Cold and Compression After Rotator Cuff Repair or Arthroscopic Rotator Cuff Repair Pain Attenuation: A Randomized, Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Healthy Volunteers: f
View:
• Aged 35 yr or older
• Patient of Drs. Michael Hartman (PI), Ian Elliott, Jay French, or Paul Phillips at Ochsner Kenner scheduled for arthroscopic rotator cuff repair
• Will receive outpatient physical therapy at OTW Driftwood for the entire post-op rehabilitation period
• English speaking
• Diagnosis of high-grade partial or full thickness rotator cuff tears
Locations
United States
Louisiana
Ochsner Medical Center - Kenner
RECRUITING
Kenner
Contact Information
Primary
Richard Hartman, MD
mhart1@lsuhsc.edu
(504) 412-1705
Backup
Ken Bode
ken.bode@ochsner.org
504-842-1936
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2029-08-31
Participants
Target number of participants: 90
Treatments
Active_comparator: Standard of Care Arm
Patients in this arm will receive standard therapy post-surgery and 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)
Experimental: Cold and Compression
Patients 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 \& compression therapy device provided by Sponsor)
Related Therapeutic Areas
Sponsors
Collaborators: BREG, Inc
Leads: Ochsner Health System