Benign Paroxysmal Positional VertigoNCT02475239
Efficacy of Postural Restriction in Treating Benign Paroxysmal Positional Vertigo
A study testing Postural restriction and Normal daily activity in people with Benign Paroxysmal Positional Vertigo, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
The standard treatment of posterior semicircular canal benign paroxysmal positional vertigo is the canalith repositioning procedure or the Epley maneuver. Based on the present literature, there is controversy on the efficacy of post-maneuver postural restrictions.The aim of this study was to conduct a randomized… 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?
- Postural restriction and Normal daily activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2014to Jun 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 with unilateral posterior semicircular canal benign paroxysmal positional vertigo and
- A negative neurologic examination
Who cannot join
- Secondary benign paroxysmal positional vertigo caused by trauma head injury, inner ear surgery, viral labyrinthitis or Meniere's disease
- Patients with central vertigo, cervical spine, neurologic, otologic, psychiatric diseases
- Patients who used medications that affected the neurologic and otologic systems for less than 48 hours
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Yuvatiya Plodpoai
Hat Yai, Changwat Songkhla, 90110
Yuvatiya Plodpoa, MD, 66015988403, yuvatiya.plodpai@gmail.com
About this study
The standard treatment of posterior semicircular canal benign paroxysmal positional vertigo is the canalith repositioning procedure or the Epley maneuver. Based on the present literature, there is controversy on the efficacy of post-maneuver postural restrictions.The aim of this study was to conduct a randomized controlled trial to compare the treatment efficacy of post-maneuver postural restriction with CRP alone in patients with posterior semicircular canal benign paroxysmal positional vertigo.
Read the detailed description
Benign paroxysmal positional vertigo is the most common cause of vertigo. Based on the present literature, there is controversy on the efficacy of post-maneuver postural restrictions.Some study designs were not randomized controlled trials. The present study offers an alternative way of postural restriction to maintain postural restriction as much as possible.
- Conditions
- Benign Paroxysmal Positional Vertigo
- Being tested
- Postural restriction, Normal daily activity
- Keywords
- Benign Paroxysmal Positional Vertigo, Postural Restriction
- Medical subject headings
- Benign Paroxysmal Positional Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postural restrictionBehavioural
The patients were instructed to avoid head movements, wear a soft collar during the daytime, wear a supporting pillow and sleep in the semi-upright position at a 45 degree head elevation from the horizontal plane during the nighttime for 48 hours.
Normal daily activityBehavioural
The patients did not follow any postural restrictions and were asked to live as normally as possible.
| Study group | Role | What they receive |
|---|---|---|
| Postural restriction | Experimental | The patients were instructed to avoid head movements, wear a soft collar during the daytime, wear a supporting pillow and sleep in the semi-upright position at a 45 degree head elevation from the horizontal plane during the nighttime for 48 hours. Receives: Behavioral: Postural restriction |
| Normal daily activity | Active comparator | The patients did not follow any postural restrictions and were asked to live as normally as possible. Receives: Behavioral: Normal daily activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Dix-Hallpike test
The Dix-Hallpike test results
Measured: 2 weeks
Secondary outcomes (4)
Resolution time
Time interval until the patient report recurrent vertigo confirmed by positive Dix-Hallpike
Measured: 24 weeks
Medication needed
Need of medication to treat vertigo (in this study, betahistine)
Measured: 24 weeks
the Dizziness Handicap Inventory (DHI)
Measured: 24 weeks
Recurrent rate
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startDec 2014
- Primary completionMar 2017 (estimated)
- Study completionJun 2017 (estimated)
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.
- 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
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuvatiya Plodpai, Prince of Songkla University
- Investigators
- Yuvatiya Plodpai, MD, Principal investigator, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475239
- Sponsor's protocol ID
- REC 57-0082-13-1
- Status last verified
- Jun 2015
- First submitted
- 10 Jun 2015
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Postural Restriction in Treating Benign Paroxysmal Positional Vertigo
- ClinicalTrials.gov ID
- NCT02475239
- Acronym / sponsor ID
- REC 57-0082-13-1
- Conditions
- Benign Paroxysmal Positional Vertigo
- Keywords
- Benign Paroxysmal Positional Vertigo, Postural Restriction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 18 Jun 2015 (estimated)
- 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.
The standard treatment of posterior semicircular canal benign paroxysmal positional vertigo is the canalith repositioning procedure or the Epley maneuver. Based on the present literature, there is controversy on the efficacy of post-maneuver postural restrictions.The aim of this study was to conduct a randomized controlled trial to compare the treatment efficacy of post-maneuver postural restriction with CRP alone in patients with posterior semicircular canal benign paroxysmal positional vertigo.
Detailed description
Benign paroxysmal positional vertigo is the most common cause of vertigo. Based on the present literature, there is controversy on the efficacy of post-maneuver postural restrictions.Some study designs were not randomized controlled trials. The present study offers an alternative way of postural restriction to maintain postural restriction as much as possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postural restriction | Experimental | Behavioral: Postural restrictionThe patients were instructed to avoid head movements, wear a soft collar during the daytime, wear a supporting pillow and sleep in the semi-upright position at a 45 degree head elevation from the horizontal plane during the nighttime for 48 hours. |
| Normal daily activity | Active comparator | Behavioral: Normal daily activityThe patients did not follow any postural restrictions and were asked to live as normally as possible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with unilateral posterior semicircular canal benign paroxysmal positional vertigo and
- A negative neurologic examination
Key exclusion criteria (3 listed)
- Secondary benign paroxysmal positional vertigo caused by trauma head injury, inner ear surgery, viral labyrinthitis or Meniere's disease
- Patients with central vertigo, cervical spine, neurologic, otologic, psychiatric diseases
- Patients who used medications that affected the neurologic and otologic systems for less than 48 hours
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 |
|---|---|---|
| Postural restrictionThe patients were instructed to avoid head movements, wear a soft collar during the daytime, wear a supporting pillow and sleep in the semi-upright position at a 45 degree head elevation from the horizontal plane during the nighttime for 48 hours. | Behavioural | Postural restriction |
| Normal daily activityThe patients did not follow any postural restrictions and were asked to live as normally as possible. | Behavioural | Normal daily activity |
Primary outcome
The Dix-Hallpike test
Time frame: 2 weeks
The Dix-Hallpike test results
4 secondary outcomes
Resolution time
Time frame: 24 weeks
Medication needed
Time frame: 24 weeks
the Dizziness Handicap Inventory (DHI)
Time frame: 24 weeks
Recurrent rate
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2015.
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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.
Yuvatiya Plodpai, MD principal investigator
Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postural restriction and Normal daily activity in people with Benign Paroxysmal Positional Vertigo, run by Prince of Songkla University at 1 site in Thailand.
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 2 inclusion and 3 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 18 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuvatiya Plodpai, MD (66815988403, yuvatiya.plodpai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Dix-Hallpike test (time frame: 2 weeks). 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 18 Jun 2015.