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
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
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
NCT ID
NCT04578262
First Posted
September 20, 2020
Last Updated
October 6, 2020
Sponsor
University of Seville
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
Learn more about this trial
Epley Manoeuvre in Participants With Multiple Sclerosis Diagnosed From Benign Paroxysmal Positional Vertigo
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