Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

Randomized Multicenter Study of Treatment of Horizontal Canal Benign Paroxysmal Positional Vertigo

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00810641

Acronym

BPPV-HC

Enrollment

157

Registered

2008-12-18

Start date

2009-01-31

Completion date

2011-05-31

Last updated

2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HC-BPPV

Keywords

BPPV(benign paroxysmal positional vertigo), HC-BPPV(BPPV involving the horizontal semicircular canal), Nystagmus, Treatment outcome, Horizontal Canal Benign Paroxysmal Positional Vertigo

Brief 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).

Detailed description

A randomized prospective study of patients with HC-BPPV. Patients with apogeotropic type of HC-BPPV were randomized to one of each three treatment groups at their first clinic visit. These groups included the Gufoni maneuver, head-shaking maneuver, and sham group in apogeotropic HC-BPPV. Responsiveness of treatment maneuver was determined by positioning maneuver immediately after each treatment method based on resolves of vertigo and positional nystagmus.

Interventions

PROCEDUREGufoni 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).

PROCEDUREHead-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.

PROCEDUREsham maneuver

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* a history of brief episodes of positional vertigo, * direction-changing horizontal nystagmus beating toward the uppermost (apogeotropic nystagmus) or undermost (geotropic nystagmus) ear in both the lateral head turning positions, * no spontaneous nystagmus during upright sitting position, and * 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

Design outcomes

Primary

Measure	Time frame	Description
Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial	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.

Countries

South Korea

Participant flow

Recruitment details

Between February 2009 and October 2009, consecutive patients with a diagnosis of apogeotropic HC-BPPV were recruited from nationwide 10 Dizziness Clinics in Korea.

Pre-assignment details

We defined the transition as a conversion into another canal type of BPPV without intervening periods of remission. In contrast, recurrence was defined as a redevelopment of any type of BPPV after a confirmed resolution of the positioning nystagmus and vertigo.

Participants by arm

Arm	Count
Gufoni Maneuver Gufoni maneuver for apogeotropic HC-BPPV	52
Headshaking Maneuver headshaking maneuver for apogeotropic HC BPPV	54
Sham Maneuver sham maneuver for apogeotropci HC BPPV	51
Total	157

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Withdrawal by Subject	0	1	2

Baseline characteristics

Characteristic	Headshaking Maneuver	Sham Maneuver	Gufoni Maneuver	Total
Age, Categorical <=18 years	0 Participants	0 Participants	1 Participants	1 Participants
Age, Categorical >=65 years	24 Participants	24 Participants	19 Participants	67 Participants
Age, Categorical Between 18 and 65 years	30 Participants	27 Participants	32 Participants	89 Participants
Age Continuous	60.5 years STANDARD_DEVIATION 12.4	61.5 years STANDARD_DEVIATION 14.9	57.8 years STANDARD_DEVIATION 13.5	59.9 years STANDARD_DEVIATION 13.6
Region of Enrollment Korea, Republic of	54 participants	51 participants	52 participants	157 participants
Sex: Female, Male Female	30 Participants	28 Participants	39 Participants	97 Participants
Sex: Female, Male Male	24 Participants	23 Participants	13 Participants	60 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0	0 / 0

Outcome results

Primary