RECRUITING

Shoulder RFA Pilot Study

Conditions

Shoulder Pain Rotator Cuff Injuries shoulder radiofrequency ablation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-02-07

Study Completion:2025-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06039345

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.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Amanda Cooper, PhD

CONTACT

985-516-2225

amanda.cooper@utah.edu

Taylor Burnham, DO

CONTACT

801-587-5488

taylor.burnham@hsc.utah.edu

Study Locations (Sites)

University of Utah Farmington Health Center

Farmington, Utah, 84025

United States

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108

United States

University of Utah South Jordan Health Center

South Jordan, Utah, 84009

United States

Collaborators and Investigators

Sponsor: University of Utah

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 Registration Dates

Study Start Date2024-02-07

Study Completion Date2025-02

Study Record Updates

Study Start Date2024-02-07

Study Completion Date2025-02

Terms related to this study

Keywords Provided by Researchers

shoulder radiofrequency ablation

Additional Relevant MeSH Terms

Shoulder Pain
Rotator Cuff Injuries