Cold and compression for recovery after rotator cuff repair
Cold and Compression After Rotator Cuff Repair or Arthroscopic Rotator Cuff Repair Pain Attenuation: A Randomized, Controlled Trial
This will test whether using a cold-and-compression device after arthroscopic rotator cuff repair reduces post-surgical pain for adults 35 and older with high-grade partial or full-thickness tears.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | Ochsner Health System Academic / other |
| Locations | 1 site (Kenner, Louisiana) |
| Trial ID | NCT07516327 on ClinicalTrials.gov |
What this trial studies
This interventional study compares standard postoperative care to standard care plus a cold-and-compression device in adults undergoing arthroscopic repair for high-grade partial or full-thickness rotator cuff tears. Participants must be patients of specified Ochsner Kenner surgeons and complete outpatient physical therapy at OTW Driftwood. Pain is measured with the PROMIS NRS Pain Subscale preoperatively, daily for 14 days after surgery, weekly for three months, and again at six months. Key exclusions include recent or chronic opioid use, inflammatory disease, significant vascular problems, cold intolerance, or discharge to skilled nursing.
Who should consider this trial
Good fit: Adults aged 35 or older with a diagnosed high-grade partial or full-thickness rotator cuff tear scheduled for arthroscopic repair by one of the listed Ochsner surgeons and planning to attend OTW Driftwood physical therapy are the ideal candidates.
Not a fit: Patients with recent or chronic opioid use, inflammatory disorders, significant vascular impairment, cold intolerance, or those discharged to skilled nursing are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, the device could reduce early postoperative pain and decrease reliance on opioids while improving comfort during recovery.
How similar studies have performed: Previous studies of postoperative cryotherapy and compression after shoulder surgery have shown modest short-term pain reductions but mixed longer-term effects, so the approach has some supporting evidence but is not definitively established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kenner, Louisiana
- Ochsner Medical Center - Kenner — Kenner, Louisiana, United States (Recruiting)
Study contacts
- Principal investigator: Michael Hartman, MD — Ochsner Medical Center - Kenner
- Study coordinator: Richard Hartman, MD
- Email: mhart1@lsuhsc.edu
- Phone: (504) 412-1705
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.