Skin Temperature Changes When Using a Cryocompression Device

NCT05136482 | Completed

• 1 other identifier: HWB_REC_210927_Faulkner
• Study Type: interventional
• Target: 32
• 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 (Wilke and Weiner, 2003; Bleakley, McDonough and MacAuley, 2004). The temperature range at which a device 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 of the device does not equal that to which the skin is reduced, plus different devices do not achieve the same reduction in skin temperature despite the ice-water within the knee sleeve being maintained at similar temperatures (Selfe et al., 2009). Therefore, it is not sufficient to assume that the temperature setting of a cryo-compression device reflects the skin temperature achieved. The aim of this study is to determine which temperature of ice-water flowing through a Physiolab S1 cryocompression device is able to reduce skin temperature around the knee to within the previously stated therapeutic range.

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℃.

  up to 14 days

Study Arms (5)

Control

NO INTERVENTION

Participants will wear the cryocompression device for 30 mins without any cold or pressure being applied to the lower limb by the cuff.

Condition A

EXPERIMENTAL

Participants will wear the cryocompression device for 30 minutes while ice-water at a temperature of 6℃ and a pressure of 25 mmHg is applied to the lower limb by the cuff.

Device: Cryocompression

Condition B

EXPERIMENTAL

Participants will wear the cryocompression device for 30 minutes while ice-water at a temperature of 8℃ and a pressure of 25 mmHg is applied to the lower limb by the cuff.

Device: Cryocompression

Condition C

EXPERIMENTAL

Participants will wear the cryocompression device for 30 minutes while ice-water at a temperature of 10℃ and a pressure of 25 mmHg is applied to the lower limb by the cuff.

Device: Cryocompression

Condition D

EXPERIMENTAL

Participants will wear the cryocompression device for 30 minutes while ice-water at a temperature of 12℃ and a pressure of 25 mmHg is applied to the lower limb by the cuff.

Device: Cryocompression

Interventions

Cryocompression DEVICE

A 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 constant pressure of 25 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). Depending on the condition, the temperature of the water being pumped through the device will be either 6, 8, 10, or 12℃. 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℃.

Condition A; Condition B; Condition C; Condition D

Eligibility Criteria

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

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
• These criteria have been selected in accordance with the common contraindications for cold therapy (Selfe et al, 2009; Fang et al, 2012; Waterman et al, 2012) and those laid out in the manufacturer's guidelines of the specific device to be used (S1; Physiolab Technologies Ltd)

Sponsors & Collaborators

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

Study Sites (1)

Physiology Laboratory

Winchester, United Kingdom

Location

Related Publications (5)

• 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

• 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

• 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

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: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 29, 2021
• Study Start: November 10, 2021
• Primary Completion: May 11, 2022
• Study Completion: May 11, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)