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Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients

Primary Purpose

Benign Paroxysmal Positional Vertigo

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meclizine
Epley Maneuver
Lorazepam
Diphenhydramine
Ondansetron
Sponsored by
Lehigh Valley Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Paroxysmal Positional Vertigo focused on measuring Canalith Repositioning Technique, Vertigo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lehigh Valley Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm 1, Conventional Therapy

Arm 2, Epley Maneuver

Arm Description

Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron).

Patients will receive vestibular rehabilitation (the Epley Maneuver).

Outcomes

Primary Outcome Measures

Likert Scale for Satisfaction
The Likert Scale measured patient satisfaction on a 0-10 score range (0 = Least Satisfied; 10 = Most Satisfied).

Secondary Outcome Measures

Full Information

First Posted
February 13, 2008
Last Updated
March 5, 2018
Sponsor
Lehigh Valley Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00641797
Brief Title
Treating Benign Paroxysmal Positional Vertigo (BPPV) in 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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lehigh Valley Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: To evaluate the improvement of vertigo in patients diagnosed with BPPV in the ED. To evaluate disposition time for those patients receiving vestibular rehabilitation in the ED compared to those patients who receive conventional therapy. To demonstrate the long-term improvement of symptomatology utilizing vestibular rehabilitation versus conventional therapy. Compare patient satisfaction between those patients who receive standard care vs. those who receive vestibular rehabilitation. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Paroxysmal Positional Vertigo
Keywords
Canalith Repositioning Technique, Vertigo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1, Conventional Therapy
Arm Type
Active Comparator
Arm Description
Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron).
Arm Title
Arm 2, Epley Maneuver
Arm Type
Experimental
Arm Description
Patients will receive vestibular rehabilitation (the Epley Maneuver).
Intervention Type
Drug
Intervention Name(s)
Meclizine
Other Intervention Name(s)
Antivert
Intervention Description
medication administration 25mg PO one time
Intervention Type
Other
Intervention Name(s)
Epley Maneuver
Other Intervention Name(s)
Canalith Repositioning Technique
Intervention Description
Patient has vestibular rehabilitation utilizing the Epley Maneuver.
Intervention Type
Drug
Intervention Name(s)
Lorazepam
Other Intervention Name(s)
Valium
Intervention Description
Lorazepam 1 - 5mg PO/IV prn
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Other Intervention Name(s)
Benedryl
Intervention Description
25 - 50mg PO/IV once prn
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Zofran
Intervention Description
Ondansetron 4 - 8 mg PO/IV prn
Primary Outcome Measure Information:
Title
Likert Scale for Satisfaction
Description
The Likert Scale measured patient satisfaction on a 0-10 score range (0 = Least Satisfied; 10 = Most Satisfied).
Time Frame
0 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David B. Burmeister, DO
Organizational Affiliation
Lehigh Valley Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD, just publish the study's results.
Citations:
PubMed Identifier
24462034
Citation
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.
Results Reference
result

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Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients

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