NCT07455474

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Nevada, Reno · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Rotator Cuff Tear

Interventions

Type	Name	Description
DEVICE	Breg Polar Care Wave Cold Compression Device	cold compression sleeve

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-03-01
• Completion: 2026-03-03
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study