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临床试验/NCT04701125
NCT04701125已完成不适用

Selective Head-neck Cooling Following Concussion Shortens Return-to-play in Ice Hockey Players

Region Skane1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Region Skane
入组人数
81
试验地点
1
主要终点
return-to-play

研究概览

简要总结

The incidence of Sports-related concussions (SRCs) has risen in recent years, not least in ice hockey, and available treatment options are limited. Here, we addressed the hypotheses that immediate controlled head- and neck cooling could hasten return-to-play in a Swedish cohort of concussed professional ice hockey players. Over three seasons, 15 teams used either immediate head- and neck cooling or standard management for SRC. All players (81) followed the same return-to-play management protocol.

详细描述

Sports-related concussions (SRCs) are a growing health concern, since they may lead to persistent symptoms and, particularly if repeated, to e.g. depression, accelerated dementia onset, and development of chronic traumatic encephalopathy. Here, we addressed the hypotheses that immediate controlled head- and neck cooling could hasten return-to-play in a Swedish cohort of concussed professional ice hockey players. Over three seasons, 15 teams used either immediate head- and neck cooling or standard management for SRC. All players followed the same return-to-play management protocol. Using a baseline questionnaire, no difference in the number of previous SRCs between groups was observed. In total, 92 SRCs were recorded. Eleven players did not complete the study protocol, and thus 81 players were included. Of these, 29 were treated by immediate selective head- and neck cooling for ≥ 30 min, and 52 controls received standard acute SRC management.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Elite ice hockey players diagnosed by a team physician to have suffered a sports-related concussion. Selective head-neck cooling following the concussion. Duration of cooling a minimum of 45 minutes.

排除标准

  • •Presence of red flags (loss of consciousness, seizure, worsening headache, repeated vomiting, focal neurological deficits, neck pain, tingling in arms). Inability to tolerate cooling for a minimum of 30 minutes. Age <18 years old.

研究组 & 干预措施

Study group

Experimental

Players receive selective head-neck cooling after concussion

干预措施: selective head-neck cooling using PolarCap system (Device)

control group

No Intervention

Players receive the standard sport-related concussion management

结局指标

主要结局

return-to-play

时间窗: two weeks

The primary endpoint of the study was time (in days) from concussion until returning to full practice or game

次要结局

未报告次要终点

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (1)

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