The Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo

NCT ID: NCT02029508

Last Updated: 2014-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-06-30

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.

Conditions

Benign Paroxysmal Positional Vertigo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Epley maneuver

The group using modified Epley maneuver for PSCC BPPV

Group Type: ACTIVE_COMPARATOR

Modified Epley maneuver

Intervention Type: 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.

Semont maneuver

The group using Semont maneuver for PSCC BPPV

Group Type: ACTIVE_COMPARATOR

Semont maneuver

Intervention Type: 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.

Sham

The group using Reverse Epley maneuver for PSCC BPPV

Group Type: SHAM_COMPARATOR

Reverse Epley maneuver

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Reverse Epley maneuver

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Hong Ju Park

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongju Park, Professor

Role: STUDY_DIRECTOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, Songpa-gu, South Korea

Countries

South Korea

Other Identifiers

PSCC_BPPV_Kr

Identifier Type: -

Identifier Source: org_study_id