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| ID | Type | Description | Link |
|---|---|---|---|
| HSS 2015-189 |
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Tendinopathy is a clinical syndrome of chronic pain and tendon degeneration that impairs a person's ability to perform daily activities and recreation. Traditional conservative treatments include activity modification, exercises, ice/heat, and medications and corticosteroid injection. A newer treatment is percutaneous needle tenotomy (PNT), in which the affected area is repetitively needled to disrupt pathological tissue and induce bleeding. This turns a nonhealing chronic injury into an acute injury with enhanced healing capability. Another is Platelet Rich Plasma (PRP), whereby patients' own platelets are injected into the affected area, also activating growth factors. There has been promising research in these tendinopathy treatments but more research is needed.
The investigators plan to expand on prior studies to identify a reproducible and efficacious treatment for chronic tendinopathy to reduce pain and improve function and quality of life. Our goal in this study is to assess the efficacy of ultrasound guided (USG) PNT versus PNT with peritendinous PRP as a treatment for chronic tendinopathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PNT + PRP | Active Comparator | percutaneous needle tenotomy with peritendinous platelet-rich plasma injection |
|
| PNT alone | Active Comparator | percutaneous needle tenotomy alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PNT + PRP | Procedure | The PNT + PRP group will undergo needle tenotomy under direct and continuous ultrasound guidance with even distribution of PRP into the peritendinous area(s) of PNT around the affected tendon. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in pain based on a visual analog score | Week 2 | |
| Improvement in pain based on a visual analog score | Week 4 | |
| Improvement in pain based on a visual analog score | Week 6 | |
| Improvement in pain based on a visual analog score | Week 8 | |
| Improvement in pain based on a visual analog score | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Activity Level | Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage. | Week 2 |
| Activity Level | Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage. |
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Inclusion Criteria:
Exclusion Criteria:
taking coumadin or other anti-coagulant or anti-platelet medication
known coagulopathy or bleeding dyscrasia
current or recent fluoroquinolone prescription
prior PNT or PRP for the affected tendon(s)
known systemic illness such as vasculitis, an autoimmune or an inflammatory disease, or uncontrolled diabetes
presence of other musculoskeletal injury or tendon rupture in the region
currently are or plan to become pregnant during the study.
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Kirschner, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States | ||
| Department of Rehabilitation Medicine, Icahn School of Medicine at Mount Sinai |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24149868 | Background | Kaux JF, Forthomme B, Goff CL, Crielaard JM, Croisier JL. Current opinions on tendinopathy. J Sports Sci Med. 2011 Jun 1;10(2):238-53. | |
| 16934204 | Background | Scott A, Ashe MC. Common tendinopathies in the upper and lower extremities. Curr Sports Med Rep. 2006 Sep;5(5):233-41. doi: 10.1097/01.csmr.0000306421.85919.9c. |
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| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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|
| PNT alone | Procedure | The PNT group will undergo needle tenotomy under direct and continuous ultrasound guidance local anesthesia into the affected tendon. 10 minutes after the injection, the ultrasound machine probe will be passed over the areas treated both to evaluate for any structural changes and for any complications. |
|
|
| Week 4 |
| Activity Level | Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage. | Week 6 |
| Activity Level | Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage. | Week 8 |
| Activity Level | Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage. | Week 12 |
| Complications | bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke | Week 2 |
| Complications | bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke | Weeks 4 |
| Complications | bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke | Weeks 6 |
| Complications | bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke | Weeks 8 |
| Complications | bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke | Weeks 12 |
| New York |
| New York |
| 10029 |
| United States |
| 18294189 | Background | Fredberg U, Stengaard-Pedersen K. Chronic tendinopathy tissue pathology, pain mechanisms, and etiology with a special focus on inflammation. Scand J Med Sci Sports. 2008 Feb;18(1):3-15. doi: 10.1111/j.1600-0838.2007.00746.x. |
| 14977675 | Background | Struijs PA, Kerkhoffs GM, Assendelft WJ, Van Dijk CN. Conservative treatment of lateral epicondylitis: brace versus physical therapy or a combination of both-a randomized clinical trial. Am J Sports Med. 2004 Mar;32(2):462-9. doi: 10.1177/0095399703258714. |
| 20970844 | Background | Coombes BK, Bisset L, Vicenzino B. Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials. Lancet. 2010 Nov 20;376(9754):1751-67. doi: 10.1016/S0140-6736(10)61160-9. Epub 2010 Oct 21. |
