Treatment of Geotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

Benign Paroxysmal Positional Vertigo Clinical Trial

— HC BPPV  

Official title:

Treatment of Geotropic Horizontal Canal Benign Paroxysmal Positional Vertigo; Randomized Controlled Trial of Barbeque Rotation and Gufoni Maneuver

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366430
• Other study ID #: Treatment of HC BPPV
• Status: Completed
• Phase: Phase 3
• First received: May 31, 2011
• Last updated: June 2, 2011
• Start date: January 2009
• Est. completion date: April 2011

Study information

• Verified date: January 2009
• Source: Chonbuk National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Paroxysmal Positional Vertigo
• Dizziness
• Vertigo

Intervention

Procedure:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital	Jeonju	Cholabuk-do
Korea, Republic of	Chonnam National University Hospital	Kwangju	Cholanam-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Kyungki-do

Sponsors (2)

Lead Sponsor	Collaborator
Chonbuk National University	Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one hour	No