Utility of Intermittent Cryo-Compression Versus Traditional Icing Following Arthroscopic Rotator Cuff Repair — ICC  

Rotator Cuff Injuries Clinical Trial

Official title: Utility of Intermittent Cryo-Compression Versus Traditional Icing Following Arthroscopic Rotator Cuff Repair

Status Recruiting

Clinical Trial Summary

Effective post - operative pain control following orthopedic surgical procedures without excessive reliance upon opioid pain medication has garnered increased attention in recent years. This study will evaluate the utilization of a non-invasive, novel cryo - compression, post-operative modality to improve pain control versus standard ice wraps in the immediate post-operative phase of arthroscopic rotator cuff surgery via a randomized controlled study design. Furthermore, if this study demonstrates improved pain control, improved quality of life and decreased opioid usage with the intermittent cold compression unit, recommendations may be considered for system-wide utilization.

Clinical Trial Description

The purpose of this study is to test the proposed increase efficacy of combining both cold and compression modalities through cryo-compression therapy in post-operative pain management in arthroscopic rotator cuff repair surgery versus a control group of standard ice wraps. As opioid use within the field of orthopedics continues to grow as an area of investigation, surgeons must look elsewhere for pain management tactics.

Objectives of this study include:

1. Evaluate effectiveness of intermittent cryo-compression therapy versus standard ice wraps for post - operative pain control through patient reported visual analog pain scores and patient - reported opioid usage in patients undergoing arthroscopic rotator cuff repair.

2. Evaluate effectiveness of intermittent cryo-compression therapy versus standard ice wraps for reduction of post - operative tissue swelling in patients undergoing arthroscopic rotator cuff repair.

3. Determine cost comparison of intermittent compression cryotherapy versus interscalene catheter via historical controls as well as versus standard ice wraps.

4. Evaluate effect of intermittent cryo-compression therapy versus standard ice wraps on patient - reported quality of life via PROMIS.

Patients that are candidates for arthroscopic rotator cuff repair and complete informed consent process will be enrolled in study if no exclusion criteria are present. The study has determined an enrollment goal of 100 subjects (50 intermittent cryo-compression therapy, 50 standard cryo -therapy).

Following informed consent, patients enrolled in the study will be randomized in a 1:1 ratio using permuted blocks of sizes 2 and 4 to have post-operative cryotherapy using ice packs or with the intermittent cold compression therapy unit. Randomization assignments will be contained in sequentially numbered, opaque, sealed envelopes, which will be prepared by an individual not involved in patient consent or patient treatment. After the patient is consented, the next envelope in the sequence will be opened and the patient will be assigned to a group following the treatment listed in the envelope.

Prior to surgery, the subject will complete pre-operative data collection. The subject will be given a tracking diary in order to record immediate post-operative data through the first post-operative visit. Subjects will undergo arthroscopic rotator cuff repair by a single surgeon as a standard of care procedure.

Subjects randomized to the study group will have the compression sleeve for the NICE Recovery SystemTM applied to the operative shoulder immediately post - operatively and those randomized to the control group a standard gel ice pack with wrap. Each will use the assigned version of cold therapy with a goal of 6 hours daily and will record overages using one half hour as a minimum unit.

After enrollment and surgery, subjects will follow a post-operative follow-up visit schedule including 2-days, first post-operative visit, 60 days, 3 months, 6 months, and 12 months. ;

Related Conditions & MeSH terms

• Cryotherapy Effect
• Rotator Cuff Injuries

• NCT number: NCT05095909
• Study type: Interventional
• Source: Allina Health System
• Contact: Ned Tervola, MA, LAT, ATC
• Phone: 952-946-9777
• Email: ned.tervola@allina.com
• Status: Recruiting
• Phase: N/A
• Start date: March 2023
• Completion date: June 2025