Benign Paroxysmal Positional VertigoNCT03230513
Comparison of Home-Based Exercise on the Posterior Canal Benign Paroxysmal Positional Vertigo Symptoms
A study testing Self Epley Manoeuvre and Brandt-Daroff Exercise in people with Benign Paroxysmal Positional Vertigo, run by University of Malaya.
Trial summary
Benign paroxysmal positional vertigo (BPPV) is the most common vestibular disorder in adults and the treatment of choice is by particle repositioning manoeuvres (PRM). This study aims to compare the treatment efficacy of two home-based exercises, self-Epley manoeuvre (SEM) and Brandt-Daroff exercise (BDE) in patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo
- What is being tested?
- Self Epley Manoeuvre and Brandt-Daroff Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 1 May 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who have had symptoms of vertigo for at least 1 week duration,
- patients with a documented positive Dix-Hallpike test on referral,
- patients with intact cognitive function and had the ability to communicate and understand instructions to perform a home-based exercise.
Who cannot join
- patients with history of prior ear surgery,
- patients with orthopaedic or connective tissue disorder that impairs functional neck or trunk range of motion,
- patients with a significant neurological disorder or spinal cord damage, and
- patients who have been prescribed with home-based exercises for BPPV.
About this study
Official title: Comparison of Home-Based Modified Self-Epley Manoeuvre and Brandt-Daroff Exercise on the Posterior Canal Benign Paroxysmal Positional Vertigo Symptoms: A Randomized Single-Blind Controlled Trial
Benign paroxysmal positional vertigo (BPPV) is the most common vestibular disorder in adults and the treatment of choice is by particle repositioning manoeuvres (PRM). This study aims to compare the treatment efficacy of two home-based exercises, self-Epley manoeuvre (SEM) and Brandt-Daroff exercise (BDE) in patients with posterior canal BPPV based on vertigo resolution, reduction of vertigo intensity, the Dizziness Handicap Inventory scores and the conversion of a positive to negative Dix-Hallpike test.
Read the detailed description
Study Objective:
To compare the efficacy of the self-Epley manoeuvre to the Brandt-Daroff exercise in resolving vertigo symptoms in patients with unilateral posterior canal BPPV.
Study Design:
Single-blind randomized controlled study
Sample Size:
Fifty patients were recruited in the study and were divided with 25 patients in each treatment arm.
Study Method:
Patients who satisfy the inclusion criteria and have given informed consent were randomized into the 2 treatment groups. A dedicated physiotherapist will demonstrate the selected exercise (either SEM or BDE) and observed the patient performing the exercise twice to ensure the ability of the patient to perform it correctly at home. A diary was provided for the patients to chart the therapy sessions performed at home as well as a pamphlet with simple illustrated instructions of the chosen exercise. The patients were asked to perform the home-based exercise for 2 weeks.
Primary Outcome Measure
- Resolution of vertigo symptoms in patients with unilateral posterior canal BPPV.
Secondary Outcome Measures
- Vertigo resolution at 1 and 6 months;
- The conversion of positive to negative Dix-Hallpike test between both groups after 1 month;
- Vertigo intensity in unresolved vertigo patients at 1 \& 6 months;
- The Dizziness Handicap Inventory between both groups at 1 and 6 months.
- Conditions
- Benign Paroxysmal Positional Vertigo
- Being tested
- Self Epley Manoeuvre, Brandt-Daroff Exercise
- Keywords
- vertigo, benign paroxysmal positional vertigo, particle repositioning manoeuvre
- Medical subject headings
- Benign Paroxysmal Positional Vertigo, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Epley ManoeuvreOther
Also called SEM
The patient has to position himself long sitting on the bed, then turn his head 45 degrees to the problematic side. When in this head position, he will rapidly lie himself supine with a pillow under his shoulders. He then turns his head 90 degrees to the opposite direction followed by turning of his body to the same side before returning to a sitting position at the edge of the bed. Each position should be kept for 30 seconds each, and the patient is required to perform 3 cycles of this manoeuvre just prior to going to bed daily for 2 weeks.
Brandt-Daroff ExerciseOther
Also called BDE
The patient has to sit at the edge of the bed, turn his head laterally 45 degrees to one side and move rapidly into the side lying position, keeping his head in the same position. He then returns upright and turns his head to the opposite direction and the same movement is repeated on the other side. Each position is held for at least 30 seconds and the patient is required to perform it for 5 repetitions, three times a day, daily for 2 weeks duration.
| Study group | Role | What they receive |
|---|---|---|
| Self Epley Manoeuvre | Active comparator | Self Epley Manoeuvre. Receives: Other: Self Epley Manoeuvre |
| Brandt-Daroff Exercise | Active comparator | Brandt-Daroff Exercise. Receives: Other: Brandt-Daroff Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertigo resolution
Present or absent
Measured: Assessed at 1 month and 6 months following initiation of home-based exercise.
Secondary outcomes (3)
Conversion of a positive to negative Dix-Hallpike test
Positive or negative
Measured: Assessed at 1 month following initiation of home-based exercise.
Vertigo intensity
Patients were asked to rate the average severity or intensity of the vertigo episode in the previous one week based on a 1-to-5 Likert scale, with a scale of 5 implying the most intense or severe.
Measured: Assessed on first assessment during recruitment, at 1 month and 6 months following initiation of home-based exercise.
Dizziness Handicap Inventory
A 25 item questionnaire that encompasses 3 domains which are functional, physical and emotional. The scores are summed with maximum score of 100 and the higher the score, the greater the perceived handicap.
