Actively Recruiting
Cold and Compression After Rotator Cuff Repair (RCR)
Led by Ochsner Health System · Updated on 2026-04-14
90
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
Sponsors
O
Ochsner Health System
Lead Sponsor
B
BREG, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Cold and Compression After Rotator Cuff Repair (RCR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 35 years or older
- Scheduled for arthroscopic rotator cuff repair with study doctors at Ochsner Kenner
- Will receive outpatient physical therapy at OTW Driftwood throughout post-op rehabilitation
- English speaking
- Diagnosis of high-grade partial or full thickness rotator cuff tears
You will not qualify if you...
- Chronic opioid use
- Opioid use within the last 3 months
- Diagnosis of inflammatory diseases such as gout, rheumatoid arthritis, or systemic lupus erythematosus
- Discharge to skilled nursing facility
- Cold intolerance related to diseases like Raynaud's
- Significant vascular impairment in the affected area
- Signs of inflammatory phlebitis, venous ulcers, or cellulitis
- Risk factors or signs of embolism including pulmonary embolus or myocardial infarction
- Conditions where increased venous or lymphatic return is undesirable, such as lymphedema after breast cancer
- Uncontrolled hypertension, cardiac failure, low blood pressure, or decompensated cardiac insufficiency
- Localized unstable skin conditions like dermatitis or recent skin graft in the affected region
- Recent toe surgery in the affected area
- Signs of significant peripheral edema or acute unstable fracture in the affected area
- Any active local or systemic infection
- Conditions like diabetes mellitus, multiple sclerosis, poor circulation, spinal cord injuries, or rheumatoid arthritis
- Skin breakdown or damage causing uneven heat conduction; open wounds must be dressed before device use
- Presumptive congestive heart failure or pre-existing deep vein thrombosis
- Acute venous thrombosis, pulmonary embolism, pulmonary edema, or thrombophlebitis
- Arterial dysregulation, erysipelas, carcinoma or metastasis in the affected extremity
- Decompensated hypertonia or acute inflammatory skin diseases or infections
- Venous or arterial occlusive disease
- Medical situations where increased venous or lymphatic return is undesirable
- Poor peripheral circulation, severe arteriosclerosis, or active infection
- Known blood disorders predisposing to thrombosis such as paroxysmal cold hemoglobinuria or sickle cell disease
- Inflamed tissues from recent injury or chronic inflammation flare-ups
- Compromised local circulation or neurological impairment including paralysis
- Cognitive or communication impairments preventing accurate feedback
- Cold allergy or cold agglutinin disorders
- Buerger's disease, chilblains, cryoglobulinemia, sickle cell anemia
- Uncontrolled diabetes
- Hypersensitivity to cold or cold agglutinin disorders like paroxysmal cold hemoglobinuria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ochsner Medical Center - Kenner
Kenner, Louisiana, United States, 70065
Actively Recruiting
Research Team
R
Richard Hartman, MD
CONTACT
K
Ken Bode
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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