CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 157 enrolled
Drug / intervention
Gufoni maneuver +2 moreprocedure
Likely dose
Not stated in record
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Search/NCT00810641
NCT00810641Phase 3Completed
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Randomized Multicenter Study of Treatment of Horizontal Canal Benign Paroxysmal Positional Vertigo

Chonbuk National University·interventional·Posted Dec 18, 2008·Updated Jun 27, 2011

In Brief

A Phase 3 clinical trial evaluating Gufoni maneuver, Head-shaking maneuver, and 1 other intervention for HC-BPPV. Completed, enrolled 157 participants across 2 sites.

Detailed Summary

The purpose of this study was to compare the immediate efficacies of each treatment maneuvers in treatment of apogeotropic horizontal canal benign paroxysmal positional vertigo (HC-BPPV).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHC-BPPV
CountriesSouth Korea
CollaboratorsSeoul National University Bundang Hospital

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 18, 2008
Enrollment StartJan 1, 2009
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.5 years ago

Interventions

Gufoni maneuverprocedure

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).

Head-shaking maneuverprocedure

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 maneuverprocedure

For the sham maneuver, patients quickly lied on the unaffected side, and returned to the sitting position after one minute.