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

NCT07455474 | Completed FDA Device

• 1 other identifier: 2045754-2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Rotator Cuff Tear

Keywords

cold compression; postoperative pain; shoulder surgery; arthroscopy

Outcome Measures

Primary Outcomes (1)

• postoperative opioid consumption using milligram morphine equivalents

  opioid consumption conversion of opioid consumption to MMEQ

  6 weeks

Secondary Outcomes (2)

• VAS

  6 weeks

• sleep quality

  6 weeks

Study Arms (2)

cold compression

EXPERIMENTAL

These patients will receive a cold compression device in addition to standard postoperative care

Device: Breg Polar Care Wave Cold Compression Device

control

NO INTERVENTION

This group will have standard postoperative care

Interventions

Breg Polar Care Wave Cold Compression Device DEVICE

cold compression sleeve

cold compression

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• University of Nevada, Reno: lead
• Taos Orthopedic Institute: collaborator
• Mammoth Orthopedic Institute: collaborator

Study Sites (2)

Mammoth Hospital

Mammoth Lakes, California, 93546, United States

Location

Taos Orthopedic Institute

Taos, New Mexico, 87571, United States

Location

Related Publications (1)

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

  BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries; Pain, Postoperative

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Dan Guttmann, MD

  Taos Orthopedic Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Surgery CF

Model Details: The study will enroll a total of at least 60 subjects. The sample size is based on a matter of practical convenience, i.e., based on the number of arthroscopic rotator cuff repair procedures reasonably expected to be performed on eligible patients during the study's time period at the clinical sites. We carried out power analysis using our anticipated sample size of 60 subjects for a two-sided t-test with a 95% confidence interval in G\*Power. For a small (0.2), medium (0.5), or large effect size (d=0.8), the achieved power would be 0.12, 0.48, or 0.86, respectively. Therefore, we anticipate good power for a large effect size and plan to carry out post hoc power analysis for insignificant results. An equal number of subjects are required for the control group and test group (described below); thus, each group of the study will be comprised of at least 30 subjects. This will be a multi-site study. As such, all study participants will be enrolled at one of the two clinical sites.

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: March 6, 2026
• Study Start: October 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 3, 2026
• Last Updated: March 6, 2026

Record last verified: 2025-03

Locations

US (2)