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
Part of paid clinical trials in Mammoth Lakes, California.
- Sponsor
- University of Nevada, Reno
- Study ID
- NCT07455474
- Status
- Completed
Conditions
- Rotator Cuff Tear
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Breg Polar Care Wave Cold Compression Device — DEVICEcold compression sleeve
Study Details
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 Dates
- Start date
- Oct 1, 2023
- Status verified
- Mar 2025
- Primary completion
- Mar 1, 2025
- Completion
- Mar 3, 2026
Study Design
- Enrollment
- 50 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: cold compressionThese patients will receive a cold compression device in addition to standard postoperative care
- No Intervention: controlThis group will have standard postoperative care
Primary Outcome Measure
postoperative opioid consumption using milligram morphine equivalents [ Time Frame: 6 weeks ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mammoth Hospital | Mammoth Lakes | California | 93546 | - |
| Taos Orthopedic Institute | Taos | New Mexico | 87571 | - |
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