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NICE ICE Trial: A comparison of an iceless cooling compression device with traditional ice pack therapy

NICE ICE Trial: A randomised control trial investigating the effect of iceless compression cryotherapy with traditional ice pack therapy on post-operative outcomes in patients undergoing total knee arthroplasty

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN68667916
Enrollment
120
Registered
2025-06-20
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative patients following Total Knee Arthroplasty Surgery

Interventions

A. Ice pack therapy for 20 minutes 6 times per day B. NICE1 Cold compression device for 20 minutes 6 times per day Treatment will only be for the duration of post-operative admission. Follow up will

Sponsors

Cappagh National Orthopaedic Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. Undergoing primary TKA at NOHC 3. Able to provide informed consent 4. End stage arthritis

Exclusion criteria

Exclusion criteria: 1. BMI >40 kg/m² 2. Cognitive impairment 3. Prior infection or vascular compromise in the operative limb 4. Refusal or inability to comply with assigned treatment 5. Use of another post-operative cooling therapy outside of the study protocol

Design outcomes

Primary

MeasureTime frame
1. Pain intensity is measured using the Visual Analogue Scale (VAS) at 6, 12, 24, and 48 hours post-operatively 2. Opioid consumption is measured using medication administration records during the inpatient stay

Secondary

MeasureTime frame
1. Knee range of motion (flexion and extension) is measured using a goniometer at baseline, 6, 12, 24, and 48 hours post-operatively 2.Limb swelling is measured using mid-patella circumference at baseline, 6, 12, 24, and 48 hours post-operatively 3. Patient satisfaction is measured using a patient satisfaction questionnaire at discharge 4. Adverse events and tolerability issues are measured using clinical observation and patient self-reporting during the inpatient stay and at discharge 5. Length of stay measured using patient records 6. Time to physio discharge measured using patient records

Countries

Ireland

Contacts

Public ContactJoshua Hayes
joshuahayes@rcsi.ie+353 18140400

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026