| 18645071 | Background | McShane JM, Shah VN, Nazarian LN. Sonographically guided percutaneous needle tenotomy for treatment of common extensor tendinosis in the elbow: is a corticosteroid necessary? J Ultrasound Med. 2008 Aug;27(8):1137-44. doi: 10.7863/jum.2008.27.8.1137. |
| 16998100 | Background | McShane JM, Nazarian LN, Harwood MI. Sonographically guided percutaneous needle tenotomy for treatment of common extensor tendinosis in the elbow. J Ultrasound Med. 2006 Oct;25(10):1281-9. doi: 10.7863/jum.2006.25.10.1281. |
| 19710216 | Background | Housner JA, Jacobson JA, Misko R. Sonographically guided percutaneous needle tenotomy for the treatment of chronic tendinosis. J Ultrasound Med. 2009 Sep;28(9):1187-92. doi: 10.7863/jum.2009.28.9.1187. |
| 22341021 | Background | Skjong CC, Meininger AK, Ho SS. Tendinopathy treatment: where is the evidence? Clin Sports Med. 2012 Apr;31(2):329-50. doi: 10.1016/j.csm.2011.11.003. |
| 21048180 | Background | Maffulli N, Longo UG, Denaro V. Novel approaches for the management of tendinopathy. J Bone Joint Surg Am. 2010 Nov 3;92(15):2604-13. doi: 10.2106/JBJS.I.01744. |
| 12512406 | Background | Paavola M, Kannus P, Jarvinen TA, Jarvinen TL, Jozsa L, Jarvinen M. Treatment of tendon disorders. Is there a role for corticosteroid injection? Foot Ankle Clin. 2002 Sep;7(3):501-13. doi: 10.1016/s1083-7515(02)00056-6. |
| 16882889 | Background | Bahr R, Fossan B, Loken S, Engebretsen L. Surgical treatment compared with eccentric training for patellar tendinopathy (Jumper's Knee). A randomized, controlled trial. J Bone Joint Surg Am. 2006 Aug;88(8):1689-98. doi: 10.2106/JBJS.E.01181. |
| 21402369 | Background | Nguyen RT, Borg-Stein J, McInnis K. Applications of platelet-rich plasma in musculoskeletal and sports medicine: an evidence-based approach. PM R. 2011 Mar;3(3):226-50. doi: 10.1016/j.pmrj.2010.11.007. |
| 21872551 | Background | Finnoff JT, Fowler SP, Lai JK, Santrach PJ, Willis EA, Sayeed YA, Smith J. Treatment of chronic tendinopathy with ultrasound-guided needle tenotomy and platelet-rich plasma injection. PM R. 2011 Oct;3(10):900-11. doi: 10.1016/j.pmrj.2011.05.015. Epub 2011 Aug 26. |
| 20068208 | Background | de Vos RJ, Weir A, van Schie HT, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Tol JL. Platelet-rich plasma injection for chronic Achilles tendinopathy: a randomized controlled trial. JAMA. 2010 Jan 13;303(2):144-9. doi: 10.1001/jama.2009.1986. |
| 21602565 | Background | de Jonge S, de Vos RJ, Weir A, van Schie HT, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Tol JL. One-year follow-up of platelet-rich plasma treatment in chronic Achilles tendinopathy: a double-blind randomized placebo-controlled trial. Am J Sports Med. 2011 Aug;39(8):1623-9. doi: 10.1177/0363546511404877. Epub 2011 May 21. |
| 19641918 | Background | Filardo G, Kon E, Della Villa S, Vincentelli F, Fornasari PM, Marcacci M. Use of platelet-rich plasma for the treatment of refractory jumper's knee. Int Orthop. 2010 Aug;34(6):909-15. doi: 10.1007/s00264-009-0845-7. Epub 2009 Jul 31. |
| 19380129 | Background | Kon E, Filardo G, Delcogliano M, Presti ML, Russo A, Bondi A, Di Martino A, Cenacchi A, Fornasari PM, Marcacci M. Platelet-rich plasma: new clinical application: a pilot study for treatment of jumper's knee. Injury. 2009 Jun;40(6):598-603. doi: 10.1016/j.injury.2008.11.026. Epub 2009 Apr 19. |
| 14760802 | Background | Naredo E, Cabero F, Beneyto P, Cruz A, Mondejar B, Uson J, Palop MJ, Crespo M. A randomized comparative study of short term response to blind injection versus sonographic-guided injection of local corticosteroids in patients with painful shoulder. J Rheumatol. 2004 Feb;31(2):308-14. |
| 17464615 | Background | Rutten MJ, Maresch BJ, Jager GJ, de Waal Malefijt MC. Injection of the subacromial-subdeltoid bursa: blind or ultrasound-guided? Acta Orthop. 2007 Apr;78(2):254-7. doi: 10.1080/17453670710013762. |
| 21705157 | Background | Wolf JM, Ozer K, Scott F, Gordon MJ, Williams AE. Comparison of autologous blood, corticosteroid, and saline injection in the treatment of lateral epicondylitis: a prospective, randomized, controlled multicenter study. J Hand Surg Am. 2011 Aug;36(8):1269-72. doi: 10.1016/j.jhsa.2011.05.014. Epub 2011 Jun 25. |
| 21406450 | Background | Creaney L, Wallace A, Curtis M, Connell D. Growth factor-based therapies provide additional benefit beyond physical therapy in resistant elbow tendinopathy: a prospective, single-blind, randomised trial of autologous blood injections versus platelet-rich plasma injections. Br J Sports Med. 2011 Sep;45(12):966-71. doi: 10.1136/bjsm.2010.082503. Epub 2011 Mar 15. |
| 19481375 | Background | Kaux JF, Le Goff C, Seidel L, Peters P, Gothot A, Albert A, Crielaard JM. [Comparative study of five techniques of preparation of platelet-rich plasma]. Pathol Biol (Paris). 2011 Jun;59(3):157-60. doi: 10.1016/j.patbio.2009.04.007. Epub 2009 May 28. French. |
| 12037247 | Background | Koh ES, Williams AJ, Povlsen B. Upper-limb pain in long-term poliomyelitis. QJM. 2002 Jun;95(6):389-95. doi: 10.1093/qjmed/95.6.389. |
| 33644963 | Derived | Kirschner JS, Cheng J, Hurwitz N, Santiago K, Lin E, Beatty N, Kingsbury D, Wendel I, Milani C. Ultrasound-guided percutaneous needle tenotomy (PNT) alone versus PNT plus platelet-rich plasma injection for the treatment of chronic tendinosis: A randomized controlled trial. PM R. 2021 Dec;13(12):1340-1349. doi: 10.1002/pmrj.12583. Epub 2021 Apr 28. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |