Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients

NCT ID: NCT00641797

Last Updated: 2018-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2013-11-30

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.

Conditions

Benign Paroxysmal Positional Vertigo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1, Conventional Therapy

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

Group Type: ACTIVE_COMPARATOR

Meclizine

Intervention Type: DRUG

medication administration 25mg PO one time

Lorazepam

Intervention Type: DRUG

Lorazepam 1 - 5mg PO/IV prn

Diphenhydramine

Intervention Type: DRUG

25 - 50mg PO/IV once prn

Ondansetron

Intervention Type: DRUG

Ondansetron 4 - 8 mg PO/IV prn

Arm 2, Epley Maneuver

Patients will receive vestibular rehabilitation (the Epley Maneuver).

Group Type: EXPERIMENTAL

Epley Maneuver

Intervention Type: OTHER

Patient has vestibular rehabilitation utilizing the Epley Maneuver.

Interventions

Meclizine

medication administration 25mg PO one time

Intervention Type: DRUG

Epley Maneuver

Patient has vestibular rehabilitation utilizing the Epley Maneuver.

Intervention Type: OTHER

Lorazepam

Lorazepam 1 - 5mg PO/IV prn

Intervention Type: DRUG

Diphenhydramine

25 - 50mg PO/IV once prn

Intervention Type: DRUG

Ondansetron

Ondansetron 4 - 8 mg PO/IV prn

Intervention Type: DRUG

Other Intervention Names

Antivert; Canalith Repositioning Technique; Valium; Benedryl; Zofran

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lehigh Valley Hospital

OTHER

Sponsor Role: lead

Responsible Party

David Burmeister

Chair, Department of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David B. Burmeister, DO

Role: PRINCIPAL_INVESTIGATOR

Lehigh Valley Hospital

Locations

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24462034 (View on PubMed)

Other Identifiers

2-2006123IRB#

Identifier Type: -

Identifier Source: org_study_id