Cold and Compression After Rotator Cuff Repair (RCR)

Recruiting now · Not applicable

Conditions studied: High-grade Partial or Full Thickness Rotator Cuff Tears

In brief

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.

Key facts

Study ID

NCT07516327

Run by

Ochsner Health System

People needed

90

Starts

2026-03-01

Expected to finish

2029-08-31

Last updated by the study team

2026-04-14

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Chronic opioid use
• Opioid use within the last 3 months
• Diagnosis of inflammatory disease process (i.e., gout, rheumatoid arthritis, systematic lupus erythematosus...)
• Discharge to skilled nursing
• Cold intolerance related to diseases, like Raynaud's
• Significant vascular impairment in the affected region
• Current clinical signs of inflammatory phlebitis, venous ulcers, or cellulitis
• Significant risk factors or current clinical signs of embolism (e.g., pulmonary embolus, pulmonary edema, cerebral infarction, atrial fibrillation, endocarditis, myocardial infarction, or atheromatous embolic plaque)
• A condition in which increased venous or lymphatic return is not desired in the affected extremity (e.g., lymphedema after breast cancer or other local carcinoma and/or carcinoma metastasis in the affected extremity).
• Uncontrolled hypertension (physician discretion), cardiac failure, extreme low blood pressure, or decompensated cardiac insufficiency.
• Localized unstable skin condition (e.g., dermatitis, vein ligation, gangrene, or recent skin graft) in the affected region.
• Had recent toe surgery in the affected region
• Current clinical signs in the affected region of significant peripheral edema (e.g., deep vein thrombosis, chronic venous insufficiency, acute compartment syndrome, systemic venous hypertension, congestive heart failure, cirrhosis/liver failure, renal failure).
• An acute, unstable (untreated) fracture in the affected region.
• Any active local or systemic infection.
• Obtunded or with diabetes mellitus, multiple sclerosis, poor circulation, spinal cord injuries, and rheumatoid arthritis
• Areas of skin breakdown or damage (damaged or at-risk skin) producing uneven heat conduction across the skin (e.g., open wound, scar tissue, burn or skin graft). Any open wound must be dressed prior to use of the Polar Care Wave System.
• Presumptive evidence of congestive heart failure
• Pre-existing DVT condition
• Deep acute venal thrombosis (Phlebothrombosis)
• Episodes of pulmonary embolism
• Pulmonary edema
• Acute inflammation of the veins (Thrombophlebitis)
• Decompensated cardiac insufficiency
• Arterial dysregulation

Where it is running

• Ochsner Medical Center - Kenner — Kenner, Louisiana, United States (enrolling)

Full record on ClinicalTrials.gov

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