Laminectomy, Spinal Fusion, Spinal Surgery
Conditions
Keywords
cryotherapy, cryopneumatic therapy, spinal surgery, laminectomy
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.
Interventions
DEVICEice-free cryopneumatic therapy device
Nice1 cold + compression therapy system is an FDA-approved cryopneumatic device manufactured by Quick Recovery Systems
Sponsors
Sarasota Memorial Health Care System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Patients will be randomly assigned in a 1:1 ratio to either the intervention group or a usual care group using block randomization.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of 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. | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | From time of enrollment in the study until the patient is discharged from the hospital, typically 3 days. | The time the patient is admitted in the hospital will be tracked for all patients enrolled and compared between the two groups. |
| 30-day readmissions | From the date that the patient is discharged from the hospital, until 30 days after discharge. | Any readmissions to the hospital, within 30 days of the patients discharge, will be collected as a data point for comparison. |
| Patient mobility during recovery | A baseline score and then daily until the patient is discharged from the hospital, typically 3 days. | Mobility will be checked daily using a 0-5 scale, with 0 representing total assistance needed and 5 representing independent mobility with supervision. |
| 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. | 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. |
| 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. | The Neck Disability Index (NDI) questionnaire is used to assess neck pain, and the impact this may have on the patients' quality of life. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJulie Collins, RN, BSN
Sarasota Memorial Health Care System
Outcome results
None listed