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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT03425786
Study groupRoleWhat they receive
Early BPPV ManagementExperimentalDiagnostic and treatment training for BPPV.
Receives: Behavioral: Diagnostic and treatment training
Late BPPV ManagementActive comparatorDiagnostic 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted8 Feb 2018
  2. Study start29 Sep 2021
  3. Primary completion31 Jan 2023
  4. Study completion1 Mar 2023

Resources

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)
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 9082176
  • Meehan 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 23628374
  • Lau 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 21712482
  • Kim 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 24645946
  • Hoffer 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 15021772
  • Hilton 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 12472509
  • Brodsky, 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.

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.

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