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ENROLLING BY INVITATION
NCT07542470
PHASE4

Comparing Outcomes in Patients Who Have Spinal Surgery Who Have No-Ice Cold and Compression Therapy Using the NICE1 Device Versus Standard of Care

Sponsor: Sarasota Memorial Health Care System

View on ClinicalTrials.gov

Summary

A two-arm randomized controlled trial design will be used for this study to evaluate health outcomes of patients who receive Nice1 cryotherapy with compression (cryopneumatic) therapy (intervention group) versus those who receive standard of care (usual care group) postoperatively.

Official title: Assessing Outcomes in Spinal Surgery Patients Who Receive Iceless Cryopneumatic Therapy Using the NICE1 Device as Compared to Standard of Care

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

156

Start Date

2026-03-15

Completion Date

2028-03

Last Updated

2026-04-21

Healthy Volunteers

No

Interventions

DEVICE

ice-free cryopneumatic therapy device

Nice1 cold + compression therapy system is an FDA-approved cryopneumatic device manufactured by Quick Recovery Systems

Locations (1)

Sarasota Memorial Health Care System

Sarasota, Florida, United States