Medical Cooling of Ice Hockey Players

NCT ID: NCT04701125

Last Updated: 2021-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-07-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sports-related Concussions, Selective Head-neck Cooling, Return to Play

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Twenty-eight teams from the elite ice hockey leagues for males in Sweden were invited to participate in the study. Participating teams were given the option to be in the study group (receiving selective head-neck cooling after SRC) or the control group (standard SRC management). Any player with a suspected or diagnosed concussion was immediately removed from practice or game participation for further evaluation. Concussion diagnosis was established using the concussion in the sports consensus statement. At the time of SRC, any presence of "red flags" mandated the player to be taken to the hospital. As soon as the diagnosis of SRC was established the player was included in the study and players in the intervention teams were treated by selective head-neck cooling system for a minimum of 30 minutes. The primary endpoint of the study was the time (in days) from concussion until returning to full practice or game.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Study group

Players receive selective head-neck cooling after concussion

Group Type EXPERIMENTAL

selective head-neck cooling using PolarCap system

Intervention Type DEVICE

Players receiving selective head-neck cooling after SRC

control group

Players receive the standard sport-related concussion management

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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selective head-neck cooling using PolarCap system

Players receiving selective head-neck cooling after SRC

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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BC123122334

Identifier Type: -

Identifier Source: org_study_id

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