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

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

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.

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