Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

NCT ID: NCT02046980

Last Updated: 2016-03-11

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-07-31

Brief Summary

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To determine the short term therapeutic efficacies of Gufoni maneuver and mastoid oscillation in apogeotropic type of benign paroxysmal positional vertigo (BPPV) involving the horizontal semicircular canal (HC-BPPV), a randomized, prospective, sham-controlled study was conducted.

Detailed Description

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The apogeotropic type of benign paroxysmal positional vertigo involving the horizontal canal (HC-BPPV) is likely due to otolithic debris in the anterior arm of the canal (canalithiasis) or the debris attached to the cupula (cupulolithiasis). It is important to seek the method to convert treatment-resistant apogeotropic form to the more treatment-responsive geotropic form in HC-BPPV. Recent randomized trials demonstrated that head shaking maneuver was more effective than the modified Semont maneuver and the Gufoni and head shaking maneuvers showed similar efficacy in treating apogeotropic HC-BPPV. Moreover, new repositioning maneuver using mastoid vibration showed good efficacies in patients with apogeotropic HC-BPPV in recent study. So we tried to compare the short term therapeutic efficacies of Gufoni maneuver and mastoid oscillation in apogeotropic HC-BPPV with a randomized, prospective, sham-controlled study.

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 Outcome Assessors

Study Groups

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Gufoni

Gufoni maneuver for apogeotropic horizontal BPPV at the first day

Group Type EXPERIMENTAL

Gufoni

Intervention Type PROCEDURE

Vibration

Vibration maneuver for apogeotropic horizontal BPPV at the first day

Group Type EXPERIMENTAL

Vibration

Intervention Type PROCEDURE

Sham

Sham maneuver for apogeotropic horizontal BPPV at the first day

Group Type SHAM_COMPARATOR

Sham

Intervention Type PROCEDURE

Interventions

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Gufoni

Intervention Type PROCEDURE

Vibration

Intervention Type PROCEDURE

Sham

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. history of vertigo associated with changes in head position
2. direction-changing horizontal nystagmus beating toward the uppermost ear (apogeotropic nystagmus) in both turning positions detected with Frenzel glasses or videoculography in the Head turning test
3. vertigo associated with the elicited nystagmus
4. symptom within 2 weeks
5. put one's signature on consent

Exclusion Criteria

1. patients with identifiable central nervous system disorders that could explain the positional vertigo and nystagmus
2. the patients with apogeotropic form which was transited from geotropic after previous therapeutic maneuvers
3. the patients who transited from apogeotropic from vertical canal BPPV during study
4. patients who had possible cause of secondary BPPV such as Meniere's disease, migraine or recent trauma history
5. patients whose affected ear cannot be identified
6. patients with multiple canal atypical positional nystagmus or who were treated previously with repositioning maneuvers were excluded.
7. patients with cervical or lumbar spine problem
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keimyung University Dongsan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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HyunAh Kim

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyun Ah Kim

Role: STUDY_DIRECTOR

Daegu KyungBook Dizziness society

Hyung Lee

Role: STUDY_CHAIR

Keimyung University Dongsan Medical Centerl

Locations

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Daegu Kyungbook Dizziness society

Daegu, , South Korea

Site Status

Countries

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South Korea

References

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Kim HA, Park SW, Kim J, Kang BG, Lee J, Han BI, Seok JI, Chung EJ, Kim J, Lee H. Efficacy of mastoid oscillation and the Gufoni maneuver for treating apogeotropic horizontal benign positional vertigo: a randomized controlled study. J Neurol. 2017 May;264(5):848-855. doi: 10.1007/s00415-017-8422-2. Epub 2017 Feb 20.

Reference Type DERIVED
PMID: 28220291 (View on PubMed)

Other Identifiers

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DK-0001

Identifier Type: -

Identifier Source: org_study_id

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