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Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00641797
Recruitment Status : Completed
First Posted : March 24, 2008
Results First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Information provided by (Responsible Party):
David Burmeister, Lehigh Valley Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Benign Paroxysmal Positional Vertigo Drug: Meclizine Other: Epley Maneuver Drug: Lorazepam Drug: Diphenhydramine Drug: Ondansetron Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : November 2006
Actual Primary Completion Date : December 2010
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

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 Name: Antivert

Drug: Lorazepam
Lorazepam 1 - 5mg PO/IV prn
Other Name: Valium

Drug: Diphenhydramine
25 - 50mg PO/IV once prn
Other Name: Benedryl

Drug: Ondansetron
Ondansetron 4 - 8 mg PO/IV prn
Other Name: 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 Name: Canalith Repositioning Technique

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00641797

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United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
Sponsors and Collaborators
Lehigh Valley Hospital
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Principal Investigator: David B. Burmeister, DO Lehigh Valley Hospital

Publications of Results:
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Responsible Party: David Burmeister, Chair, Department of Emergency Medicine, Lehigh Valley Hospital Identifier: NCT00641797     History of Changes
Other Study ID Numbers: 2-2006123IRB#
First Posted: March 24, 2008    Key Record Dates
Results First Posted: April 3, 2018
Last Update Posted: April 3, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD, just publish the study's results.
Keywords provided by David Burmeister, Lehigh Valley Hospital:
Canalith Repositioning Technique
Additional relevant MeSH terms:
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Benign Paroxysmal Positional Vertigo
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants