drugset / Trial / NCT03077009
Functional Improvement and UTC of the Achilles Tendon After Sodium Hyaluronate Injection for Plantaris Syndrome
NaSingle-groupOpen-labelTreatment
Summary
This is a study to assess the benefit of sodium hyaluronate (Ostenil) injection for plantaris friction syndrome (PFS) associated with midportion Achilles tendinopathy. Functional outcome scores will be recorded prior to treatment and at regular intervals up to 2 years. Changes in tendon structure will be assessed using ultrasonographic tissue characterisation (UTC). UTC will be performed prior to treatment and also at regular intervals up to 6 months following injection.
Timeline
- Start
- 2017-03-20
- Primary completion
- 2020-03-20
- Completion
- 2020-03-20
Publications
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- Background Bedi HS, Jowett C, Ristanis S, Docking S, Cook J. Plantaris Excision and Ventral Paratendinous Scraping for Achilles Tendinopathy in an Athletic Population. Foot Ankle Int. 2016 Apr;37(4):386-93. doi: 10.1177/1071100715619989. Epub 2015 Dec 4.
- Background van Schie HT, de Vos RJ, de Jonge S, Bakker EM, Heijboer MP, Verhaar JA, Tol JL, Weinans H. Ultrasonographic tissue characterisation of human Achilles tendons: quantification of tendon structure through a novel non-invasive approach. Br J Sports Med. 2010 Dec;44(16):1153-9. doi: 10.1136/bjsm.2009.061010. Epub 2009 Aug 6.
- Background Docking SI, Rosengarten SD, Cook J. Achilles tendon structure improves on UTC imaging over a 5-month pre-season in elite Australian football players. Scand J Med Sci Sports. 2016 May;26(5):557-63. doi: 10.1111/sms.12469. Epub 2015 May 5.
- Background Docking SI, Rosengarten SD, Daffy J, Cook J. Structural integrity is decreased in both Achilles tendons in people with unilateral Achilles tendinopathy. J Sci Med Sport. 2015 Jul;18(4):383-7. doi: 10.1016/j.jsams.2014.06.004. Epub 2014 Jun 20.
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- Background Pearce CJ, Carmichael J, Calder JD. Achilles tendinoscopy and plantaris tendon release and division in the treatment of non-insertional Achilles tendinopathy. Foot Ankle Surg. 2012 Jun;18(2):124-7. doi: 10.1016/j.fas.2011.04.008. Epub 2011 May 26.
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- Background Calder JD, Freeman R, Pollock N. Plantaris excision in the treatment of non-insertional Achilles tendinopathy in elite athletes. Br J Sports Med. 2015 Dec;49(23):1532-4. doi: 10.1136/bjsports-2014-093827. Epub 2014 Nov 13.
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- Background Robinson JM, Cook JL, Purdam C, Visentini PJ, Ross J, Maffulli N, Taunton JE, Khan KM; Victorian Institute Of Sport Tendon Study Group. The VISA-A questionnaire: a valid and reliable index of the clinical severity of Achilles tendinopathy. Br J Sports Med. 2001 Oct;35(5):335-41. doi: 10.1136/bjsm.35.5.335.
- Background Lintz F, Higgs A, Millett M, Barton T, Raghuvanshi M, Adams MA, Winson IG. The role of Plantaris Longus in Achilles tendinopathy: a biomechanical study. Foot Ankle Surg. 2011 Dec;17(4):252-5. doi: 10.1016/j.fas.2010.08.004. Epub 2010 Sep 15.
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- Background McAuliffe S, McCreesh K, Culloty F, Purtill H, O'Sullivan K. Can ultrasound imaging predict the development of Achilles and patellar tendinopathy? A systematic review and meta-analysis. Br J Sports Med. 2016 Dec;50(24):1516-1523. doi: 10.1136/bjsports-2016-096288. Epub 2016 Sep 15.
- 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.
- Background Alfredson H, Ohberg L. Sclerosing injections to areas of neo-vascularisation reduce pain in chronic Achilles tendinopathy: a double-blind randomised controlled trial. Knee Surg Sports Traumatol Arthrosc. 2005 May;13(4):338-44. doi: 10.1007/s00167-004-0585-6. Epub 2005 Feb 2.
- Background Chan O, O'Dowd D, Padhiar N, Morrissey D, King J, Jalan R, Maffulli N, Crisp T. High volume image guided injections in chronic Achilles tendinopathy. Disabil Rehabil. 2008;30(20-22):1697-708. doi: 10.1080/09638280701788225.
- Background Wheeler PC, Mahadevan D, Bhatt R, Bhatia M. A Comparison of Two Different High-Volume Image-Guided Injection Procedures for Patients With Chronic Noninsertional Achilles Tendinopathy: A Pragmatic Retrospective Cohort Study. J Foot Ankle Surg. 2016 Sep-Oct;55(5):976-9. doi: 10.1053/j.jfas.2016.04.017. Epub 2016 Jun 7.
- Background Alfredson H, Pietila T, Jonsson P, Lorentzon R. Heavy-load eccentric calf muscle training for the treatment of chronic Achilles tendinosis. Am J Sports Med. 1998 May-Jun;26(3):360-6. doi: 10.1177/03635465980260030301.
- Background Roche AJ, Calder JD. Achilles tendinopathy: A review of the current concepts of treatment. Bone Joint J. 2013 Oct;95-B(10):1299-307. doi: 10.1302/0301-620X.95B10.31881.
- Background Saxena A, Ramdath S Jr, O'Halloran P, Gerdesmeyer L, Gollwitzer H. Extra-corporeal pulsed-activated therapy ("EPAT" sound wave) for Achilles tendinopathy: a prospective study. J Foot Ankle Surg. 2011 May-Jun;50(3):315-9. doi: 10.1053/j.jfas.2011.01.003. Epub 2011 Mar 15.
- Background Lynen N, De Vroey T, Spiegel I, Van Ongeval F, Hendrickx NJ, Stassijns G. Comparison of Peritendinous Hyaluronan Injections Versus Extracorporeal Shock Wave Therapy in the Treatment of Painful Achilles' Tendinopathy: A Randomized Clinical Efficacy and Safety Study. Arch Phys Med Rehabil. 2017 Jan;98(1):64-71. doi: 10.1016/j.apmr.2016.08.470. Epub 2016 Sep 14.
- Results Daseler EH, Anson BJ. The Plantaris muscle an anatomical study of 750 specimens. J Bone Joint Surg [Am] 1943;25-A:822-827.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hyaluronic Acid | Other / unclassified | 2 ml | Other |
| Subject | Hyaluronic Acid | Other / unclassified | 3 ml | Other |