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CompletedNCT03425786Updated Nov 25, 2024

Benign Paroxysmal Positional Vertigo (BPPV) Training for Sports Medicine Providers in a Pediatric Concussion Program

An interventional study of Diagnostic training and Diagnostic and treatment training in Benign Paroxysmal Positional Vertigo, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-11-25.

Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
221
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Benign Paroxysmal Positional Vertigo
03

In context

Benign Paroxysmal Positional Vertigo

75 studies on the registry are indexed under Benign Paroxysmal Positional Vertigo; 15 are open to participants now.

This study's enrollment of 221 is above the median of 78 across 62 interventional studies indexed under Benign Paroxysmal Positional Vertigo.

Browse Benign Paroxysmal Positional Vertigo studies →

Lead sponsor

Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Sports Medicine providers at Boston Children's Hospital who see a high volume of concussion patients

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
221 participants (actual)

Study arms

  • Experimental
    Early BPPV Management

    Diagnostic and treatment training for BPPV.

    Behavioral: Diagnostic and treatment training

  • Active comparator
    Late BPPV Management

    Diagnostic training for BPPV. Sports Medicine providers will refer patients positive for BPPV to an Otolaryngologist at our institution for treatment.

    Behavioral: Diagnostic training

Interventions

  • BehavioralDiagnostic training

    Training in the Dix-Hallpike maneuver and the supine head roll test to diagnose BPPV.

  • BehavioralDiagnostic and treatment training

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 1 year

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 1 year

07

Study locations

1 site
  • Boston Children's Hospital Waltham
    Waltham, Massachusetts 02453, United States
08

References and documents

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.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03425786
Responsible party
Jacob Brodsky (Director of the Balance and Vestibular Program, Boston Children's Hospital) — Principal investigator
First posted
Feb 8, 2018
Start date
Sep 29, 2021
Primary completion
Jan 31, 2023
Completion
Mar 1, 2023
Last update
Nov 25, 2024

Study contacts

Jacob R Brodsky, MD
principal investigator · Boston Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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