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Cryoneurolysis for Pain Control After Shoulder Replacement Surgery

This study is investigating whether a treatment called cryoneurolysis can help reduce pain after reverse total shoulder arthroplasty (RTSA) surgery. Cryoneurolysis uses cold to temporarily block a nerve in the shoulder. Researchers want to see if people who receive this treatment need less opioid pain medication after surgery compared to those who don't. You may be able to join if you are between 30 and 85 years old, have a BMI of 45 or less, and are scheduled for a primary reverse total shoulder replacement due to osteoarthritis. The study aims to enroll 20 participants and is currently unclear on its recruitment status.

Study design
This is a randomized controlled pilot study. It will compare 20 participants who receive cryoneurolysis to a control group who do not.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants' opioid use will be measured for 90 days after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07125833

Cryoneurolysis of the Suprascapular Nerve for Perioperative Pain Control After Receiving a Reverse Total Shoulder Arthroplasty (RTSA)

Recruiting
NAAges 30–85InterventionalTreatment
North Texas Medical Research Institute, PLLC
~20 participants
Updated 2025-08-15 on ClinicalTrials.gov
What's tested:CryoneurolysisNo cryoneurolysis

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The primary endpoint for the primary objective would be decreased opioid utilization in the post-operative period after a reverse total shoulder arthroplasty (RTSA) as measured by Morphine Milligram Equivalents (MME).
Measured over 90 days

Conditions

Degenerative Joint Disease of Shoulder

Explore related trials

Osteoarthritis

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Mohammad U Burney, MD · PRINCIPAL_INVESTIGATOR · North Texas Medical Research Institute, PLLC

Who to contact

Jeff Neumann, PA-C
[email protected]
972-503-9495
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male patients or female who are not pregnant and do not plan on future pregnancy during trial participation
between 30-85 years of age
BMI less than or equal to 45
Currently setup for an elective primary reverse total shoulder arthroplasty due to primary osteoarthritis
Ability to provide informed consent to participate in the clinical trial
Ability to understand and communicate in English
Willingness to comply with all study procedures

Exclusion

poorly controlled comorbidities that would not allow surgical intervention such as poorly controlled diabetes (HbA1C \> 8.0) renal insufficiency (eGFR \<60) poorly controlled CV disease such as CHF that is NYHA class 3 and 4
inability to receive the intervention including contraindications:
Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and open and/or infected wounds at or near the treatment site
patients with history of total joint infection ever or any infection in the last 6 months
ASA score \>3 and Outpatient Arthroplasty Risk Assessment (OARA; medical risk stratification scoring system to help determine day surgery vs inpatient)1 score \> 80.
previous cryoneurolysis of the suprascapular nerve-utilization of supplemental/holistic methods specifically for pain control (e.g. cannabidiol). This will be discontinued 30 days prior to RTSA and will not be used during the duration of study participation. This will be evaluated by the Principal Investigator and study team prior to consent.
significant anti-coagulation usage (other than aspirin) 7 days prior to treatment
CV surgery within the last 6 months
significant neurologic compromise (acquired or congenital/genetic) of the upper extremity to be operated on or underlying neurologic condition that would confound results in the opinion of the investigator such as a

What this trial measures

  • The primary endpoint for the primary objective would be decreased opioid utilization in the post-operative period after a reverse total shoulder arthroplasty (RTSA) as measured by Morphine Milligram Equivalents (MME).90 days

    Pain medication usage as recorded by MME. MME is calculated by multiplying the opioid dose (in mg) by a drug-specific conversion factor (e.g., oxycodone × 1.5, hydromorphone × 4, fentanyl patch mcg/hr × 2.4). In research and clinical practice, MME helps quantify total opioid burden, assess risk for overdose, and standardize analgesic reporting in clinical trials. Higher daily MMEs are associated with increased adverse event risk. This will be recorded at every clinical visit.