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

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

Overview[ - collapse ][ - ]

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	Benign Paroxysmal Positional Vertigo
Intervention	Drug: Meclizine Other: Epley Maneuver Drug: Lorazepam Drug: Diphenhydramine Drug: Oldansetron
Phase	N/A
Sponsor	Lehigh Valley Hospital
Responsible Party	Lehigh Valley Hospital
ClinicalTrials.gov Identifier	NCT00641797
First Received	February 13, 2008
Last Updated	May 1, 2012
Last verified	May 2012

Tracking Information[ + expand ][ + ]

First Received Date	February 13, 2008
Last Updated Date	May 1, 2012
Start Date	November 2006
Estimated Primary Completion Date	December 2013
Current Primary Outcome Measures	Likert Scale for improvement [Time Frame: 0, 3, 7, 30 days] [Designated as safety issue: No]
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	The Vertigo Study: Comparison Between Convention Therapy and Vestibular Rehabilitation for Benign Paroxysmal Positional Vertigo (BPPV) in Emergency Department (ED) Patients
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)
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.
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
Study Phase	N/A
Study Design	Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
Condition	Benign Paroxysmal Positional Vertigo
Intervention	Drug: Meclizine medication administration 25mg PO once Other Names: AtivertOther: Epley Maneuver Patient has vestibular rehabilitation utilizing the Epley Maneuver. Other Names: Canalith Repositioning TechniqueDrug: Lorazepam Lorazepam 1 - 5mg PO/IV prn Other Names: ValiumDrug: Diphenhydramine 25 - 50mg PO/IV once prn Other Names: BenedrylDrug: Oldansetron Oldansetron 4 - 8 mg PO/IV prn Other Names: Zofran
Study Arm (s)	Active Comparator: 1 Patients who received conventional medication therapy. Experimental: 2 Patients who receive vestibular rehabilitation

Recruitment Information[ + expand ][ + ]

Recruitment Status	Enrolling by invitation
Estimated Enrollment	30
Estimated Completion Date	December 2013
Estimated Primary Completion Date	March 2013
Eligibility 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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00641797
Other Study ID Numbers	2-2006123IRB#
Has Data Monitoring Committee	Yes
Information Provided By	Lehigh Valley Hospital
Study Sponsor	Lehigh Valley Hospital
Collaborators	Not Provided
Investigators	Principal Investigator: David B. Burmeister, DO Lehigh Valley Hospital
Verification Date	May 2012

Locations[ + expand ][ + ]