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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Assessment of pain [Срок оценки: 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.]
• Amount and need for opioid medication to control pain [Срок оценки: 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.]

Вторичные конечные точки (5)

• Length of hospital stay [Срок оценки: From time of enrollment in the study until the patient is discharged from the hospital, typically 3 days.]
• 30-day readmissions [Срок оценки: From the date that the patient is discharged from the hospital, until 30 days after discharge.]
• Patient mobility during recovery [Срок оценки: A baseline score and then daily until the patient is discharged from the hospital, typically 3 days.]
• Quality of Life Questionnaire [Срок оценки: 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.]
• Quality of life questionnaire [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Sarasota Memorial Health Care System — Sarasota

Публикации

• Yang JH, Hwang KT, Lee MK, Jo S, Cho E, Lee JK. Comparison of a Cryopneumatic Compression Device and Ice Packs for Cryotherapy Following Anterior Cruciate Ligament Reconstruction. Clin Orthop Surg. 2023 Apr;15(2):234-240. doi: 10.4055/cios21246. Epub 2022 Aug 26. PMID 37008961
• Su EP, Perna M, Boettner F, Mayman DJ, Gerlinger T, Barsoum W, Randolph J, Lee G. A prospective, multi-center, randomised trial to evaluate the efficacy of a cryopneumatic device on total knee arthroplasty recovery. J Bone Joint Surg Br. 2012 Nov;94(11 Suppl A):153-6. doi: 10.1302/0301-620X.94B11.30832. PMID 23118406
• Murgier J, Cassard X. Cryotherapy with dynamic intermittent compression for analgesia after anterior cruciate ligament reconstruction. Preliminary study. Orthop Traumatol Surg Res. 2014 May;100(3):309-12. doi: 10.1016/j.otsr.2013.12.019. Epub 2014 Mar 25. PMID 24679367
• Khan M, Phillips SA, Mathew P, Venkateswaran V, Haverstock J, Dagher D, Yardley D, Dick D, Bhandari M. Cryo-Pneumatic Compression Results in a Significant Decrease in Opioid Consumption After Shoulder Surgery: A Multicenter Randomized Controlled Trial. Am J Sports Med. 2024 Sep;52(11):2860-2865. doi: 10.1177/03635465241270138. Epub 2024 Aug 21. PMID 39165152
• From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke PMID 29786478

Идентификаторы

NCT: NCT07542470 · 25-NURS-124

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