Johna K Register-Mihalik, Kevin M Guskiewicz, Stephen W Marshall, Karen L McCulloch, Jason P Mihalik, Martin Mrazik, Ian Murphy, Dhiren Naidu, Shabbar I Ranapurwala, Kathryn J Schneider, Paula Gildner, Danielle M Salmon, Brandon Auton, Thomas G Bowman, Eric E Hall, Loriann M Hynes, Elizabeth Jewell, Caroline J Ketcham, Caroline Wesley Siler, S John Sullivan, Vasiliki Kostogiannes, Michael A McCrea
{"title":"早期脑震荡康复随机试验中的症状加重和不良事件。","authors":"Johna K Register-Mihalik, Kevin M Guskiewicz, Stephen W Marshall, Karen L McCulloch, Jason P Mihalik, Martin Mrazik, Ian Murphy, Dhiren Naidu, Shabbar I Ranapurwala, Kathryn J Schneider, Paula Gildner, Danielle M Salmon, Brandon Auton, Thomas G Bowman, Eric E Hall, Loriann M Hynes, Elizabeth Jewell, Caroline J Ketcham, Caroline Wesley Siler, S John Sullivan, Vasiliki Kostogiannes, Michael A McCrea","doi":"10.4085/1062-6050-0696.23","DOIUrl":null,"url":null,"abstract":"<p><strong>Context: </strong>Few studies utilize randomized clinical trials (RCT) to quantify clinical intervention safety of rehabilitation after sport-related concussion across sport levels.</p><p><strong>Objective: </strong>Describe symptom exacerbation and adverse events (AEs) associated with two concussion rehabilitation interventions.</p><p><strong>Design: </strong>Cluster Randomized Controlled Trial (XXX).</p><p><strong>Setting: </strong>Sports medicine clinic and field settings.</p><p><strong>Participants: </strong>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).</p><p><strong>Interventions: </strong>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).</p><p><strong>Main outcome measures: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>Participants in MDR+EGE and EGE-only activities reported equivalently low rates of symptom exacerbation.</p>","PeriodicalId":54875,"journal":{"name":"Journal of Athletic Training","volume":" ","pages":""},"PeriodicalIF":2.6000,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Symptom Exacerbation and Adverse Events during a Randomized Trial of Early-stage Concussion Rehabilitation.\",\"authors\":\"Johna K Register-Mihalik, Kevin M Guskiewicz, Stephen W Marshall, Karen L McCulloch, Jason P Mihalik, Martin Mrazik, Ian Murphy, Dhiren Naidu, Shabbar I Ranapurwala, Kathryn J Schneider, Paula Gildner, Danielle M Salmon, Brandon Auton, Thomas G Bowman, Eric E Hall, Loriann M Hynes, Elizabeth Jewell, Caroline J Ketcham, Caroline Wesley Siler, S John Sullivan, Vasiliki Kostogiannes, Michael A McCrea\",\"doi\":\"10.4085/1062-6050-0696.23\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Context: </strong>Few studies utilize randomized clinical trials (RCT) to quantify clinical intervention safety of rehabilitation after sport-related concussion across sport levels.</p><p><strong>Objective: </strong>Describe symptom exacerbation and adverse events (AEs) associated with two concussion rehabilitation interventions.</p><p><strong>Design: </strong>Cluster Randomized Controlled Trial (XXX).</p><p><strong>Setting: </strong>Sports medicine clinic and field settings.</p><p><strong>Participants: </strong>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).</p><p><strong>Interventions: </strong>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).</p><p><strong>Main outcome measures: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>Participants in MDR+EGE and EGE-only activities reported equivalently low rates of symptom exacerbation.</p>\",\"PeriodicalId\":54875,\"journal\":{\"name\":\"Journal of Athletic Training\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2024-05-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Athletic Training\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.4085/1062-6050-0696.23\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"SPORT SCIENCES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Athletic Training","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.4085/1062-6050-0696.23","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"SPORT SCIENCES","Score":null,"Total":0}
Symptom Exacerbation and Adverse Events during a Randomized Trial of Early-stage Concussion Rehabilitation.
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.
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.
期刊介绍：
The mission of the Journal of Athletic Training is to enhance communication among professionals interested in the quality of health care for the physically active through education and research in prevention, evaluation, management and rehabilitation of injuries.
The Journal of Athletic Training offers research you can use in daily practice. It keeps you abreast of scientific advancements that ultimately define professional standards of care - something you can''t be without if you''re responsible for the well-being of patients.
京公网安备 11010802042870号
京ICP备2023020795号-1
分享
求助内容：
应助结果提醒方式：
扫码关注我们
