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The goal of this randomized controlled trial is to evaluate the efficacy of the Epley maneuver versus a sham maneuver in treating patients presenting to the emergency department (ED) with BPPV. The main questions that the study aims to answer are:
Researchers will compare the Epley maneuver arm to the sham maneuver arm to see if the Epley maneuver is more effective in reducing BPPV symptoms.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epley Maneuver | Experimental | The patient's head is turned 45 degrees towards the side that caused the most nystagmus or reproduced their initial symptoms. The patient is then laid down with their head hanging over the edge of the bed. After that, the head will be rotated 90 degrees in the opposite direction, with the head remaining in a dependent position. The patient is then asked to roll onto their side with their head facing downward. They are then brought back to a sitting position and the head is moved forward 45 degrees. Each position is held until the vertigo and/or nystagmus subsides or for at least 30 seconds |
|
| Sham Maneuver | Sham Comparator | This maneuver will involve coordinated movements of the hands and legs, while excluding any head movement. Patients will be at first in a sitting position with both feet on the ground and both hands placed on the thighs and then they will be asked to lift both hands off the thighs, keeping the arms extended. They will then be asked to return to their initial upright sitting position. Patients will then raise their right foot off the ground while keeping the left one planted on the ground. It will be an alternating movement between lifting the right and left feet while maintaining a smooth and well-controlled rhythm for 90 seconds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epley Maneuver | Procedure | The patient's head is turned 45 degrees towards the side that caused the most nystagmus or reproduced their initial symptoms. The patient is then laid down with their head hanging over the edge of the bed. After that, the head will be rotated 90 degrees in the opposite direction, with the head remaining in a dependent position. The patient is then asked to roll onto their side with their head facing downward. They are then brought back to a sitting position and the head is moved forward 45 degrees. Each position is held until the vertigo and/or nystagmus subsides or for at least 30 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Epley | The study will compare the average Dizziness Handicap Inventory score change from baseline to day 3 between the Epley maneuver group and the sham maneuver group. The DHI is a 25-item self-administered questionnaire designed to assess the effects of dizziness on various aspects of life, including functional, emotional, and physical domains. Scores range from 0, indicating no disability, to 100, representing severe disability. This scale enables patients to indicate how much dizziness interferes with their daily activities. A higher score reflects a greater perceived handicap caused by dizziness. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate response of patients | The severity of vertigo will be evaluated using both a 0 to 10-point Likert scale before and after applying the Epley/Sham maneuver. | 15-30 minutes after intervention |
| Rate of bounce-back to the ED |
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Inclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eveline Hitti, MD | Contact | 00961-1-350000 | 6616 | eh16@aub.edu.lb |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American University of Beirut | Recruiting | Beirut | Lebanon |
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| ID | Term |
|---|---|
| D065635 | Benign Paroxysmal Positional Vertigo |
| D014717 | Vertigo |
| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Sham maneuver | Procedure | This control maneuver will involve coordinated movements of the hands and legs, while excluding any head movement. Patients will be at first in a sitting position with both feet on the ground and both hands placed on the thighs and then they will be asked to lift both hands off the thighs, keeping the arms extended. They will then be asked to return to their initial upright sitting position. Patients will then raise their right foot off the ground while keeping the left one planted on the ground. It will be an alternating movement between lifting the right and left feet while maintaining a smooth and well- controlled rhythm for 90 seconds. |
|
Calculate the proportion of patients in each arm of the study who return to the ED.
| 3 days |
| Proportion of patients unable to undergo the full Epley maneuver | The percentage of patients who agreed to participate but could not complete the Epley maneuver due to the severity of their symptoms. | 15 minutes |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |