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Clinical Trials/NCT00810641
NCT00810641CompletedPhase 3

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

Chonbuk National University3 sites in 1 country157 target enrollmentStarted: January 1, 2009Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
157
Locations
3
Primary Endpoint
Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Chonbuk National University
Sponsor Class
Other

Study Sites (3)

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