Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
10 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-02-07
Study Completion Date
2025-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Shoulder Pain
Rotator Cuff Injuries
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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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
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
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
Minimum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Utah
OTHER
Sponsor Role
lead
Responsible Party
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Allison Glinka Przybysz
Assistant Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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University of Utah Farmington Health Center
Farmington, Utah, United States
Site Status
RECRUITING
University of Utah Orthopaedic Center
Salt Lake City, Utah, United States
Site Status
RECRUITING
University of Utah South Jordan Health Center
South Jordan, Utah, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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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.
Reference Type
BACKGROUND
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.
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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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Conger A, Cushman DM, Walker K, Petersen R, Walega DR, Kendall R, McCormick ZL. A Novel Technical Protocol for Improved Capture of the Genicular Nerves by Radiofrequency Ablation. Pain Med. 2019 Nov 1;20(11):2208-2212. doi: 10.1093/pm/pnz124.
Reference Type
BACKGROUND
Koshi E, Cheney CW, Sperry BP, Conger A, McCormick ZL. Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain Using a Three-Tined Electrode: A Technical Description and Case Series. Pain Med. 2020 Dec 25;21(12):3344-3349. doi: 10.1093/pm/pnaa204.
Reference Type
BACKGROUND
McCormick ZL, Cohen SP, Walega DR, Kohan L. Technical considerations for genicular nerve radiofrequency ablation: optimizing outcomes. Reg Anesth Pain Med. 2021 Jun;46(6):518-523. doi: 10.1136/rapm-2020-102117. Epub 2021 Jan 22.
Reference Type
BACKGROUND
McCormick ZL, Reddy R, Korn M, Dayanim D, Syed RH, Bhave M, Zhukalin M, Choxi S, Ebrahimi A, Kendall MC, McCarthy RJ, Khan D, Nagpal G, Bouffard K, Walega DR. A Prospective Randomized Trial of Prognostic Genicular Nerve Blocks to Determine the Predictive Value for the Outcome of Cooled Radiofrequency Ablation for Chronic Knee Pain Due to Osteoarthritis. Pain Med. 2018 Aug 1;19(8):1628-1638. doi: 10.1093/pm/pnx286.
Reference Type
BACKGROUND
Roberts SL, Stout A, Dreyfuss P. Review of Knee Joint Innervation: Implications for Diagnostic Blocks and Radiofrequency Ablation. Pain Med. 2020 May 1;21(5):922-938. doi: 10.1093/pm/pnz189.
Reference Type
BACKGROUND
Tran A, Reiter DA, Fritz J, Cruz AR, Reimer NB, Lamplot JD, Gonzalez FM. Pilot study for treatment of symptomatic shoulder arthritis utilizing cooled radiofrequency ablation: a novel technique. Skeletal Radiol. 2022 Aug;51(8):1563-1570. doi: 10.1007/s00256-022-03993-y. Epub 2022 Jan 14.
Reference Type
BACKGROUND
Eckmann MS, McCormick ZL, Beal C, Julia J, Cheney CW, Nagpal AS. Putting Our Shoulder to the Wheel: Current Understanding and Gaps in Nerve Ablation for Chronic Shoulder Pain. Pain Med. 2021 Jul 25;22(Suppl 1):S2-S8. doi: 10.1093/pm/pnab152.
Reference Type
BACKGROUND
Bogduk N. On diagnostic blocks for lumbar zygapophysial joint pain. F1000 Med Rep. 2010 Aug 9;2:57. doi: 10.3410/M2-57.
Reference Type
BACKGROUND
Schneider BJ, Joshi M, Ehsanian R, McCormick ZL, Patel J, Zheng P, Nagpal AS. Patient-perceived duration of effect of lidocaine and bupivacaine following diagnostic medial branch blocks; a multicenter study. Interv Pain Med. 2022 Mar 18;1(2):100083. doi: 10.1016/j.inpm.2022.100083. eCollection 2022 Jun.
Reference Type
BACKGROUND
Kohn MD, Sassoon AA, Fernando ND. Classifications in Brief: Kellgren-Lawrence Classification of Osteoarthritis. Clin Orthop Relat Res. 2016 Aug;474(8):1886-93. doi: 10.1007/s11999-016-4732-4. Epub 2016 Feb 12. No abstract available.
Reference Type
BACKGROUND
Diagnosis and treatment of incomplete rotator cuff tears - PubMed. Accessed June 22, 2022. https://pubmed.ncbi.nlm.nih.gov/2182260/
Reference Type
BACKGROUND
Other Identifiers
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159158
Identifier Type: -
Identifier Source: org_study_id
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