RecruitingNCT06039345

Shoulder RFA Pilot Study

The Effectiveness of Shoulder Terminal Sensory Articular Nerve Radiofrequency Ablation for Non-surgical Refractory Shoulder Pain Due to Rotator Cuff Pathology and Osteoarthritis; A Prospective Pilot Study

Sponsor

University of Utah

Enrollment

10 participants

Start Date

Feb 7, 2024

Study Type

OBSERVATIONAL

Conditions

Shoulder Pain

Summary

Through this prospective, single-arm cohort pilot study, we plan to explore the safety and effectiveness of Shoulder Radiofrequency Ablation (SRFA) in patients with non-operative chronic shoulder pain due to shoulder osteoarthritis with or without rotator cuff tears.

Eligibility

Min Age: 50 Years

Inclusion Criteria7

≥50 years old capable of understanding and providing consent in English, and capable of complying with the outcome instruments used
≥3 months of shoulder pain refractory to conventional treatment (i.e., physiotherapy, medication, steroid injections)
Persistent shoulder pain ≥ 4/10 in intensity on a 7-day average
Shoulder pain refractory to conventional treatment (i.e., physical therapy, oral analgesics, steroid injection)
Prior consultation with a board-certified orthopedic shoulder surgeon, deemed a non-surgical candidate for the primary diagnosis of glenohumeral joint pain +/- rotator cuff pain
≥80% pain relief for at least 30 minutes after a single fluoroscopically-guided block of the sensory branches of the SN, AN, and LPN with 0.5 mL of lidocaine at each nerve
Scheduled for procedure of interest

Exclusion Criteria12

Infection
Allergy to any medication needed to participate in this study
Previous partial/total/reverse shoulder arthroplasty. Participants with a history of RTC repair will not be excluded.
Neurologic disorders including radiculopathy, connective tissue/inflammatory joint disease/widespread soft tissue pain disorder
Severe, uncontrolled psychiatric disorder requiring hospitalization within 6 months
Intraarticular or subacromial injection to the study shoulder within 3 months before C-SRFA
Uncontrolled bleeding diathesis
Pregnancy
Pacemaker, neurostimulator, or other implanted device potentially sensitive to RF energy
Active Worker's compensation claim, litigation, or other possible reason for secondary gain.
Prior shoulder radiofrequency ablation
Daily opioid use