Overview
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.
Description
This will be one of the first collaborative prospective, single-arm cohort using a standardized selection protocol and comprehensive SRFA protocol to treat chronic, refractory shoulder pain due radiographically confirmed glenohumeral joint OA with or without RTC pain, in patients deemed non-surgical candidates by a board-certified orthopedic shoulder surgeon. Upon completing the proposed research, we expect our contribution to fill the knowledge gap on whether SRFA is a potentially viable treatment option for this patient population. This contribution is expected to be substantial because SRFA may be a safe and effective treatment option for many people suffering shoulder pain and debility who are sub-optimal surgical candidates and have historically either been undertreated to have less than ideal treatments options, including opioid-based pain management in particular.
Eligibility
Inclusion Criteria:
- ≥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 Criteria:
- 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