Shoulder RFA Pilot Study

Description

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

Study Overview

Study Details

Study overview

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.

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

Shoulder RFA Pilot Study

Condition
Shoulder Pain
Intervention / Treatment

-

Contacts and Locations

Farmington

University of Utah Farmington Health Center, Farmington, Utah, United States, 84025

Salt Lake City

University of Utah Orthopaedic Center, Salt Lake City, Utah, United States, 84108

South Jordan

University of Utah South Jordan Health Center, South Jordan, Utah, United States, 84009

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Utah,

Study Record Dates

2025-02