NCT07125833

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

A Randomized Pilot Trial for Cryoneurolysis of the Suprascapular Nerve for Perioperative Pain Control After Receiving a Reverse Total Shoulder Arthroplasty

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: North Texas Medical Research Institute, PLLC · Academic / Other
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

Randomized controlled, pilot clinical trial to assess the administration of and feasibility for cyroneurolysis of the suprascapular nerve in the pre-operative setting for patients that will receive a reverse total shoulder arthroplasty (RTSA). Our primary research hypothesis is that patients who receive the intervention treatment of cryoneurolysis will experience decreased opioid usage compared to the control patient population. Primary: Assess the effectiveness and feasibility of cryoneurolysis of the suprascapular nerve performed pre-operatively for RTSA patients in reduction of the cumulative opioid consumption in the post-operative of 90 days as measured by morphine milligram equivalents (MMEs) compared to those patients who did not receive the intervention prior to a RTSA. Secondary: Assess the effectiveness of cryoneurolysis of the suprascapular nerve performed pre-operatively for RTSA patients to show: 1. a decreased pain score as measured by a Pain Assessment Documentation Tool (PADT) score 2. increased range of motion 3. increased patient reported outcome scores via the American Shoulder and Elbow Surgeons (ASES) shoulder score when compared to those that did not receive any intervention prior to a RTSA?

Conditions

• Degenerative Joint Disease of Shoulder

Interventions

Type	Name	Description
DEVICE	Cryoneurolysis	Cryoneurolysis of the suprascapular nerve
OTHER	No cryoneurolysis	Control Group

Timeline

• Start date: 2025-07-30
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2025-08-15
• Last updated: 2025-08-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study