The Effect of Hyperbaric Oxygen Therapy on Acute Treatment of Sport-related Traumatic Brain Injuries: A Double Blind Randomized Clinical Trial

Principal Investigator: Jason P. Mihalik, PhD, CAT(C), ATC

Institution: The University of North Carolina at Chapel Hill

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 triple blind randomized clinical trial.

Materials and Methods: High school student-athletes suffering from sport-related concussion will all underwent a well-accepted standard of care including physical and cognitive rest, symptom tracking, computerized neurocognitive testing, and balance assessment. These same athletes were randomly assigned into one of two clinical intervention groups: 1)HBO2 therapy (experimental), or 2) control (sham treatment). The HBO2 therapy treatments consisted 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 also completed five one-hour sessions consisting of medical grade air also delivered at 1.5 ATM. Participants were unable to tell the difference. Participants were blinded to their treatment group, and medical care providers and researchers were blinded to treatment group assignment. Certified Hyperbaric Technicians adhered to a predetermined randomized block schedule, and administered HBO2 therapy or control treatments accordingly.

Main Outcome Measures: Computerized neurocognitive testing, mental status examination, balance performance, graded symptom checklist, and the number of days from injury until the physician permit ted 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 hypothesized that an active treatment intervention in the acute phase of injury recovery would result in fewer athletes requiring more than 10 days to recover and, thus, reduce the number of athletes that were likely to complain of persistent post-concussion symptoms. The study was the first triple blind randomized clinical treatment intervention for concussion in this young and at-risk population.