The Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo (BPPV)

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

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.

Study Overview

• Status: Completed
• Conditions: Benign Paroxysmal Positional Vertigo
• Intervention / Treatment: Procedure: Modified Epley maneuver; Procedure: Semont maneuver; Procedure: Reverse Epley 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 Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 138-736
      • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Epley maneuver; The group using modified Epley maneuver for PSCC BPPV	Procedure: Modified Epley maneuver; For Modified Epley maneuver, the patient was placed in the upright position with the head turned 45 degrees toward the affected ear. And then the patient was rapidly laid back to the supine head-hanging position for 1 minute. Next, the head was turned 90 degrees toward the other (unaffected) side for 1 minute. Next, the head is turned a further 90 degrees (usually necessitating the patient's body to also move from the supine position to the lateral decubitus position) such that the patient' head is nearly in the facedown position for 1 minute. The patient is then brought into the upright sitting position for 1 minute, completing the maneuver.
Active Comparator: Semont maneuver; The group using Semont maneuver for PSCC BPPV	Procedure: Semont maneuver; Patient's head was turned 45 degrees toward the healthy side. And then patient was rapidly moved to affected side-lying position and sustained for 2 minutes. Next, Patient is rapidly taken to the opposite side-lying position without pausing in the sitting position or changing the head position relative to the shoulder for 2 minutes. Next, Patient returns slowly with the head still tilted and fixed until the seated position for 1 minute.
Sham Comparator: Sham; The group using Reverse Epley maneuver for PSCC BPPV	Procedure: Reverse Epley maneuver; Like the modified Epley maneuver, but the direction was reverse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Study Director: Hongju Park, Professor, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: January 6, 2014
• First Submitted That Met QC Criteria: January 6, 2014
• First Posted (Estimate): January 8, 2014

Study Record Updates

• Last Update Posted (Estimate): January 8, 2014
• Last Update Submitted That Met QC Criteria: January 6, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Vertigo; Otorhinolaryngologic Diseases; PSCC(Posterior semicircular canal); BPPV(Bening paroxysmal positional vertigo)
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness
• Other Study ID Numbers: PSCC_BPPV_Kr