Status:
RECRUITING
Shoulder RFA Pilot Study
Lead Sponsor:
University of Utah
Conditions:
Shoulder Pain
Rotator Cuff Injuries
Eligibility:
All Genders
50+ years
Brief 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...
Detailed 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 radiog...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
February 7 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06039345
Start Date
February 7 2024
End Date
February 1 2025
Last Update
June 7 2024
Active Locations (3)
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1
University of Utah Farmington Health Center
Farmington, Utah, United States, 84025
2
University of Utah Orthopaedic Center
Salt Lake City, Utah, United States, 84108
3
University of Utah South Jordan Health Center
South Jordan, Utah, United States, 84009