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

Primary Purpose

Benign Paroxysmal Positional Vertigo, Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Epley Manoeuvre
Sham Manoeuvre
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Paroxysmal Positional Vertigo focused on measuring Multiple Sclerosis, Benign Paroxysmal Positional Vertigo, Epley Manoeuvre, Vertigo, Dizziness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Epley Manoeuvre

    Sham Manoeuvre

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Impact of dizziness in the quality of life in participants with Multiple Sclerosis. Dizziness Handicap Inventory (DHI).
    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.
    Independency in activities of daily living measure by Vestibular Disorders Activities of Daily Living Scale (VADL).
    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.

    Full Information

    First Posted
    September 20, 2020
    Last Updated
    October 6, 2020
    Sponsor
    University of Seville
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04578262
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2020 (Anticipated)
    Primary Completion Date
    February 2022 (Anticipated)
    Study Completion Date
    March 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Seville

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Benign Paroxysmal Positional Vertigo, Multiple Sclerosis
    Keywords
    Multiple Sclerosis, Benign Paroxysmal Positional Vertigo, Epley Manoeuvre, Vertigo, Dizziness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Epley Manoeuvre
    Arm Type
    Experimental
    Arm Description
    Epley manoeuvre in participants with Multiple Sclerosis who suffer from benign paroxysmal positional vertigo. Only one administration.
    Arm Title
    Sham Manoeuvre
    Arm Type
    Sham Comparator
    Arm Description
    The second group will received a sham manoeuvre. However after the experimental intervention ends, this groups will also receive Epley manoeuvre.
    Intervention Type
    Procedure
    Intervention Name(s)
    Epley Manoeuvre
    Other Intervention Name(s)
    canalith repositioning procedure for posterior semi-circular canal
    Intervention Description
    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).
    Intervention Type
    Procedure
    Intervention Name(s)
    Sham Manoeuvre
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Changes in the conversion of a positive to a negative Dix Hallpike Test
    Description
    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.
    Time Frame
    Baseline, immediately after intervention and 48 hours after intervention.
    Secondary Outcome Measure Information:
    Title
    Impact of dizziness in the quality of life in participants with Multiple Sclerosis. Dizziness Handicap Inventory (DHI).
    Description
    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.
    Time Frame
    Baseline, immediately after intervention and 48 hours after intervention.
    Title
    Independency in activities of daily living measure by Vestibular Disorders Activities of Daily Living Scale (VADL).
    Description
    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.
    Time Frame
    Baseline, immediately after intervention and 48 hours after intervention.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cristina García-Muñoz
    Phone
    +34689371303
    Email
    ccriss.g@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cristina García-Muñoz
    Organizational Affiliation
    University of Seville
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Maria Jesus Casuso-Holgado
    Organizational Affiliation
    University of Seville
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Marilo Dolores Cortes-Vega
    Organizational Affiliation
    University of Seville
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    33737443
    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. Erratum In: BMJ Open. 2021 Apr 14;11(4):1.
    Results Reference
    derived

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

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