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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 35 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Standard of Care Arm 		Patients in this arm will receive standard therapy post-surgery and 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: 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:
Experimental
Cold and Compression 		Patients 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 & compression therapy device provided by Sponsor)
  • 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.

Recruiting Locations

Ochsner Medical Center - Kenner
Kenner, Louisiana 70065
Contact:
Michael Hartman, MD
(504) 412-1705
mhart1@lsuhsc.edu

More Details

Status
Recruiting
Sponsor
Ochsner Health System

Study Contact

Richard Hartman, MD
(504) 412-1705
mhart1@lsuhsc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.