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Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

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ClinicalTrials.gov Identifier: NCT02046980
Recruitment Status : Completed
First Posted : January 28, 2014
Results First Posted : March 11, 2016
Last Update Posted : March 11, 2016
Sponsor:
Information provided by (Responsible Party):
HyunAh Kim, Keimyung University Dongsan Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Benign Paroxysmal Positional Vertigo Procedure: Gufoni Procedure: Vibration Procedure: Sham Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus [ Time Frame: 2 days ]


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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: HyunAh Kim, Assistant Professor, Keimyung University Dongsan Medical Center
ClinicalTrials.gov Identifier: NCT02046980     History of Changes
Other Study ID Numbers: DK-0001
First Posted: January 28, 2014    Key Record Dates
Results First Posted: March 11, 2016
Last Update Posted: March 11, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Vertigo
Dizziness
Benign Paroxysmal Positional Vertigo
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders