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Active Not RecruitingNCT06039345

Shoulder RFA Pilot Study

The Effectiveness of Shoulder Terminal Sensory Articular Nerve Radiofrequency Ablation for Non-surgical Refractory Shoulder Pain Due to Rotator Cuff Pathology and Osteoarthritis; A Prospective Pilot Study

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
10 (estimated)
Sponsor
University of Utah · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

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.

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 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.

Conditions

Timeline

Start date
2024-02-07
Primary completion
2026-12-01
Completion
2026-12-01
First posted
2023-09-15
Last updated
2026-04-13

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT06039345. Inclusion in this directory is not an endorsement.