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

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

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).

Study Overview

• Status: Completed
• Conditions: Benign Paroxysmal Positional Vertigo
• Intervention / Treatment: Procedure: Gufoni; Procedure: Sham; Procedure: Barbecue

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 Type: Interventional
• Enrollment (Actual): 170
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Cholabuk-do
    • Jeonju, Cholabuk-do, Korea, Republic of, 560-712
      • Chonbuk National University Hospital
  • Cholanam-do
    • Kwangju, Cholanam-do, Korea, Republic of
      • Chonnam National University Hospital
  • Kyungki-do
    • Seongnam, Kyungki-do, Korea, Republic of
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gefoni manenuver; Gefoni manenuver for Geotropic HC-BPPV	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.
Active Comparator: sham maneuver; sham maneuver for geotropic HC-BPPV	Procedure: 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.
Active Comparator: barbecue maneuver; barbecue maneuver for geotropic HC-BPPV	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chonbuk National University
• Collaborators: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: May 31, 2011
• First Submitted That Met QC Criteria: June 2, 2011
• First Posted (Estimate): June 6, 2011

Study Record Updates

• Last Update Posted (Estimate): June 6, 2011
• Last Update Submitted That Met QC Criteria: June 2, 2011
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: Nystagmus; Treatment outcome; BPPV(benign paroxysmal positional vertigo); HC-BPPV(BPPV involving the horizontal semicircular canal); Horizontal Canal Benign Paroxysmal Positional Vertigo
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness
• Other Study ID Numbers: Treatment of HC BPPV