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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1, Conventional Therapy | Active Comparator | Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron). |
|
| Arm 2, Epley Maneuver | Experimental | Patients will receive vestibular rehabilitation (the Epley Maneuver). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meclizine | Drug | medication administration 25mg PO one time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Likert Scale for Satisfaction | The Likert Scale measured patient satisfaction on a 0-10 score range (0 = Least Satisfied; 10 = Most Satisfied). | 0 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David B. Burmeister, DO | Lehigh Valley Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24462034 | Result | Sacco RR, Burmeister DB, Rupp VA, Greenberg MR. Management of benign paroxysmal positional vertigo: a randomized controlled trial. J Emerg Med. 2014 Apr;46(4):575-81. doi: 10.1016/j.jemermed.2013.08.116. Epub 2014 Jan 22. |
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No plan to share IPD, just publish the study's results.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1, Conventional Therapy | Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron). Meclizine: medication administration 25mg PO one time Lorazepam: Lorazepam 1 - 5mg PO/IV prn Diphenhydramine: 25 - 50mg PO/IV once prn Ondansetron: Ondansetron 4 - 8 mg PO/IV prn |
| FG001 | Arm 2, Epley Maneuver | Patients will receive vestibular rehabilitation (the Epley Maneuver). Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
To be included in the study, patients had to be at least 18 years of age, presenting to the ED weekdays during business hours, and have a positive DH test.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1, Conventional Therapy | Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron). Meclizine: medication administration 25mg PO one time Lorazepam: Lorazepam 1 - 5mg PO/IV prn Diphenhydramine: 25 - 50mg PO/IV once prn Ondansetron: Ondansetron 4 - 8 mg PO/IV prn |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Likert Scale for Satisfaction | The Likert Scale measured patient satisfaction on a 0-10 score range (0 = Least Satisfied; 10 = Most Satisfied). | Posted | Mean | Standard Deviation | units on a scale | 0 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1, Conventional Therapy | Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron). Meclizine: medication administration 25mg PO one time Lorazepam: Lorazepam 1 - 5mg PO/IV prn Diphenhydramine: 25 - 50mg PO/IV once prn Ondansetron: Ondansetron 4 - 8 mg PO/IV prn |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regina Sacco, DPT, BA, BHSC | Lehigh Valley Health Network | 610-969-0300 | Regina_R.Sacco@lvhn.org |
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| ID | Term |
|---|---|
| D065635 | Benign Paroxysmal Positional Vertigo |
| D014717 | Vertigo |
| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D008468 | Meclizine |
| D008140 | Lorazepam |
| D003975 | Diazepam |
| D004155 | Diphenhydramine |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Epley Maneuver | Other | Patient has vestibular rehabilitation utilizing the Epley Maneuver. |
|
|
| Lorazepam | Drug | Lorazepam 1 - 5mg PO/IV prn |
|
|
| Diphenhydramine | Drug | 25 - 50mg PO/IV once prn |
|
|
| Ondansetron | Drug | Ondansetron 4 - 8 mg PO/IV prn |
|
|
| BG001 |
| Arm 2, Epley Maneuver |
Patients will receive vestibular rehabilitation (the Epley Maneuver). Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Arm 2, Epley Maneuver | Patients will receive vestibular rehabilitation (the Epley Maneuver). Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver. | 0 | 15 | 0 | 15 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005021 | Ethylamines |
| D000588 | Amines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006575 | Heterocyclic Compounds, 3-Ring |