Benign Paroxysmal Positional Vertigo Clinical Trial
— BPPVOfficial title:
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
Verified date | January 2014 |
Source | Asan Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Korea: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 99 |
Est. completion date | June 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center | Seoul | Songpa-gu |
Lead Sponsor | Collaborator |
---|---|
Asan Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Initial Effectiveness of Treatment for the Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo | 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. | 20 minutes | No |
Secondary | Delayed Effectiveness of Treatment for the Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo | Ather 1 day and 7 days after the initial treatment was applied, the patients were re-visit the clinic and re-examined with the Dix-Hallpike test. The absence of nystagmus and vertigo was determinded. | 1, 7 day | No |
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