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NCT Number: NCT07516327

Cold and Compression After Rotator Cuff Repair (RCR)

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.

Recruiting

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ochsner Medical Center - Kenner

Kenner, Louisiana, 70065, United States

Location status: Recruiting

Location contact

Ian Elliot, MD

SUB_INVESTIGATOR

Michael Hartman, MD

CONTACT

[email protected]

(504) 412-1705

Michael Hartman, MD

PRINCIPAL_INVESTIGATOR

Nicole Villemarette-Pittman, PhD

CONTACT

[email protected]

Nicole Villemarette-Pittman, PhD

SUB_INVESTIGATOR

Paul Phillips, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Erysipelas
  • 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
  • Chilblains
  • Cryoglobulinemia
  • Sickle cell anemia
  • Uncontrolled diabetes (physician discretion)
  • Hypersensitivity to cold

Treatment and study plan

SOC (Standard of care)

Other

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:

Cold and Compression

Device

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 outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ken Bode

CONTACT

[email protected]

504-842-1936

Richard Hartman, MD

CONTACT

[email protected]

(504) 412-1705

Sponsors and collaborators

Lead sponsor

Ochsner Health System

Other

Collaborators

  • BREG, Inc

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Apr 8, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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