CompletedNot Applicable

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

United States50 participantsStarted 2023-10-01

Plain-language summary

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

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

postoperative opioid consumption using milligram morphine equivalents

Timeframe: 6 weeks

Trial details

NCT IDNCT07455474

SponsorUniversity of Nevada, Reno

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-01

View on ClinicalTrials.gov More Rotator Cuff Tear trials