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Enrolling by Invitation

NCT Number: NCT07542470

Comparing Outcomes in Patients Who Have Spinal Surgery Who Have No-Ice Cold and Compression Therapy Using the NICE1 Device Versus Standard of Care

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.

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Key information

Conditions

Spinal Surgery Laminectomy Spinal Fusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sarasota Memorial Health Care System

Sarasota, Florida, 34239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ice-free cryopneumatic therapy device

Device

Nice1 cold + compression therapy system is an FDA-approved cryopneumatic device manufactured by Quick Recovery Systems

Primary outcomes

  1. 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.

  2. 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

  1. Length of hospital stay

    Time frame: 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.

  2. 30-day readmissions

    Time frame: 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.

  3. Patient mobility during recovery

    Time frame: 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.

  4. Quality of Life Questionnaire

    Time frame: 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.

  5. Quality of life questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sarasota Memorial Health Care System

Other

Registry information

Official study title

Assessing Outcomes in Spinal Surgery Patients Who Receive Iceless Cryopneumatic Therapy Using the NICE1 Device as Compared to Standard of Care

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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