Prolonged Cryocompression and Skin Temperature: a Safety and Feasibility Pilot

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

Interventions

DEVICE

Prolonged (2-hour) cryocompression therapy

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.

Sponsors & Collaborators

• Physiolab Technologies Ltd

  collaborator INDUSTRY

• University of Winchester

  lead OTHER

Principal Investigators

• Scott Hannah, PhD · University of Winchester

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-02-12

Primary Completion

2025-05-30

Completion

2025-05-30

Countries

• United Kingdom

Study Locations