Cryoneurolysis of the suprascapular nerve to reduce pain after reverse total shoulder replacement
A Randomized Pilot Trial for Cryoneurolysis of the Suprascapular Nerve for Perioperative Pain Control After Receiving a Reverse Total Shoulder Arthroplasty
This will test whether using cold to temporarily block the suprascapular nerve before a reverse total shoulder replacement reduces pain and the need for opioid pain medicines in adults having the surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 30 Years to 85 Years |
| Sex | All |
| Sponsor | North Texas Medical Research Institute, PLLC Academic / other |
| Locations | 1 site (Rockwall, Texas) |
| Trial ID | NCT07125833 on ClinicalTrials.gov |
What this trial studies
This is a randomized, controlled pilot trial comparing preoperative cryoneurolysis of the suprascapular nerve to no cryoneurolysis in patients undergoing elective primary reverse total shoulder arthroplasty for osteoarthritis. Participants will be randomly assigned to receive the cryoneurolysis procedure before surgery or to a control group and will be followed for 90 days after surgery. The primary outcome is cumulative opioid consumption measured in morphine milligram equivalents (MMEs) over 90 days; secondary outcomes include pain scores (PADT), range of motion, and ASES shoulder scores. The trial is conducted at Orthopaedic Specialists of Dallas (Rockwall, Texas) with collaboration from Pacira Pharmaceuticals.
Who should consider this trial
Good fit: Adults aged 30–85 who are scheduled for an elective primary reverse total shoulder arthroplasty for osteoarthritis, have BMI ≤45, can consent and communicate in English, and are not pregnant are the intended participants.
Not a fit: Patients with contraindications to cryoneurolysis (for example cryoglobulinemia, cold urticaria, Raynaud's), poorly controlled comorbidities that preclude surgery, prior total joint infection, or those not undergoing RTSA are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the procedure could lower postoperative pain and reduce opioid use after reverse shoulder replacement.
How similar studies have performed: Small studies and case series have suggested cryoneurolysis can reduce shoulder pain and opioid use, but larger randomized data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Rockwall, Texas
- Orthopaedic Specialists of Dallas — Rockwall, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Mohammad U Burney, MD — North Texas Medical Research Institute, PLLC
- Study coordinator: Jeff Neumann, PA-C
- Email: jneumann@dallasortho.net
- Phone: 972-503-9495
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.