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Treatment of Geotropic Horizontal Canal Benign Paroxysmal Positional Vertigo (HC BPPV)

Primary Purpose

Benign Paroxysmal Positional Vertigo

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gufoni
Sham
Barbecue
Sponsored by
Chonbuk National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Paroxysmal Positional Vertigo focused on measuring BPPV(benign paroxysmal positional vertigo), HC-BPPV(BPPV involving the horizontal semicircular canal), Nystagmus, Treatment outcome, Horizontal Canal Benign Paroxysmal Positional Vertigo

Eligibility Criteria

11 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chonbuk National University Hospital
  • Chonnam National University Hospital
  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Gefoni manenuver

sham maneuver

barbecue maneuver

Arm Description

Gefoni manenuver for Geotropic HC-BPPV

sham maneuver for geotropic HC-BPPV

barbecue maneuver for geotropic HC-BPPV

Outcomes

Primary Outcome Measures

Immediate therapeutic effects for the treatment of geotropic HC-BPPV
The immediate treatment response was determined by participating neurologists in each clinic without knowing the maneuver applied to each patient from 30 minutes to one hour after initial maneuver. The absence of both vertigo and nystagmus was required to determine a resolution. When the patient still showed positioning nystagmus or vertigo, the patient received the previously applied maneuver again.

Secondary Outcome Measures

Full Information

First Posted
May 31, 2011
Last Updated
June 2, 2011
Sponsor
Chonbuk National University
Collaborators
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01366430
Brief Title
Treatment of Geotropic Horizontal Canal Benign Paroxysmal Positional Vertigo
Acronym
HC BPPV
Official Title
Treatment of Geotropic Horizontal Canal Benign Paroxysmal Positional Vertigo; Randomized Controlled Trial of Barbeque Rotation and Gufoni Maneuver
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chonbuk National University
Collaborators
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Paroxysmal Positional Vertigo
Keywords
BPPV(benign paroxysmal positional vertigo), HC-BPPV(BPPV involving the horizontal semicircular canal), Nystagmus, Treatment outcome, Horizontal Canal Benign Paroxysmal Positional Vertigo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gefoni manenuver
Arm Type
Active Comparator
Arm Description
Gefoni manenuver for Geotropic HC-BPPV
Arm Title
sham maneuver
Arm Type
Active Comparator
Arm Description
sham maneuver for geotropic HC-BPPV
Arm Title
barbecue maneuver
Arm Type
Active Comparator
Arm Description
barbecue maneuver for geotropic HC-BPPV
Intervention Type
Procedure
Intervention Name(s)
Gufoni
Intervention Description
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
Intervention Name(s)
Sham
Intervention Description
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
Intervention Name(s)
Barbecue
Intervention Description
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.
Primary Outcome Measure Information:
Title
Immediate therapeutic effects for the treatment of geotropic HC-BPPV
Description
The immediate treatment response was determined by participating neurologists in each clinic without knowing the maneuver applied to each patient from 30 minutes to one hour after initial maneuver. The absence of both vertigo and nystagmus was required to determine a resolution. When the patient still showed positioning nystagmus or vertigo, the patient received the previously applied maneuver again.
Time Frame
one hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chonbuk National University Hospital
City
Jeonju
State/Province
Cholabuk-do
ZIP/Postal Code
560-712
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Kwangju
State/Province
Cholanam-do
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Kyungki-do
Country
Korea, Republic of

12. IPD Sharing Statement

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Treatment of Geotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

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