Benign Paroxysmal Positional VertigoNCT04578262
Epley Manoeuvre in Participants With Multiple Sclerosis Diagnosed From Benign Paroxysmal Positional Vertigo
A study testing Epley Manoeuvre in people with Benign Paroxysmal Positional Vertigo and Multiple Sclerosis, run by University of Seville.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo, Multiple Sclerosis
- What is being tested?
- Epley Manoeuvre
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Epley Manoeuvre for Posterior Semi-circular Canal Benign Paroxysmal Positional Vertigo in People With Multiple Sclerosis: Protocol of a Randomized Controlled Trial
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.
Read the 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
- Being tested
- Epley Manoeuvre, Sham Manoeuvre
- Keywords
- Multiple Sclerosis, Benign Paroxysmal Positional Vertigo, Epley Manoeuvre, Vertigo, Dizziness
- Medical subject headings
- Benign Paroxysmal Positional Vertigo, Multiple Sclerosis, Vertigo, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epley ManoeuvreProcedure or surgery
Also called canalith repositioning procedure for posterior semi-circular canal
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).
Sham ManoeuvreProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Epley Manoeuvre | Experimental | Epley manoeuvre in participants with Multiple Sclerosis who suffer from benign paroxysmal positional vertigo. Only one administration. Receives: Procedure: Epley Manoeuvre |
| Sham Manoeuvre | Sham comparator | The second group will received a sham manoeuvre. However after the experimental intervention ends, this groups will also receive Epley manoeuvre. Receives: Procedure: Sham Manoeuvre |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately after intervention and 48 hours after intervention.
Secondary outcomes (2)
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.
Measured: Baseline, immediately after intervention and 48 hours after intervention.
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.
Measured: Baseline, immediately after intervention and 48 hours after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Paroxysmal Positional VertigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina García Muñoz, University of Seville
- Investigators
- Cristina García-Muñoz, Principal investigator, University of SevilleMaria Jesus Casuso-Holgado, Principal investigator, University of SevilleMarilo Dolores Cortes-Vega, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578262
- Sponsor's protocol ID
- University of Seville Protocol
- Status last verified
- Oct 2020
- First submitted
- 20 Sep 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 33737443
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epley Manoeuvre for Posterior Semi-circular Canal Benign Paroxysmal Positional Vertigo in People With Multiple Sclerosis: Protocol of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04578262
- Acronym / sponsor ID
- University of Seville Protocol
- Keywords
- Multiple Sclerosis, Benign Paroxysmal Positional Vertigo, Epley Manoeuvre, Vertigo, Dizziness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epley Manoeuvre | Experimental | Procedure: Epley ManoeuvreEpley manoeuvre in participants with Multiple Sclerosis who suffer from benign paroxysmal positional vertigo. Only one administration. |
| Sham Manoeuvre | Sham comparator | Procedure: Sham ManoeuvreThe second group will received a sham manoeuvre. However after the experimental intervention ends, this groups will also receive Epley manoeuvre. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epley ManoeuvreAlso: canalith repositioning procedure for posterior semi-circular canalThis 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). | Procedure or surgery | Epley Manoeuvre |
| Sham ManoeuvreThe 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). | Procedure or surgery | Sham Manoeuvre |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 33737443Garcia-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.
- Individual participant dataSharing planned: Yes
Related trials for Benign Paroxysmal Positional Vertigo
Recruiting
Effectiveness of Epley Maneuver Versus Semont Maneuver on Dizziness and Balance in Stroke Survivors With Posterior Canal BPPV
Stroke
Not yet recruiting
Epley Versus Semont-plus Maneuver for Benign Paroxysmal Positional Vertigo
Benign Paroxysmal Positional Vertigo (BPPV)
Enrolling by invitationObservational study
Comparison of Two Mechanical Rotation Chairs With Diagnostics of Benign Paroxysmal Positional Vertigo.
Benign Paroxysmal Positional Vertigo (BPPV)
Not yet recruiting
The Effect of Chewing Gum on Dizziness in Patients Diagnosed With Posterior Canal Benign Paroxysmal Positional Vertigo in the Emergency Department
Vertigo Benign Positional, Dizziness
Active, not recruiting
Benign Paroxysmal Positional Vertigo With and Without Vestibular Hypofunction: Protocol for an Integrated Home-Based Exercise With Self-Managed Education Programme
Benign Paroxysmal Positional Vertigo (BPPV), Vestibular Hypofunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina García-Muñoz principal investigator
University of Seville
Maria Jesus Casuso-Holgado principal investigator
University of Seville
Marilo Dolores Cortes-Vega principal investigator
University of Seville
Questions about this trial
What is this clinical trial studying?
A study testing Epley Manoeuvre in people with Benign Paroxysmal Positional Vertigo and Multiple Sclerosis, run by University of Seville.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristina García-Muñoz (+34689371303, ccriss.g@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the conversion of a positive to a negative Dix Hallpike Test (time frame: Baseline, immediately after intervention and 48 hours after intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04578262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.