Prolonged Cryocompression and Skin Temperature: a Safety and Feasibility Pilot

NCT06673277 | Completed

• 1 other identifier: HWB_REC_2405_Belsey
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Guidelines for treatment duration for cold and compression therapy after knee surgery are typically based on the use of ice packs for 30 minutes. However, electronic devices are beginning to be used more commonly in post-operative settings and while they have been shown to be able to provide a therapeutic dose of cooling, the necessary reduction in tissue temperature to realise the benefits of the therapy is much more gradual than ice packs and takes a longer time. Therefore, longer treatment durations may be needed with electronic devices. Although other research has demonstrated that skin temperature can be safely cooled continuously for several hours, no study has done this with an electronic device and monitored whether skin temperature is controlled to remain with a known therapeutic range of 10-15 ℃. This pilot study aims to test the feasibility and safety of a 2-hour treatment duration while skin temperature around the knee of 15-17 healthy volunteers is recorded. Each participant will take part in two treatments, whereby the first 30-minutes of both treatments involves cooling at a temperature of 8 ℃ (known to effectively reduce skin temperature), immediately followed by 90 minutes of cooling at either 10 ℃ or 12 ℃ (depending on the treatment condition) with the aim of maintaining skin temperature within the 10-15 ℃ target range. At least 24 hours will be left in between treatments with same participant.

Conditions

Skin Temperature Change; Adverse Effects; Safety of Intervention; Cryotherapy; Feasibility Pilot Study

Keywords

skin temperature; cryotherapy; cryocompression; safety; feasibility

Outcome Measures

Primary Outcomes (1)

• Skin temperature of the knee

  Measured in ℃ using 2 iButton temperature sensors attached with microporous tape. One positioned 20 mm distal to the patella, and one positioned in an equivalent location on the back of the leg.

  From the baseline measurement immediately prior to the treatment, then every 5 mins during the treatments, until a maximum of 30 minutes following the end of the treatment. This timeframe will apply to both treatments that participants will receive.

Secondary Outcomes (6)

• Skin temperature of the toe

  From the baseline measurement immediately prior to the treatment, then every 30 mins during the treatments, then at 15 and 30 minutes following the end of the treatment. This timeframe will apply to both treatments that participants will receive.

• Normalisation of perfusion of the toe

  Once at baseline immediately prior to the test, then every 30 minutes during each test, and at 15 and 30 minutes following each test.

• Range-of-motion of the knee

  Once at baseline immediately prior to the test, then 15 and 30 minutes following the treatment. This will be repeated for each of the 2 tests participants receive.

• Perceived pain

  At baseline immediately prior to the test, then every 30 minutes during the treatment, and after 15 and 30 minutes following each treatment.

• Adverse effects

  At baseline immediately prior to testing, then every 30 minutes during treatments, and after 15 and 30 minutes following treatments.

Study Arms (2)

Prolonged cooling at 8 ℃ then 10 ℃

EXPERIMENTAL

The device will be set to circulate water through the cuff around the knee at 8 ℃ for the first 30-minutes, then at 10 ℃ for the subsequent 90-minutes.

Device: Prolonged (2-hour) cryocompression therapy

Prolonged cooling at 8 ℃ then 12 ℃

EXPERIMENTAL

The device will be set to circulate water through the cuff around the knee at 8 ℃ for the first 30-minutes, then at 12 ℃ for the subsequent 90-minutes.

Interventions

Prolonged (2-hour) cryocompression therapy DEVICE

The cuff of the device will be attached around the knee randomised to receive the treatment as per the manufacturer's instruction. Then the device will be set to apply a standard 30-minute treatment with a temperature of 8 ℃ and intermittent compression of 25-50 mmHg. Following this, and depending on the randomised condition, the treatment will continue for a further 90-minutes with a temperature of either 10 ℃ or 12 ℃ being applied by the device. The level of compression will remain the same (25-50 mmHg) throughout all tests.

Prolonged cooling at 8 ℃ then 10 ℃

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years

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)

University of Winchester

Winchester, Hampshire, SO22 4NR, United Kingdom

Location

Related Publications (17)

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  PMID: 12776983 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

• Thienpont E. Does advanced cryotherapy reduce pain and narcotic consumption after knee arthroplasty? Clin Orthop Relat Res. 2014 Nov;472(11):3417-23. doi: 10.1007/s11999-014-3810-8. Epub 2014 Jul 25.