Measured: Assessed on first assessment during recruitment, at 1 month and 6 months following initiation of home-based exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start1 Oct 2015
- Primary completion31 Oct 2016
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Paroxysmal Positional VertigoStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Model description
- Participants were assigned to either the SEM group (written as "Group A") or the BDE group (written as "Group B") throughout the duration of the study.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mazlina Mazlan, MBBS, MRM, Study chair, University of MalayaNor Hanim Mohamad Hanapi, MBBS, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230513
- Sponsor's protocol ID
- MREC ID NO: 20155-1337
- Status last verified
- Jul 2017
- First submitted
- 24 Jul 2017
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Home-Based Modified Self-Epley Manoeuvre and Brandt-Daroff Exercise on the Posterior Canal Benign Paroxysmal Positional Vertigo Symptoms: A Randomized Single-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT03230513
- Acronym / sponsor ID
- MREC ID NO: 20155-1337
- Conditions
- Benign Paroxysmal Positional Vertigo
- Keywords
- vertigo, benign paroxysmal positional vertigo, particle repositioning manoeuvre
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 26 Jul 2017 (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.
Benign paroxysmal positional vertigo (BPPV) is the most common vestibular disorder in adults and the treatment of choice is by particle repositioning manoeuvres (PRM). This study aims to compare the treatment efficacy of two home-based exercises, self-Epley manoeuvre (SEM) and Brandt-Daroff exercise (BDE) in patients with posterior canal BPPV based on vertigo resolution, reduction of vertigo intensity, the Dizziness Handicap Inventory scores and the conversion of a positive to negative Dix-Hallpike test.
Detailed description
Study Objective:
To compare the efficacy of the self-Epley manoeuvre to the Brandt-Daroff exercise in resolving vertigo symptoms in patients with unilateral posterior canal BPPV.
Study Design:
Single-blind randomized controlled study
Sample Size:
Fifty patients were recruited in the study and were divided with 25 patients in each treatment arm.
Study Method:
Patients who satisfy the inclusion criteria and have given informed consent were randomized into the 2 treatment groups. A dedicated physiotherapist will demonstrate the selected exercise (either SEM or BDE) and observed the patient performing the exercise twice to ensure the ability of the patient to perform it correctly at home. A diary was provided for the patients to chart the therapy sessions performed at home as well as a pamphlet with simple illustrated instructions of the chosen exercise. The patients were asked to perform the home-based exercise for 2 weeks.
Primary Outcome Measure
- Resolution of vertigo symptoms in patients with unilateral posterior canal BPPV.
Secondary Outcome Measures
- Vertigo resolution at 1 and 6 months;
- The conversion of positive to negative Dix-Hallpike test between both groups after 1 month;
- Vertigo intensity in unresolved vertigo patients at 1 \& 6 months;
- The Dizziness Handicap Inventory between both groups at 1 and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants were assigned to either the SEM group (written as "Group A") or the BDE group (written as "Group B") throughout the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Self Epley Manoeuvre | Active comparator | Other: Self Epley ManoeuvreSelf Epley Manoeuvre. |
| Brandt-Daroff Exercise | Active comparator | Other: Brandt-Daroff ExerciseBrandt-Daroff Exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients who have had symptoms of vertigo for at least 1 week duration,
- patients with a documented positive Dix-Hallpike test on referral,
- patients with intact cognitive function and had the ability to communicate and understand instructions to perform a home-based exercise.
Key exclusion criteria (4 listed)
- patients with history of prior ear surgery,
- patients with orthopaedic or connective tissue disorder that impairs functional neck or trunk range of motion,
- patients with a significant neurological disorder or spinal cord damage, and
- patients who have been prescribed with home-based exercises for BPPV.
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 |
|---|---|---|
| Self Epley ManoeuvreAlso: SEMThe patient has to position himself long sitting on the bed, then turn his head 45 degrees to the problematic side. When in this head position, he will rapidly lie himself supine with a pillow under his shoulders. He then turns his head 90 degrees to the opposite direction followed by turning of his body to the same side before returning to a sitting position at the edge of the bed. Each position should be kept for 30 seconds each, and the patient is required to perform 3 cycles of this manoeuvre just prior to going to bed daily for 2 weeks. | Other | Self Epley Manoeuvre |
| Brandt-Daroff ExerciseAlso: BDEThe patient has to sit at the edge of the bed, turn his head laterally 45 degrees to one side and move rapidly into the side lying position, keeping his head in the same position. He then returns upright and turns his head to the opposite direction and the same movement is repeated on the other side. Each position is held for at least 30 seconds and the patient is required to perform it for 5 repetitions, three times a day, daily for 2 weeks duration. | Other | Brandt-Daroff Exercise |
Primary outcome
Vertigo resolution
Time frame: Assessed at 1 month and 6 months following initiation of home-based exercise.
Present or absent
3 secondary outcomes
Conversion of a positive to negative Dix-Hallpike test
Time frame: Assessed at 1 month following initiation of home-based exercise.
Vertigo intensity
Time frame: Assessed on first assessment during recruitment, at 1 month and 6 months following initiation of home-based exercise.
Dizziness Handicap Inventory
Time frame: Assessed on first assessment during recruitment, at 1 month and 6 months following initiation of home-based exercise.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Individual participant dataSharing planned: Undecided
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Comparison of Two Mechanical Rotation Chairs With Diagnostics of Benign Paroxysmal Positional Vertigo.
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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.
Mazlina Mazlan, MBBS, MRM study chair
University of Malaya
Nor Hanim Mohamad Hanapi, MBBS principal investigator
University of Malaya
Questions about this trial
What is this clinical trial studying?
A study testing Self Epley Manoeuvre and Brandt-Daroff Exercise in people with Benign Paroxysmal Positional Vertigo, run by University of Malaya.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 1 Aug 2017. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertigo resolution (time frame: Assessed at 1 month and 6 months following initiation of home-based exercise.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2017.