Cryopneumatic Therapy for Spinal Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called cryopneumatic therapy, which combines cold therapy and compression, to aid recovery after spinal surgery. The researchers aim to determine if this treatment improves recovery compared to usual care. It targets individuals planning complex spinal surgeries, such as level 2 or higher spinal fusion. As a Phase 4 trial, this research explores how this FDA-approved and effective treatment can benefit more patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for the NICE1 Device?
Earlier studies have shown that the NICE1 device, which uses cold therapy with pressure, is well-tolerated by patients. Research indicates that the NICE1 device can help reduce pain and swelling after back surgery, suggesting its general safety. No major reports of serious side effects have been linked to the device. Patients have used it after surgeries like spinal fusion to reduce pain and the need for pain medication. As this trial is in a later phase, the treatment has been tested before and found safe for many people. Discuss any concerns with the trial team or your doctor.12345
Why are researchers enthusiastic about this study treatment?
Researchers are excited about cryopneumatic therapy using the NICE1 device for spinal surgery recovery because it combines cold therapy with compression, which is different from the usual pain medications and physical therapies that are typically used. This innovative approach aims to reduce swelling and pain more effectively and quickly compared to standard methods. The potential for faster recovery times and improved comfort for patients after spinal surgery is what makes this therapy particularly promising.
What evidence suggests that the NICE1 Device is effective for postoperative spinal surgery?
Studies have shown that cryopneumatic therapy, such as that provided by the NICE1 device, effectively reduces pain after spinal surgery. This therapy combines cold treatment with gentle pressure to decrease pain and swelling. In this trial, some participants will receive cryopneumatic therapy using the NICE1 device, while others will receive standard postoperative care. Previous studies found that patients using similar devices reported less discomfort than those receiving standard care. This method aims to speed up recovery by reducing swelling and improving blood flow, offering a promising way to manage pain after spinal surgery.12345
Who Is on the Research Team?
Julie Collins, RN, BSN
Principal Investigator
Sarasota Memorial Health Care System
Are You a Good Fit for This Trial?
This trial is for adults aged 18 or older who are scheduled to have elective spinal surgery, such as a laminectomy or spinal fusion involving at least two levels. Participants must be able to consent and agree to join the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo spinal surgery and receive either cryopneumatic therapy using the NICE1 device or standard of care postoperatively
Follow-up
Participants are monitored for pain, opioid use, and quality of life after discharge
Extended Follow-up
Participants complete quality of life questionnaires at 3 months post-discharge
What Are the Treatments Tested in This Trial?
Interventions
- NICE1 Device
Trial Overview
The study compares recovery after spinal surgery between patients using the NICE1 device (which provides cold and compression therapy without ice) and those receiving standard post-surgery care. Patients are randomly assigned to one of these groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients who undergo an elective spinal surgery classified as a level 2 spinal fusion or greater will receive cryopneumatic therapy using the Nice1 device.
Patients will receive the standard care for postoperative spinal patients at Sarasota Memorial Health Care System.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sarasota Memorial Health Care System
Lead Sponsor
Citations
Cryo-Compression Therapy After Elective Spinal Surgery for ...
The results of this prospective study have demonstrated that DC is found to be effective in reducing postoperative pain after elective lumbar spine surgery ...
Comparing Outcomes in Patients Who Have Spinal ...
Assessing Outcomes in Spinal Surgery Patients Who Receive Iceless Cryopneumatic Therapy Using the NICE1 Device as Compared to Standard of Care.
3.
trial.medpath.com
trial.medpath.com/clinical-trial/60dcaae2daef6e74/nct07542470-spinal-surgery-nice1-device-cold-compression-therapy-vs-standard-careComparing Outcomes in Patients Who Have Spinal Surgery ...
A two-arm randomized controlled trial design will be used for this study to evaluate health outcomes of patients who receive Nice1 ...
Comparing Outcomes in Patients Who Have Spinal ...
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 for Spinal Surgery
A two-arm randomized controlled trial design will be used for this study to evaluate health outcomes of patients who receive Nice1 cryotherapy with ...
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