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

Autor: Register-Mihalik JK; Matthew Gfeller Center, Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.; Injury Prevention Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA., Guskiewicz KM; Matthew Gfeller Center, Department of Exercise and Sport Science, 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.; Injury Prevention Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.; Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA., McCulloch KL; Division of Physical Therapy, Department of Health Sciences, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA., Mihalik JP; Matthew Gfeller Center, Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA., Mrazik M; Faculty of Education, University of Alberta, Edmonton, AB, Canada.; Canadian Football League, Toronto, ON, Canada., Murphy I; Injury Prevention and Player Welfare, New Zealand Rugby, Wellington, New Zealand., Naidu D; Canadian Football League, Toronto, ON, Canada.; Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada., Ranapurwala SI; Injury Prevention Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.; Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA., Schneider KJ; Sport Injury Prevention Research Centre, Faculty of Kinesiology, Alberta Children's Hospital Research Institute, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada., Gildner P; Injury Prevention Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA., Salmon DM; Injury Prevention and Player Welfare, New Zealand Rugby, Wellington, New Zealand.; World Rugby, Player Welfare and Rugby Services, Dublin, Ireland., Auton B; Catawba College, Salisbury, NC, USA., Bowman TG; College of Health Sciences, University of Lynchburg, Lynchburg, VA, USA., Hall EE; Department of Exercise Science, Elon University, Elon, NC, USA., Hynes LM; School of Kinesiology & Health Science, York University, Toronto, ON, Canada., Jewell E; Department of Kinesiology and Recreation Administration, North Carolina Central University, Durham, NC, USA., Ketcham CJ; Department of Exercise Science, Elon University, Elon, NC, USA., Siler CW; College of Health Sciences, University of Lynchburg, Lynchburg, VA, USA., Sullivan SJ; Injury Prevention and Player Welfare, New Zealand Rugby, Wellington, New Zealand., Kostogiannes V; Injury Prevention Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA., McCrea MA; Center for Neurotrauma Research (CNTR), Department of Neurosurgery, Medical College of Wisconsin, Milwaukee, WI, USA.
Jazyk: angličtina
Zdroj: Journal of athletic training [J Athl Train] 2024 May 22. Date of Electronic Publication: 2024 May 22.
DOI: 10.4085/1062-6050-0696.23
Abstrakt: 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% CI:14.1%,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.
Conclusions: Participants in MDR+EGE and EGE-only activities reported equivalently low rates of symptom exacerbation.
Databáze: MEDLINE