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

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Sarasota Memorial Health Care System
Study ID
NCT07542470
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Laminectomy
  • Spinal Fusion
  • Spinal Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ice-free cryopneumatic therapy device — DEVICE
    Nice1 cold + compression therapy system is an FDA-approved cryopneumatic device manufactured by Quick Recovery Systems

Study Details

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.

Key Dates

Start date
Mar 15, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Cryotherapy with compression (cryopneumatic) therapy group
    Patients who undergo an elective spinal surgery classified as a level 2 spinal fusion or greater will receive cryopneumatic therapy using the Nice1 device.
  • No Intervention: Standard of Care
    Patients will receive the standard care for postoperative spinal patients at Sarasota Memorial Health Care System.

Primary Outcome Measure

Assessment of pain [ Time Frame: For enrolled patients, a baseline pain scores will be recorded, and then daily during 7am-7pm shifts, and at 7pm-7am shifts, until the patient is discharged from the hospital, and at two weeks after the patient has been discharged from the hospital. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sarasota Memorial Health Care SystemSarasotaFlorida34239-

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Sarasota Memorial Health Care System· Sarasota, FL

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