The Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo

Phase 3

Completed

• Conditions: Benign Paroxysmal Positional Vertigo
• Interventions: Procedure: Modified Epley maneuver; Procedure: Semont maneuver; Procedure: Reverse Epley maneuver

• Registration Number: NCT02029508
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-02
• Study Completion: 2013-06
• Status Verified: 2014-01
• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-06
• Last Update Submitted: 2014-01-06
• Study First Posted: 2014-01-08
• Last Update Posted: 2014-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epley maneuver	Modified Epley maneuver	The group using modified Epley maneuver for PSCC BPPV
Semont maneuver	Semont maneuver	The group using Semont maneuver for PSCC BPPV
Sham	Reverse Epley maneuver	The group using Reverse Epley maneuver for PSCC BPPV

Primary Outcome Measures

Name	Time	Method
Initial Effectiveness of Treatment for the Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo	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 Outcome Measures

Name	Time	Method
Delayed Effectiveness of Treatment for the Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo	1, 7 day	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.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of