Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients

• Sponsor: Lehigh Valley Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00641797
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 2
• Duration (Months): 84
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Paroxysmal Positional Vertigo	Drug: Meclizine; Other: Epley Maneuver; Drug: Lorazepam; Drug: Diphenhydramine; Drug: Ondansetron	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Treatment
• 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 Start Date: Nov 1, 2006
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1, Conventional Therapy Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron).	Drug: Meclizine; medication administration 25mg PO one time; Other Names: Antivert ; Drug: Lorazepam; Lorazepam 1 - 5mg PO/IV prn; Other Names: Valium ; Drug: Diphenhydramine; 25 - 50mg PO/IV once prn; Other Names: Benedryl ; Drug: Ondansetron; Ondansetron 4 - 8 mg PO/IV prn; Other Names: Zofran
Experimental: Arm 2, Epley Maneuver Patients will receive vestibular rehabilitation (the Epley Maneuver).	Other: Epley Maneuver; Patient has vestibular rehabilitation utilizing the Epley Maneuver.; Other Names: Canalith Repositioning Technique

Outcome Measures

Primary Outcome Measures

1. Likert Scale for Satisfaction [0 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lehigh Valley Hospital	Allentown	Pennsylvania	United States	18103

Sponsors and Collaborators

• Lehigh Valley Hospital

Investigators

• Principal Investigator: David B. Burmeister, DO, Lehigh Valley Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Burmeister, Chair, Department of Emergency Medicine, Lehigh Valley Hospital
• ClinicalTrials.gov Identifier: NCT00641797
• Other Study ID Numbers: 2-2006123IRB#
• First Posted: Mar 24, 2008
• Last Update Posted: Apr 3, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by David Burmeister, Chair, Department of Emergency Medicine, Lehigh Valley Hospital: Canalith Repositioning Technique; Vertigo
• Additional relevant MeSH terms: Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness; Diphenhydramine; Promethazine; Meclizine; Lorazepam; Ondansetron

Study Results

Participant Flow

Arm/Group Title	Arm 1, Conventional Therapy	Arm 2, Epley Maneuver
Arm/Group Description	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	Patients will receive vestibular rehabilitation (the Epley Maneuver). Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver.
Period Title: Overall Study
STARTED	11	15
COMPLETED	11	15
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Arm 1, Conventional Therapy	Arm 2, Epley Maneuver	Total
Arm/Group Description	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	Patients will receive vestibular rehabilitation (the Epley Maneuver). Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver.	Total of all reporting groups
Overall Participants	11	15	26
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59 (12.6)	64 (11.2)	61.5 (11.9)
Sex: Female, Male (Count of Participants)
Female	3 27.3%	10 66.7%	13 50%
Male	8 72.7%	5 33.3%	13 50%
Region of Enrollment (Count of Participants)
United States	11 100%	15 100%	26 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1, Conventional Therapy	Arm 2, Epley Maneuver
Arm/Group Description	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	Patients will receive vestibular rehabilitation (the Epley Maneuver). Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver.
Measure Participants	11	15
Mean (Standard Deviation) [units on a scale]	9 (1.5)	9 (1.0)

Adverse Events

Arm/Group Title	Arm 1, Conventional Therapy		Arm 2, Epley Maneuver
Arm/Group Description	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		Patients will receive vestibular rehabilitation (the Epley Maneuver). Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver.
All Cause Mortality
	Arm 1, Conventional Therapy		Arm 2, Epley Maneuver
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1, Conventional Therapy		Arm 2, Epley Maneuver
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1, Conventional Therapy		Arm 2, Epley Maneuver
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.