By InvitationPhase 4

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

United States156 participantsStarted 2026-03-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of pain

Timeframe: 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

Timeframe: 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.

Trial details

NCT IDNCT07542470

SponsorSarasota Memorial Health Care System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03

View on ClinicalTrials.gov More Spinal Surgery trials