Shoulder RFA Pilot Study

NCT06039345 | Active Not Recruiting DMC

• 1 other identifier: 159158
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Shoulder Pain; Rotator Cuff Injuries

Keywords

shoulder radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• Numerical 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.

  1, 3, 6 and 12 months

Secondary Outcomes (3)

• Myotomal strength at 1, 3, 6 and 12 months after SRFA

  1, 3, 6 and 12 months after SRFA

• American Shoulder and Elbow Surgeons Score (ASES) at 1,3, 6 and 12 months after SRFA

  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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥50 years old capable of understanding and providing consent in English, and capable of complying with the outcome instruments used
• ≥3 months of shoulder pain refractory to conventional treatment (i.e., physiotherapy, medication, steroid injections)
• Persistent shoulder pain ≥ 4/10 in intensity on a 7-day average
• Shoulder pain refractory to conventional treatment (i.e., physical therapy, oral analgesics, steroid injection)
• 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
• ≥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
• Scheduled for procedure of interest

You may not qualify if:

• Infection
• Allergy to any medication needed to participate in this study
• Previous partial/total/reverse shoulder arthroplasty. Participants with a history of RTC repair will not be excluded.
• Neurologic disorders including radiculopathy, connective tissue/inflammatory joint disease/widespread soft tissue pain disorder
• Severe, uncontrolled psychiatric disorder requiring hospitalization within 6 months
• Intraarticular or subacromial injection to the study shoulder within 3 months before C-SRFA
• Uncontrolled bleeding diathesis
• Pregnancy
• Pacemaker, neurostimulator, or other implanted device potentially sensitive to RF energy
• Active Worker's compensation claim, litigation, or other possible reason for secondary gain.
• Prior shoulder radiofrequency ablation
• Daily opioid use

Sponsors & Collaborators

• University of Utah: lead

Study Sites (3)

University of Utah Farmington Health Center

Farmington, Utah, 84025, United States

Location

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

University of Utah South Jordan Health Center

South Jordan, Utah, 84009, United States

Location

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  BACKGROUND

MeSH Terms

Conditions

Shoulder Pain; Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 15, 2023
• Study Start: February 7, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)