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Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00641797
Enrollment
26
Registered
2008-03-24
Start date
2006-11-30
Completion date
2013-11-30
Last updated
2018-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Paroxysmal Positional Vertigo

Keywords

Canalith Repositioning Technique, Vertigo

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.

Interventions

medication administration 25mg PO one time

Patient has vestibular rehabilitation utilizing the Epley Maneuver.

DRUGLorazepam

Lorazepam 1 - 5mg PO/IV prn

DRUGDiphenhydramine

25 - 50mg PO/IV once prn

DRUGOndansetron

Ondansetron 4 - 8 mg PO/IV prn

Sponsors

Lehigh Valley Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Likert Scale for Satisfaction0 daysThe Likert Scale measured patient satisfaction on a 0-10 score range (0 = Least Satisfied; 10 = Most Satisfied).

Countries

United States

Participant flow

Participants by arm

ArmCount
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
11
Arm 2, Epley Maneuver
Patients will receive vestibular rehabilitation (the Epley Maneuver). Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver.
15
Total26

Baseline characteristics

CharacteristicArm 1, Conventional TherapyArm 2, Epley ManeuverTotal
Age, Continuous59 years
STANDARD_DEVIATION 12.6
64 years
STANDARD_DEVIATION 11.2
61.5 years
STANDARD_DEVIATION 11.9
Region of Enrollment
United States
11 Participants15 Participants26 Participants
Sex: Female, Male
Female
3 Participants10 Participants13 Participants
Sex: Female, Male
Male
8 Participants5 Participants13 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 110 / 15
serious
Total, serious adverse events
0 / 110 / 15

Outcome results

Primary

Likert Scale for Satisfaction

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

Time frame: 0 days

ArmMeasureValue (MEAN)Dispersion
Arm 1, Conventional TherapyLikert Scale for Satisfaction9 units on a scaleStandard Deviation 1.5
Arm 2, Epley ManeuverLikert Scale for Satisfaction9 units on a scaleStandard Deviation 1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026