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

Phase 4Enrolling By InvitationNCT07542470

Sarasota Memorial Health Care System156 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

156

Conditions

Spinal Surgery Spinal Fusion Laminectomy

Interventions

ice-free cryopneumatic therapy deviceDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sarasota Memorial Health Care System

Sarasota, Florida, United States

Outcomes

Primary Outcomes

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.

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.

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.

Time frame: 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

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.

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

30-day readmissions

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

Time frame: 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.

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.