NCT07516327

Cold and Compression After Rotator Cuff Repair (RCR)

Cold and Compression After Rotator Cuff Repair or Arthroscopic Rotator Cuff Repair Pain Attenuation: A Randomized, Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Ochsner Health System · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups pre-surgically, daily after surgery for 14 days, then weekly after surgery for 3 months, and at 6 months post-surgery.

Conditions

• High-grade Partial or Full Thickness Rotator Cuff Tears

Interventions

Type	Name	Description
OTHER	SOC (Standard of care)	Patients enrolled in this arm will be discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold therapy (bag of ice or gel pack) Other Name:
DEVICE	Cold and Compression	External mechanical compression therapy (e.g., compression stockings) has been shown to reduce swelling and risk of deep vein thrombosis in the lower limbs following TKA.12,13 Combining advanced cryotherapy (continuous circulating cold flow) and dynamic compression may offer added benefits than either traditional cryotherapy (e.g., cold packs) or compression (e.g., stockings) alone.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-09-01
• Completion: 2029-08-31
• First posted: 2026-04-08
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study