Shoulder RFA Pilot Study

Shoulder Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06039345
• Other study ID #: 159158
• Status: Recruiting
• Start date: September 2023
• Est. completion date: September 2024

Study information

• Verified date: September 2023
• Source: University of Utah
• Contact: Amanda Cooper, PhD
• Phone: 985-516-2225
• Email: amanda.cooper[@]utah.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Shoulder Pain

Locations

Country	Name	City	State
United States	University of Utah Farmington Health Center	Farmington	Utah
United States	University of Utah Orthopaedic Center	Salt Lake City	Utah
United States	University of Utah South Jordan Health Center	South Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (26)

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. — View Citation

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. — View Citation

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. — View Citation

Bogduk N. On diagnostic blocks for lumbar zygapophysial joint pain. F1000 Med Rep. 2010 Aug 9;2:57. doi: 10.3410/M2-57. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Classifications in Brief: Kellgren-Lawrence Classification of Osteoarthritis - PMC. Accessed June 22, 2022. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4925407/

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. — View Citation

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. — View Citation

Diagnosis and treatment of incomplete rotator cuff tears - PubMed. Accessed June 22, 2022. https://pubmed.ncbi.nlm.nih.gov/2182260/

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Schneider BJ, Joshi M, Ehsanian R, et al. Patient-perceived duration of effect of lidocaine and bupivacaine following diagnostic medial branch blocks; a multicenter study. Interventional Pain Medicine. 2022;1(2):100083. doi:10.1016/j.inpm.2022.100083

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. — View Citation

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. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1, 3, 6 and 12 months
Secondary	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.	1, 3, 6 and 12 months after SRFA
Secondary	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.	1, 3, 6 and 12 months after SRFA
Secondary	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.	1, 3, 6 and 12 months after SRFA