Treatment of Geotropic Horizontal Canal Benign Paroxysmal Positional Vertigo (HC BPPV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01366430|
Recruitment Status : Completed
First Posted : June 6, 2011
Last Update Posted : June 6, 2011
|Condition or disease||Intervention/treatment||Phase|
|Benign Paroxysmal Positional Vertigo||Procedure: Gufoni Procedure: Sham Procedure: Barbecue||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Treatment of Geotropic Horizontal Canal Benign Paroxysmal Positional Vertigo; Randomized Controlled Trial of Barbeque Rotation and Gufoni Maneuver|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Active Comparator: Gefoni manenuver
Gefoni manenuver for Geotropic HC-BPPV
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
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
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.
- Immediate therapeutic effects for the treatment of geotropic HC-BPPV [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366430
|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|