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Shoulder PainNCT06039345

Shoulder RFA Pilot Study

An observational study of Shoulder Pain and Rotator Cuff Injuries, run by University of Utah at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Shoulder Pain, Rotator Cuff Injuries
How many people
10 participants
Where
3 sitesUnited States
Study dates
7 Feb 2024to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • ≥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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Utah Farmington Health Center

    Farmington, Utah, 84025

  • University of Utah Orthopaedic Center

    Salt Lake City, Utah, 84108

  • University of Utah South Jordan Health Center

    South Jordan, Utah, 84009

Other trials in United States

About this study

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

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.

Read the 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.

Keywords
shoulder radiofrequency ablation
Medical subject headings
Shoulder Pain, Rotator Cuff Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1, 3, 6 and 12 months

Secondary outcomes (3)

  1. Myotomal strength at 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.

    Measured: 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

    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.

    Measured: 1, 3, 6 and 12 months after SRFA

  3. Patient Global Impression of Change (PGIC) at 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.

    Measured: 1, 3, 6 and 12 months after SRFA

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2023
  2. Study start7 Feb 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06039345
Sponsor's protocol ID
159158
Status last verified
Apr 2026
First submitted
29 Aug 2023
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Andersson HI, Ejlertsson G, Leden I, Rosenberg C. Chronic pain in a geographically defined general population: studies of differences in age, gender, social class, and pain localization. Clin J Pain. 1993 Sep;9(3):174-82. doi: 10.1097/00002508-199309000-00004.

    PubMed 8219517

  • Chard MD, Hazleman R, Hazleman BL, King RH, Reiss BB. Shoulder disorders in the elderly: a community survey. Arthritis Rheum. 1991 Jun;34(6):766-9. doi: 10.1002/art.1780340619.

    PubMed 2053923

  • Allander E. Prevalence, incidence, and remission rates of some common rheumatic diseases or syndromes. Scand J Rheumatol. 1974;3(3):145-53. doi: 10.3109/03009747409097141. No abstract available.

    PubMed 4428194

  • Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.

    PubMed 15163107

  • Virta L, Joranger P, Brox JI, Eriksson R. Costs of shoulder pain and resource use in primary health care: a cost-of-illness study in Sweden. BMC Musculoskelet Disord. 2012 Feb 10;13:17. doi: 10.1186/1471-2474-13-17.

    PubMed 22325050

  • Eckmann MS, Bickelhaupt B, Fehl J, Benfield JA, Curley J, Rahimi O, Nagpal AS. Cadaveric Study of the Articular Branches of the Shoulder Joint. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):564-570. doi: 10.1097/AAP.0000000000000652.

    PubMed 28786899

  • Eckmann MS, Johal J, Bickelhaupt B, McCormick Z, Abdallah RT, Menzies R, Soliman S, Nagpal AS. Terminal Sensory Articular Nerve Radiofrequency Ablation for the Treatment of Chronic Intractable Shoulder Pain: A Novel Technique and Case Series. Pain Med. 2020 Apr 1;21(4):868-871. doi: 10.1093/pm/pnz335. No abstract available.

    PubMed 31851366

  • Bohannon RW. Reference values for extremity muscle strength obtained by hand-held dynamometry from adults aged 20 to 79 years. Arch Phys Med Rehabil. 1997 Jan;78(1):26-32. doi: 10.1016/s0003-9993(97)90005-8.

    PubMed 9014953

  • Bohannon RW. Grip strength impairments among older adults receiving physical therapy in a home-care setting. Percept Mot Skills. 2010 Dec;111(3):761-4. doi: 10.2466/03.10.15.PMS.111.6.761-764.

    PubMed 21319615

  • Hayes K, Walton JR, Szomor ZL, Murrell GA. Reliability of 3 methods for assessing shoulder strength. J Shoulder Elbow Surg. 2002 Jan-Feb;11(1):33-9. doi: 10.1067/mse.2002.119852.

    PubMed 11845146

  • Kolber MJ, Beekhuizen K, Cheng MS, Fiebert IM. The reliability of hand-held dynamometry in measuring isometric strength of the shoulder internal and external rotator musculature using a stabilization device. Physiother Theory Pract. 2007 Mar-Apr;23(2):119-24. doi: 10.1080/09593980701213032.

    PubMed 17530541

  • Awatani T, Mori S, Shinohara J, Koshiba H, Nariai M, Tatsumi Y, Nagata A, Morikita I. Same-session and between-day intra-rater reliability of hand-held dynamometer measurements of isometric shoulder extensor strength. J Phys Ther Sci. 2016 Mar;28(3):936-9. doi: 10.1589/jpts.28.936. Epub 2016 Mar 31.

    PubMed 27134388

  • Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002 Nov-Dec;11(6):587-94. doi: 10.1067/mse.2002.127096.

    PubMed 12469084

  • Jones IA, Togashi R, Heckmann N, Vangsness CT Jr. Minimal clinically important difference (MCID) for patient-reported shoulder outcomes. J Shoulder Elbow Surg. 2020 Jul;29(7):1484-1492. doi: 10.1016/j.jse.2019.12.033. Epub 2020 Apr 3.

    PubMed 32249146

  • Conger A, Gililland J, Anderson L, Pelt CE, Peters C, McCormick ZL. Genicular Nerve Radiofrequency Ablation for the Treatment of Painful Knee Osteoarthritis: Current Evidence and Future Directions. Pain Med. 2021 Jul 25;22(Suppl 1):S20-S23. doi: 10.1093/pm/pnab129.

    PubMed 34308957

Questions about this trial

What is this clinical trial studying?

An observational study of Shoulder Pain and Rotator Cuff Injuries, run by University of Utah at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numerical Rating Scale (NRS) at 1, 3, 6 and 12 months after the SRFA (time frame: 1, 3, 6 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06039345, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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