Cold and Compression After Rotator Cuff Repair (RCR)

Official title

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

Overview

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

• 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:
• 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.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

• Aged 35 yr or older
• Patient of Drs. Michael Hartman (PI), Ian Elliott, Jay French, or Paul Phillips at Ochsner Kenner scheduled for arthroscopic rotator cuff repair
• Will receive outpatient physical therapy at OTW Driftwood for the entire post-op rehabilitation period
• English speaking
• Diagnosis of high-grade partial or full thickness rotator cuff tears

Exclusion criteria

• Chronic opioid use
• Opioid use within the last 3 months
• Diagnosis of inflammatory disease process (i.e., gout, rheumatoid arthritis, systematic lupus erythematosus...)
• Discharge to skilled nursing
• Cold intolerance related to diseases, like Raynaud's
• Significant vascular impairment in the affected region
• Current clinical signs of inflammatory phlebitis, venous ulcers, or cellulitis
• 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)
• 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).
• Uncontrolled hypertension (physician discretion), cardiac failure, extreme low blood pressure, or decompensated cardiac insufficiency.
• Localized unstable skin condition (e.g., dermatitis, vein ligation, gangrene, or recent skin graft) in the affected region.
• Had recent toe surgery in the affected region
• 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).
• An acute, unstable (untreated) fracture in the affected region.
• Any active local or systemic infection.
• Obtunded or with diabetes mellitus, multiple sclerosis, poor circulation, spinal cord injuries, and rheumatoid arthritis
• 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.
• Presumptive evidence of congestive heart failure
• Pre-existing DVT condition
• Deep acute venal thrombosis (Phlebothrombosis)
• Episodes of pulmonary embolism
• Pulmonary edema
• Acute inflammation of the veins (Thrombophlebitis)
• Decompensated cardiac insufficiency
• Arterial dysregulation
• Erysipelas
• Carcinoma and carcinoma metastasis in the affected extremity
• Decompensated hypertonia
• Acute inflammatory skin diseases or infection
• Venous or arterial occlusive disease
• Medical situations where increased venous or lymphatic return is undesirable
• Poor peripheral circulation
• Severe arteriosclerosis, or active infection
• Known hematological dyscrasias that predispose to thrombosis (e.g., paroxysmal cold hemoglobinuria, cryoglobulinemia, sicklecell disease, serum cold agglutinins).
• Tissues inflamed as a result of recent injury or exacerbation of chronic inflammatory condition.
• Compromised local circulation or neurologic impairment (including paralysis or localized compromise due to multiple surgical procedures or diabetes) in the affected region.
• Cognition or communication impairments that prevent them from giving accurate and timely feedback.
• Cold allergy
• Cold agglutinin disorders like paroxysmal cold hemoglobinuria
• Buerger's disease
• Chilblains
• Cryoglobulinemia
• Sickle cell anemia
• Uncontrolled diabetes (physician discretion)
• Hypersensitivity to cold

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Ochsner Medical Center - Kenner — Kenner

Publications

• Su EP, Perna M, Boettner F, Mayman DJ, Gerlinger T, Barsoum W, Randolph J, Lee G. 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 Nov;94(11 Suppl A):153-6. doi: 10.1302/0301-620X.94B11.30832. PMID 23118406
• Song M, Sun X, Tian X, Zhang X, Shi T, Sun R, Dai W. Compressive cryotherapy versus cryotherapy alone in patients undergoing knee surgery: a meta-analysis. Springerplus. 2016 Jul 13;5(1):1074. doi: 10.1186/s40064-016-2690-7. eCollection 2016. PMID 27462522
• 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 Sep;32(9):2788-2791. doi: 10.1016/j.arth.2017.03.052. Epub 2017 Mar 31. PMID 28465126
• 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 Feb 28;25(1):182. doi: 10.1186/s12891-024-07310-7. PMID 38419032
• Chughtai M, Sodhi N, Jawad M, Newman JM, Khlopas A, Bhave A, Mont MA. Cryotherapy Treatment After Unicompartmental and Total Knee Arthroplasty: A Review. J Arthroplasty. 2017 Dec;32(12):3822-3832. doi: 10.1016/j.arth.2017.07.016. Epub 2017 Jul 21. PMID 28802778
• 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. PMID 25825138
• 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. PMID 33512971
• 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. PMID 32876791

Identifiers

NCT: NCT07516327 · 2025.403

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