Trial Outcomes & Findings for Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients (NCT NCT00641797)
NCT ID: NCT00641797
Last Updated: 2018-04-03
Results Overview
The Likert Scale measured patient satisfaction on a 0-10 score range (0 = Least Satisfied; 10 = Most Satisfied).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
0 days
Results posted on
2018-04-03
Participant Flow
Participant milestones
| Measure |
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
|
Arm 2, Epley Maneuver
Patients will receive vestibular rehabilitation (the Epley Maneuver).
Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
15
|
|
Overall Study
COMPLETED
|
11
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients
Baseline characteristics by cohort
| Measure |
Arm 1, Conventional Therapy
n=11 Participants
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
|
Arm 2, Epley Maneuver
n=15 Participants
Patients will receive vestibular rehabilitation (the Epley Maneuver).
Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
64 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
61.5 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 daysThe Likert Scale measured patient satisfaction on a 0-10 score range (0 = Least Satisfied; 10 = Most Satisfied).
Outcome measures
| Measure |
Arm 1, Conventional Therapy
n=11 Participants
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
|
Arm 2, Epley Maneuver
n=15 Participants
Patients will receive vestibular rehabilitation (the Epley Maneuver).
Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver.
|
|---|---|---|
|
Likert Scale for Satisfaction
|
9 units on a scale
Standard Deviation 1.5
|
9 units on a scale
Standard Deviation 1.0
|
Adverse Events
Arm 1, Conventional Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2, Epley Maneuver
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Regina Sacco, DPT, BA, BHSC
Lehigh Valley Health Network
Phone: 610-969-0300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place