Testing the Epley Maneuver for Treating Dizziness in the Emergency Department

Официальное название

Evaluating the Efficacy of Epley Maneuver in the Treatment of Benign Paroxysmal Positional Vertigo in the Emergency Department: A Randomized Controlled Trial.

Обзор

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: * What is the mean difference in Dizziness Handicap Inventory (DHI) scores between patients receiving the Epley maneuver and those receiving the sham maneuver 3 days after enrollment? * What is the immediate response (using a 0-10-point Likert scale) of patients in each arm of the study? * What is the proportion of patients who, despite agreeing to participate, were unable to complete the full Epley maneuver due to symptom severity? 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: * Undergo either the Epley maneuver or a sham maneuver. * Complete the Dizziness Handicap Inventory (DHI) questionnaire at baseline and 3 days post-discharge. * Patients with insufficient improvement in the sham maneuver group will receive a rescue Epley maneuver. * Have their vertigo severity assessed using a 0-10 point Likert scale at baseline, immediately and post-maneuver.

Вмешательства

• Процедура Epley Maneuver
  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 degre
• Процедура Sham maneuver
  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

Первичные конечные точки

• Efficacy of Epley [Срок оценки: 3 days]

Вторичные конечные точки (3)

• Immediate response of patients [Срок оценки: 15-30 minutes after intervention]
• Rate of bounce-back to the ED [Срок оценки: 3 days]
• Proportion of patients unable to undergo the full Epley maneuver [Срок оценки: 15 minutes]

Критерии участия

Критерии включения

• Age: above 18 years old
• Patients presenting to the ED with symptoms of BPPV (single or recurrent episodes of vertigo lasting up to 2 minutes) and a positive DHT (episode of vertigo associated with torsional upbeating nystagmus) indicating a posterior semicircular canal BPPV.
• Patients who are able to understand and provide a signed informed consent to participate in the study Exclusion Criteria
• Severe cervical diseases (e.g., soft tissue disorders, cervical spondylosis, prolapsed intervertebral disks and severe rheumatoid arthritis with cervical instability …)
• Unstable cardiovascular diseases (e.g., hemodynamically unstable, decompensated heart failure, acute myocardial infarction, decompensated valvular diseases, severe arrhythmias …)
• Suspected vertebrobasilar diseases (e.g., cerebellar signs, vision changes, numbness or tingling in the extremities, slurred speech, changes in mental status, confusion …)
• History of high-grade carotid stenosis
• Recent (<24 hours) intake of aminoglycosides, chemotherapeutic agents, cyclophosphamide, loop diuretics, or quinines
• Patients with peripheral causes of vertigo other than BPPV (such as Meniere's disease or vestibular neuritis)
• Patients with central causes of vertigo (vestibular migraine, Arnold Chiari malformation, history of CNS tumor(s), multiple sclerosis)
• Patients with focal deficits on neurological exam
• Patients with an episode of vertigo lasting more than 2 minutes
• Patients with a negative DHT
• Patients with pure horizontal or vertical nystagmus
• Patients with lateral and anterior semicircular canals BPPV
• Participants refusing to undergo Epley maneuver
• Pregnancy beyond the 24th week of gestation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Ливан · 1 центр

• American University of Beirut — Beirut

Идентификаторы

NCT: NCT07111000 · BIO-2023-0184

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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