Clinical Research Study of the Benefits of BREG Polar Care Wave to Reduce Opioid Use by Patients Having Undergone Arthroscopic Rotator Cuff Repair Shoulder Surgery (CCROUT)

Clinical Research Study of the Benefits of Cold Compression to Reduce Opioid Use by Patients Having Undergone Arthroscopic Rotator Cuff Repair Shoulder Surgery

The goal of this clinical trial is to compare effect of cold compression to standard of care in patients undergoing rotator cuff repair. The main question[s] it aims to answer are:

• whether opioid use is decreased in the experimental cold compression group
• whether patient reported outcomes and pain scores are reduced in the experimental cold compression group Participants will be randomized to standard postoperative care versus standard postoperative care with use of cold compression therapy Researchers will compare control and experimental cold compression groups to see if there are differences between groups

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Device: Breg Polar Care Wave Cold Compression Device

Detailed Description

The primary objective of this study is to determine whether patients, who have undergone arthroscopic rotator cuff repair surgery and who use the Polar Care Wave, use fewer opioids for a shorter duration post-operatively relative to the standard of care. Therefore, all patients enrolled in the study will be prescribed opioids for pain control after surgery. These medications will be taken at the discretion of each patient but not more than the dose recommended by the physician.

The secondary objectives of this study are to determine whether patients who have undergone arthroscopic rotator cuff repair surgery and who use the Polar Care Wave:

• experience lower pain during the 30-day post-operative period relative to the standard of care.
• experience improved quality of sleep during the 30-day post-operative period relative to the standard of care assessed via the Pittsburg Sleep Quality Index (Appendix B).
• experience improved post-surgical physical therapy outcomes measured by range of motion (ROM) relative to the standard of care.

We hypothesize that patients using the Polar Care Wave will report less frequent use and lower doses of opioid pain medications, a lower degree of pain, and improved sleep quality during the 30-day post-operative recovery period compared to patients recovering with the current standard of care (the control). We also hypothesize that these patients will have better ROM measures at 6 weeks post-operative compared to the control.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Mammoth Lakes, California, United States, 93546
      • Mammoth Hospital
  • New Mexico
    • Taos, New Mexico, United States, 87571
      • Taos Orthopedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Patients scheduled for arthroscopic rotator cuff surgical repair between the dates of July 17, 2023, and November 30, 2023

  • Adult males and females ages 18 to 70
  • No prior experience using the Breg Polar Care Wave device
  • No adverse underlying medical conditions or comorbidities that may enhance pain, require drugs that interact with opioids, or otherwise confound the results
  • Ownership of or daily access to a smart phone or internet-connected computer

Exclusion Criteria:

• • Patients scheduled for arthroscopic rotator cuff surgical repair outside the dates of July 17, 2023, and November 30, 2023

  • Adults aged 71 and above
  • Children below the age of 18

  • Other medical conditions or concomitant medication use that are known to negatively impact the outcome of rotator cuff repair

    o These include diabetes, current smoker, workers compensation claim, history of prior surgery on same shoulder, chronic pain, and pre-operative opioid use. Exclusion of this population is necessary in order to limit the introduction of confounding factors that could affect opioid usage independent of the Polar Care Wave.

  • Concurrent participation in other studies
  • Prior experience using the Breg Polar Care Wave device
  • Do not have daily access to an internet-connected device to provide study data

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cold compression; These patients will receive a cold compression device in addition to standard postoperative care	Device: Breg Polar Care Wave Cold Compression Device; cold compression sleeve
No Intervention: control; This group will have standard postoperative care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative opioid consumption using milligram morphine equivalents	opioid consumption conversion of opioid consumption to MMEQ	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS	VAS pain scores	6 weeks
sleep quality	pittsburgh sleep quality index	6 weeks

Collaborators and Investigators

• Sponsor: University of Nevada, Reno
• Collaborators: Taos Orthopedic Institute; Mammoth Orthopedic Institute
• Investigators: Study Director: Dan Guttmann, MD, Taos Orthopedic Institute

Publications and helpful links

General Publications

• 8 Reeves, B. Using Cold Therapy To Improve Patient Satisfaction and Reduce Opioid Use Post Surgery, 2018.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 3, 2026

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: postoperative pain; arthroscopy; shoulder surgery; cold compression
• Additional Relevant MeSH Terms: Shoulder Injuries; Pain; Neurologic Manifestations; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Rupture; Tendon Injuries; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Rotator Cuff Injuries; Pain, Postoperative
• Other Study ID Numbers: 2045754-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: only as necessary for piublication and verification of results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes