CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Cryocompressiondevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05454982
NCT05454982N/ACompleted

Effect of the Different Pressure Settings of a Continuous Cold-flow Cryocompression Device on Skin Temperature of the Knee: a Randomised Crossover Trial

University of Winchester·interventional·Posted Jul 12, 2022·Updated Oct 15, 2024

In Brief

A clinical study evaluating Cryocompression for Temperature Change, Body. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
2023202420252026
First PostedJul 12, 2022
Enrollment StartJul 11, 2022
Primary CompletionNov 22, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 4.0 years ago

Interventions

Cryocompressiondevice

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℃.