Comparison Between Platelet Rich Plasma and Corticosteroids for the Treatment of Rotator Cuff Tendinopathy

Summary

The goal of this clinical trial is to test if Plateth-rich plasma would provide improved pain relief and function in patients with rotator cuff tendinopathy compared to standard treatment of corticosterone injections. Researchers will compare a control group of patients treated with a corticosterone injection with a case group of patients treated with Plateth-rich plasma injection. The purpose of this study is to perform a double-blind randomized controlled trial, comparing PRP with corticosteroids to provide pain relief and improve function in patients with rotator cuff tendinopathy. The hypothesis of this study is that PRP would provide improved pain relief and function in patients with rotator cuff tendinopathy compared to standard treatment of CS injections.

Timeline

Start

2022-09-30

Primary completion

2023-08-01

Completion

2023-08-31

Publications

• Background Garving C, Jakob S, Bauer I, Nadjar R, Brunner UH. Impingement Syndrome of the Shoulder. Dtsch Arztebl Int. 2017 Nov 10;114(45):765-776. doi: 10.3238/arztebl.2017.0765.
• Background Rossi LA, Ranalletta M. Subacromial Decompression Is Not Beneficial for the Management of Rotator Cuff Disease. JBJS Rev. 2020 Jan;8(1):e0045. doi: 10.2106/JBJS.RVW.19.00045.
• Background Diercks R, Bron C, Dorrestijn O, Meskers C, Naber R, de Ruiter T, Willems J, Winters J, van der Woude HJ; Dutch Orthopaedic Association. Guideline for diagnosis and treatment of subacromial pain syndrome: a multidisciplinary review by the Dutch Orthopaedic Association. Acta Orthop. 2014 Jun;85(3):314-22. doi: 10.3109/17453674.2014.920991. Epub 2014 May 21.
• Background Gutierrez-Espinoza H, Araya-Quintanilla F, Cereceda-Muriel C, Alvarez-Bueno C, Martinez-Vizcaino V, Cavero-Redondo I. Effect of supervised physiotherapy versus home exercise program in patients with subacromial impingement syndrome: A systematic review and meta-analysis. Phys Ther Sport. 2020 Jan;41:34-42. doi: 10.1016/j.ptsp.2019.11.003. Epub 2019 Nov 6.
• Background Larsson R, Bernhardsson S, Nordeman L. Effects of eccentric exercise in patients with subacromial impingement syndrome: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2019 Oct 14;20(1):446. doi: 10.1186/s12891-019-2796-5.
• Background Takeno K, Glaviano NR, Norte GE, Ingersoll CD. Therapeutic Interventions for Scapular Kinematics and Disability in Patients With Subacromial Impingement: A Systematic Review. J Athl Train. 2019 Mar;54(3):283-295. doi: 10.4085/1062-6050-309-17. Epub 2019 Mar 4.
• Background Lin MT, Chiang CF, Wu CH, Huang YT, Tu YK, Wang TG. Comparative Effectiveness of Injection Therapies in Rotator Cuff Tendinopathy: A Systematic Review, Pairwise and Network Meta-analysis of Randomized Controlled Trials. Arch Phys Med Rehabil. 2019 Feb;100(2):336-349.e15. doi: 10.1016/j.apmr.2018.06.028. Epub 2018 Aug 2.
• Background Rossi LA, Molina Romoli AR, Bertona Altieri BA, Burgos Flor JA, Scordo WE, Elizondo CM. Does platelet-rich plasma decrease time to return to sports in acute muscle tear? A randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Oct;25(10):3319-3325. doi: 10.1007/s00167-016-4129-7. Epub 2016 Apr 16.
• Background Rossi LA, Piuzzi NS, Shapiro SA. Glenohumeral Osteoarthritis: The Role for Orthobiologic Therapies: Platelet-Rich Plasma and Cell Therapies. JBJS Rev. 2020 Feb;8(2):e0075. doi: 10.2106/JBJS.RVW.19.00075.
