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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

High-grade Partial or Full Thickness Rotator Cuff TearsRotator CuffRCRCold CompressionAcute PainPost surgical pain

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

📊
1 of 90 participants interested
1% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Kenner

Louisiana

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for High-grade Partial or Full Thickness Rotator Cuff Tears Treatment in Kenner?

Join others in Louisiana exploring innovative treatment options through clinical research

High-grade Partial or Full Thickness Rotator Cuff Tears Treatment Options in Kenner, Louisiana

If you're searching for High-grade Partial or Full Thickness Rotator Cuff Tears treatment in Kenner, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Kenner and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with High-grade Partial or Full Thickness Rotator Cuff Tears. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Louisiana
Now Enrolling
Up to 90 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for High-grade Partial or Full Thickness Rotator Cuff Tears?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for High-grade Partial or Full Thickness Rotator Cuff Tears

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This High-grade Partial or Full Thickness Rotator Cuff Tears Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07516327. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.