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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01366430
Other study ID # Treatment of HC BPPV
Secondary ID
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


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
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