Cryopneumatic Therapy for Spinal Surgery

Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Sarasota Memorial Health Care System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

JC

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

I am able to understand the study and agree to take part.
I am 18 years old or older.
I am scheduled for elective spinal surgery with a level 2+ fusion or laminectomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo spinal surgery and receive either cryopneumatic therapy using the NICE1 device or standard of care postoperatively

3 days
Daily monitoring during hospital stay

Follow-up

Participants are monitored for pain, opioid use, and quality of life after discharge

2 weeks
Follow-up at 2 weeks post-discharge

Extended Follow-up

Participants complete quality of life questionnaires at 3 months post-discharge

3 months

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

Group I: Cryotherapy with compression (cryopneumatic) therapy groupExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sarasota Memorial Health Care System

Lead Sponsor

Trials
5
Recruited
770+

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.

Comparing 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 ...