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Benign Paroxysmal Positional VertigoNCT00641797

Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients

A study testing Meclizine, Epley Maneuver and Lorazepam in people with Benign Paroxysmal Positional Vertigo, run by Lehigh Valley Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Benign Paroxysmal Positional Vertigo
What is being tested?
Meclizine, Epley Maneuver and Lorazepam
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
Nov 2006to Nov 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

Other trials in United States

About this study

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)

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.

Read the 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.

Being tested
Meclizine, Epley Maneuver, Lorazepam, Diphenhydramine, Ondansetron
Keywords
Canalith Repositioning Technique, Vertigo
Medical subject headings
Benign Paroxysmal Positional Vertigo, Vertigo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MeclizineDrug

    Also called Antivert

    medication administration 25mg PO one time

  • Epley ManeuverOther

    Also called Canalith Repositioning Technique

    Patient has vestibular rehabilitation utilizing the Epley Maneuver.

  • LorazepamDrug

    Also called Valium

    Lorazepam 1 - 5mg PO/IV prn

  • DiphenhydramineDrug

    Also called Benedryl

    25 - 50mg PO/IV once prn

  • OndansetronDrug

    Also called Zofran

    Ondansetron 4 - 8 mg PO/IV prn

Study groups in NCT00641797
Study groupRoleWhat they receive
Arm 1, Conventional TherapyActive comparatorPatients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron).
Receives: Drug: Meclizine; Drug: Lorazepam; Drug: Diphenhydramine; Drug: Ondansetron
Arm 2, Epley ManeuverExperimentalPatients will receive vestibular rehabilitation (the Epley Maneuver).
Receives: Other: Epley Maneuver

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Likert Scale for Satisfaction

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

    Measured: 0 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2008 (estimated)
  2. Study startNov 2006
  3. Primary completionDec 2010
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00641797
Sponsor's protocol ID
2-2006123IRB#
Status last verified
Mar 2018
First submitted
13 Feb 2008
Last updated
3 Apr 2018
Data monitoring committee
Yes
Individual data sharing
No: No plan to share IPD, just publish the study's results.

Publications

  • 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.

    PubMed 24462034

Questions about this trial

What is this clinical trial studying?

A study testing Meclizine, Epley Maneuver and Lorazepam in people with Benign Paroxysmal Positional Vertigo, run by Lehigh Valley Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Likert Scale for Satisfaction (time frame: 0 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00641797, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018.

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