Symptom Exacerbation and Adverse Events during a Randomized Trial of Early-stage Concussion Rehabilitation.

Register-Mihalik, Johna K; Guskiewicz, Kevin M; Marshall, Stephen W; McCulloch, Karen L; Mihalik, Jason P; Mrazik, Martin; Murphy, Ian; Naidu, Dhiren; Ranapurwala, Shabbar I; Schneider, Kathryn J; Gildner, Paula; Salmon, Danielle M; Auton, Brandon; Bowman, Thomas G; Hall, Eric E; Hynes, Loriann M; Jewell, Elizabeth; Ketcham, Caroline J; Siler, Caroline Wesley; Sullivan, S John; Kostogiannes, Vasiliki; McCrea, Michael A

Register-Mihalik, Johna K; Guskiewicz, Kevin M; Marshall, Stephen W; McCulloch, Karen L; Mihalik, Jason P; Mrazik, Martin; Murphy, Ian; Naidu, Dhiren; Ranapurwala, Shabbar I; Schneider, Kathryn J; Gildner, Paula; Salmon, Danielle M; Auton, Brandon; Bowman, Thomas G; Hall, Eric E; Hynes, Loriann M; Jewell, Elizabeth; Ketcham, Caroline J; Siler, Caroline Wesley; Sullivan, S John; Kostogiannes, Vasiliki; McCrea, Michael A.

Afiliação

Register-Mihalik JK; Matthew Gfeller Center, Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Guskiewicz KM; Injury Prevention Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Marshall SW; Matthew Gfeller Center, Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
McCulloch KL; Matthew Gfeller Center, Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Mihalik JP; Injury Prevention Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Mrazik M; Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Murphy I; Division of Physical Therapy, Department of Health Sciences, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Naidu D; Matthew Gfeller Center, Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Ranapurwala SI; Faculty of Education, University of Alberta, Edmonton, AB, Canada.
Schneider KJ; Canadian Football League, Toronto, ON, Canada.
Gildner P; Injury Prevention and Player Welfare, New Zealand Rugby, Wellington, New Zealand.
Salmon DM; Canadian Football League, Toronto, ON, Canada.
Auton B; Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada.
Bowman TG; Injury Prevention Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Hall EE; Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Hynes LM; Sport Injury Prevention Research Centre, Faculty of Kinesiology, Alberta Children's Hospital Research Institute, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.
Jewell E; Injury Prevention Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Ketcham CJ; Injury Prevention and Player Welfare, New Zealand Rugby, Wellington, New Zealand.
Siler CW; World Rugby, Player Welfare and Rugby Services, Dublin, Ireland.
Sullivan SJ; Catawba College, Salisbury, NC, USA.
Kostogiannes V; College of Health Sciences, University of Lynchburg, Lynchburg, VA, USA.
McCrea MA; Department of Exercise Science, Elon University, Elon, NC, USA.

J Athl Train ; 2024 May 22.

Article em En | MEDLINE | ID: mdl-38775119

ABSTRACT

ABSTRACT

CONTEXT Few studies utilize randomized clinical trials (RCT) to quantify clinical intervention safety of rehabilitation after sport-related concussion across sport levels.

OBJECTIVE:

Describe symptom exacerbation and adverse events (AEs) associated with two concussion rehabilitation interventions.

DESIGN:

Cluster Randomized Controlled Trial (XXX).

SETTING:

Sports medicine clinic and field settings.

PARTICIPANTS:

The RCT enrolled 251 concussed athletes (median age=20 years; female n=48) across 28 sites from New Zealand professional rugby (n=31), Canadian professional football (n=52), United States (U.S.)/Canadian colleges (n=128) and U.S. high schools (n=40).

INTERVENTIONS:

Two medically supervised

interventions:

1) Enhanced Graded Exertion (EGE) international return to sport strategy and sport specific activities only (EGE-only n=119) and 2) Multidimensional Rehabilitation (MDR) followed by EGE early symptom-directed exercises once symptoms were stable, followed by EGE after symptoms resolved (MDR+EGE n=132). MAIN OUTCOME

MEASURES:

Primary outcomes were intrasession total symptom severity score exacerbation and significant intersession (increase 10+ severity points) sustained total symptom severity exacerbation, each measured with a Postconcussion Symptom Scale (132 total severity points on scale). Reported AEs were also described. Activity-based rehabilitation sessions (n=1437) were the primary analysis unit. Frequencies, proportions, medians, and Interquartile Ranges (IQRs) were calculated for outcomes by treatment group.

RESULTS:

The 251 post-injury participants completed 1437 (MDR+EGE=819, EGE-only=618) activity-based intervention sessions. A total of 110 and 105 participants contributed data (those missing had no documented session data) to at least 1 activity-based session in the MDR+EGE and EGE-only arms respectively. Intrasession symptom exacerbations were equivilantly low in MDR+EGE and EGE-only arms (MDR+EGE 16.7%, 95% CI14.1%,19.1%; EGE-only 15.7%, 95% CI 12.8%,18.6%). In total, 9/819 MDR+EGE sessions (0.9%) and 1/618 EGE-only sessions (0.2%) resulted in a pre- to post-session symptom exacerbation beyond a 10+ severity point increase; 8/9 resolved to <10 points by the next session. Two study-related AEs (1 in each arm) were reported.