Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients

NCT00641797 | Completed Results DMC

• 1 other identifier: 2-2006123IRB#
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Paroxysmal Positional Vertigo

Keywords

Canalith Repositioning Technique; Vertigo

Outcome Measures

Primary Outcomes (1)

• Likert Scale for Satisfaction

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

  0 days

Study Arms (2)

Arm 1, Conventional Therapy

ACTIVE COMPARATOR

Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron).

Drug: Meclizine; Drug: Lorazepam; Drug: Diphenhydramine; Drug: Ondansetron

Arm 2, Epley Maneuver

EXPERIMENTAL

Patients will receive vestibular rehabilitation (the Epley Maneuver).

Other: Epley Maneuver

Interventions

Meclizine DRUG

medication administration 25mg PO one time

Also known as: Antivert

Arm 1, Conventional Therapy

Epley Maneuver OTHER

Patient has vestibular rehabilitation utilizing the Epley Maneuver.

Also known as: Canalith Repositioning Technique

Arm 2, Epley Maneuver

Lorazepam DRUG

Lorazepam 1 - 5mg PO/IV prn

Also known as: Valium

Arm 1, Conventional Therapy

Diphenhydramine DRUG

25 - 50mg PO/IV once prn

Also known as: Benedryl

Arm 1, Conventional Therapy

Ondansetron DRUG

Ondansetron 4 - 8 mg PO/IV prn

Also known as: Zofran

Arm 1, Conventional Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lehigh Valley Hospital: lead

Study Sites (1)

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

Related Publications (1)

• 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.

  PMID: 24462034 RESULT

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo; Vertigo

Interventions

Meclizine; Lorazepam; Diazepam; Diphenhydramine; Ondansetron

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ethylamines; Amines; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Regina Sacco, DPT, BA, BHSC
• Organization: Lehigh Valley Health Network

Regina_R.Sacco@lvhn.org

610-969-0300

Study Officials

• David B. Burmeister, DO

  Lehigh Valley Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Emergency Medicine

Study Record Dates

• First Submitted: February 13, 2008
• First Posted: March 24, 2008
• Study Start: November 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: November 1, 2013
• Last Updated: April 3, 2018
• Results First Posted: April 3, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)