Nerve cooling for pain after reverse shoulder replacement surgery
Tests cryoneurolysis for pain after reverse shoulder replacement in people with shoulder joint degeneration.
Key facts
- Who runs it
- North Texas Medical Research Institute, PLLC
- Where
- Rockwall, United StatesSee the site
- Trial code
- Registry title
- Cryoneurolysis of the Suprascapular Nerve for Perioperative Pain Control After Receiving a Reverse Total Shoulder Arthroplasty (RTSA)
- Status
- Recruiting
- People taking part
- 20 people, planned
- Started
- 30 Jul 2025
- Planned end
- Aug 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Cryoneurolysis
- No cryoneurolysis
- Record updated
- 15 August 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults scheduled for a planned first reverse total shoulder replacement because of osteoarthritis. It tests whether freezing a shoulder nerve (cryoneurolysis) lowers pain and opioid use after surgery.
- Age
- 30 to 85 years
- Sex
- Men and women. Women cannot be pregnant or plan a pregnancy during the trial.
- Disease stage
- Primary osteoarthritis of the shoulder, with a planned (elective) first reverse total shoulder arthroplasty. BMI less than or equal to 45.
- Earlier treatment
- No earlier cryoneurolysis of the suprascapular nerve. Supplemental pain methods such as cannabidiol must stop 30 days before surgery.
Main reasons for not taking part
- Poorly controlled health problems, such as diabetes with HbA1C > 8.0, kidney problems with eGFR <60, or heart failure NYHA class 3 and 4
- Cold-related conditions (cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease) or open or infected wounds near the treatment site
- Any past joint replacement infection, or any infection in the last 6 months
- Significant blood thinner use (other than aspirin) 7 days before treatment, or heart surgery in the last 6 months
- ASA score >3 or OARA score > 80, or significant nerve problems in the arm to be operated on
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- 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
- 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:
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 85 years old?
Where in United States
- Orthopaedic Specialists of DallasRockwall, United StatesContact: Jeffery Neumann, PA-CTaking people
About the trial
What the trial wants to find out
The main purpose of this research is to find out if a treatment called cryoneurolysis can reduce pain after reverse total shoulder replacement surgery. This treatment uses cold to temporarily block a nerve in the shoulder. The study will compare people who receive the treatment to those who do not, to see if it helps lower pain and reduce the need for opioid pain medications after a reverse total shoulder surgery (RTSA).
The 2 groups in the trial
- ControlExisting treatment, for comparison
Those that do not receive cryoneurolysis of the suprascapular nerve prior to RTSA
Treatment: No cryoneurolysis
- InterventionTreatment being tested
Those that do receive cryoneurolysis of the suprascapular nerve prior to RTSA
Treatment: Cryoneurolysis
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Randomized Pilot Trial for Cryoneurolysis of the Suprascapular Nerve for Perioperative Pain Control After Receiving a Reverse Total Shoulder Arthroplasty
- Plain-language title
- Nerve cooling for pain after reverse shoulder replacement surgeryGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT07125833, who can take part
- Record updated
- 15 August 2025