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

University of Seville

Status: Unknown

Conditions: Benign Paroxysmal Positional Vertigo; Multiple Sclerosis

Treatments: Procedure: Sham Manoeuvre; Procedure: Epley Manoeuvre

Study type: Interventional

Funder types: Other

Identifiers

NCT04578262

University of Seville Protocol

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Epley Manoeuvre

Experimental group

Description:

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

Treatment:

Procedure: Epley Manoeuvre

Sham Manoeuvre

Sham Comparator group

Description:

The second group will received a sham manoeuvre. However after the experimental intervention ends, this groups will also receive Epley manoeuvre.

Treatment:

Procedure: Sham Manoeuvre