Benign Paroxysmal Positional VertigoNCT03425786
Benign Paroxysmal Positional Vertigo (BPPV) Training for Sports Medicine Providers in a Pediatric Concussion Program
A study testing Diagnostic training and Diagnostic and treatment training in people with Benign Paroxysmal Positional Vertigo, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The investigators are training a group of four pediatric Sports Medicine providers in BPPV maneuvers. All four providers will be trained in the diagnostic maneuvers, and two will be randomly selected to also be trained in the treatment maneuvers. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo
- What is being tested?
- Diagnostic training and Diagnostic and treatment training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2021to 1 Mar 2023
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sports Medicine providers at Boston Children's Hospital who see a high volume of concussion patients
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital Waltham
Waltham, Massachusetts, 02453
About this study
The investigators are training a group of four pediatric Sports Medicine providers in BPPV maneuvers. All four providers will be trained in the diagnostic maneuvers, and two will be randomly selected to also be trained in the treatment maneuvers. The providers will be encouraged to use the diagnostic maneuvers on all new concussion patients whose initial visit is within 28 days of their injury. They will complete a survey at the start and end of the study to determine if they thought the training affected their understanding of BPPV and confidence in managing it, as well as determine any challenges they faced with learning/administering the maneuvers. Additionally, the investigators will determine if the additional training impacts time to recovery from concussion, as well as determine potential risk factors for BPPV in concussion.
Read the detailed description
Benign paroxysmal positional vertigo (BPPV) is a common disorder of the inner ear that causes episodes of vertigo. BPPV occurs as a result of displacement of otoliths from their position on the utricle into one of the semicircular canals. Posterior canal BPPV is diagnosed by performing the Dix-Hallpike maneuver, and lateral canal BPPV is diagnosed by performing the supine head roll test (Pagnini-McClure maneuver). Most cases of BPPV will resolve spontaneously, but this can take weeks to months without intervention, and approximately a third of cases will not resolve without treatment. Repositioning maneuvers, such as the Epley maneuver and Barbecue maneuver, move the otolith crystals out of the affected semicircular canal and back to their position on the utricle organ. Such maneuvers have been shown to be highly effective at resolving BPPV, and typically only 1-2 treatments are required.
BPPV most commonly occurs as an isolated spontaneous disorder, but it can also occur following a concussion. While the diagnosis and treatment of BPPV is a routine component of most Otolaryngology and Neurology training programs, it is not a component of most Sports Medicine training programs. It is also common that providers who are taught to diagnose BPPV do not know how to treat it. Furthermore, the role of BPPV in concussion recovery has not been well studied. Hoffer and colleagues found BPPV to be present in nearly a third of adult military patients with dizziness immediately following a concussion, and they found that these patients had rapid symptom resolution following repositioning maneuvers. The investigators recently found evidence of BPPV in 21% of patients referred to their pediatric vestibular program clinic for prolonged dizziness symptoms following a concussion. The majority of these patients were successfully treated with repositioning maneuvers following their first visit to the vestibular clinic, but that visit occurred at a mean of 4 months following their initial injury.
In order to determine if early recognition and management of BPPV will expedite recovery from concussion in affected patients, the investigators will train a group of four pediatric Sports Medicine providers in BPPV maneuvers. All four providers will be trained by Dr. Jacob Brodsky in the Dix-Hallpike and head roll maneuvers (BPPV diagnosis; Both Groups A \& B), and two will be randomly selected to also be trained by Dr. Brodsky in the Epley and Barbecue maneuvers (BPPV treatment; Group A only). The providers will be encouraged to use the Dix-Hallpike and head roll maneuvers on all new concussion patients whose initial visit is within 28 days of their injury to determine if the patients have BPPV. Providers who have been trained in treatment maneuvers (Group A, Early BPPV Management) will be encouraged to perform them accordingly on any patients with positive diagnostic maneuvers. Providers who have not been trained in treatment maneuvers (Group B, Late BPPV Management) will refer patients with suspected BPPV to Dr. Brodsky for treatment, as is currently the routine. Patients are not being directly randomized and do not need to do anything beyond attend their regularly scheduled appointments.
