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

November 21, 2024 updated by: Jacob Brodsky, Boston Children's Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
221

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Early BPPV Management
Diagnostic and treatment training for BPPV.
Behavioral: Diagnostic 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.
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
Training in the Dix-Hallpike maneuver and the supine head roll test to diagnose BPPV.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to recovery from concussion
Time Frame: 1 year
A comparison of time to recovery from concussion in patients whose providers had diagnostic training versus patients whose providers had diagnostic and treatment training.
1 year
Mode of concussion
Time Frame: 1 year
A comparison of concussion patients by mode of concussion to determine if mode of concussion is a potential risk factor for BPPV.
1 year
Site of impact
Time Frame: 1 year
A comparison of concussion patients by site of impact to determine if site of impact is a potential risk factor for BPPV.
1 year
Sport played when concussion sustained
Time Frame: 1 year
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.
1 year
Number of lifetime concussions
Time Frame: 1 year
A comparison of concussion patients by number of lifetime concussions to determine if number of lifetime concussions is a potential risk factor for BPPV.
1 year
History of migraine
Time Frame: 1 year
A comparison of concussion patients by history of migraine to determine if history of migraine is a potential risk factor for BPPV.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Children's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jacob R Brodsky, MD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-P00025099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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