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

Completed · Not applicable

Conditions studied: Rotator Cuff Tear

In brief

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

Key facts

Study ID

NCT07455474

Run by

University of Nevada, Reno

People needed

50

Starts

2023-10-01

Expected to finish

2026-03-03

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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

You may not qualify if…

• • 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

Where it is running

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

Full record on ClinicalTrials.gov

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