The effect of hyper baric oxygen therapy on acute treatment of sport-related traumatic brain injuries: A double blind randomized clinical trial.
Principle Investigator: Jason P. Mihalik, PhD, CAT(C), ATC: Assistant Professor, Department of Exercise and Sport Science
Institution:The University of North Carolina
Title: The effect of hyperbaric oxygen therapy on acute treatment of sport-related traumatic brain injuries: A double blind randomized clinical trial
Abstract: As many as 3.8 million sport-related traumatic brain injuries (TBI) are sustained each year in the United States. The current standard of care for those athletes suffering from concussion consists of both physical and cognitive rest until their self-reported symptoms resolve and objective clinical measures of concussion show signs of recovery. Unfortunately, it is a wait-and-see approach for which clinicians have very little understanding. The need for empirically supported interventions targeted at minimizing the risks of developing persistent complications related to concussion in young athletes is clearly evident.
Aims: To study the effectiveness of hyperbaric oxygen (HBO2) therapy on reducing recovery time in young athletes suffering from sport-related concussion.
Study Design: A prospective double blind randomized clinical trial.
Materials and Methods: High school student-athletes suffering from sport-related concussion will all undergo a well-accepted standard of care including physical and cognitive rest, symptom tracking, computerized neurocognitive testing, and balance assessment. These same athletes will be randomly assigned into one of two clinical intervention groups:
- HBO2 therapy (experimental) or
- control (sham treatment). The HBO2 therapy treatments will consist of five one-hour treatments at 1.5 Atmospheres (ATM), consisting of delivering 100% oxygen at a pressure equivalent to 15 feet below sea level. The control sham treatment group will also complete five one-hour sessions consisting of medical grade air also delivered at 1.5 ATM. Participants are unable to tell the difference. Participants will be blinded to their treatment group, and medical care providers and researchers will be blinded to treatment group assignment. Certified Hyperbaric Technicians will adhere to a predetermined randomized block schedule, and administer HBO2 therapy or control treatments accordingly.
Main Outcome Measures: Computerized neurocognitive testing, mental status examination, balance performance, graded sympton checklist, and the number of days from injury until the physician permits the student-athlete to return to exertional participation.
Significance: Young athletes are at particular risk for catastrophic secondary injuries related to sport-related concussion. Internationally accepted consensus statements suggest clinicians should rest their athletes until they fully recover. Unfortunately, these guidelines provide little to no active treatment options beyond their highly supported passive approaches to patient care. When patients begin experiencing persistent symptoms, clinicians are at an impasse for how to manage these cases. Our study hypothesizes that an active treatment intervention in the acute phase of injury recovery will result in fewer athletes requiring more than 10 days to recover and, thus, reduce the number of athletes that are likely to complain of persistent post-concussion symptoms. The study is the first double blind randomized clinical treatment intervention for concussion in this young and at-risk population.