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

This study has been completed.
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by:
Chonbuk National University
ClinicalTrials.gov Identifier:
NCT01366430
First received: May 31, 2011
Last updated: June 2, 2011
Last verified: January 2009
  Purpose

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).


Condition Intervention Phase
Benign Paroxysmal Positional Vertigo
Procedure: Gufoni
Procedure: Sham
Procedure: Barbecue
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Geotropic Horizontal Canal Benign Paroxysmal Positional Vertigo; Randomized Controlled Trial of Barbeque Rotation and Gufoni Maneuver

Resource links provided by NLM:


Further study details as provided by Chonbuk National University:

Primary Outcome Measures:
  • Immediate therapeutic effects for the treatment of geotropic HC-BPPV [ Time Frame: one hour ] [ Designated as safety issue: No ]
    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.


Enrollment: 170
Study Start Date: January 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   11 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366430

Locations
Korea, Republic of
Chonbuk National University Hospital
Jeonju, Cholabuk-do, Korea, Republic of, 560-712
Chonnam National University Hospital
Kwangju, Cholanam-do, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Kyungki-do, Korea, Republic of
Sponsors and Collaborators
Chonbuk National University
Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: KONOS, Korean neuro-ophthalmology and neuro-otology society
ClinicalTrials.gov Identifier: NCT01366430     History of Changes
Other Study ID Numbers: Treatment of HC BPPV
Study First Received: May 31, 2011
Last Updated: June 2, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chonbuk National University:
BPPV(benign paroxysmal positional vertigo)
HC-BPPV(BPPV involving the horizontal semicircular canal)
Nystagmus
Treatment outcome
Horizontal Canal Benign Paroxysmal Positional Vertigo

Additional relevant MeSH terms:
Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders

ClinicalTrials.gov processed this record on July 22, 2014