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Cold and Compression After Rotator Cuff Repair (RCR)

Cold and Compression After Rotator Cuff Repair (RCR)

Recruiting
35 years and older
All
Phase N/A

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Overview

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

Inclusion Criteria:

  1. Aged 35 yr or older
  2. Patient of Drs. Michael Hartman (PI), Ian Elliott, Jay French, or Paul Phillips at Ochsner Kenner scheduled for arthroscopic rotator cuff repair
  3. Will receive outpatient physical therapy at OTW Driftwood for the entire post-op rehabilitation period
  4. English speaking
  5. Diagnosis of high-grade partial or full thickness rotator cuff tears

Exclusion Criteria:

  1. Chronic opioid use
  2. Opioid use within the last 3 months
  3. Diagnosis of inflammatory disease process (i.e., gout, rheumatoid arthritis, systematic lupus erythematosus...)
  4. Discharge to skilled nursing
  5. Cold intolerance related to diseases, like Raynaud's
  6. Significant vascular impairment in the affected region
  7. Current clinical signs of inflammatory phlebitis, venous ulcers, or cellulitis
  8. 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)
  9. 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).
  10. Uncontrolled hypertension (physician discretion), cardiac failure, extreme low blood pressure, or decompensated cardiac insufficiency.
  11. Localized unstable skin condition (e.g., dermatitis, vein ligation, gangrene, or recent skin graft) in the affected region.
  12. Had recent toe surgery in the affected region
  13. 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).
  14. An acute, unstable (untreated) fracture in the affected region.
  15. Any active local or systemic infection.
  16. Obtunded or with diabetes mellitus, multiple sclerosis, poor circulation, spinal cord injuries, and rheumatoid arthritis
  17. 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.
  18. Presumptive evidence of congestive heart failure
  19. Pre-existing DVT condition
  20. Deep acute venal thrombosis (Phlebothrombosis)
  21. Episodes of pulmonary embolism
  22. Pulmonary edema
  23. Acute inflammation of the veins (Thrombophlebitis)
  24. Decompensated cardiac insufficiency
  25. Arterial dysregulation
  26. Erysipelas
  27. Carcinoma and carcinoma metastasis in the affected extremity
  28. Decompensated hypertonia
  29. Acute inflammatory skin diseases or infection
  30. Venous or arterial occlusive disease
  31. Medical situations where increased venous or lymphatic return is undesirable
  32. Poor peripheral circulation
  33. Severe arteriosclerosis, or active infection
  34. Known hematological dyscrasias that predispose to thrombosis (e.g., paroxysmal cold hemoglobinuria, cryoglobulinemia, sicklecell disease, serum cold agglutinins).
  35. Tissues inflamed as a result of recent injury or exacerbation of chronic inflammatory condition.
  36. Compromised local circulation or neurologic impairment (including paralysis or localized compromise due to multiple surgical procedures or diabetes) in the affected region.
  37. Cognition or communication impairments that prevent them from giving accurate and timely feedback.
  38. Cold allergy
  39. Cold agglutinin disorders like paroxysmal cold hemoglobinuria
  40. Buerger's disease
  41. Chilblains
  42. Cryoglobulinemia
  43. Sickle cell anemia
  44. Uncontrolled diabetes (physician discretion)
  45. Hypersensitivity to cold

Study details
    High-grade Partial or Full Thickness Rotator Cuff Tears

NCT07516327

Ochsner Health System

13 May 2026

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