An interventional study of Physiolab S1 and Breg Vpulse in Temperature Change, Body, sponsored by University of Winchester. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-06.
Sponsored by University of Winchester · Not applicable, Interventional, and Treatment
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.
Design This prospective randomised controlled trial will recruit healthy adult volunteers from a university population to participate. A power analysis demonstrated that a total of 30 participants would be required to achieve a power of 0.8 and alpha error probability of 0.05 for a small-medium effect size of f=0.2. Each participant will take part in every condition to eliminate the risk of demographic factors confounding the results. Each of the 5 devices being investigated will comprise each of the test conditions. The order in which participants complete the 5 test conditions will be randomised in advance using a computer random number generator. Testing will involve each device being applied and used according to the manufacturers' recommendations. Each testing session will take around 60 minutes to complete, depending on the treatment application guidelines of each device, with at least 24 hours between tests involving the same participant. In total, participants will be giving around 5 hours of time across 5 days to complete their participation.
Protocol All eligible participants will first be required to provide informed consent prior to their participation in the study. Once this has been obtained, participants will each attend 5 individual testing sessions, each lasting no longer than 60 minutes. The height and mass of the participants will be measured during the first testing session in order to calculate BMI, and participants' age and sex will be recorded and included in the later data analysis.
Participants will be required to remain in a seated position with their leg in full extension and elevated, parallel to the floor, for the duration of each test. The leg that will be used for the study will be randomly selected for each participant, and will remain the same for each condition. Skin temperature will be measured using a thermocouple, which will be attached with tape 20 mm distal to the patella. One of the cryocompression devices (Physiolab S1; Physiolab ice pack; GameReady; Cryo/Cuff; or VPulse) will then be attached to the leg of the participant and the test will begin. Depending on the condition to which a participant has been randomly assigned for a given test, a different device will be used. The temperature and pressure settings for each test will be set according to the maximum capability of each device, which varies between devices. The lowest temperature setting that will be used throughout the study will be 1℃ (GameReady device) and the highest pressure setting that will be used is 50 mmHg (GameReady and Physiolab S1 devices). None of the temperature or pressure settings used are deemed to be unsafe or have a high risk of adverse reactions, as long as participants are not contraindicated according to the exclusion criteria for this study.
The temperature of the skin will be measured using a k-type thermocouple attached to an infrared thermometer immediately prior to the application of a device, and then every 5 minutes for the duration of the test. The length of a test will be 30 minutes, in accordance with the manufacturers' instructions/recommendations for each device.
Upon completion of a test, the cuff will be removed. If the temperature of the skin has been reduced to within 10-15℃, skin temperature will continue to be monitored every 5 minutes after the cuff has been removed until it rises above 15℃, at which point the test will end. This will allow for the total time to be measured that skin temperature remains within the target therapeutic range as a result of a single application of the cryocompression device. If the skin temperature is not reduced to within 10-15℃ while the cuff is worn, then the test will end after the cuff is initially removed. Upon completion of the test, the temperature sensor will be removed from the leg of the participant; thus completing their participation in the test. Once each participant has taken part in all conditions, they will have completed their participation in the study.
The following measures will be recorded: skin temperature at each time point, minimum skin temperature achieved, time to achieve minimum skin temperature, length of time with skin temperature within therapeutic range of 10-15℃. After each test, participants will also be asked to respond to the following question using a 5-point Likert scale: "How comfortable did you find the treatment you just experienced?" The possible answers to this question will be: "Very comfortable, Comfortable, Neutral, Uncomfortable, Very uncomfortable". This will provide insight into differences in perception of the treatment, which could be relevant for the likelihood of protocol adherence by patients in clinical settings.
Analysis The data will be analysed to detect any differences during testing compared to baseline measures, and between groups. All data will be first subjected to a Kolmogorov-Smirnov test to assess whether they are normally distributed. A repeated measures analysis of variance will be performed on all normally distributed data. A Friedman test will be performed on any data that are not normally distributed.
Ethical issues There is a low risk of cold injury to participants if their skin temperature is reduced to \<10℃ for any prolonged period of time (>60 mins). The coldest temperature setting for this study is 1℃ (GameReady), which will be applied for 30 mins. However, device temperature settings do not equal the actual skin temperatures achieved, and it is not expected that skin temperatures will be reduced to lower than 5℃ for more than 15 minutes during any test. Therefore, the risk of harm to the participant is deemed to be minimal for this study.
Participants have the right to withdraw themselves and any collected data from the study at any time during, and for the first 7 days after, their participation without having to give a reason. They also have the right to terminate a test session at any time. Testing shall also be terminated as a result of any adverse reactions that emerge. Adverse reactions (e.g. pain) to the testing protocol are not expected due to the low-risk nature of the study, however any that occur shall be recorded and monitored until things return to baseline/normal. In order to monitor any pain/discomfort that might occur, a Numerical Pain Rating Scale (0-10 scale) will be within sight of the participant at all times during testing: a test will be terminated if reported pain/discomfort exceeds 5/10, though none is expected. Any reported pain (or other adverse reactions) shall be stored along with the data collected for that participant. If a test is terminated for a reason that could be mitigated in future, participants will be offered the opportunity to repeat the test another day, should they wish to continue taking part in the study. If a test is terminated due to an adverse reaction that can not be mitigated in future, the participant (and any collect-ed data) will be thanked for their time and withdrawn from the study.
