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.
Study Type
OBSERVATIONAL
Enrollment
10
University of Utah Farmington Health Center
Farmington, Utah, United States
RECRUITINGUniversity of Utah Orthopaedic Center
Salt Lake City, Utah, United States
RECRUITINGUniversity of Utah South Jordan Health Center
South Jordan, Utah, United States
RECRUITINGNumerical 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
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