  PMID: 25059851 BACKGROUND

• Smith AD, Crabtree DR, Bilzon JL, Walsh NP. The validity of wireless iButtons and thermistors for human skin temperature measurement. Physiol Meas. 2010 Jan;31(1):95-114. doi: 10.1088/0967-3334/31/1/007. Epub 2009 Nov 26.

  PMID: 19940348 BACKGROUND

• Selfe, J. et al. (2009) 'An investigation into the effect on skin surface temperature of three cryotherapy modali-ties', Thermology International, 19(4), pp. 119-124.

  BACKGROUND

• Priego-Quesada JI, Gandia-Soriano A, Pellicer-Chenoll MT, Catala-Vilaplana I, Bermejo-Ruiz JL, Encarnacion-Martinez A, Salvador-Palmer R, Cibrian Ortiz de Anda R. Reproducibility of Skin Temperature Response after Cold Stress Test Using the Game Ready System: Preliminary Study. Int J Environ Res Public Health. 2021 Aug 5;18(16):8295. doi: 10.3390/ijerph18168295.

  PMID: 34444044 BACKGROUND

• Morsi E. Continuous-flow cold therapy after total knee arthroplasty. J Arthroplasty. 2002 Sep;17(6):718-22. doi: 10.1054/arth.2002.33562.

  PMID: 12216025 BACKGROUND

• van Marken Lichtenbelt WD, Daanen HA, Wouters L, Fronczek R, Raymann RJ, Severens NM, Van Someren EJ. Evaluation of wireless determination of skin temperature using iButtons. Physiol Behav. 2006 Jul 30;88(4-5):489-97. doi: 10.1016/j.physbeh.2006.04.026. Epub 2006 Jun 23.

  PMID: 16797616 BACKGROUND

• Mac Auley DC. Ice therapy: how good is the evidence? Int J Sports Med. 2001 Jul;22(5):379-84. doi: 10.1055/s-2001-15656.

  PMID: 11510876 BACKGROUND

• Long, B.C. and Jutte, L.S. (2020) '21st Century Attacks on Cryotherapy in Sports Health Care-Clinician Be-ware', Athletic Training & Sports Health Care, 12(3), pp. 99-101. Available at: https://doi.org/10.3928/19425864-20200401-02.

  BACKGROUND

• Kwiecien SY, McHugh MP, Howatson G. Don't Lose Your Cool With Cryotherapy: The Application of Phase Change Material for Prolonged Cooling in Athletic Recovery and Beyond. Front Sports Act Living. 2020 Oct 15;2:118. doi: 10.3389/fspor.2020.00118. eCollection 2020.

  PMID: 33345107 BACKGROUND

• Julious, S.A. (2005) 'Sample size of 12 per group rule of thumb for a pilot study', Pharmaceutical Statistics, 4(4), pp. 287-291. Available at: https://doi.org/10.1002/pst.185.

  BACKGROUND

• Johanson, G.A. and Brooks, G.P. (2010) 'Initial scale development: Sample size for pilot studies', Educational and Psychological Measurement, 70(3), pp. 394-400. Available at: https://doi.org/10.1177/0013164409355692.

  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

• Bleakley, C.M. and Hopkins, J.T. (2010) 'Is it possible to achieve optimal levels of tissue cooling in cryothera-py?', Physical Therapy Reviews, 15(4), pp. 344-350. Available at: https://doi.org/10.1179/174328810X12786297204873.

  BACKGROUND

• Belsey J, Gregory R, Paine E, Faulkner J. Skin temperature of the knee was effectively reduced when using a new continuous cold-flow cryocompression device: a randomised controlled crossover trial. Physiotherapy. 2024 Jun;123:11-18. doi: 10.1016/j.physio.2023.12.001. Epub 2023 Dec 14.

  PMID: 38244486 BACKGROUND

• Belsey J, Reid A, Paine E, Faulkner J. A randomised crossover trial of five cryocompression devices' ability to reduce skin temperature of the knee. PLoS One. 2024 Jan 16;19(1):e0296634. doi: 10.1371/journal.pone.0296634. eCollection 2024.

  PMID: 38227605 BACKGROUND

Study Officials

• Scott Hannah, PhD

  University of Winchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 4, 2024
• Study Start: February 12, 2025
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)