Medical Cooling of Ice Hockey Players

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04701125
• Other study ID #: BC123122334
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: December 2020
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• selective head-neck cooling using PolarCap system
Players receiving selective head-neck cooling after SRC

Locations

Country	Name	City	State
Sweden	University	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	return-to-play	The primary endpoint of the study was time (in days) from concussion until returning to full practice or game	two weeks