• Background Rossi LA, Murray IR, Chu CR, Muschler GF, Rodeo SA, Piuzzi NS. Classification systems for platelet-rich plasma. Bone Joint J. 2019 Aug;101-B(8):891-896. doi: 10.1302/0301-620X.101B8.BJJ-2019-0037.R1.
• Background Zicaro JP, Yacuzzi C, Losino A, Costa Paz M. Use of Platelet Rich Plasma for the treatment of patellar tendinopathy. AATD Magazine Volume 25 - N°1 - 2018:30-34
• Background Nally FJ, Zanotti G, Buttaro MA, Diaz Dilernia F, Mansilla IG, Comba FM, Piccaluga F. THA conversion rate comparing decompression alone, with autologous bone graft or stem cells in osteonecrosis. Hip Int. 2018 Mar;28(2):189-193. doi: 10.5301/hipint.5000552. Epub 2017 Sep 10.
• Background Murray IR, LaPrade RF, Musahl V, Geeslin AG, Zlotnicki JP, Mann BJ, Petrigliano FA. Biologic Treatments for Sports Injuries II Think Tank-Current Concepts, Future Research, and Barriers to Advancement, Part 2: Rotator Cuff. Orthop J Sports Med. 2016 Mar 31;4(3):2325967116636586. doi: 10.1177/2325967116636586. eCollection 2016 Mar.
• Background Wang D, Rodeo SA. Platelet-Rich Plasma in Orthopaedic Surgery: A Critical Analysis Review. JBJS Rev. 2017 Sep;5(9):e7. doi: 10.2106/JBJS.RVW.17.00024. No abstract available.
• Background Sadoghi P, Lohberger B, Aigner B, Kaltenegger H, Friesenbichler J, Wolf M, Sununu T, Leithner A, Vavken P. Effect of platelet-rich plasma on the biologic activity of the human rotator-cuff fibroblasts: A controlled in vitro study. J Orthop Res. 2013 Aug;31(8):1249-53. doi: 10.1002/jor.22360. Epub 2013 Apr 8.
• Background Hurley ET, Hannon CP, Pauzenberger L, Fat DL, Moran CJ, Mullett H. Nonoperative Treatment of Rotator Cuff Disease With Platelet-Rich Plasma: A Systematic Review of Randomized Controlled Trials. Arthroscopy. 2019 May;35(5):1584-1591. doi: 10.1016/j.arthro.2018.10.115. Epub 2019 Apr 15.
• Background Moraes VY, Lenza M, Tamaoki MJ, Faloppa F, Belloti JC. Platelet-rich therapies for musculoskeletal soft tissue injuries. Cochrane Database Syst Rev. 2014 Apr 29;2014(4):CD010071. doi: 10.1002/14651858.CD010071.pub3.
• 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.
• Background Constant CR, Gerber C, Emery RJ, Sojbjerg JO, Gohlke F, Boileau P. A review of the Constant score: modifications and guidelines for its use. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):355-61. doi: 10.1016/j.jse.2007.06.022. Epub 2008 Jan 22. No abstract available.
• Background Backhaus J, Junghanns K, Broocks A, Riemann D, Hohagen F. Test-retest reliability and validity of the Pittsburgh Sleep Quality Index in primary insomnia. J Psychosom Res. 2002 Sep;53(3):737-40. doi: 10.1016/s0022-3999(02)00330-6.
• Background Thigpen CA, Shaffer MA, Gaunt BW, Leggin BG, Williams GR, Wilcox RB 3rd. The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2016 Apr;25(4):521-35. doi: 10.1016/j.jse.2015.12.018.
• Background Tashjian RZ, Deloach J, Porucznik CA, Powell AP. Minimal clinically important differences (MCID) and patient acceptable symptomatic state (PASS) for visual analog scales (VAS) measuring pain in patients treated for rotator cuff disease. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):927-32. doi: 10.1016/j.jse.2009.03.021. Epub 2009 Jun 16.
• Background Senn S. Review of Fleiss, statistical methods for rates and proportions. Res Synth Methods. 2011 Sep;2(3):221-2. doi: 10.1002/jrsm.50. Epub 2011 Dec 14. No abstract available.

Drugs

Indications