Shoulder RFA Pilot Study

Recruiting

• Conditions: Shoulder Pain; Rotator Cuff Injuries

• Registration Number: NCT06039345
• Lead Sponsor: University of Utah

Brief 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.

Study Timeline

• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-15
• Study Start: 2024-02-07
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale (NRS) at 1, 3, 6 and 12 months after the SRFA	1, 3, 6 and 12 months	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.

Secondary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeons Score (ASES) at 1,3, 6 and 12 months after SRFA	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.
Myotomal strength at 1, 3, 6 and 12 months after SRFA	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.
Patient Global Impression of Change (PGIC) at 1,3, 6 and 12 months after SRFA	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.

Trial Locations

Locations (3)

University of Utah Farmington Health Center; 🇺🇸 Farmington, Utah, United States

University of Utah Orthopaedic Center; 🇺🇸 Salt Lake City, Utah, United States

University of Utah South Jordan Health Center; 🇺🇸 South Jordan, Utah, United States