RecruitingACTRN12619001039178

The use of the Epley Omniax device in the treatment of Benign Paroxysmal Positional Vertigo (BPPV)

Comparing clinical effectiveness of the Epley manoeuvre versus the Somersault manoeuvre using a multi-axial repositioning device for Benign Paroxysmal Positional Vertigo (BPPV)

Sponsor

Royal Victorian Eye and Ear Hospital

Enrollment

100 participants

Start Date

Sep 9, 2019

Study Type

Interventional

Conditions

Benign Paroxysmal Positional Vertigo

Summary

Research Aims: To determine the clinical effectiveness of the Epley manoeuvre versus the somersault manoeuvre using a multi-axial repositioning device (Epley Omniax Machine) for the treatment of posterior canal Benign Paroxysmal Positional Vertigo (BPPV). This will be a randomised controlled trial. Participants: ~100 participants with Posterior canal Benign Paroxysmal Positional Vertigo Methods: Participants will be recruited from The Royal Victorian Eye and Ear Hospital Balance Disorders and Ataxia Clinic from those referred to the Epley Omniax for repositioning treatment of BPPV. For those determined to have posterior canal BPPV, they will be randomly assigned to one of two treatment groups being either the Epley manoeuvre, or the Somersault manoeuvre. A maximum of four treatments will be performed before removing from the trial. Patients will receive the alternative treatment if the experimental treatment is not successful. Treatment success is determined by resolution of nystagmus and symptoms on re-assessment. Expected outcomes: It is anticipated the somersault manoeuvre could be more clinically effective than the Epley manoeuvre for the treatment of BPPV, particularly in the case of refractory presentations.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Benign Paroxysmal Positional Vertigo (BPPV) is one of the most common causes of dizziness. It happens when tiny calcium crystals in the inner ear shift out of place, causing brief but intense spinning sensations when you move your head. The good news is it's usually treatable with specific head movements called repositioning manoeuvres. This study compares two repositioning manoeuvres — the well-established Epley manoeuvre and a newer technique called the somersault manoeuvre — using a specialised device called the Epley Omniax that can rotate a person in multiple directions with great precision. Researchers want to find out whether one technique is more effective than the other, particularly for stubborn or recurring cases of BPPV. You may be eligible if you are 18 or older and have been diagnosed with posterior canal BPPV — confirmed by a specific pattern of eye movements during a Dix-Hallpike test. People with BPPV in other ear canals, or with dizziness caused by something other than BPPV, are not eligible.

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Interventions

This study will be a randomised controlled trial (RCT) comparing two treatment conditions on the Epley Omniax System (EOS) a mechanical treatment system by Vesticon for the treatment of Benign Paroxysmal Positional Vertigo (BPPV). The EOS is a combined motorized positioning and real time infra-red videooculography system. It consists of a chair with a five-point harness incorporated into a two-axis rotator that allows 360-degree movement of the whole patient in any direction. Oculomotor characteristics are recorded using the systems infrared video oculography goggles, which have the capture rate of 30 Hz and allow the removal of visual fixation.This treatment trial will be for the treatment of posterior canal (PC) BPPV using either the mechanical Epley, or Somersault manoeuvres on the EOS as described below. Any nystagmus elicited will be recorded using infra-red video-nystagmography (VNG) (1) Epley manoeuvre: * with patients in the seated position, they are rotated to 45 degrees to the affected side, before being tilted to 120 degrees down, awaiting the elicitation of nystagmus and vertigo as per the usual dix-hallpike position. They are then rotated to 90 degrees to opposite side, rolled over and sat up, similar to the bedside Epley manoeuvre. (2) Somersault manoeuvre: * With patients in the seated position, they will undergo a 360 degree reverse somersault. Patients will be randomised into one of two treatment groups. There will be no control group in this study, as current clinical guidelines recommend the treatment of BPPV and therefore withholding treatment would be a breach of ethical guidelines regarding ‘best practice’. Patients will undergo a maximum of 4 clinical treatments in their specified treatment group (i.e. until they display a negative Dix-Hallpike (DHP) test (defined as an absence of PC BPPV nystagmus on repeat DHP testing). The number of treatments per clinical session will be determined by patient tolerance i.e. the presence of nausea or severity of symptoms, and response to treatment, i.e. the presence or absence of nystagmus. This will be used to monitor fidelity of intervention and will be documented in the clinicians notes by either a Physiotherapist or Audiologist administering the intervention. Initial consultations are 45 minutes and follow up consultations are 30 minutes. The number of clinical sessions depends on whether the BPPV resolves, based on previous studies, this is typically within 4 or less treatment manoeuvres or 2 or less sessions. Alternate treatment manoeuvres will be completed either within the same session or the following session depending on patient tolerance. Treatment sessions will be once per week until the BPPV resolves. Should patients experience nausea, they will be appropriately managed with antiemetic medications such as stemetil or ondansetron as required, as prescribed by an accompanying Oto-neurologist. Should patients continue to display nystagmus consistent with BPPV after 4 clinical treatments in their selected treatment group, the treatment will be deemed unsuccessful and the patient with be offered the alternate manoeuvre to ensure effective and appropriate clinical care. Should patients experience canal conversion i.e. to horizontal canal BPPV, results will be documented and recorded, and patients will be treated with the alternate treatment manoeuvre as appropriate i.e. Barbeque roll for horizontal canal BPPV. In our earlier study (Power, 2018) patients with PC BPPV, 94% (n = 74/79) experienced relief after three manoeuvres, hence it is anticipated the majority of patients will be effectively treated in 4 or less manoeuvres. These patient treatment procedures do not vary from standard clinic procedures, except for the random allocation to one of two treatment groups. Power, L., Murray, K., Szmulewicz, D. (2018) Early Experience with a multi-axial, whole body positioning system in the treatment of Benign Paroxysmal Positional Vertigo (BPPV). Journal of Clinical Neuroscience. 61; 186 - 188