Phase 2
N=217
Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo
Benign Paroxysmal Positional Vertigo
Bottom Line
View on ClinicalTrials.gov: NCT02046980 ↗Enrolled (actual)
217
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus — 51; 46; 38 participants — p=0.02839
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gufoni (Procedure); Vibration (Procedure); Sham (Procedure)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Keimyung University Dongsan Medical Center
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus |
51; 46; 38 | 0.02839 sig |
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.
Eligibility Criteria
Inclusion Criteria
- history of vertigo associated with changes in head position
- 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
- vertigo associated with the elicited nystagmus
- symptom within 2 weeks
- put one's signature on consent
Exclusion Criteria
- patients with identifiable central nervous system disorders that could explain the positional vertigo and nystagmus
- the patients with apogeotropic form which was transited from geotropic after previous therapeutic maneuvers
- the patients who transited from apogeotropic from vertical canal BPPV during study
- patients who had possible cause of secondary BPPV such as Meniere's disease, migraine or recent trauma history
- patients whose affected ear cannot be identified
- patients with multiple canal atypical positional nystagmus or who were treated previously with repositioning maneuvers were excluded.
- patients with cervical or lumbar spine problem
Data sourced from ClinicalTrials.gov (NCT02046980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.