The Effectiveness Comparison of Three Different Methods for the Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo: Prospective, Double Blinded, Randomized, Multicenter Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Benign Paroxysmal Positional Vertigo
- Sponsor
- Asan Medical Center
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Initial Effectiveness of Treatment for the Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study was to compare the treatment effectiveness of three different methods for posterior semicircular canal benign paroxysmal positional vertigo. The included methods are Modified Epley maneuver, Semont maneuver and Sham maneuver.
Detailed Description
This study was a prospective, double blinded, randomized, multicenter clinical trial. The enrolled posterior semicircular canal benign paroxysmal positional vertigo patients were randomized to one of the three treatment regimens when they are diagnosed with the Dix-Hallpike test. An then the patient was treated with one of the three maneuvers. After 20 minutes, the patient was examined with the Dix-Hallpike test again. The resolution of nystagmus and symptoms were checked. When the nystagmus was sustained, the same treatment was applied once again. And after 20 minutes, the patient was examined with the Dix-Hallpike test too. 1 day after and 7 days after, the patient was re-examined with the Dix-Hallpike test.
Investigators
Hong Ju Park
Professor
Asan Medical Center
Eligibility Criteria
Inclusion Criteria
- •a symptom of positional vertigo
- •rotational and upbeating nystagmus in Dix-Hallpike test
- •the nystagmus should be disappear within 60 seconds
- •no spontaneous nystagmus
Exclusion Criteria
- •ages under 18 years
- •suspicious or verified a central nervous system lesion
- •traumatic vertigo patients
- •other otologic disease(acute/chronic otitis media, otosclerosis, etc)
- •other vestibular disease(vestibular neuronitis, Meniere's disease, etc)
- •congenital nystagmus patients
- •the patients with spinal disease
- •the patients with the limitation of cervical movement
Outcomes
Primary Outcomes
Initial Effectiveness of Treatment for the Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo
Time Frame: 20 minutes
The immediate effectiveness of treatment was determined by otolaryngologists with the Dix-Hallpike test 20 minutes after initial manerver applied. The investigator had no information of the treatment applied to the patient. The complete resolution means absence of nystagmus and paroxysmal vertigo symptom. If there was a sustained nystagmus, the latency and duration was measured.
Secondary Outcomes
- Delayed Effectiveness of Treatment for the Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo(1, 7 day)