Shoulder RFA Pilot Study

April 6, 2026 updated by: Allison Glinka Przybysz, University of Utah

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Farmington, Utah, United States, 84025
        • University of Utah Farmington Health Center
      • Salt Lake City, Utah, United States, 84108
        • University of Utah Orthopaedic Center
      • South Jordan, Utah, United States, 84009
        • University of Utah South Jordan Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale (NRS) at 1, 3, 6 and 12 months after the SRFA
Time Frame: 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.
1, 3, 6 and 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

September 8, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 159158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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