The Sports Medicine providers will complete a source document after each visit to document which maneuvers were performed and if the patient has recovered from concussion. They will also complete a survey at the start and end of the study to determine if they thought the training affected their understanding of BPPV and confidence in managing it, as well as determine any challenges they faced with learning/administering the maneuvers. The patients managed by providers in Group A will then be compared to patients managed by providers in Group B by multiple variables, including their post concussion symptom scores (PCSS), time to clearance for return to play, and time to symptom resolution. The investigators will also compare patients who were diagnosed with BPPV to those who were not to evaluate for risk factors for post-concussion BPPV, including comparison of age, gender, migraine history, prior concussion history, and mode of injury.
- Conditions
- Benign Paroxysmal Positional Vertigo
- Being tested
- Diagnostic training, Diagnostic and treatment training
- 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.
Diagnostic trainingBehavioural
Training in the Dix-Hallpike maneuver and the supine head roll test to diagnose BPPV.
Diagnostic and treatment trainingBehavioural
Training in the Dix-Hallpike maneuver and the supine head roll test to diagnose BPPV. Training in the Epley and Barbecue maneuvers to treat BPPV.
| Study group | Role | What they receive |
|---|---|---|
| Early BPPV Management | Experimental | Diagnostic and treatment training for BPPV. Receives: Behavioral: Diagnostic and treatment training |
| Late BPPV Management | Active comparator | Diagnostic training for BPPV. Sports Medicine providers will refer patients positive for BPPV to an Otolaryngologist at our institution for treatment. Receives: Behavioral: Diagnostic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey of level of confidence in managing BPPV in concussion patients
Providers will complete a survey before and after the study to assess if their level of confidence in managing BPPV in concussion patients has changed. Providers will rate their level of confidence from 1 to 10, with 1 meaning not at all confident and 10 meaning very confident.
Measured: 1 year
Secondary outcomes (6)
Time to recovery from concussion
A comparison of time to recovery from concussion in patients whose providers had diagnostic training versus patients whose providers had diagnostic and treatment training.
Measured: 1 year
Mode of concussion
A comparison of concussion patients by mode of concussion to determine if mode of concussion is a potential risk factor for BPPV.
Measured: 1 year
Site of impact
A comparison of concussion patients by site of impact to determine if site of impact is a potential risk factor for BPPV.
Measured: 1 year
Sport played when concussion sustained
A comparison of concussion patients by which sport they were playing when the concussion was sustained to determine if certain sports are a potential risk factor for BPPV.
Measured: 1 year
Number of lifetime concussions
A comparison of concussion patients by number of lifetime concussions to determine if number of lifetime concussions is a potential risk factor for BPPV.
Measured: 1 year
History of migraine
A comparison of concussion patients by history of migraine to determine if history of migraine is a potential risk factor for BPPV.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start29 Sep 2021
- Primary completion31 Jan 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Benign Paroxysmal Positional VertigoStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Brodsky, Boston Children's Hospital
- Investigators
- Jacob R Brodsky, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425786
- Sponsor's protocol ID
- IRB-P00025099
- Status last verified
- Nov 2024
- First submitted
- 25 Jan 2018
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Centers for Disease Control and Prevention (CDC). Sports-related recurrent brain injuries--United States. MMWR Morb Mortal Wkly Rep. 1997 Mar 14;46(10):224-7.
PubMed 9082176Meehan WP 3rd, Mannix RC, Stracciolini A, Elbin RJ, Collins MW. Symptom severity predicts prolonged recovery after sport-related concussion, but age and amnesia do not. J Pediatr. 2013 Sep;163(3):721-5. doi: 10.1016/j.jpeds.2013.03.012. Epub 2013 Apr 26.
PubMed 23628374Lau BC, Kontos AP, Collins MW, Mucha A, Lovell MR. Which on-field signs/symptoms predict protracted recovery from sport-related concussion among high school football players? Am J Sports Med. 2011 Nov;39(11):2311-8. doi: 10.1177/0363546511410655. Epub 2011 Jun 28.
PubMed 21712482Kim JS, Zee DS. Clinical practice. Benign paroxysmal positional vertigo. N Engl J Med. 2014 Mar 20;370(12):1138-47. doi: 10.1056/NEJMcp1309481. No abstract available.
PubMed 24645946Hoffer ME, Gottshall KR, Moore R, Balough BJ, Wester D. Characterizing and treating dizziness after mild head trauma. Otol Neurotol. 2004 Mar;25(2):135-8. doi: 10.1097/00129492-200403000-00009.
