Shoulder RFA Pilot Study (NCT06039345) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Shoulder RFA Pilot Study
United States10 participantsStarted 2024-02-07
Plain-language 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.
Who can participate
Age range50 Years
SexALL
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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
✓. 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.