Trial Outcomes & Findings for Different Cryocompression Devices and Skin Temperature of the Knee (NCT NCT05355116)

Last Updated: 2024-11-06

Results Overview

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℃.

Recruitment status

COMPLETED

Study phase

Target enrollment

32 participants

Primary outcome timeframe

Up to 40 minutes per treatment

Results posted on

2024-11-06

Participant Flow

Healthy adult participants were recruited from a University population between April 2022 and July 2022. The data collection took place in a University laboratory.

32 participants were enrolled and began the data collection phase.

Participant milestones

Participant milestones
Measure	All Study Participants This study employed a crossover design, wherein each of the participants received a 30-minute cryocompression treatment with all of the 5 modalities under investigation. The order in which each participation underwent a treatment with each modality was conducted in a randomised manner.
Overall Study STARTED	32
Overall Study Physiolab S1	32
Overall Study Breg VPulse	31
Overall Study Cryo/Cuff	31
Overall Study GameReady	30
Overall Study Gel Wrap	31
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	All Study Participants This study employed a crossover design, wherein each of the participants received a 30-minute cryocompression treatment with all of the 5 modalities under investigation. The order in which each participation underwent a treatment with each modality was conducted in a randomised manner.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=32 Participants According to a randomised order, each participant had the relevant cryocompression device attached to their lower limb using a cuff positioned centrally over the knee. Where relevant, each device was applied according to the manufacturer's guidelines, or where unclear, according to precedent in the literature. Each treatment lasted for 30 minutes. Participants took part in all conditions, with at least 24 hours rest in between test sessions. Skin temperature around the knee was 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℃.
Age, Continuous	26.3 years STANDARD_DEVIATION 7.9 • n=32 Participants
Sex: Female, Male Female	12 Participants n=32 Participants
Sex: Female, Male Male	20 Participants n=32 Participants
Region of Enrollment United Kingdom	32 participants n=32 Participants
Leg (L:R) Left	16 Legs n=32 Participants
Leg (L:R) Right	16 Legs n=32 Participants
Height (m)	1.75 metres STANDARD_DEVIATION 0.1 • n=32 Participants
Mass (kg)	76.3 kilograms STANDARD_DEVIATION 10.1 • n=32 Participants
Body mass index (kg/m2)	24.8 kilograms per square metre STANDARD_DEVIATION 2.7 • n=32 Participants
Skin temperature (°C)	31.4 degrees celsius STANDARD_DEVIATION 1.8 • n=32 Participants
Ambient temperature (°C)	21.8 degrees celsius STANDARD_DEVIATION 1.1 • n=32 Participants

PRIMARY outcome

Timeframe: Up to 40 minutes per treatment

Population: Individuals who completed their participation in all test conditions were included in the final analysis.