97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.
This study's enrollment of 32 is below the median of 40 across 68 interventional studies indexed under Body Temperature Changes.
Browse Body Temperature Changes studies →University of Winchester is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
>40 kg/m2
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The cryocompression device will be attached to the lower limb of participants using a cuff spanning from the mid-thigh to mid-calf. The device will exert an intermittent pressure of 25-50 mmHg throughout each test session. The device will pump temperature-controlled cold water through the cuff in order to reduce the skin temperature around the knee (and intra-articular temperature). The temperature of the water being pumped through the device will be 8℃. Each test session will last for 30 minutes. Participants will take part in all conditions, with at least 24 hours rest in between test sessions. Skin temperature around the knee will be measured prior to the cryocompression device being applied; every 5 minutes during the 30 minute test; and every 5 minutes after the test until skin temperature \>15℃.
Device: Physiolab S1
The cryocompression device will be attached to the lower limb of participants using a cuff spanning from the mid-thigh to mid-calf. The device will exert a dynamic peak pressure of 50 mmHg throughout each test session. The device will pump temperature-controlled cold water through the cuff in order to reduce the skin temperature around the knee (and intra-articular temperature). The temperature of the water being pumped through the device will not be lower than 5.5℃. The selected pressure and temperature represents the maximum capability of this device. Each test session will last for 30 minutes. Participants will take part in all conditions, with at least 24 hours rest in between test sessions. Skin temperature around the knee will be measured prior to the cryocompression device being applied; every 5 minutes during the 30 minute test; and every 5 minutes after the test until skin temperature \>15℃.
Device: Breg Vpulse
The cryocompression device will be attached to the lower limb of participants using a cuff spanning from the mid-thigh to mid-calf. The pressure and temperature that the device applies to the treatment area is non-modifiable and undefined. The device will be used according to the manufacturer's recommendations, which will represent the maximum capability of this device. Each test session will last for 30 minutes. Participants will take part in all conditions, with at least 24 hours rest in between test sessions. Skin temperature around the knee will be measured prior to the cryocompression device being applied; every 5 minutes during the 30 minute test; and every 5 minutes after the test until skin temperature \>15℃.
Device: Aircast Cryo/Cuff
The cryocompression device will be attached to the lower limb of participants using a cuff spanning from the mid-thigh to mid-calf. The device will exert an intermittent pressure of 5-50 mmHg throughout each test session. The device will pump temperature-controlled cold water through the cuff in order to reduce the skin temperature around the knee (and intra-articular temperature). The temperature of the water being pumped through the device will be 1℃. Each test session will last for 30 minutes. Participants will take part in all conditions, with at least 24 hours rest in between test sessions. Skin temperature around the knee will be measured prior to the cryocompression device being applied; every 5 minutes during the 30 minute test; and every 5 minutes after the test until skin temperature \>15℃.
Device: GameReady
The cryocompression device will be attached to the lower limb of participants using a cuff spanning from the mid-thigh to mid-calf. The pressure and temperature that the device applies to the treatment area is non-modifiable and undefined. The device will be used according to the manufacturer's recommendations, which will represent the maximum capability of this device. Each test session will last for 30 minutes. Participants will take part in all conditions, with at least 24 hours rest in between test sessions. Skin temperature around the knee will be measured prior to the cryocompression device being applied; every 5 minutes during the 30 minute test; and every 5 minutes after the test until skin temperature \>15℃.
Device: Physiolab Gel Therapy Wrap
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.
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.
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.
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.
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.
Skin Temperature
Skin temperature will be measured using a thermocouple positioned 20 mm distal to the patella. This sensor will be attached prior to the cryocompression device being applied, and will remain in place until the testing session is complete and skin temperature is \>15℃. (The therapeutic skin temperature range for cryotherapy is thought to be 10-15℃). Temperature will be measured prior to the cryocompression device being applied; every 5 minutes during the test; and every 5 minutes after a test until the skin temperature reaches \>15℃.
Time frame: Up to 40 minutes per treatment
Subjective Comfort
After each test, participants will also be asked to respond to the following question using a 5-point Likert scale: "How comfortable did you find the treatment you just experienced?" The possible answers to this ques-tion will be: "Very comfortable, Comfortable, Neutral, Uncomfortable, Very uncomfortable". This will provide insight into differences in perception of the treatment, which could be relevant for the likelihood of protocol adherence by patients in clinical settings.
