Clinical trial NCT04578262: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Paroxysmal Positional Vertigo
Multiple Sclerosis
Keywords: Multiple Sclerosis
Benign Paroxysmal Positional Vertigo
Epley Manoeuvre
Vertigo
Dizziness
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Changes in the conversion of a positive to a negative Dix Hallpike Test
timeFrame: Baseline, immediately after intervention and 48 hours after intervention.
Secondary outcomes:
measure: Impact of dizziness in the quality of life in participants with Multiple Sclerosis. Dizziness Handicap Inventory (DHI).
timeFrame: Baseline, immediately after intervention and 48 hours after intervention.
measure: Independency in activities of daily living measure by Vestibular Disorders Activities of Daily Living Scale (VADL).
timeFrame: Baseline, immediately after intervention and 48 hours after intervention.
Other outcomes:
Locations:
Study officials:
affiliation: University of Seville
name: Cristina García-Muñoz
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Seville
name: Maria Jesus Casuso-Holgado
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Seville
name: Marilo Dolores Cortes-Vega
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia-Munoz C, Cortes-Vega MD, Hernandez-Rodriguez JC, Palomo-Carrion R, Martin-Valero R, Casuso-Holgado MJ. Epley manoeuvre for posterior semicircular canal benign paroxysmal positional vertigo in people with multiple sclerosis: protocol of a randomised controlled trial. BMJ Open. 2021 Mar 18;11(3):e046510. doi: 10.1136/bmjopen-2020-046510.