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The Vertigo Study: Comparison Between Convention Therapy and Vestibular Rehabilitation for Benign Paroxysmal Positional Vertigo (BPPV) in Emergency Department (ED) Patients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
David Burmeister, Lehigh Valley Hospital
ClinicalTrials.gov Identifier:
NCT00641797
First received: February 13, 2008
Last updated: May 1, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
Benign Paroxysmal Positional Vertigo
 Drug: Meclizine
Other: Epley Maneuver
Drug: Lorazepam
Drug: Diphenhydramine
Drug: Oldansetron

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lehigh Valley Hospital:

Primary Outcome Measures:
  • Likert Scale for improvement [ Time Frame: 0, 3, 7, 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Patients who received conventional medication therapy.
 Drug: Meclizine
medication administration 25mg PO once
Other Name: Ativert
Drug: Lorazepam
Lorazepam 1 - 5mg PO/IV prn
Other Name: Valium
Drug: Diphenhydramine
25 - 50mg PO/IV once prn
Other Name: Benedryl
Drug: Oldansetron
Oldansetron 4 - 8 mg PO/IV prn
Other Name: Zofran
Experimental: 2
Patients who receive vestibular rehabilitation
 Other: Epley Maneuver
Patient has vestibular rehabilitation utilizing the Epley Maneuver.
Other Name: Canalith Repositioning Technique

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641797

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

No publications provided

Responsible Party: David Burmeister, Chair, Department of Emergency Medicine, Lehigh Valley Hospital
ClinicalTrials.gov Identifier: NCT00641797     History of Changes
Other Study ID Numbers: 2-2006123IRB#
Study First Received: February 13, 2008
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Lehigh Valley Hospital:
Canalith Repositioning Technique
Vertigo

Additional relevant MeSH terms:
Emergencies
Vertigo
Dizziness
Disease Attributes
Pathologic Processes
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders
Diphenhydramine
Meclizine
 Lorazepam
Promethazine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013