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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02046980
Other study ID # DK-0001
Secondary ID
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
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