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Spinal SurgeryPhase 4NCT07542470

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

A Phase 4 study testing ice-free cryopneumatic therapy device in people with Spinal Surgery and Spinal Fusion, run by Sarasota Memorial Health Care System at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spinal Surgery, Spinal Fusion, Laminectomy
What is being tested?
ice-free cryopneumatic therapy device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
1 siteUnited States
Study dates
15 Mar 2026to Mar 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Sarasota Memorial Health Care System

    Sarasota, Florida, 34239

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
ice-free cryopneumatic therapy device
Keywords
cryotherapy, cryopneumatic therapy, spinal surgery, laminectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ice-free cryopneumatic therapy deviceDevice

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

Study groups in NCT07542470
Study groupRoleWhat they receive
Cryotherapy with compression (cryopneumatic) therapy groupExperimentalPatients who undergo an elective spinal surgery classified as a level 2 spinal fusion or greater will receive cryopneumatic therapy using the Nice1 device.
Receives: Device: ice-free cryopneumatic therapy device
Standard of CareNo interventionPatients will receive the standard care for postoperative spinal patients at Sarasota Memorial Health Care System.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of pain

    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.

    Measured: 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.

  2. Amount and need for opioid medication to control pain

    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.

    Measured: 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 outcomes (5)

  1. Length of hospital stay

    The time the patient is admitted in the hospital will be tracked for all patients enrolled and compared between the two groups.

    Measured: From time of enrollment in the study until the patient is discharged from the hospital, typically 3 days.

  2. 30-day readmissions

    Any readmissions to the hospital, within 30 days of the patients discharge, will be collected as a data point for comparison.

    Measured: From the date that the patient is discharged from the hospital, until 30 days after discharge.

  3. Patient mobility during recovery

    Mobility will be checked daily using a 0-5 scale, with 0 representing total assistance needed and 5 representing independent mobility with supervision.

    Measured: A baseline score and then daily until the patient is discharged from the hospital, typically 3 days.

  4. Quality of Life Questionnaire

    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.

    Measured: 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.

  5. Quality of life questionnaire

    The Neck Disability Index (NDI) questionnaire is used to assess neck pain, and the impact this may have on the patients' quality of life.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2026
  2. Study start15 Mar 2026
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomly assigned in a 1:1 ratio to either the intervention group or a usual care group using block randomization.
Masking
None (open label)
Enrolment
156 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07542470
Sponsor's protocol ID
25-NURS-124
Status last verified
Oct 2026
First submitted
15 Dec 2025
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Yang JH, Hwang KT, Lee MK, Jo S, Cho E, Lee JK. Comparison of a Cryopneumatic Compression Device and Ice Packs for Cryotherapy Following Anterior Cruciate Ligament Reconstruction. Clin Orthop Surg. 2023 Apr;15(2):234-240. doi: 10.4055/cios21246. Epub 2022 Aug 26.

    PubMed 37008961

  • Su EP, Perna M, Boettner F, Mayman DJ, Gerlinger T, Barsoum W, Randolph J, Lee G. A prospective, multi-center, randomised trial to evaluate the efficacy of a cryopneumatic device on total knee arthroplasty recovery. J Bone Joint Surg Br. 2012 Nov;94(11 Suppl A):153-6. doi: 10.1302/0301-620X.94B11.30832.

    PubMed 23118406

  • Murgier J, Cassard X. Cryotherapy with dynamic intermittent compression for analgesia after anterior cruciate ligament reconstruction. Preliminary study. Orthop Traumatol Surg Res. 2014 May;100(3):309-12. doi: 10.1016/j.otsr.2013.12.019. Epub 2014 Mar 25.

    PubMed 24679367

  • Khan M, Phillips SA, Mathew P, Venkateswaran V, Haverstock J, Dagher D, Yardley D, Dick D, Bhandari M. Cryo-Pneumatic Compression Results in a Significant Decrease in Opioid Consumption After Shoulder Surgery: A Multicenter Randomized Controlled Trial. Am J Sports Med. 2024 Sep;52(11):2860-2865. doi: 10.1177/03635465241270138. Epub 2024 Aug 21.

    PubMed 39165152

  • From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke Organization (ESO), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS), and World Stroke Organization (WSO); Sacks D, Baxter B, Campbell BCV, Carpenter JS, Cognard C, Dippel D, Eesa M, Fischer U, Hausegger K, Hirsch JA, Shazam Hussain M, Jansen O, Jayaraman MV, Khalessi AA, Kluck BW, Lavine S, Meyers PM, Ramee S, Rufenacht DA, Schirmer CM, Vorwerk D. Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke. Int J Stroke. 2018 Aug;13(6):612-632. doi: 10.1177/1747493018778713. Epub 2018 May 22. No abstract available.

    PubMed 29786478

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ice-free cryopneumatic therapy device in people with Spinal Surgery and Spinal Fusion, run by Sarasota Memorial Health Care System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07542470, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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