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 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.

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