CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
Physiolab S1 +4 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05355116
NCT05355116N/ACompleted

A Comparison of Skin Temperature Changes Around the Knee When Using Cryocompression Devices

University of Winchester·interventional·Posted May 2, 2022·Updated Nov 6, 2024

In Brief

A clinical study evaluating Physiolab S1, Breg Vpulse, and 3 other interventions for Temperature Change, Body. Completed, enrolled 32 participants across 1 site.

Detailed Summary

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 (Wilke and Weiner, 2003; Bleakley, McDonough and MacAuley, 2004). However, a recent study noted that where cryocompression devices have previously been used to reduce the skin temperature \<10°C, no complications relating to the device have been reported, suggesting that the risk to the user at these lower temperatures is minimal (Bellon et al., 2019). 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. Furthermore, there is evidence to suggest that the temperature setting of the device does not equal that to which the skin is reduced (Selfe et al., 2009). Therefore, it is not sufficient to assume that the temperature setting of a cryocompression device accurately reflects skin temperature. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
2023202420252026
First PostedMay 2, 2022
Enrollment StartApr 20, 2022
Primary CompletionJul 27, 2022
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 4.2 years ago

Interventions

Physiolab S1device

A cryocompression device capable of circulating ice-water through a cuff at 6-12℃ with either a static pressure of 25mmHg or dynamic pressure of 25-50 mmHg or 25-75mmHg. The lowest temperature setting, and highest pressure setting will be used for this study.

Breg Vpulsedevice

A cryocompression device capable of circulating ice-water through a cuff at no lower than 5.5℃ with a dynamic peak pressure of 50 mmHg. The temperature of the ice-water, and the applied pressure, is not modifiable by the user.

Aircast Cryo/Cuffdevice

A cryocompression device capable of circulating ice-water through a cuff at an undefined, non-modifiable temperature with a static pressure that is also undefined and non-modifiable. The device will be applied as per the manufacturer's instructions, which will represent its maximum capability.

GameReadydevice

A cryocompression device capable of circulating ice-water through a cuff at 1-12℃ with a dynamic pressure of 5-15 mmHg, 5-50 mmHg, or 5-75 mmHg. The lowest temperature setting, and highest pressure setting will be used for this study.

Physiolab Gel Therapy Wrapdevice

A cryocompression cuff that applies an undefined, non-modifiable temperature with a static pressure that is also undefined and non-modifiable. The device will be applied as per the manufacturer's instructions, which will represent its maximum capability.