Effect of Pressure on Skin Temperature When Using a Cryocompression Device

NCT05454982 | Completed

• 1 other identifier: HWB_REC_ 220530_Faulkner
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Cryotherapy after surgery is widely utilised and has numerous practical applications for post-operative rehabili-tation. 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 degree to which the pressure applied by a cuff to the knee has an effect on the achieved skin temperature of the treatment area is unknown. The aim of this study is to determine the effect that different pressure settings have on skin temperature around the knee during a 30-minute cryocompression 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℃.

  up to 14 days

Study Arms (3)

Low pressure

EXPERIMENTAL

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

Device: Cryocompression

Medium pressure

EXPERIMENTAL

Participants will wear the cryocompression device for 30 minutes while ice-water at a temperature of 8℃ and an intermittent pressure of 25-50 mmHg is applied to the lower limb by the cuff.

Device: Cryocompression

High pressure

EXPERIMENTAL

Participants will wear the cryocompression device for 30 minutes while ice-water at a temperature of 8℃ and an intermittent pressure of 25-75 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 circulate ice-water at a constant temperature of 8℃ throughout each test session. Depending on the condition, the cuff will also apply varying levels of pressure for the duration of each test. 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℃.

High pressure; Low pressure; Medium pressure

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

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

• 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

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

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 12, 2022
• Study Start: July 11, 2022
• Primary Completion: November 22, 2022
• Study Completion: November 22, 2022
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)