Exploring Shoulder Radiofrequency Ablation for Chronic Pain
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
This study is testing whether Shoulder Radiofrequency Ablation can help people with chronic shoulder pain from osteoarthritis or rotator cuff injuries who can't have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Locations | 3 sites (Farmington, Utah and 2 other locations) |
| Trial ID | NCT06039345 on ClinicalTrials.gov |
What this trial studies
This observational pilot study aims to assess the safety and effectiveness of Shoulder Radiofrequency Ablation (SRFA) in patients suffering from chronic shoulder pain due to osteoarthritis and/or rotator cuff injuries. It will involve a single-arm cohort of patients who are non-surgical candidates, following a standardized selection and treatment protocol. The study seeks to fill a knowledge gap regarding SRFA as a potential treatment option for individuals who have not responded to conventional therapies. By evaluating outcomes, the research hopes to provide insights into a viable alternative for managing shoulder pain in this population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older with chronic shoulder pain refractory to conventional treatments and deemed non-surgical candidates.
Not a fit: Patients with infections, allergies to necessary medications, or those who have previously undergone shoulder surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new, effective treatment option for patients with chronic shoulder pain who are not candidates for surgery.
How similar studies have performed: While this approach is relatively novel, previous studies on radiofrequency ablation for pain management have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ≥50 years old capable of understanding and providing consent in English, and capable of complying with the outcome instruments used 2. ≥3 months of shoulder pain refractory to conventional treatment (i.e., physiotherapy, medication, steroid injections) 3. Persistent shoulder pain ≥ 4/10 in intensity on a 7-day average 4. Shoulder pain refractory to conventional treatment (i.e., physical therapy, oral analgesics, steroid injection) 5. 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 6. ≥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 7. Scheduled for procedure of interest Exclusion Criteria: 1. Infection 2. Allergy to any medication needed to participate in this study 3. Previous partial/total/reverse shoulder arthroplasty. Participants with a history of RTC repair will not be excluded. 4. Neurologic disorders including radiculopathy, connective tissue/inflammatory joint disease/widespread soft tissue pain disorder 5. Severe, uncontrolled psychiatric disorder requiring hospitalization within 6 months 6. Intraarticular or subacromial injection to the study shoulder within 3 months before C-SRFA 7. Uncontrolled bleeding diathesis 8. Pregnancy 9. Pacemaker, neurostimulator, or other implanted device potentially sensitive to RF energy 10. Active Worker's compensation claim, litigation, or other possible reason for secondary gain. 11. Prior shoulder radiofrequency ablation 12. Daily opioid use
Where this trial is running
Farmington, Utah and 2 other locations
- University of Utah Farmington Health Center — Farmington, Utah, United States (Recruiting)
- University of Utah Orthopaedic Center — Salt Lake City, Utah, United States (Recruiting)
- University of Utah South Jordan Health Center — South Jordan, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Amanda Cooper, PhD
- Email: amanda.cooper@utah.edu
- Phone: 985-516-2225
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.