Symptom Exacerbation and Adverse Events during a Randomized Trial of Early-stage Concussion Rehabilitation.
J Athl Train
; 2024 May 22.
Article
em En
| MEDLINE
| ID: mdl-38775119
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 supervisedinterventions:
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 OUTCOMEMEASURES:
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.CONCLUSIONS:
Participants in MDR+EGE and EGE-only activities reported equivalently low rates of symptom exacerbation.
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1
Coleções:
01-internacional
Base de dados:
MEDLINE
Idioma:
En
Revista:
J Athl Train
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Estados Unidos