A Comparison of Skin Temperature Changes Around the Knee When Using Cryocompression Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Skin Temperature
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>18 years of age
排除标准
- •• BMI >40 kg/m2
- •History of nerve damage or sensory deficit in the lower limbs (including frostbite)
- •Hypersensitivity to cold, including hives
- •Active inflammation or pain of the knee
- •History of thrombosis, embolism, or other conditions related to impaired peripheral circulation
- •Suffering from diagnosed diabetes, multiple sclerosis, rheumatoid arthritis, spinal cord injury, cardio-vascular disease, hypertension, Raynaud disease, cryoglobulinemia, or haemoglobinuria
- •Confirmed or suspected tissue infection, an unstable fracture, a skin condition, or a tumour in the treatment area
- •Cognitive impairment or communication barriers where adjustments can not be reasonably made
研究组 & 干预措施
Group A: 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 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℃.
干预措施: Physiolab S1 (Device)
Group B: 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 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℃.
干预措施: Breg Vpulse (Device)
Group C: 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 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℃.
干预措施: Aircast Cryo/Cuff (Device)
Group D: 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 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℃.
干预措施: GameReady (Device)
Group E: Physiolab Gel Therapy Wrap
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℃.
干预措施: Physiolab Gel Therapy Wrap (Device)
结局指标
主要结局
Skin Temperature
时间窗: Up to 40 minutes per treatment
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℃.
次要结局
- Subjective Comfort(1 minute - recorded once immediately following treatments with each of the 5 devices under investigation)