Assessing Outcomes in Spinal Surgery Patients Who Receive Iceless Cryopneumatic Therapy Using the NICE1 Device as Compared to Standard of Care
Trial Snapshot
- Phase
- Phase 4
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Assessment of pain
Study Overview
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Cryotherapy with compression (cryopneumatic) therapy group
Patients who undergo an elective spinal surgery classified as a level 2 spinal fusion or greater will receive cryopneumatic therapy using the Nice1 device.
Intervention: ice-free cryopneumatic therapy device (Device)
Standard of Care
Patients will receive the standard care for postoperative spinal patients at Sarasota Memorial Health Care System.
Outcomes
Primary Outcomes
Assessment of 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.
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.
Amount and need for opioid medication to control pain
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.
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.
Secondary Outcomes
- 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.)
Investigators
Julie Collins
Principal Investigator
Sarasota Memorial Health Care System