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.
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
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:
- To evaluate the improvement of vertigo in patients diagnosed with BPPV in the ED.
- To evaluate disposition time for those patients receiving vestibular rehabilitation in the ED compared to those patients who receive conventional therapy.
- To demonstrate the long-term improvement of symptomatology utilizing vestibular rehabilitation versus conventional therapy.
- Compare patient satisfaction between those patients who receive standard care vs. those who receive vestibular rehabilitation.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
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
- 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 group | Role | What they receive |
|---|---|---|
| Arm 1, Conventional Therapy | Active comparator | Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron). Receives: Drug: Meclizine; Drug: Lorazepam; Drug: Diphenhydramine; Drug: Ondansetron |
| Arm 2, Epley Maneuver | Experimental | Patients 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.
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.
- First posted24 Mar 2008 (estimated)
- Study startNov 2006
- Primary completionDec 2010
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Paroxysmal Positional VertigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Lehigh Valley Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Burmeister, Lehigh Valley Hospital
- Investigators
- David B. Burmeister, DO, Principal investigator, Lehigh Valley Hospital
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00641797
- Acronym / sponsor ID
- 2-2006123IRB#
- Conditions
- Benign Paroxysmal Positional Vertigo
- Keywords
- Canalith Repositioning Technique, Vertigo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Lehigh Valley HospitalUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Posted 3 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the improvement of vertigo in patients diagnosed with BPPV in the ED.
- To evaluate disposition time for those patients receiving vestibular rehabilitation in the ED compared to those patients who receive conventional therapy.
- To demonstrate the long-term improvement of symptomatology utilizing vestibular rehabilitation versus conventional therapy.
- Compare patient satisfaction between those patients who receive standard care vs. those who receive vestibular rehabilitation.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1, Conventional Therapy | Active comparator | Drug: Meclizine, Drug: Lorazepam, Drug: Diphenhydramine, Drug: OndansetronPatients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron). |
| Arm 2, Epley Maneuver | Experimental | Other: Epley ManeuverPatients will receive vestibular rehabilitation (the Epley Maneuver). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeclizineAlso: Antivertmedication administration 25mg PO one time | Drug | Arm 1, Conventional Therapy |
| Epley ManeuverAlso: Canalith Repositioning TechniquePatient has vestibular rehabilitation utilizing the Epley Maneuver. | Other | Arm 2, Epley Maneuver |
| LorazepamAlso: ValiumLorazepam 1 - 5mg PO/IV prn | Drug | Arm 1, Conventional Therapy |
| DiphenhydramineAlso: Benedryl25 - 50mg PO/IV once prn | Drug | Arm 1, Conventional Therapy |
| OndansetronAlso: ZofranOndansetron 4 - 8 mg PO/IV prn | Drug | Arm 1, Conventional Therapy |
Primary outcome
Likert Scale for Satisfaction
Time frame: 0 days
The Likert Scale measured patient satisfaction on a 0-10 score range (0 = Least Satisfied; 10 = Most Satisfied).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24462034Sacco 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.
- Individual participant dataSharing planned: No. No plan to share IPD, just publish the study's results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David B. Burmeister, DO principal investigator
Lehigh Valley Hospital
1 site in 1 country: see every site and its status.
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.