Clinical trial NCT06039345: Shoulder RFA Pilot Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Shoulder Pain
Rotator Cuff Injuries
Keywords: shoulder radiofrequency ablation
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility 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

Primary outcomes:
measure: Numerical Rating Scale (NRS) at 1, 3, 6 and 12 months after the SRFA
timeFrame: 1, 3, 6 and 12 months
Secondary outcomes:
measure: Myotomal strength at 1, 3, 6 and 12 months after SRFA
timeFrame: 1, 3, 6 and 12 months after SRFA
measure: American Shoulder and Elbow Surgeons Score (ASES) at 1,3, 6 and 12 months after SRFA
timeFrame: 1, 3, 6 and 12 months after SRFA
measure: Patient Global Impression of Change (PGIC) at 1,3, 6 and 12 months after SRFA
timeFrame: 1, 3, 6 and 12 months after SRFA
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Utah Farmington Health Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Orthopaedic Center
state: Utah
city: South Jordan
country: United States
facility: University of Utah South Jordan Health Center
state: Utah
Study officials:
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