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

• ClinicalTrials.gov Identifier: NCT04578262
• Recruitment Status: Not yet recruiting
• First Posted: October 8, 2020
• Last Update Posted: October 8, 2020
• Sponsor: University of Seville
• Information provided by (Responsible Party): Cristina García Muñoz, University of Seville

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Benign Paroxysmal Positional Vertigo; Multiple Sclerosis	Procedure: Epley Manoeuvre; Procedure: Sham Manoeuvre	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Epley Manoeuvre for Posterior Semi-circular Canal Benign Paroxysmal Positional Vertigo in People With Multiple Sclerosis: Protocol of a Randomized Controlled Trial
• Estimated Study Start Date: November 1, 2020
• Estimated Primary Completion Date: February 2022
• Estimated Study Completion Date: March 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Epley Manoeuvre; Epley manoeuvre in participants with Multiple Sclerosis who suffer from benign paroxysmal positional vertigo. Only one administration.	Procedure: Epley Manoeuvre; This manoeuvre is constituted by five steps. In the first step, while the patient is in supine posture the head will be positioned 45 degrees turned towards the unaffected ear and the head slightly overhang on the edge of the couch. In this second step maintaining the previous position of the head, physiotherapist will turn head 45 degrees turned towards the affected ear. Next, in the third step, the whole body will turn until is located 135 degrees from the baseline supine position. In the fourth step, while the head keeps turned to the affected ear the subject will be incorporated until he is sitting. In the fifth step, while the subject is seated with the head in neutral position the chin will be bended 20 degrees. Each procedure will be held among 30 seconds or two minutes, while the dizziness or the nystagmus vanish. The intervention will be conducted at the Physical Therapy Department of the University of Sevilla (Spain).; Other Name: canalith repositioning procedure for posterior semi-circular canal
Sham Comparator: Sham Manoeuvre; The second group will received a sham manoeuvre. However after the experimental intervention ends, this groups will also receive Epley manoeuvre.	Procedure: Sham Manoeuvre; The sham manoeuvre consist is going to star with the participant in a neutral seated position. Sum to it, head is rotated 45 degrees towards the unaffected vestibule. After that, the participant will be guided by the physiotherapist to a lateral decubitus position towards the affected side on which his nose will be pointing above. To conclude, the seated position will be reached again without head rotation. Each position of the sham manoeuvre will be maintained along one minute. During all the process the videonystagmography glasses will be dressed by participants and they will be indicated not to close eyes in the intervention. After the execution of the manoeuvre, also this group will be evaluated 48 hours after. The intervention will be conducted at the Physical Therapy Department of the University of Sevilla (Spain).

Outcome Measures

Primary Outcome Measures :

1. Changes in the conversion of a positive to a negative Dix Hallpike Test [ Time Frame: Baseline, immediately after intervention and 48 hours after intervention. ]
   The performance of Dix Hallpike Test consists on a participant sit on a table and the head is turn 45 degrees towards the tested side. Once this position is stablished, the evaluator is going to laid back the participant in a quick movement sum to a neck extension of 20 degrees with the affected ear down. Throughout the process subject will be indicated to keep eyes open to allow the search of nystagmus. If torsional nystagmus or vertigo appears while the head is down it is indicative of posterior canal benign paroxysmal positional vertigo.

Secondary Outcome Measures :

1. Impact of dizziness in the quality of life in participants with Multiple Sclerosis. Dizziness Handicap Inventory (DHI). [ Time Frame: Baseline, immediately after intervention and 48 hours after intervention. ]
   Dizziness Handicap Inventory is a self-assessment questionnaire of 25- items and the total score is 100. The score is calculated by summing ordinal scales responses, higher scores means higher level of disability and handicap constituted by the physical, emotional and functional subscale. Physical and emotional subscales range from 0 to 36 points, and functional from 0 to 28.
2. Independency in activities of daily living measure by Vestibular Disorders Activities of Daily Living Scale (VADL). [ Time Frame: Baseline, immediately after intervention and 48 hours after intervention. ]
   Vestibular Disorders Activities of Daily Living Scale (VADL) is a self-reported questionnaire that measures the independence on activities of daily living in people with vestibular disorders. This scale is composed by 28 items divided in three subcategories: 12 questions of functional skills, 9 questions of ambulation skills and 7 questions of instrumental skills. Each item is rate un a 10-point scale, in which higher score means less independence in ADL. The total score is the median of each subscale.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Cristina García-Muñoz; +34689371303; ccriss.g@gmail.com

Sponsors and Collaborators

University of Seville

Investigators

• Principal Investigator: Cristina García-Muñoz; University of Seville
• Principal Investigator: Maria Jesus Casuso-Holgado; University of Seville
• Principal Investigator: Marilo Dolores Cortes-Vega; University of Seville

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

García-Muñoz C, Cortés-Vega MD, Hernández-Rodríguez JC, Palomo-Carrión R, Martín-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. Erratum in: BMJ Open. 2021 Apr 14;11(4):1.

• Responsible Party: Cristina García Muñoz, Principal Investigator, University of Seville
• ClinicalTrials.gov Identifier: NCT04578262
• Other Study ID Numbers: University of Seville Protocol
• First Posted: October 8, 2020
• Last Update Posted: October 8, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol; Clinical Study Report (CSR)

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cristina García Muñoz, University of Seville:

Multiple Sclerosis; Benign Paroxysmal Positional Vertigo; Epley Manoeuvre; Vertigo; Dizziness

Additional relevant MeSH terms:

Vertigo; Benign Paroxysmal Positional Vertigo; Multiple Sclerosis; Sclerosis; Dizziness; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Sensation Disorders