Epley Manoeuvre in Participants With Multiple Sclerosis Diagnosed From Benign Paroxysmal Positional Vertigo

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Brief Title

Epley Manoeuvre in Participants With Multiple Sclerosis Diagnosed From Benign Paroxysmal Positional Vertigo

Official Title

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

Brief Summary

      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.
    

Detailed Description

      After given oral and written information to participants, they will be freedom to decide
      their wish to participate. After the invitation, those participants who desire to be part of
      study will sign the written informed consent.The study describes a two-arms, parallel groups
      design and double-blind randomized clinical trial. A prospective study with randomized and
      conceal allocation will be performed to prevent possible bias. Participants and evaluators
      will be blinded to group allocation. The randomized controlled trial have 3 evaluations of
      the sample, that will be carried out at baseline, immediately after intervention and 48 hours
      later
    


Study Type

Interventional


Primary Outcome

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

Secondary Outcome

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

Condition

Benign Paroxysmal Positional Vertigo

Intervention

Epley Manoeuvre

Study Arms / Comparison Groups

 Epley Manoeuvre
Description:  Epley manoeuvre in participants with Multiple Sclerosis who suffer from benign paroxysmal positional vertigo. Only one administration.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

80

Start Date

November 1, 2020

Completion Date

March 2022

Primary Completion Date

February 2022

Eligibility 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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Cristina García-Muñoz, +34689371303, [email protected]



Administrative Informations


NCT ID

NCT04578262

Organization ID

University of Seville Protocol


Responsible Party

Principal Investigator

Study Sponsor

University of Seville


Study Sponsor

Cristina García-Muñoz, Principal Investigator, University of Seville


Verification Date

October 2020