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

NCT07542470 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

  • Spinal Surgery
  • Spinal Fusion
  • Laminectomy

Interventions

DEVICE

ice-free cryopneumatic therapy device

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

Sponsors & Collaborators

  • Sarasota Memorial Health Care System

    lead OTHER

Principal Investigators

  • Julie Collins, RN, BSN · Sarasota Memorial Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-15
Primary Completion
2028-03-31
Completion
2028-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07542470 on ClinicalTrials.gov