Treatment of Geotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

Phase 3

Completed

• Conditions: Benign Paroxysmal Positional Vertigo
• Interventions: Procedure: Gufoni; Procedure: Sham; Procedure: Barbecue

• Registration Number: NCT01366430
• Lead Sponsor: Chonbuk National University

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.

Study Timeline

• Status Verified: 2009-01
• Study Start: 2009-01
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-06-02
• Last Update Submitted: 2011-06-02
• Study First Posted: 2011-06-06
• Last Update Posted: 2011-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gefoni manenuver	Gufoni	Gefoni manenuver for Geotropic HC-BPPV
sham maneuver	Sham	sham maneuver for geotropic HC-BPPV
barbecue maneuver	Barbecue	barbecue maneuver for geotropic HC-BPPV

Primary Outcome Measures

Name	Time	Method
Immediate therapeutic effects for the treatment of geotropic HC-BPPV	one hour	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.

Trial Locations

Locations (3)

Chonnam National University Hospital; 🇰🇷 Kwangju, Cholanam-do, Korea, Republic of

Chonbuk National University Hospital; 🇰🇷 Jeonju, Cholabuk-do, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Kyungki-do, Korea, Republic of