Recruiting

Cold/Compression

Sponsor:

Ochsner Health System

Code:

NCT07516327

Conditions

High-grade Partial or Full Thickness Rotator Cuff Tears

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

Interventions

SOC (Standard of care)

Cold and Compression

Study Details

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.

Conditions

High-grade Partial or Full Thickness Rotator Cuff Tears

Study ID

NCT07516327

Start date

Mar 1, 2026

Status verified date

Apr, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

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

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

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)

Interventions

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:

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.

Primary outcome measure

  • PROMIS Pain NRS subscale [ Time Frame: Enrollment to 6 months post RCR ]

Central Contacts and Locations

Locations

Ochsner Medical Center - Kenner

Recruiting

Kenner, Louisiana, United States, 70065

Contacts

Nicole Villemarette-Pittman, PhD

nicole.villemarettepittman@ochsner.org

Principal Investigator:

Michael Hartman, MD

More Information

Sponsor

Ochsner Health System

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Keywords

  • Rotator Cuff
  • RCR
  • Cold Compression
  • Acute Pain
  • Post surgical pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ochsner Health System on 2026-04-14.