Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

NCT ID: NCT00810641

Last Updated: 2011-06-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-05-31

Brief Summary

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The purpose of this study was to compare the immediate efficacies of each treatment maneuvers in treatment of apogeotropic 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 apogeotropic type of HC-BPPV were randomized to one of each three treatment groups at their first clinic visit. These groups included the Gufoni maneuver, head-shaking maneuver, and sham group in apogeotropic 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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HC-BPPV

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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Gufoni maneuver

Gufoni maneuver for apogeotropic HC-BPPV

Group Type ACTIVE_COMPARATOR

Gufoni maneuver

Intervention Type PROCEDURE

For Gufoni maneuver,16,18 the patient was quickly brought down to the side-lying position on the affected ear from the sitting position. After one minute in this position, the head of the patient was quickly turned 45O upward, so that the nose directed upward. Approximately 2 minutes later, the patient was returned to the upright position (Figure 2A).

Headshaking maneuver

headshaking maneuver for apogeotropic HC BPPV

Group Type ACTIVE_COMPARATOR

Head-shaking maneuver

Intervention Type PROCEDURE

For head-shaking maneuver,15 patients were brought into a sitting position. After pitching the head forward by approximately 30O, we moved the head sideways in a sinusoidal fashion at an approximate rate of 3 Hz for 15 seconds.

sham maneuver

sham maneuver for apogeotropic HC BPPV

Group Type SHAM_COMPARATOR

sham maneuver

Intervention Type PROCEDURE

For the sham maneuver, patients quickly lied on the unaffected side, and returned to the sitting position after one minute.

Interventions

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Gufoni maneuver

For Gufoni maneuver,16,18 the patient was quickly brought down to the side-lying position on the affected ear from the sitting position. After one minute in this position, the head of the patient was quickly turned 45O upward, so that the nose directed upward. Approximately 2 minutes later, the patient was returned to the upright position (Figure 2A).

Intervention Type PROCEDURE

Head-shaking maneuver

For head-shaking maneuver,15 patients were brought into a sitting position. After pitching the head forward by approximately 30O, we moved the head sideways in a sinusoidal fashion at an approximate rate of 3 Hz for 15 seconds.

Intervention Type PROCEDURE

sham maneuver

For the sham maneuver, patients quickly lied on the unaffected side, and returned to the sitting position after one minute.

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) or undermost (geotropic nystagmus) ear in both the lateral head turning positions,
* no spontaneous nystagmus during upright sitting position, and
* 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

18 Years

Maximum Eligible Age

80 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

Seoul National University Bundang Hospital

Seongnam, Kyoungki-do, South Korea

Site Status

Countries

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South Korea

References

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Kim JS, Oh SY, Lee SH, Kang JH, Kim DU, Jeong SH, Choi KD, Moon IS, Kim BK, Oh HJ, Kim HJ. Randomized clinical trial for apogeotropic horizontal canal benign paroxysmal positional vertigo. Neurology. 2012 Jan 17;78(3):159-66. doi: 10.1212/WNL.0b013e31823fcd26. Epub 2011 Dec 14.

Reference Type DERIVED
PMID: 22170885 (View on PubMed)

Other Identifiers

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KONOS

Identifier Type: -

Identifier Source: org_study_id

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