PubMed 15021772Hilton M, Pinder D. The Epley manoeuvre for benign paroxysmal positional vertigo--a systematic review. Clin Otolaryngol Allied Sci. 2002 Dec;27(6):440-5. doi: 10.1046/j.1365-2273.2002.00613.x.
PubMed 12472509Brodsky, J.R., Cusick, B.A., Zhou, G. Delayed diagnosis and treatment of benign paroxysmal positioning vertigo (BPPV) in children and adolescents with post-concussive syndrome. Poster presentation at the Triological Society Meeting, Miami, FL, 2016.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benign Paroxysmal Positional Vertigo (BPPV) Training for Sports Medicine Providers in a Pediatric Concussion Program
- ClinicalTrials.gov ID
- NCT03425786
- Acronym / sponsor ID
- IRB-P00025099
- Conditions
- Benign Paroxysmal Positional Vertigo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 8 Feb 2018 (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.
The investigators are training a group of four pediatric Sports Medicine providers in BPPV maneuvers. All four providers will be trained in the diagnostic maneuvers, and two will be randomly selected to also be trained in the treatment maneuvers. The providers will be encouraged to use the diagnostic maneuvers on all new concussion patients whose initial visit is within 28 days of their injury. They will complete a survey at the start and end of the study to determine if they thought the training affected their understanding of BPPV and confidence in managing it, as well as determine any challenges they faced with learning/administering the maneuvers. Additionally, the investigators will determine if the additional training impacts time to recovery from concussion, as well as determine potential risk factors for BPPV in concussion.
Detailed description
Benign paroxysmal positional vertigo (BPPV) is a common disorder of the inner ear that causes episodes of vertigo. BPPV occurs as a result of displacement of otoliths from their position on the utricle into one of the semicircular canals. Posterior canal BPPV is diagnosed by performing the Dix-Hallpike maneuver, and lateral canal BPPV is diagnosed by performing the supine head roll test (Pagnini-McClure maneuver). Most cases of BPPV will resolve spontaneously, but this can take weeks to months without intervention, and approximately a third of cases will not resolve without treatment. Repositioning maneuvers, such as the Epley maneuver and Barbecue maneuver, move the otolith crystals out of the affected semicircular canal and back to their position on the utricle organ. Such maneuvers have been shown to be highly effective at resolving BPPV, and typically only 1-2 treatments are required.
BPPV most commonly occurs as an isolated spontaneous disorder, but it can also occur following a concussion. While the diagnosis and treatment of BPPV is a routine component of most Otolaryngology and Neurology training programs, it is not a component of most Sports Medicine training programs. It is also common that providers who are taught to diagnose BPPV do not know how to treat it. Furthermore, the role of BPPV in concussion recovery has not been well studied. Hoffer and colleagues found BPPV to be present in nearly a third of adult military patients with dizziness immediately following a concussion, and they found that these patients had rapid symptom resolution following repositioning maneuvers. The investigators recently found evidence of BPPV in 21% of patients referred to their pediatric vestibular program clinic for prolonged dizziness symptoms following a concussion. The majority of these patients were successfully treated with repositioning maneuvers following their first visit to the vestibular clinic, but that visit occurred at a mean of 4 months following their initial injury.
In order to determine if early recognition and management of BPPV will expedite recovery from concussion in affected patients, the investigators will train a group of four pediatric Sports Medicine providers in BPPV maneuvers. All four providers will be trained by Dr. Jacob Brodsky in the Dix-Hallpike and head roll maneuvers (BPPV diagnosis; Both Groups A \& B), and two will be randomly selected to also be trained by Dr. Brodsky in the Epley and Barbecue maneuvers (BPPV treatment; Group A only). The providers will be encouraged to use the Dix-Hallpike and head roll maneuvers on all new concussion patients whose initial visit is within 28 days of their injury to determine if the patients have BPPV. Providers who have been trained in treatment maneuvers (Group A, Early BPPV Management) will be encouraged to perform them accordingly on any patients with positive diagnostic maneuvers. Providers who have not been trained in treatment maneuvers (Group B, Late BPPV Management) will refer patients with suspected BPPV to Dr. Brodsky for treatment, as is currently the routine. Patients are not being directly randomized and do not need to do anything beyond attend their regularly scheduled appointments.
