Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients

March 5, 2018 updated by: David Burmeister, Lehigh Valley Hospital

A Randomized Trial to Evaluate Resolution of Symptoms Using Vestibular Rehab Versus Conventional Therapy in Patients Presenting to the Emergency Department (ED) With Diagnosis of Benign Paroxysmal Positional Vertigo (BPPV)

Benign Paroxysmal Positional Vertigo (BPPV) is a common complaint of emergency department patients. The importance of early diagnosis and treatment can lead to a much improved quality of life for patients afflicted by this ailment. It is the purpose of this study to evaluate and examine two methods of treatment. Patients will be randomized to receive the more common conventional medication therapy versus the canalith repositioning technique. All patients enrolled into this study are emergency department patients who have been diagnosed with BPPV via a positive Dix-Hallpike Maneuver. The hypothesis of this study is that vestibular rehabilitation will allow for resolution of symptoms without the use of conventional medication therapy in the acute management of BPPV in the emergency department patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Benign paroxysmal positional vertigo (BPPV) is the most common peripheral vestibular disorder, accounting for 20% of all vertigo cases. It was first described by Barany in 1921, and later described in more detail by Dix and Hallpike in 1952. Common practice by ED physicians is to rule out serious medical causes for their symptoms. It is presently common for ED physicians to treat these patients mainly with benzodiazepines, antihistamines, and anticholinergic medications, especially if the history and physical is consistent with BPPV. This method of treatment has had questionable success. Several reviews of the management of vertigo have shown that no medication in current use has well established curative or prophylactic value or is suitable for long-term treatment.

The purpose of this study is to compare the efficacy of vestibular rehabilitation vs. conventional therapy in ED patients who present with vertigo. The objectives to be determined in this study are as follows:

Objectives:

  1. To evaluate the improvement of vertigo in patients diagnosed with BPPV in the ED.
  2. To evaluate disposition time for those patients receiving vestibular rehabilitation in the ED compared to those patients who receive conventional therapy.
  3. To demonstrate the long-term improvement of symptomatology utilizing vestibular rehabilitation versus conventional therapy.
  4. Compare patient satisfaction between those patients who receive standard care vs. those who receive vestibular rehabilitation.

Inclusion Criteria:

  1. Subject is a male or female >18 years of age.
  2. Subject has presented to the Emergency Department Monday through Friday during the hours of 8 AM to 4:30 PM or possibly extended into the evening and weekend hours if research or physical therapy staff is available, and is diagnosed with BPPV.
  3. Subject has positive findings of vertigo and nystagmus when the Dix-Hallpike maneuver is performed during physical examination. A Dix-Hallpike maneuver will be considered positive when the patient experiences nystagmus but resolves or fatigues in less than 60 seconds
  4. Informed consent can be obtained for participation in this study.

Exclusion Criteria:

  1. Subject has taken any antihistamines or anticholinergics within the past 12 hours.
  2. Subjects who are unable to ambulate.
  3. Subjects with severe cervical spine disease or known cerebral vascular disease.
  4. Any positive findings during the neurological exam during physical examination.
  5. Subjects who have negative finding of vertigo and nystagmus when the Dix- Hallpike maneuver is performed by the Physical Therapist or research staff even if the subject had a positive finding of vertigo and nystagmus when the Dix-Hallpike maneuver was performed by the physician or resident.
  6. Subjects with a known history of Meniere's Disease.
  7. Any cardiac complaints during physical examination or subject has experienced a positive loss of consciousness.
  8. Subject has been previously enrolled in this study.
  9. Subjects with mental conditions that render them unable to understand the nature,
  10. Subjects who are unlikely to comply with the study such as subjects with uncooperative attitude, unlikely to complete follow-up visits, or unlikely to complete the study.
  11. Any other condition which would confound or interfere with evaluation or prevent compliance with the study protocol.

Statistical Considerations/Data Analysis:

Statistical analysis will be completed under consult with Health Studies Research. Inter-Rater Reliability analysis will be completed by the physical therapists and nurse researchers prior to the study using video analysis of nystagmus and post-test of technique by a physical therapist certified in vestibular rehabilitation. After enrollment of these subjects a data peak power analysis will be conducted to calculate exact sample size needed to complete this study. This will also give us an indication of the length of time needed to conduct this study.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is a male or female >18 years of age.
  2. Subject has presented to the Emergency Department Monday through Friday during the hours of 8 AM to 4:30 PM or possibly extended into the evening and weekend hours if research or physical therapy staff is available, and is diagnosed with BPPV.
  3. Subject has positive findings of vertigo and nystagmus when the Dix-Hallpike maneuver is performed during physical examination. A Dix-Hallpike maneuver will be considered positive when the patient experiences nystagmus but resolves or fatigues in less than 60 seconds
  4. Informed consent can be obtained for participation in this study.

Exclusion Criteria:

  1. Subject has taken any antihistamines or anticholinergics within the past 12 hours.
  2. Subjects who are unable to ambulate.
  3. Subjects with severe cervical spine disease or known cerebral vascular disease.
  4. Any positive findings during the neurological exam during physical examination.
  5. Subjects who have negative finding of vertigo and nystagmus when the Dix- Hallpike maneuver is performed by the Physical Therapist or research staff even if the subject had a positive finding of vertigo and nystagmus when the Dix-Hallpike maneuver was performed by the physician or resident.
  6. Subjects with a known history of Meniere's Disease.
  7. Any cardiac complaints during physical examination or subject has experienced a positive loss of consciousness.
  8. Subject has been previously enrolled in this study.
  9. Subjects with mental conditions that render them unable to understand the nature,
  10. Subjects who are unlikely to comply with the study such as subjects with uncooperative attitude, unlikely to complete follow-up visits, or unlikely to complete the study.
  11. Any other condition which would confound or interfere with evaluation or prevent compliance with the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1, Conventional Therapy
Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron).
Drug: Meclizine
medication administration 25mg PO one time
Other Names:
  • Antivert
Drug: Lorazepam
Lorazepam 1 - 5mg PO/IV prn
Other Names:
  • Valium
Drug: Diphenhydramine
25 - 50mg PO/IV once prn
Other Names:
  • Benedryl
Drug: Ondansetron
Ondansetron 4 - 8 mg PO/IV prn
Other Names:
  • Zofran
Experimental: Arm 2, Epley Maneuver
Patients will receive vestibular rehabilitation (the Epley Maneuver).
Other: Epley Maneuver
Patient has vestibular rehabilitation utilizing the Epley Maneuver.
Other Names:
  • Canalith Repositioning Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Likert Scale for Satisfaction
Time Frame: 0 days
The Likert Scale measured patient satisfaction on a 0-10 score range (0 = Least Satisfied; 10 = Most Satisfied).
0 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lehigh Valley Hospital

Investigators

  • Principal Investigator: David B. Burmeister, DO, Lehigh Valley Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

February 13, 2008

First Submitted That Met QC Criteria

March 21, 2008

First Posted (Estimate)

March 24, 2008

Study Record Updates

Last Update Posted (Actual)

April 3, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-2006123IRB#

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plan to share IPD, just publish the study's results.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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