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| 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) |
| 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.
|
Hide Detailed DescriptionBenign 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:
Inclusion Criteria:
Exclusion Criteria:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| Lehigh Valley Hospital | |
| Allentown, Pennsylvania, United States, 18103 | |
| Principal Investigator: | David B. Burmeister, DO | Lehigh Valley Hospital |
More Information
| 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 |
|
Canalith Repositioning Technique Vertigo |
|
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 |