NCT07516327 · Ochsner Health System
Cold and Compression After Rotator Cuff Repair (RCR)
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
PROMIS Pain NRS subscale
Time frame: Enrollment to 6 months post RCR
Compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- Carcinoma and carcinoma metastasis in the affected extremity
- Decompensated hypertonia
- Acute inflammatory skin diseases or infection
- Venous or arterial occlusive disease
- Medical situations where increased venous or lymphatic return is undesirable
- Poor peripheral circulation
- Severe arteriosclerosis, or active infection
- Known hematological dyscrasias that predispose to thrombosis (e.g., paroxysmal cold hemoglobinuria, cryoglobulinemia, sicklecell disease, serum cold agglutinins).
- Tissues inflamed as a result of recent injury or exacerbation of chronic inflammatory condition.
- Compromised local circulation or neurologic impairment (including paralysis or localized compromise due to multiple surgical procedures or diabetes) in the affected region.
- Cognition or communication impairments that prevent them from giving accurate and timely feedback.
- Cold allergy
- Cold agglutinin disorders like paroxysmal cold hemoglobinuria
- Buerger's disease
- Cryoglobulinemia
- Sickle cell anemia
- Uncontrolled diabetes (physician discretion)
- Hypersensitivity to cold
Where
- Kenner, Louisiana
Collaborators
BREG, Inc
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 14, 2026 · Source of record for eligibility and locations