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| Tracking Information | |||||
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| First Received Date ICMJE | February 13, 2008 | ||||
| Last Updated Date | March 21, 2008 | ||||
| Start Date ICMJE | November 2006 | ||||
| Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Likert Scale for improvement [ Time Frame: 0, 3, 7, 30 days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00641797 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Vertigo Study: Comparison Between Convention Therapy and Vestibular Rehabilitation for Benign Paroxysmal Positional Vertigo (BPPV) in Emergency Department (ED) Patients | ||||
| Official Title ICMJE | 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. |
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| 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:
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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Caregiver), Active Control, Parallel Assignment | ||||
| Condition ICMJE | Benign Paroxysmal Positional Vertigo | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | December 2011 | ||||
| Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00641797 | ||||
| Responsible Party | David B. Burmeister DO, FACEP, LVH | ||||
| Study ID Numbers ICMJE | 2-2006123IRB# | ||||
| Study Sponsor ICMJE | Lehigh Valley Hospital | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Lehigh Valley Hospital | ||||
| Verification Date | March 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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