Epley Manoeuvre for Posterior Semi-circular Canal Benign Paroxysmal Positional Vertigo in People With Multiple Sclerosis: Protocol of a Randomized Controlled Trial

Status unknownNot a drug-phase studyRelapsing and progressiveNCT04578262

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Epley Manoeuvre

Placebo

  • Sham Manoeuvre

What it measured

Main measures

  • Changes in the conversion of a positive to a negative Dix Hallpike Test

    Baseline, immediately after intervention and 48 hours after intervention.

Other measures (2)

  • Impact of dizziness in the quality of life in participants with Multiple Sclerosis. Dizziness Handicap Inventory (DHI).

    Baseline, immediately after intervention and 48 hours after intervention.

    Quality of life (reported by participants)
  • Independency in activities of daily living measure by Vestibular Disorders Activities of Daily Living Scale (VADL).

    Baseline, immediately after intervention and 48 hours after intervention.

Who could take part

Relapsing and progressive · 18 to 65 · EDSS 1 to 5

Show the full criteria

Inclusion criteria

* Adults of both genders aged from 18 to 65 years old. * clinically diagnosed of any MS subtype (relapsing-remitting, primary progressive and secondary progressive), * with an Expanded Disability Status Scale (EDSS) ranging from 1 to 5 points, * diagnosed of posterior semi-circular canals benign paroxysmal positional vertigo by an otolaryngologist and a physical therapist expert in vestibular rehabilitation.

Exclusion criteria

* Changes in MS pharmacotherapy within the last 3 months, * BPPV treatments as vestibular sedatives, corticosteroids, morphic and antihistamines, at least 72 hours before intervention, * alcohol consumption in the last 72 hours, * severe visual impairments, * participants who have received vestibular rehabilitation within the last 3 months, * existence of any other neurologic disease.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Vertigo, dizziness and control postural disturbance are one of the most disabling symptoms in Multiple Sclerosis. These could be caused by a peripheral or central vestibular disorder. Although, central vestibular damage is more prevalent, peripheral vestibular disturbance aetiology is significantly common in this disease. Within peripheral vestibulopathy, benign paroxysmal positional vertigo is the most common syndrome. Impairments of posterior semi-circular canals in benign paroxysmal positional vertigo represent among the 60-90 % of the cases. Gold standard treatment in this syndrome is the canalith repositioning procedure, called Epley manoeuvre. This manoeuvre has been deeply investigated in previous studies for participants who only suffer from benign paroxysmal positional vertigo. Any randomized clinical trials have been carried out to assess the effectiveness of Epley manoeuvre. However, a retrospective research and a case study reported encouraging results for the resolution of posterior semi-circular canal benign paroxysmal positional vertigo, through the Epley manoeuvre. The main objective of the study is to assess the effectiveness of the Epley Manoeuvre for the improvement of the benign paroxysmal positional vertigo of participants with multiple sclerosis, compared to a passive control group.

Papers

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History

    1. Started

      Nov 2020

    2. Main results due

      Feb 2022

    3. Finished

      Mar 2022

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