Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00641797
Other study ID # 2-2006123IRB#
Secondary ID
Status Completed
Phase N/A
First received February 13, 2008
Last updated March 5, 2018
Start date November 2006
Est. completion date November 2013

Study information

Verified date March 2018
Source Lehigh Valley Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date November 2013
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Meclizine
medication administration 25mg PO one time
Other:
Epley Maneuver
Patient has vestibular rehabilitation utilizing the Epley Maneuver.
Drug:
Lorazepam
Lorazepam 1 - 5mg PO/IV prn
Diphenhydramine
25 - 50mg PO/IV once prn
Ondansetron
Ondansetron 4 - 8 mg PO/IV prn

Locations

Country Name City State
United States Lehigh Valley Hospital Allentown Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Lehigh Valley Hospital

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Likert Scale for Satisfaction The Likert Scale measured patient satisfaction on a 0-10 score range (0 = Least Satisfied; 10 = Most Satisfied). 0 days
See also
  Status Clinical Trial Phase
Completed NCT03425786 - Benign Paroxysmal Positional Vertigo (BPPV) Training for Sports Medicine Providers in a Pediatric Concussion Program N/A
Completed NCT02046980 - Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo Phase 2
Withdrawn NCT00978809 - Effects of Physical Treatment on Postural Stability in Benign Paroxysmal Positional Vertigo (BPPV) Patients N/A
Completed NCT02029508 - The Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo Phase 3
Completed NCT02809599 - Evidence Based Best Care Practice for Benign Paroxysmal Positional Vertigo N/A
Completed NCT03230513 - Comparison of Home-Based Exercise on the Posterior Canal Benign Paroxysmal Positional Vertigo Symptoms N/A
Completed NCT03643354 - Evaluation of the Prevalence of BPPV and Longterm Effects of Its Therapy Using the Rotundum Device in Retirement Homes N/A
Recruiting NCT06001047 - Head Acupuncture Treat Residual Symptoms After Canalith Repositioning Procedure for BPPV N/A
Not yet recruiting NCT04578262 - Epley Manoeuvre in Participants With Multiple Sclerosis Diagnosed From Benign Paroxysmal Positional Vertigo N/A
Not yet recruiting NCT04578470 - Benign Paroxysmal Positional Vertigo (BPPV) in Older Patients Phase 2
Completed NCT05748249 - Evaluation of the Efficacy of Vertistop® D and Vertistop® L in the Prevention of BPPV Recurrence Phase 1
Active, not recruiting NCT06314581 - Effect of a Multifaceted Educational Intervention on the Implementation of Evidence-based Practices for Benign Paroxysmal Positional Vertigo in an Emergency Department
Completed NCT04715282 - The Epley Maneuver Versus Cawthorne-Cooksey Exercises in the Treatment of Benign Paroxysmal Positional Vertigo (BPPV) N/A
Terminated NCT03161470 - Efficacy of a Mechanical Chair for Treatment of Benign Paroxysmal Positional Vertigo (BPPV) N/A
Completed NCT05425199 - Habituation Exercises Versus Proprioceptive Training in Benign Paroxysmal Positional Vertigo N/A
Recruiting NCT05922774 - Cervical Vestibular Evoked Myogenic Potentials in Recurrent and Persistant Benign Paroxysmal Positional Vertigo
Recruiting NCT05013684 - Benign Paroxysmal Positional Vertigo in Older Adults N/A
Not yet recruiting NCT05863949 - Clinical Trial of Vit D and Calcium for Recurrent BPPV N/A
Completed NCT05127694 - Treatment In Acute Benign Paroxysmal Positional Vertigo N/A
Suspended NCT04026516 - CAVA: Dizziness Trial N/A