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 | Enrolling By Invitation Phase 4 FDA Device

• 1 other identifier: 25-NURS-124
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cryotherapy; cryopneumatic therapy; spinal surgery; laminectomy

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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 Outcomes (5)

• Length of hospital stay

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

• 30-day readmissions

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

• Patient mobility during recovery

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

• Quality of Life Questionnaire

  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

  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.

Study Arms (2)

Cryotherapy with compression (cryopneumatic) therapy group

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

Patients will receive the standard care for postoperative spinal patients at Sarasota Memorial Health Care System.

Interventions

ice-free cryopneumatic therapy device DEVICE

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

Cryotherapy with compression (cryopneumatic) therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sarasota Memorial Health Care System: lead

Study Sites (1)

Sarasota Memorial Health Care System

Sarasota, Florida, 34239, United States

Location

Related Publications (5)

• 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.

  PMID: 37008961 BACKGROUND

• 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.

  PMID: 23118406 BACKGROUND

• 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.

  PMID: 24679367 BACKGROUND

• 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.

  PMID: 39165152 BACKGROUND

• 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.

  PMID: 29786478 BACKGROUND

Related Links

• NICE1 Cold \& Compression - Engineered for the comeback
• MMWR Recommendations and Reports 2022
• Chronic pain and high-impact chronic pain among US adults, 2019

Study Officials

• Julie Collins, RN, BSN

  Sarasota Memorial Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be randomly assigned in a 1:1 ratio to either the intervention group or a usual care group using block randomization.

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: April 21, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)