Cryoneurolysis for Shoulder Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether cryoneurolysis, a treatment using cold to temporarily block a nerve, can reduce pain after reverse total shoulder replacement surgery. The goal is to determine if this treatment can lower pain and decrease the need for opioid medications post-surgery. Participants will be divided into two groups: one receiving cryoneurolysis and the other not, for comparison. Individuals with shoulder osteoarthritis scheduled for a reverse total shoulder replacement may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative pain management research.
Do I have to stop taking my current medications for the trial?
The trial requires stopping certain medications, like significant anti-coagulation drugs (except aspirin) 7 days before treatment and any supplemental pain control methods like cannabidiol 30 days before surgery. Other medications are not specifically mentioned, so it's best to discuss with the study team.
What prior data suggests that cryoneurolysis is safe for reducing pain after shoulder surgery?
Research has shown that cryoneurolysis is generally well-tolerated by patients. This treatment uses cold to temporarily block a nerve, reducing pain. Studies have found that patients often experience pain relief with cryoneurolysis and may require fewer opioid painkillers. Importantly, movement usually returns fully after two to three weeks. Some patients might experience temporary muscle weakness, typically lasting about 14 to 18 days. Overall, evidence suggests that cryoneurolysis is a safe option for managing pain with manageable side effects.12345
Why are researchers excited about this trial?
Researchers are excited about cryoneurolysis for shoulder osteoarthritis because it offers a unique approach to pain management. Unlike traditional treatments like physical therapy, pain relievers, or corticosteroid injections, cryoneurolysis targets the suprascapular nerve directly by freezing it, which can help block pain signals more effectively. This targeted technique could potentially provide faster and longer-lasting relief from shoulder pain without the need for ongoing medication. As a result, it might offer an innovative alternative for those who haven't found success with existing treatments.
What evidence suggests that cryoneurolysis might be an effective treatment for shoulder osteoarthritis?
Research has shown that cryoneurolysis effectively reduces pain and improves shoulder movement. This treatment uses cold to temporarily block nerves, relieving pain. One study found that it improved shoulder movement and reduced muscle tightness. Patients experienced less pain and reported greater satisfaction with their treatment. Another review found that cryoneurolysis provided long-term pain relief and reduced the need for opioid pain medications. In this trial, participants in the intervention arm will receive cryoneurolysis of the suprascapular nerve before RTSA, while those in the control arm will not receive this treatment. This evidence suggests that cryoneurolysis could be a promising option for managing pain after shoulder surgery.12367
Who Is on the Research Team?
Mohammad U Burney, MD
Principal Investigator
North Texas Medical Research Institute, PLLC
Are You a Good Fit for This Trial?
This trial is for individuals undergoing reverse total shoulder replacement surgery who are looking to manage postoperative pain. It's not specified who can't join, but typically those with conditions affecting the nerves or skin near the treatment site, or allergies to related procedures might be excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Treatment
Cryoneurolysis of the suprascapular nerve is performed pre-operatively for patients undergoing reverse total shoulder arthroplasty
Post-operative Monitoring
Participants are monitored for opioid usage, pain scores, range of motion, and patient-reported outcomes for 90 days post-surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cryoneurolysis
Find a Clinic Near You
Who Is Running the Clinical Trial?
North Texas Medical Research Institute, PLLC
Lead Sponsor
Pacira Pharmaceuticals, Inc
Industry Sponsor
Dr. Jonathan Slonin
Pacira Pharmaceuticals, Inc
Chief Medical Officer since 2020
BSc in Biomedical Engineering and MD from University of Miami, MBA from George Washington University
Frank D. Lee
Pacira Pharmaceuticals, Inc
Chief Executive Officer since 2024
BSc in Chemical Engineering from Vanderbilt University, MBA from Wharton Graduate School of Business