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Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients

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ClinicalTrials.gov Identifier: NCT00641797
Recruitment Status : Completed
First Posted : March 24, 2008
Results First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
David Burmeister, Lehigh Valley Hospital

Tracking Information
First Submitted Date  ICMJE February 13, 2008
First Posted Date  ICMJE March 24, 2008
Results First Submitted Date  ICMJE September 19, 2017
Results First Posted Date  ICMJE April 3, 2018
Last Update Posted Date April 3, 2018
Study Start Date  ICMJE November 2006
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: March 21, 2008)
Likert Scale for improvement [ Time Frame: 0, 3, 7, 30 days ]
Change History Complete list of historical versions of study NCT00641797 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Benign Paroxysmal Positional Vertigo
Intervention  ICMJE
  • Drug: Meclizine
    medication administration 25mg PO one time
    Other Name: Antivert
  • Other: Epley Maneuver
    Patient has vestibular rehabilitation utilizing the Epley Maneuver.
    Other Name: Canalith Repositioning Technique
  • Drug: Lorazepam
    Lorazepam 1 - 5mg PO/IV prn
    Other Name: Valium
  • Drug: Diphenhydramine
    25 - 50mg PO/IV once prn
    Other Name: Benedryl
  • Drug: Ondansetron
    Ondansetron 4 - 8 mg PO/IV prn
    Other Name: Zofran
Study Arms  ICMJE
  • Active Comparator: Arm 1, Conventional Therapy
    Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron).
    Interventions:
    • Drug: Meclizine
    • Drug: Lorazepam
    • Drug: Diphenhydramine
    • Drug: Ondansetron
  • Experimental: Arm 2, Epley Maneuver
    Patients will receive vestibular rehabilitation (the Epley Maneuver).
    Intervention: Other: Epley Maneuver
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2016)
26
Original Estimated Enrollment  ICMJE
 (submitted: March 21, 2008)
30
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00641797
Other Study ID Numbers  ICMJE 2-2006123IRB#
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan to share IPD, just publish the study's results.
Responsible Party David Burmeister, Lehigh Valley Hospital
Study Sponsor  ICMJE Lehigh Valley Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David B. Burmeister, DO Lehigh Valley Hospital
PRS Account Lehigh Valley Hospital
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP