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Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

Primary Purpose

Benign Paroxysmal Positional Vertigo

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Gufoni

Vibration

Sham

About this trial

This is an interventional treatment trial for Benign Paroxysmal Positional Vertigo

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

history of vertigo associated with changes in head position
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
vertigo associated with the elicited nystagmus
symptom within 2 weeks
put one's signature on consent

Exclusion Criteria:

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

Sites / Locations

Daegu Kyungbook Dizziness society

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Arm Label

Gufoni

Vibration

Sham

Arm Description

Gufoni maneuver for apogeotropic horizontal BPPV at the first day

Vibration maneuver for apogeotropic horizontal BPPV at the first day

Sham maneuver for apogeotropic horizontal BPPV at the first day

Outcomes

Primary Outcome Measures

Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus

Secondary Outcome Measures

Full Information

NCT ID

NCT02046980

First Posted

January 25, 2014

Last Updated

February 12, 2016

Sponsor

Keimyung University Dongsan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02046980

Brief Title

Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Keimyung University Dongsan Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Paroxysmal Positional Vertigo

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

209 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gufoni

Arm Type

Experimental

Arm Description

Gufoni maneuver for apogeotropic horizontal BPPV at the first day

Arm Title

Vibration

Arm Type

Experimental

Arm Description

Vibration maneuver for apogeotropic horizontal BPPV at the first day

Arm Title

Sham

Arm Type

Sham Comparator

Arm Description

Sham maneuver for apogeotropic horizontal BPPV at the first day

Intervention Type

Procedure

Intervention Name(s)

Gufoni

Intervention Type

Procedure

Intervention Name(s)

Vibration

Intervention Type

Procedure

Intervention Name(s)

Sham

Primary Outcome Measure Information:

Title

Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus

Time Frame

2 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: history of vertigo associated with changes in head position 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 vertigo associated with the elicited nystagmus symptom within 2 weeks put one's signature on consent Exclusion Criteria: patients with identifiable central nervous system disorders that could explain the positional vertigo and nystagmus the patients with apogeotropic form which was transited from geotropic after previous therapeutic maneuvers the patients who transited from apogeotropic from vertical canal BPPV during study patients who had possible cause of secondary BPPV such as Meniere's disease, migraine or recent trauma history patients whose affected ear cannot be identified patients with multiple canal atypical positional nystagmus or who were treated previously with repositioning maneuvers were excluded. patients with cervical or lumbar spine problem

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hyun Ah Kim

Organizational Affiliation

Daegu KyungBook Dizziness society

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Hyung Lee

Organizational Affiliation

Keimyung University Dongsan Medical Centerl

Official's Role

Study Chair

Facility Information:

Facility Name

Daegu Kyungbook Dizziness society

City

Daegu

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

28220291

Citation

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.

Results Reference

derived

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Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

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