An observational study in Shoulder Pain and Rotator Cuff Injuries, sponsored by University of Utah. Active, not recruiting at 3 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by University of Utah · Observational
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.
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.
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's planned enrollment of 10 is below the median of 82 across 130 observational studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
We will explore the effectiveness of SRFA to reduce chronic shoulder pain in 10 participants who were deemed non-surgical candidates by an orthopedic surgeon and who experienced ≥80% pain relief after a single shoulder joint anesthetic block.
Exclusion Criteria:
Numerical Rating Scale (NRS) at 1, 3, 6 and 12 months after the SRFA
Pain reduction will be measured by calculating the proportion of participants who experienced ≥50% reduction of their shoulder pain on the Numerical Rating Scale (NRS) at 1, 3, 6 and 12 months after the SRFA.
Time frame: 1, 3, 6 and 12 months
Myotomal strength at 1, 3, 6 and 12 months after SRFA
We will calculate the proportion of participants who experience a minimal clinically important difference (MCID) in shoulder abduction, elbow flexion, wrist extension, elbow extension and hand grip measured by dynamometer after SRFA. We will do this by calculating the proportion of participants who experience ≥20% change (MCID) in myotomal strength at 1, 3, 6 and 12 months after SRFA.
Time frame: 1, 3, 6 and 12 months after SRFA
American Shoulder and Elbow Surgeons Score (ASES) at 1,3, 6 and 12 months after SRFA
We will use the validated American Shoulder and Elbow Surgeons Score (ASES) questionnaire to calculate the proportion of participants who experience an MCID on ASES (defined as a score of ≥ 7) at 1,3, 6 and 12 months after SRFA.
Time frame: 1, 3, 6 and 12 months after SRFA
Patient Global Impression of Change (PGIC) at 1,3, 6 and 12 months after SRFA
We will use the validated Patient Global Impression of Change (PGIC) questionnaire to calculate the proportion of participants who experience an MCID on PGIC (defined as a score of ≥ 5) at 1,3, 6 and 12 months after SRFA.
Time frame: 1, 3, 6 and 12 months after SRFA
Plan to share: No
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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University of Utah