The Sports Medicine providers will complete a source document after each visit to document which maneuvers were performed and if the patient has recovered from concussion. They will also complete a survey at the start and end of the study to determine if they thought the training affected their understanding of BPPV and confidence in managing it, as well as determine any challenges they faced with learning/administering the maneuvers. The patients managed by providers in Group A will then be compared to patients managed by providers in Group B by multiple variables, including their post concussion symptom scores (PCSS), time to clearance for return to play, and time to symptom resolution. The investigators will also compare patients who were diagnosed with BPPV to those who were not to evaluate for risk factors for post-concussion BPPV, including comparison of age, gender, migraine history, prior concussion history, and mode of injury.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early BPPV Management | Experimental | Behavioral: Diagnostic and treatment trainingDiagnostic and treatment training for BPPV. |
| Late BPPV Management | Active comparator | Behavioral: Diagnostic trainingDiagnostic training for BPPV. Sports Medicine providers will refer patients positive for BPPV to an Otolaryngologist at our institution for treatment. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sports Medicine providers at Boston Children's Hospital who see a high volume of concussion patients
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Diagnostic trainingTraining in the Dix-Hallpike maneuver and the supine head roll test to diagnose BPPV. | Behavioural | Late BPPV Management |
| Diagnostic and treatment trainingTraining in the Dix-Hallpike maneuver and the supine head roll test to diagnose BPPV. Training in the Epley and Barbecue maneuvers to treat BPPV. | Behavioural | Early BPPV Management |
Primary outcome
Survey of level of confidence in managing BPPV in concussion patients
Time frame: 1 year
Providers will complete a survey before and after the study to assess if their level of confidence in managing BPPV in concussion patients has changed. Providers will rate their level of confidence from 1 to 10, with 1 meaning not at all confident and 10 meaning very confident.
6 secondary outcomes
Time to recovery from concussion
Time frame: 1 year
Mode of concussion
Time frame: 1 year
Site of impact
Time frame: 1 year
Sport played when concussion sustained
Time frame: 1 year
Number of lifetime concussions
Time frame: 1 year
History of migraine
Time frame: 1 year
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 25 Nov 2024.
- Background: PubMed 9082176Centers for Disease Control and Prevention (CDC). Sports-related recurrent brain injuries--United States. MMWR Morb Mortal Wkly Rep. 1997 Mar 14;46(10):224-7.
- Background: PubMed 23628374Meehan WP 3rd, Mannix RC, Stracciolini A, Elbin RJ, Collins MW. Symptom severity predicts prolonged recovery after sport-related concussion, but age and amnesia do not. J Pediatr. 2013 Sep;163(3):721-5. doi: 10.1016/j.jpeds.2013.03.012. Epub 2013 Apr 26.
- Background: PubMed 21712482Lau BC, Kontos AP, Collins MW, Mucha A, Lovell MR. Which on-field signs/symptoms predict protracted recovery from sport-related concussion among high school football players? Am J Sports Med. 2011 Nov;39(11):2311-8. doi: 10.1177/0363546511410655. Epub 2011 Jun 28.
- Background: PubMed 24645946Kim JS, Zee DS. Clinical practice. Benign paroxysmal positional vertigo. N Engl J Med. 2014 Mar 20;370(12):1138-47. doi: 10.1056/NEJMcp1309481. No abstract available.
- Background: PubMed 15021772Hoffer ME, Gottshall KR, Moore R, Balough BJ, Wester D. Characterizing and treating dizziness after mild head trauma. Otol Neurotol. 2004 Mar;25(2):135-8. doi: 10.1097/00129492-200403000-00009.
- Background: PubMed 12472509Hilton M, Pinder D. The Epley manoeuvre for benign paroxysmal positional vertigo--a systematic review. Clin Otolaryngol Allied Sci. 2002 Dec;27(6):440-5. doi: 10.1046/j.1365-2273.2002.00613.x.
- BackgroundBrodsky, J.R., Cusick, B.A., Zhou, G. Delayed diagnosis and treatment of benign paroxysmal positioning vertigo (BPPV) in children and adolescents with post-concussive syndrome. Poster presentation at the Triological Society Meeting, Miami, FL, 2016.
- Individual participant dataSharing planned: No
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.
Jacob R Brodsky, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic training and Diagnostic and treatment training in people with Benign Paroxysmal Positional Vertigo, run by Boston Children's Hospital at 1 site in United States.
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 1 inclusion and 1 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 25 Nov 2024. 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 United States. 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?
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?
Survey of level of confidence in managing BPPV in concussion patients (time frame: 1 year). 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 NCT03425786, which also lists 7 linked publications.
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 25 Nov 2024.