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New device aims to cut opioid use after back surgery

NCT ID NCT07542470

Symptom relief Sponsor: Sarasota Memorial Health Care System Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a device that delivers cold and compression therapy (NICE1) can help people recover better after spinal surgery. About 156 adults having spinal fusion or laminectomy will be randomly assigned to get either the NICE1 device or standard care after their operation. Researchers will measure pain levels, opioid use, hospital stay length, and readmission rates to see if the device makes a difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NICE1 ice-free cryopneumatic therapy device
What this could lead to
If it works, this could offer a drug-free way to manage pain after spinal surgery, potentially reducing opioid use and shortening hospital stays.
What could go wrong
This is a single-site, 156-person trial testing a device for short-term post-surgery recovery. Results may not apply to all surgeries or patients, and the device may not significantly outperform standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 156 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Laminectomy Spinal fusion Spinal surgery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sarasota Memorial Health Care System

    Sarasota, Florida, 34239, United States

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