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

April 14, 2026 updated by: Julie Collins, Sarasota Memorial Health Care System

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Recent studies have shown that cryotherapy (cold therapy) with compression (light pressure) offers treatment benefits such as decreased opioid usage after surgery. The combination of cryotherapy with compression can be referred to as cryopneumatic therapy. The purpose of this study is to assess how the use of an ice-free cryopneumatic therapy device called NICE1 affects pain levels and opioid use among post-operative patients at SMHCS. The study will also investigate the impact the cryopneumatic therapy has on patient readmissions, length of hospital stay, mobility, and quality of life.

The NICE1 cryopneumatic therapy device has been approved by the Food and Drug Administration (FDA); however, it is not currently used as part of the standard of care at SMHCS. In this study, patients undergoing spinal surgery at SMHCS will be randomized to either receive iceless cryopneumatic therapy with NICE1 (study intervention group) or to receive standard of care treatment (usual care group) after their surgery.

Study Type

Interventional

Enrollment (Estimated)

156

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients must be 18 years or older
  • Are scheduled for an elective spinal surgery that includes a level 2 or above spinal fusion and/or laminectomy
  • Have consenting capacity and voluntarily agree to participate in the study

Exclusion Criteria:

  • Patients under the age of 18
  • Are scheduled for an elective spinal surgery that includes a level 1 spinal fusion and/or laminectomy
  • Admitted from the ECC or a direct admission

  • Cold hypersensitivity or Raynaud's disease

    • Cryoglobulinemia or acute paroxysmal cold hemoglobinuria
    • Vascular impairments in the area such as that from ischemia or arteriosclerosis, diabetes, frostbite, wound injuries (with the exception of the surgical incision), and pressure sores
    • Kyphoplasty patients
    • Participants may be excluded or unenrolled from the study at the discretion of the principal investigator and/or sub-investigator based on their clinical judgment and if their health and/or safety may be impacted

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: ice-free cryopneumatic therapy device
Nice1 cold + compression therapy system is an FDA-approved cryopneumatic device manufactured by Quick Recovery Systems
No Intervention: Standard of Care
Patients will receive the standard care for postoperative spinal patients at Sarasota Memorial Health Care System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pain scores will be assessed among patients who receive cryopneumatic therapy using the NICE1 device and compared to pain scores of patients who received standard of care. Pain will be rated on a scale of 0-10, where 0= no pain and 10= the worst pain.
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.
Amount and need for opioid medication to control pain
Time Frame: At baseline at time of enrollment in the study, daily until the patient is discharged from the hospital, typically 3 days, and then at two weeks after hospital discharge.
Opioid usage among patients who receive cryopneumatic therapy using the NICE1 device will be assessed and compared to opioid use in patients who received standard of care.
At baseline at time of enrollment in the study, daily until the patient is discharged from the hospital, typically 3 days, and then at two weeks after hospital discharge.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: From time of enrollment in the study until the patient is discharged from the hospital, typically 3 days.
The time the patient is admitted in the hospital will be tracked for all patients enrolled and compared between the two groups.
From time of enrollment in the study until the patient is discharged from the hospital, typically 3 days.
30-day readmissions
Time Frame: From the date that the patient is discharged from the hospital, until 30 days after discharge.
Any readmissions to the hospital, within 30 days of the patients discharge, will be collected as a data point for comparison.
From the date that the patient is discharged from the hospital, until 30 days after discharge.
Patient mobility during recovery
Time Frame: A baseline score and then daily until the patient is discharged from the hospital, typically 3 days.
Mobility will be checked daily using a 0-5 scale, with 0 representing total assistance needed and 5 representing independent mobility with supervision.
A baseline score and then daily until the patient is discharged from the hospital, typically 3 days.
Quality of Life Questionnaire
Time Frame: This questionnaire will be sent to patients before surgery, at two weeks after discharge from the hospital, and at 3 months. If needed a study team member will call the patient to complete the questionnaire and provide assistance.
The Oswestry Disability Index (ODI) questionnaire, which measures leg and back pain will be used to determine quality of life outcomes and the effect pain may have on the patient's life.
This questionnaire will be sent to patients before surgery, at two weeks after discharge from the hospital, and at 3 months. If needed a study team member will call the patient to complete the questionnaire and provide assistance.
Quality of life questionnaire
Time Frame: This questionnaire will be sent to patients before surgery, at two weeks after discharge from the hospital, and at 3 months. If needed a study team member will call the patient to complete the questionnaire and provide assistance.
The Neck Disability Index (NDI) questionnaire is used to assess neck pain, and the impact this may have on the patients' quality of life.
This questionnaire will be sent to patients before surgery, at two weeks after discharge from the hospital, and at 3 months. If needed a study team member will call the patient to complete the questionnaire and provide assistance.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sarasota Memorial Health Care System

Investigators

  • Principal Investigator: Julie Collins, RN, BSN, Sarasota Memorial Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

December 15, 2025

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 25-NURS-124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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