- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04701125
Medical Cooling of Ice Hockey Players
January 7, 2021 updated by: Region Skane
Selective Head-neck Cooling Following Concussion Shortens Return-to-play in Ice Hockey Players
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lund, Sweden, 221 00
- University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study group
Players receive selective head-neck cooling after concussion
|
Players receiving selective head-neck cooling after SRC
|
|
No Intervention: control group
Players receive the standard sport-related concussion management
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
return-to-play
Time Frame: two weeks
|
The primary endpoint of the study was time (in days) from concussion until returning to full practice or game
|
two weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2018
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
July 1, 2020
Study Registration Dates
First Submitted
December 28, 2020
First Submitted That Met QC Criteria
January 7, 2021
First Posted (Actual)
January 8, 2021
Study Record Updates
Last Update Posted (Actual)
January 8, 2021
Last Update Submitted That Met QC Criteria
January 7, 2021
Last Verified
December 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- BC123122334
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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