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Active, Not Recruiting

NCT Number: NCT06039345

Shoulder RFA 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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