves of vertigo and positional nystagmus.

Conditions

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Benign Paroxysmal Positional Vertigo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Gefoni manenuver

Gefoni manenuver for Geotropic HC-BPPV

Group Type ACTIVE_COMPARATOR

Gufoni

Intervention Type PROCEDURE

For Gufoni maneuver, the patient was quickly brought down on the healthy side from the sitting position, and the head was then turned about 45 degree down, so that the nose was on the bed. After 2 minutes in this position, the patient was returned to the upright position.

sham maneuver

sham maneuver for geotropic HC-BPPV

Group Type ACTIVE_COMPARATOR

Sham

Intervention Type PROCEDURE

The sham maneuver the opposite of the first step for barbecue rotation; lying down from sitting position for 30 seconds, and head turn 90degree to the affected side for 1 minute, and then sit up.

barbecue maneuver

barbecue maneuver for geotropic HC-BPPV

Group Type ACTIVE_COMPARATOR

Barbecue

Intervention Type PROCEDURE

For barbecue rotation, the head was rotated rapidly 90degree while supine in the direction of the healthy ear, which was immediately followed by a truncal rotation of 90degree in the same direction to lie on the intact side. After 30-60 seconds when the induced nystagmus was dissipated, the patients were subjected to a further 90degree rotation of the head and trunk en block in the same direction to attain the nose-down position. After a further 30-60 seconds, the head was again turned in the same direction so that the affected ear was downward. Finally, after another 30-60s, the patient was brought to sitting position. Only one maneuver was performed per session.

Interventions

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Gufoni

For Gufoni maneuver, the patient was quickly brought down on the healthy side from the sitting position, and the head was then turned about 45 degree down, so that the nose was on the bed. After 2 minutes in this position, the patient was returned to the upright position.

Intervention Type PROCEDURE

Sham

The sham maneuver the opposite of the first step for barbecue rotation; lying down from sitting position for 30 seconds, and head turn 90degree to the affected side for 1 minute, and then sit up.

Intervention Type PROCEDURE

Barbecue

For barbecue rotation, the head was rotated rapidly 90degree while supine in the direction of the healthy ear, which was immediately followed by a truncal rotation of 90degree in the same direction to lie on the intact side. After 30-60 seconds when the induced nystagmus was dissipated, the patients were subjected to a further 90degree rotation of the head and trunk en block in the same direction to attain the nose-down position. After a further 30-60 seconds, the head was again turned in the same direction so that the affected ear was downward. Finally, after another 30-60s, the patient was brought to sitting position. Only one maneuver was performed per session.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* a history of brief episodes of positional vertigo, direction-changing horizontal nystagmus beating toward the uppermost (apogeotropic nystagmus) ear in both the lateral head turning positions,
* no spontaneous nystagmus during upright sitting position
* absence of identifiable central nervous system disorders that could explain the positional vertigo and nystagmus

Exclusion Criteria

* central positional nystagmus with identifiable CNS lesions that could explain the positional nystagmus
Minimum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Chonbuk National University

OTHER

Sponsor Role lead

Responsible Party

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Korean neuro-ophthalmology and neuro-otology society

Locations

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Chonbuk National University Hospital

Jeonju, Cholabuk-do, South Korea

Site Status

Chonnam National University Hospital

Kwangju, Cholanam-do, South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Treatment of HC BPPV

Identifier Type: -

Identifier Source: org_study_id

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