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

Sponsor:	Lehigh Valley Hospital
Information provided by:	Lehigh Valley Hospital
ClinicalTrials.gov Identifier:	NCT00641797

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:	Treatment, Randomized, Single Blind (Caregiver), Active Control, Parallel Assignment
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:

MedlinePlus related topics: Dizziness and Vertigo Rehabilitation

Drug Information available for: Promethazine hydrochloride Diphenhydramine Promethazine Meclizine hydrochloride Diphenhydramine citrate Diphenhydramine hydrochloride Meclizine Lorazepam

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 2011
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Patients who received conventional medication therapy.	Drug: Meclizine Drug: Lorazepam Drug: Diphenhydramine Drug: Oldansetron
2: Experimental Patients who receive vestibular rehabilitation	Other: Epley Maneuver Patient has vestibular rehabilitation utilizing the Epley Maneuver.

Show Detailed Description

Eligibility

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

Criteria

Inclusion Criteria:

Subject is a male or female >18 years of age.
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.
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
Informed consent can be obtained for participation in this study.

Exclusion Criteria:

Subject has taken any antihistamines or anticholinergics within the past 12 hours.
Subjects who are unable to ambulate.
Subjects with severe cervical spine disease or known cerebral vascular disease.
Any positive findings during the neurological exam during physical examination.
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.
Subjects with a known history of Meniere's Disease.
Any cardiac complaints during physical examination or subject has experienced a positive loss of consciousness.
Subject has been previously enrolled in this study.
Subjects with mental conditions that render them unable to understand the nature,
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.
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:	LVH ( David B. Burmeister DO, FACEP )
Study ID Numbers:	2-2006123IRB#
Study First Received:	February 13, 2008
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00641797 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Lehigh Valley Hospital:

Canalith Repositioning Technique
Vertigo

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease Attributes
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Antiemetics
Vestibular Diseases
Ear Diseases
Vertigo
Signs and Symptoms
Lorazepam
Pathologic Processes
Promethazine

Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Antipruritics
Dermatologic Agents
Tranquilizing Agents
Otorhinolaryngologic Diseases
Nervous System Diseases
Gastrointestinal Agents
Central Nervous System Depressants
Histamine Agents
Anti-Allergic Agents
Anesthetics, Local
Pharmacologic Actions
Histamine Antagonists

ClinicalTrials.gov processed this record on November 25, 2009