Time frame: 1 minute - recorded once immediately following treatments with each of the 5 devices under investigation
Healthy adult participants were recruited from a University population between April 2022 and July 2022. The data collection took place in a University laboratory.
| Milestone | All Study Participants |
|---|---|
| Started | 32 |
| Physiolab s1 | 32 |
| Breg vpulse | 31 |
| Cryo/cuff | 31 |
| Gameready | 30 |
| Gel wrap | 31 |
| Completed | 30 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
Skin temperature will be measured using a thermocouple positioned 20 mm distal to the patella. This sensor will be attached prior to the cryocompression device being applied, and will remain in place until the testing session is complete and skin temperature is \>15℃. (The therapeutic skin temperature range for cryotherapy is thought to be 10-15℃). Temperature will be measured prior to the cryocompression device being applied; every 5 minutes during the test; and every 5 minutes after a test until the skin temperature reaches \>15℃.
| degrees celsius | Group A: Physiolab S1 | Group B: Breg Vpulse | Group C: Cryo/Cuff | Group D: GameReady | Group E: Physiolab Gel Therapy Wrap |
|---|---|---|---|---|---|
| Baseline skin temp | 31.18 ± 2.34 | 31.21 ± 1.46 | 31.1 ± 1.81 | 31.93 ± 1.8 | 31.39 ± 1.45 |
| Skin temp after 5 mins | 19.97 ± 2.0 | 26.78 ± 3.17 | 24.15 ± 3.19 | 21.96 ± 2.95 | 21.2 ± 3.22 |
| Skin temp after 10 mins | 18.2 ± 1.8 | 23.94 ± 2.89 | 21.92 ± 3.54 | 19.39 ± 2.9 | 20.22 ± 3.33 |
| Skin temp after 15 mins | 16.08 ± 1.18 | 21.55 ± 2.89 | 20.39 ± 3.37 | 16.69 ± 2.59 | 19.58 ± 3.12 |
| Skin temp after 20 mins | 15.12 ± 1.05 | 19.89 ± 3.2 | 18.92 ± 3.04 | 15.32 ± 2.1 | 19.48 ± 3.0 |
| Skin temp after 25 mins | 14.52 ± 0.96 | 18.36 ± 2.72 | 18.31 ± 2.86 | 14.03 ± 1.85 | 19.6 ± 2.94 |
| Skin temp after 30 mins | 13.94 ± 0.78 | 17.24 ± 2.64 | 17.01 ± 2.93 | 13.02 ± 1.64 | 19.86 ± 2.85 |
| Skin temp after 35 mins | 17.23 ± 2.18 | 21.62 ± 1.3 | 18.45 ± 2.49 | 17.96 ± 2.35 | 18.3 ± NA |
| Skin temp after 40 mins | 19.07 ± 0.97 | — | — | 18.0 ± 0.57 | — |
After each test, participants will also be asked to respond to the following question using a 5-point Likert scale: "How comfortable did you find the treatment you just experienced?" The possible answers to this ques-tion will be: "Very comfortable, Comfortable, Neutral, Uncomfortable, Very uncomfortable". This will provide insight into differences in perception of the treatment, which could be relevant for the likelihood of protocol adherence by patients in clinical settings.
| percent | Group A: Physiolab S1 | Group B: Breg Vpulse | Group C: Cryo/Cuff | Group D: GameReady | Group E: Physiolab Gel Therapy Wrap |
|---|---|---|---|---|---|
| Participants reporting positive comfort ratings | 86.7 | 86.7 | 90.0 | 53.3 | 96.7 |
| Participants reporting neutral comfort ratings | 13.3 | 10.0 | 10.0 | 30.0 | 3.3 |
| Participants reporting negative comfort ratings | 0 | 3.3 | 0.0 | 16.7 | 0.0 |
Collected over Each participant was monitored for adverse events during each test session, which was up to 60 minutes per treatment including arrival to the lab, testing, and post-test data collection/administration.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A: Physiolab S1 | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Group B: Breg Vpulse | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Group C: Cryo/Cuff | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Group D: GameReady | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Group E: Physiolab Gel Therapy Wrap | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
Although 32 participants were originally enrolled, only the data from 30 participants was included in the final analysis due to the withdrawal of 2 participants from the study for unknown reasons prior to their completion of all test conditions.
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 26.3 ± 7.9 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 12 |
| Male | 20 |
| Race and Ethnicity Not Collected(Participants) | All Study Participants |
|---|
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United Kingdom | 32 |
| Leg (L:R)(Legs) | All Study Participants |
|---|---|
| Left | 16 |
| Right | 16 |
| Height (m)(metres) | All Study Participants |
|---|---|
| Mean | 1.75 ± 0.1 |
| Mass (kg)(kilograms) | All Study Participants |
|---|---|
| Mean | 76.3 ± 10.1 |
| Body mass index (kg/m2)(kilograms per square metre) | All Study Participants |
|---|---|
| Mean | 24.8 ± 2.7 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — No individual data will be shared outside of the researchers directly involved in the data collection itself.
Ran from Apr 2022 to primary completion in Jul 2022, 3 months.
Results were first posted in Nov 2024, 2 years 3 months after primary completion.
Of 44 non-industry interventional studies with no phase under Body Temperature Changes, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's 3 months is below that.
Counting every sponsor, half of 44 studies reached it within 5 months; a quarter within 3 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
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University of Winchester