Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
HyunAh Kim, Keimyung University Dongsan Medical Center
ClinicalTrials.gov Identifier:
NCT02046980
First received: January 25, 2014
Last updated: February 12, 2016
Last verified: February 2016
  Purpose
To determine the short term therapeutic efficacies of Gufoni maneuver and mastoid oscillation in apogeotropic type of benign paroxysmal positional vertigo (BPPV) involving the horizontal semicircular canal (HC-BPPV), a randomized, prospective, sham-controlled study was conducted.

Condition Intervention Phase
Benign Paroxysmal Positional Vertigo
Procedure: Gufoni
Procedure: Vibration
Procedure: Sham
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Keimyung University Dongsan Medical Center:

Primary Outcome Measures:
  • Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Enrollment: 209
Study Start Date: September 2013
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gufoni
Gufoni maneuver for apogeotropic horizontal BPPV at the first day
Procedure: Gufoni
Experimental: Vibration
Vibration maneuver for apogeotropic horizontal BPPV at the first day
Procedure: Vibration
Sham Comparator: Sham
Sham maneuver for apogeotropic horizontal BPPV at the first day
Procedure: Sham

Detailed Description:
The apogeotropic type of benign paroxysmal positional vertigo involving the horizontal canal (HC-BPPV) is likely due to otolithic debris in the anterior arm of the canal (canalithiasis) or the debris attached to the cupula (cupulolithiasis). It is important to seek the method to convert treatment-resistant apogeotropic form to the more treatment-responsive geotropic form in HC-BPPV. Recent randomized trials demonstrated that head shaking maneuver was more effective than the modified Semont maneuver and the Gufoni and head shaking maneuvers showed similar efficacy in treating apogeotropic HC-BPPV. Moreover, new repositioning maneuver using mastoid vibration showed good efficacies in patients with apogeotropic HC-BPPV in recent study. So we tried to compare the short term therapeutic efficacies of Gufoni maneuver and mastoid oscillation in apogeotropic HC-BPPV with a randomized, prospective, sham-controlled study.
  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. history of vertigo associated with changes in head position
  2. direction-changing horizontal nystagmus beating toward the uppermost ear (apogeotropic nystagmus) in both turning positions detected with Frenzel glasses or videoculography in the Head turning test
  3. vertigo associated with the elicited nystagmus
  4. symptom within 2 weeks
  5. put one's signature on consent

Exclusion Criteria:

  1. patients with identifiable central nervous system disorders that could explain the positional vertigo and nystagmus
  2. the patients with apogeotropic form which was transited from geotropic after previous therapeutic maneuvers
  3. the patients who transited from apogeotropic from vertical canal BPPV during study
  4. patients who had possible cause of secondary BPPV such as Meniere's disease, migraine or recent trauma history
  5. patients whose affected ear cannot be identified
  6. patients with multiple canal atypical positional nystagmus or who were treated previously with repositioning maneuvers were excluded.
  7. patients with cervical or lumbar spine problem
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02046980

Locations
Korea, Republic of
Daegu Kyungbook Dizziness society
Daegu, Korea, Republic of
Sponsors and Collaborators
Keimyung University Dongsan Medical Center
Investigators
Study Director: Hyun Ah Kim Daegu KyungBook Dizziness society
Study Chair: Hyung Lee Keimyung University Dongsan Medical Centerl
  More Information

Responsible Party: HyunAh Kim, Assistant Professor, Keimyung University Dongsan Medical Center
ClinicalTrials.gov Identifier: NCT02046980     History of Changes
Other Study ID Numbers: DK-0001 
Study First Received: January 25, 2014
Results First Received: December 4, 2015
Last Updated: February 12, 2016
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Vertigo
Ear Diseases
Labyrinth Diseases
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Signs and Symptoms
Vestibular Diseases

ClinicalTrials.gov processed this record on April 27, 2016