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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard of Care | No Intervention | Patients will receive the standard care for postoperative spinal patients at Sarasota Memorial Health Care System. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ice-free cryopneumatic therapy device | Device | Nice1 cold + compression therapy system is an FDA-approved cryopneumatic device manufactured by Quick Recovery Systems |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From time of enrollment in the study until the patient is discharged from the hospital, typically 3 days. |
| 30-day readmissions |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Julie Collins, RN, BSN | Sarasota Memorial Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarasota Memorial Health Care System | Sarasota | Florida | 34239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37008961 | Background | 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. | |
| 23118406 | 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. |
| Label | URL |
|---|---|
| NICE1 Cold \& Compression - Engineered for the comeback | View source |
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Patients will be randomly assigned in a 1:1 ratio to either the intervention group or a usual care group using block randomization.
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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 | 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 | 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 | 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. |
| 24679367 | 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. |
| 39165152 | 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. |
| 29786478 | 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. |
| MMWR Recommendations and Reports 2022 | View source |
| Chronic pain and high-impact chronic pain among US adults, 2019 | View source |