Outcome measures

Outcome measures
Measure	Group A: Physiolab S1 n=30 Participants The cryocompression device was attached to the lower limb of participants using a cuff spanning positioned centrally over the knee. The device exerted an intermittent pressure of 25-50 mmHg throughout each test session. The temperature of the water being pumped through the device was 8℃. Each treatment lasted for 30 minutes. The termperature and compression settings were chosen in line with the manufacturer recommendations. Participants took part in all conditions, with at least 24 hours rest in between test sessions. Skin temperature around the knee was 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℃.	Group B: Breg Vpulse n=30 Participants The cryocompression device was attached to the lower limb of participants using a cuff spanning positioned centrally over the knee. The device exerted the default level of intermittent compression throughout each test session. The temperature of the water pumped through the device was not lower than 5.5℃ and was not user-modifiable. Each test session lasted for 30 minutes. Participants took part in all conditions, with at least 24 hours rest in between test sessions. Skin temperature around the knee was 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℃.	Group C: Cryo/Cuff n=30 Participants The cryocompression device was attached to the lower limb of participants using a cuff spanning positioned centrally over the knee. The pressure and temperature that the device applied to the treatment area was non-modifiable and undefined. The device was used according to the manufacturer's recommendations. Each treatment lasted for 30 minutes. Participants took part in all conditions, with at least 24 hours rest in between test sessions. Skin temperature around the knee was 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℃.	Group D: GameReady n=30 Participants The cryocompression device was attached to the lower limb of participants using a cuff spanning positioned centrally over the knee. The device exerted an intermittent pressure of 5-50 mmHg throughout each test session, in line with manufacturer's recommendation. The temperature of the water pumped through the device was 1℃, in line with the precedent set in the literature and in lieu of a specific temperature setting recommended by the manufacturer. Each test session lasted for 30 minutes. Participants took part in all conditions, with at least 24 hours rest in between test sessions. Skin temperature around the knee was 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℃.	Group E: Physiolab Gel Therapy Wrap n=30 Participants The cryocompression device was attached to the lower limb of participants using a cuff spanning positioned centrally over the knee. The pressure and temperature that the device applied to the treatment area was non-modifiable and undefined. The device was used according to the manufacturer's recommendations. Each test session lasted for 30 minutes. Participants took part in all conditions, with at least 24 hours rest in between test sessions. Skin temperature around the knee was 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℃.
Skin Temperature Skin temp after 10 mins	18.2 degrees celsius Standard Deviation 1.8	23.94 degrees celsius Standard Deviation 2.89	21.92 degrees celsius Standard Deviation 3.54	19.39 degrees celsius Standard Deviation 2.9	20.22 degrees celsius Standard Deviation 3.33
Skin Temperature Skin temp after 15 mins	16.08 degrees celsius Standard Deviation 1.18	21.55 degrees celsius Standard Deviation 2.89	20.39 degrees celsius Standard Deviation 3.37	16.69 degrees celsius Standard Deviation 2.59	19.58 degrees celsius Standard Deviation 3.12
Skin Temperature Skin temp after 20 mins	15.12 degrees celsius Standard Deviation 1.05	19.89 degrees celsius Standard Deviation 3.2	18.92 degrees celsius Standard Deviation 3.04	15.32 degrees celsius Standard Deviation 2.1	19.48 degrees celsius Standard Deviation 3.0
Skin Temperature Skin temp after 25 mins	14.52 degrees celsius Standard Deviation 0.96	18.36 degrees celsius Standard Deviation 2.72	18.31 degrees celsius Standard Deviation 2.86	14.03 degrees celsius Standard Deviation 1.85	19.6 degrees celsius Standard Deviation 2.94
Skin Temperature Baseline skin temp	31.18 degrees celsius Standard Deviation 2.34	31.21 degrees celsius Standard Deviation 1.46	31.1 degrees celsius Standard Deviation 1.81	31.93 degrees celsius Standard Deviation 1.8	31.39 degrees celsius Standard Deviation 1.45
Skin Temperature Skin temp after 5 mins	19.97 degrees celsius Standard Deviation 2.0	26.78 degrees celsius Standard Deviation 3.17	24.15 degrees celsius Standard Deviation 3.19	21.96 degrees celsius Standard Deviation 2.95	21.2 degrees celsius Standard Deviation 3.22
Skin Temperature Skin temp after 30 mins	13.94 degrees celsius Standard Deviation 0.78	17.24 degrees celsius Standard Deviation 2.64	17.01 degrees celsius Standard Deviation 2.93	13.02 degrees celsius Standard Deviation 1.64	19.86 degrees celsius Standard Deviation 2.85
Skin Temperature Skin temp after 35 mins	17.23 degrees celsius Standard Deviation 2.18	21.62 degrees celsius Standard Deviation 1.3	18.45 degrees celsius Standard Deviation 2.49	17.96 degrees celsius Standard Deviation 2.35	18.3 degrees celsius Standard Deviation NA Test had ended for all other participants except one prior to this time point due to skin temperature being \>15 degrees Celsius. Since data only exist for a single participant at this time point, standard deviation is not relevant.
Skin Temperature Skin temp after 40 mins	19.07 degrees celsius Standard Deviation 0.97	—	—	18.0 degrees celsius Standard Deviation 0.57	—

SECONDARY outcome

Timeframe: 1 minute - recorded once immediately following treatments with each of the 5 devices under investigation

Population: Data were analysed for the 30 participants who fully completed their participation in the study.

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.