The Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo

NCT02029508 | Completed Phase 3

• 1 other identifier: PSCC_BPPV_Kr
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Paroxysmal Positional Vertigo

Keywords

PSCC(Posterior semicircular canal); BPPV(Bening paroxysmal positional vertigo); Vertigo; Otorhinolaryngologic Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Delayed Effectiveness of Treatment for the Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo

  1, 7 day

Study Arms (3)

Epley maneuver

ACTIVE COMPARATOR

The group using modified Epley maneuver for PSCC BPPV

Procedure: Modified Epley maneuver

Semont maneuver

ACTIVE COMPARATOR

The group using Semont maneuver for PSCC BPPV

Procedure: Semont maneuver

Sham

SHAM COMPARATOR

The group using Reverse Epley maneuver for PSCC BPPV

Procedure: Reverse Epley maneuver

Interventions

Modified Epley maneuver PROCEDURE

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.

Epley maneuver

Semont maneuver PROCEDURE

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.

Semont maneuver

Reverse Epley maneuver PROCEDURE

Like the modified Epley maneuver, but the direction was reverse.

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a symptom of positional vertigo
• rotational and upbeating nystagmus in Dix-Hallpike test
• the nystagmus should be disappear within 60 seconds
• no spontaneous nystagmus

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

Location

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo; Vertigo; Otorhinolaryngologic Diseases

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hongju Park, Professor

  Asan Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 8, 2014
• Study Start: October 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 8, 2014

Record last verified: 2014-01

Locations

KR (1)