A comparison of skin temperature changes around the knee when using cr

Treatment tested

• Physiolab S1
• GameReady
• Breg VPulse
• Aircast Cryo/Cuff
• Koolcare Gel Wrap

Other measures (1)

Background and study aims Cryotherapy after surgery is widely utilised and has numerous practical applications for post-operative rehabilitation. Previous research has suggested that during cold therapy, the skin temperature of the knee should be reduced to 10-15°C to maximise the therapeutic benefits of cooling while avoiding the risk of cold injuries such as nerve damage and frostbite. However, a recent study noted that where cryocompression devices have previously been used to reduce the skin temperature to <10°C, no complications relating to the device have been reported, suggesting that the risk to the user at these lower temperatures is minimal. The temperature range at which a cryocompression device should be set in order to achieve a skin temperature within the therapeutic range of 10-15°C is unknown. Modern cryotherapy devices often consist of some sort of cuff that can be wrapped around the knee, with a connecting tube to a central unit that supplies and circulates ice water to and from the cuff in order to cool the intended body part. Such devices offer differing levels of control over the temperature of the ice water as it leaves the central unit, but nothing is known about how this correlates to the skin temperatures that are achieved during a cryotherapy treatment. The aim of this study is to determine the ability of five different cryocompression devices to effectively lower the skin temperature of the treatment area to within the therapeutic range. Who can participate? Any adult aged over 18 years old who does not currently have any knee pain/injury What does the study involve? Five 1-hour trips to the Physiology Laboratory at the University of Winchester (UK). The first trip will involve signing a consent form and having some basic measures taken (height, age, mass, BMI) before undergoing a 30-minute cryocompression treatment with one of the five devices being tested in the study. Treatment consists of sitting on a therapy bed with a cuff wrapped around the knee, which connects to a device that applies mild pressure and circulates cold water through the cuff to cool your knee. A thermometer will be taped to your knee before the cuff is applied and skin temperature readings will be recorded before, and every 5 minutes during, the cryocompression treatment. The subsequent 4 sessions in the laboratory will consist of single 30-minute treatments using each of the remaining devices being tested. What are the possible benefits and risks of participating? By participating in this study, you will be helping to improve an area of clinical research that aims to optimise recovery and outcomes for patients around the world who undergo surgery in the future. There is a slightly increased risk of cold injury if your skin temperature is reduced to below 10°C for an extended period of time (>60 mins). Since none of the tests will last longer than this length of time, it is not expected that there is any significant risk of cold injury. It is possible that the application of the cryotherapy device will make you feel generally cold while you are wearing the cuff. You are free to wear warm clothing on your upper body and we will have blankets on hand to make you feel more comfortable, should you begin to feel too cold during your participation. If you experience severe discomfort or any other adverse reaction during testing, you are free to terminate the test and withdraw from the study, should you wish to do so. We will be using some personal information in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study either during participation or within 7 days of completing your participation, we will destroy any data of yours that we have collected. After 7 days of your completed participation, your data will be anonymised and untraceable back to you. To safeguard your rights, we will use the minimum personally identifiable information possible. This research study complies with Article 6(1)(e) of the GDPR regulations with data being processed under the basis of public task and in accordance with 5.23 of the University’s Articles of Association. For further information please contact the lead investigator with regards to obtaining the University of Winchester's Data Protection Policy. Where is the study run from? The Physiology Laboratory at the University of Winchester (UK) When is the study starting and how long is it expected to run for? January 2022 to December 2022 Who is funding the study? Physiolab Technologies Ltd (UK) Who is the main contact? James Belsey, KneeResearch@pm.me (UK)