N/A
N=32
Different Cryocompression Devices and Skin Temperature of the Knee
Temperature Change, Body
Bottom Line
View on ClinicalTrials.gov: NCT05355116 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Skin Temperature — 31.18; 31.21; 31.1; 31.93 degrees celsius
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Physiolab S1 (Device); Breg Vpulse (Device); Aircast Cryo/Cuff (Device); GameReady (Device); Physiolab Gel Therapy Wrap (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Winchester
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Skin Temperature |
31.18; 31.21; 31.1; 31.93; 31.39; 19.97 | — |
| SECONDARY Subjective Comfort |
86.7; 86.7; 90.0; 53.3; 96.7; 13.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- >18 years of age
Exclusion Criteria
- • 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
Data sourced from ClinicalTrials.gov (NCT05355116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.