Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo (BPPV-HC)
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|ClinicalTrials.gov Identifier: NCT00810641|
Recruitment Status : Completed
First Posted : December 18, 2008
Results First Posted : June 27, 2011
Last Update Posted : June 27, 2011
|Condition or disease||Intervention/treatment||Phase|
|HC-BPPV||Procedure: Gufoni maneuver Procedure: Head-shaking maneuver Procedure: sham maneuver||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||157 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized Multicenter Study of Treatment of Horizontal Canal Benign Paroxysmal Positional Vertigo|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
Active Comparator: Gufoni maneuver
Gufoni maneuver for apogeotropic HC-BPPV
Procedure: Gufoni maneuver
For Gufoni maneuver,16,18 the patient was quickly brought down to the side-lying position on the affected ear from the sitting position. After one minute in this position, the head of the patient was quickly turned 45O upward, so that the nose directed upward. Approximately 2 minutes later, the patient was returned to the upright position (Figure 2A).
Active Comparator: Headshaking maneuver
headshaking maneuver for apogeotropic HC BPPV
Procedure: Head-shaking maneuver
For head-shaking maneuver,15 patients were brought into a sitting position. After pitching the head forward by approximately 30O, we moved the head sideways in a sinusoidal fashion at an approximate rate of 3 Hz for 15 seconds.
Sham Comparator: sham maneuver
sham maneuver for apogeotropic HC BPPV
Procedure: sham maneuver
For the sham maneuver, patients quickly lied on the unaffected side, and returned to the sitting position after one minute.
- Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial [ 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810641
|Korea, Republic of|
|Chonbuk National University Hospital|
|Jeonju, Cholabuk-do, Korea, Republic of, 560-712|
|Seoul National University Bundang Hospital|
|Seongnam, Kyoungki-do, Korea, Republic of|