High-grade Partial or Full Thickness Rotator Cuff Tears
Conditions
Keywords
Rotator Cuff, RCR, Cold Compression, Acute Pain, Post surgical pain
Brief summary
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
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:
DEVICECold 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.
Sponsors
Ochsner Health System
BREG, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Pain NRS subscale | 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 |
Countries
United States
Contacts
CONTACTRichard Hartman, MD
CONTACTKen Bode
PRINCIPAL_INVESTIGATORMichael Hartman, MD
Ochsner Medical Center - Kenner
PRINCIPAL_INVESTIGATORPaul Phillips, MD
Ochsner Medical Center - Kenner
Outcome results
None listed