Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo (BPPV-HC)

This study has been completed.
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by:
Chonbuk National University
ClinicalTrials.gov Identifier:
NCT00810641
First received: December 17, 2008
Last updated: May 31, 2011
Last verified: May 2011

December 17, 2008
May 31, 2011
January 2009
May 2011   (final data collection date for primary outcome measure)
Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial [ Time Frame: one hour ] [ Designated as safety issue: No ]
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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Complete list of historical versions of study NCT00810641 on ClinicalTrials.gov Archive Site
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Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo
Randomized Multicenter Study of Treatment of Horizontal Canal Benign Paroxysmal Positional Vertigo

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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).
  • 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.
  • Procedure: sham maneuver
    For the sham maneuver, patients quickly lied on the unaffected side, and returned to the sitting position after one minute.
  • Active Comparator: Gufoni maneuver
    Gufoni maneuver for apogeotropic HC-BPPV
    Intervention: Procedure: Gufoni maneuver
  • Active Comparator: Headshaking maneuver
    headshaking maneuver for apogeotropic HC BPPV
    Intervention: Procedure: Head-shaking maneuver
  • Sham Comparator: sham maneuver
    sham maneuver for apogeotropic HC BPPV
    Intervention: Procedure: sham maneuver
Kim JS, Oh SY, Lee SH, Kang JH, Kim DU, Jeong SH, Choi KD, Moon IS, Kim BK, Oh HJ, Kim HJ. Randomized clinical trial for apogeotropic horizontal canal benign paroxysmal positional vertigo. Neurology. 2012 Jan 17;78(3):159-66. doi: 10.1212/WNL.0b013e31823fcd26. Epub 2011 Dec 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
157
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00810641
KONOS
Yes
KONOS, Korean neuro-ophthalmology and neuro-otology society
Chonbuk National University
Seoul National University Bundang Hospital
Not Provided
Chonbuk National University
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP