Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

Benign Paroxysmal Positional Vertigo Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046980
• Other study ID #: DK-0001
• Status: Completed
• Phase: Phase 2
• First received: January 25, 2014
• Last updated: February 12, 2016
• Start date: September 2013
• Est. completion date: July 2015

Study information

• Verified date: February 2016
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Benign Paroxysmal Positional Vertigo
• Vertigo

Intervention

Procedure:
• Gufoni

• Vibration

• Sham

Locations

Country	Name	City	State
Korea, Republic of	Daegu Kyungbook Dizziness society	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus		2 days	No