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Completed

NCT Number: NCT02029508

The Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo

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.

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Key information

Conditions

Benign Paroxysmal Positional Vertigo Ear Diseases Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Vertigo Vestibular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Reverse Epley maneuver

Procedure

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

Primary outcomes

  1. Initial Effectiveness of Treatment for the Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study 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

Acronym: BPPV

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 8, 2014
Registry last updated
Jan 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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