Skin Temperature Reduction With Hilotherm Device

NCT05789290 | Withdrawn

• 1 other identifier: HWB_REC_230131_Faulkner
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. The temperature to 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. Therefore, it is not sufficient to assume that the temperature setting of a cryocompression device accurately reflects the achieved skin temperature. Modern cryotherapy devices mostly 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 cold water to and from the cuff in order to cool the intended body part. The Hilotherm is one such device for use in this way, but its ability to reduce skin temperature to within the target therapeutic range is unknown. The aim of this study is to determine whether the Hilotherm device is capable of reducing skin temperature of the knee to within the 10-15℃ therapeutic range during a standard 30-minute treatment.

Conditions

Temperature Change, Body

Outcome Measures

Primary Outcomes (1)

• 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℃.

  60 minutes

Secondary Outcomes (1)

• Subjective comfort

  60 minutes

Study Arms (1)

Test group

This group will receive a 30-minute cryocompression treatment to one knee using a Hilotherm device, which is set to circulate water through the cuff at a maintained temperature of 10℃. The Hilotherm device will be administered according to the manufacturer's guidelines and each participant will undergo this treatment once.

Device: Hilotherm cryocompression device

Interventions

Hilotherm cryocompression device DEVICE

An electronic device that is capable of circulating warm or cooled water at a user-selected temperature between 10-30℃. Water is circulated from a central unit, through a tube, to a cuff wrapped around the intended therapy area (the knee). A treatment lasts for 30-minutes, at which point the device is turned off and the cuff is removed from the limb of the user.

Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy adult volunteers recruited primarily from a university population. All individuals willing to participate will be screened according to the abovementioned inclusion/exclusion criteria, and will be recruited until 30 people have completed their participation in the study.

You may qualify if:

• \>18 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Winchester: lead
• Physiolab Technologies Ltd: collaborator

Study Sites (1)

University of Winchester, Physiology Laboratory

Winchester, SO22 4NR, United Kingdom

Location

Related Publications (6)

• Wilke B, Weiner RD. Postoperative cryotherapy: risks versus benefits of continuous-flow cryotherapy units. Clin Podiatr Med Surg. 2003 Apr;20(2):307-22. doi: 10.1016/S0891-8422(03)00009-0.

  PMID: 12776983 BACKGROUND

• Bleakley C, McDonough S, MacAuley D. The use of ice in the treatment of acute soft-tissue injury: a systematic review of randomized controlled trials. Am J Sports Med. 2004 Jan-Feb;32(1):251-61. doi: 10.1177/0363546503260757.

  PMID: 14754753 BACKGROUND

• Fang L, Hung CH, Wu SL, Fang SH, Stocker J. The effects of cryotherapy in relieving postarthroscopy pain. J Clin Nurs. 2012 Mar;21(5-6):636-43. doi: 10.1111/j.1365-2702.2010.03531.x. Epub 2011 Feb 20.

  PMID: 21332855 BACKGROUND

• Waterman B, Walker JJ, Swaims C, Shortt M, Todd MS, Machen SM, Owens BD. The efficacy of combined cryotherapy and compression compared with cryotherapy alone following anterior cruciate ligament reconstruction. J Knee Surg. 2012 May;25(2):155-60. doi: 10.1055/s-0031-1299650.

  PMID: 22928433 BACKGROUND

• Bellon M, Michelet D, Carrara N, Vacher T, Gafsou B, Ilhareborde B, Mazda K, Ferrero E, Simon AL, Julien-Marsollier F, Dahmani S. Efficacy of the Game Ready(R) cooling device on postoperative analgesia after scoliosis surgery in children. Eur Spine J. 2019 Jun;28(6):1257-1264. doi: 10.1007/s00586-019-05886-6. Epub 2019 Jan 31.

  PMID: 30847706 BACKGROUND

• Selfe J, Hardaker N, Whittaker J and Hayes C. An investigation into the effect on skin surface temperature of three cryotherapy modalities. Thermology International. 2009; 19(4): 121-126.

  BACKGROUND

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James Faulkner, PhD

  University of Winchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: April 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)