Study Comparing Cold and Compression Therapy After Rotator Cuff Repair Surgery to Standard Care

What this Trial Is About

Researchers are evaluating pain levels in adults aged 35 and older who have high-grade partial or full thickness rotator cuff tears and are undergoing arthroscopic rotator cuff repair. The study compares standard post-surgical care with and without the addition of cold and compression therapy to understand how these treatments affect pain over time. The trial is randomized without masking and is sponsored by Ochsner Health System. Participants will be assigned to one of two groups. One group will receive standard therapy after surgery, including 28 hydrocodoneAPAP 7.5 mg pills with an option for a refill, plus cold therapy using ice bags or gel packs. The other group will receive the same pain medication along with a cold and compression therapy device provided by the sponsor. Treatment and monitoring will continue regularly from before surgery through six months after surgery. During the study, participants will have their pain recorded using the PROMIS Pain NRS subscale before surgery, daily for 14 days after surgery, weekly for three months, and again at six months post-surgery. Researchers will track pain scores as the primary outcome and monitor participants recovery and adherence to therapy. The study involves outpatient physical therapy for rehabilitation and requires participants to speak English and attend follow-up visits over the six-month period.

Cold and Compression After Rotator Cuff Repair (RCR)