Cold and Compression After Rotator Cuff Repair (RCR)

Cold and Compression After Rotator Cuff Repair or Arthroscopic Rotator Cuff Repair Pain Attenuation: A Randomized, Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: High-grade Partial or Full Thickness Rotator Cuff Tears
• Intervention / Treatment: Device: Cold and Compression; Other: SOC (Standard of care)

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ken Bode; Phone Number: 504-842-1936; Email: ken.bode@ochsner.org
• Study Contact Backup: Name: Richard Hartman, MD; Phone Number: (504) 412-1705; Email: mhart1@lsuhsc.edu

Study Locations

• United States
  • Louisiana
    • Kenner, Louisiana, United States, 70065
      • Recruiting
      • Ochsner Medical Center - Kenner
      • Contact: Nicole Villemarette-Pittman, PhD; Email: nicole.villemarettepittman@ochsner.org
      • Sub-Investigator: Nicole Villemarette-Pittman, PhD
      • Contact: Michael Hartman, MD; Phone Number: (504) 412-1705; Email: mhart1@lsuhsc.edu
      • Principal Investigator: Michael Hartman, MD
      • Sub-Investigator: Paul Phillips, MD
      • Sub-Investigator: Ian Elliot, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Pain NRS subscale	Compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups	Enrollment to 6 months post RCR

Collaborators and Investigators

• Sponsor: Ochsner Health System
• Collaborators: BREG, Inc
• Investigators: Principal Investigator: Michael Hartman, MD, Ochsner Medical Center - Kenner; Principal Investigator: Paul Phillips, MD, Ochsner Medical Center - Kenner

Publications and helpful links

General Publications

• Uquillas CA, Capogna BM, Rossy WH, Mahure SA, Rokito AS. Postoperative pain control after arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2016 Jul;25(7):1204-13. doi: 10.1016/j.jse.2016.01.026. Epub 2016 Apr 11.
• Kraeutler MJ, Reynolds KA, Long C, McCarty EC. Compressive cryotherapy versus ice-a prospective, randomized study on postoperative pain in patients undergoing arthroscopic rotator cuff repair or subacromial decompression. J Shoulder Elbow Surg. 2015 Jun;24(6):854-9. doi: 10.1016/j.jse.2015.02.004. Epub 2015 Mar 29.
• Su EP, Perna M, Boettner F, et al. A prospective, multi-center, randomised trial to evaluate the efficacy of a cryopneumatic device on total knee arthroplasty recovery. J Bone Joint Surg Br. 2012; 94(11 Suppl A):153-6.
• Song M, Sun X, Tian X, et al. Compressive cryotherapy versus cryotherapy alone in patients undergoing knee surgery: a meta-analysis. Springerplus. 2016; 5(1):1074.
• Murgier J, Cailliez J, Wargny M, Chiron P, Cavaignac E, Laffosse JM. Cryotherapy with dynamic intermittent compression improves recovery from revision total knee arthroplasty. J Arthroplasty. 2017; 32(9):2788-91.
• Quesnot A, Mouchel S, Salah SB, Baranes I, Martinez L, Billuart F. Randomized controlled trial of compressive cryotherapy versus standard cryotherapy after total knee arthroplasty: pain, swelling, range of motion and functional recovery. BMC Musculoskelet Disord. 2024; 25(1):182.
• Chughtai M, Sodhi N, Jawad M, et al. Cryotherapy treatment after unicompartmental and total knee arthroplasty: A review. J Arthroplasty. 2017; 32(12):3822-32.
• Kunkle BF, Kothandaraman V, Goodloe JB, Curry EJ, Friedman RJ, Li X, Eichinger JK. Orthopaedic Application of Cryotherapy: A Comprehensive Review of the History, Basic Science, Methods, and Clinical Effectiveness. JBJS Rev. 2021 Jan 26;9(1):e20.00016. doi: 10.2106/JBJS.RVW.20.00016.
• Kara YS, Hapa O, Isin Y, Kilic AI, Havitcioglu H. A comparison of ice wrap and subacromial injection for postoperative pain and edema control following arthroscopic rotator cuff repair. J Orthop Traumatol. 2020 Sep 2;21(1):17. doi: 10.1186/s10195-020-00556-6.
• Tang H, Yang P, Wang X, Zhao B, Ling K. Assessment of the efficacy of early versus delayed mobility exercise after arthroscopic rotator cuff repair. Int Orthop. 2025 Jun;49(6):1411-1420. doi: 10.1007/s00264-025-06477-5. Epub 2025 Mar 7.
• Nicholson AD, Estrada JA, Mathew JI, Finocchiaro A, Pinnamaneni S, Okeke L, Dines DM, Dines JS, Taylor SA, Warren RF, Cordasco FA, Rodeo SA, Gulotta LV. Minimum 15-year follow-up for clinical outcomes of arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2022 Aug;31(8):1696-1703. doi: 10.1016/j.jse.2022.01.116. Epub 2022 Feb 11.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Rotator Cuff; Post surgical pain; Acute Pain; RCR; Cold Compression
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Acute Pain; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 2025.403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Currently there are no plans to share the data as there are no data sharing agreements in place with other institutions.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes