Comparative study of treatment interventions for patellar tendinopathy: a protocol for a randomised controlled trial

Maria Pilar López-Royo, Eva Maria Gómez-Trullén, Maria Ortiz-Lucas, Rita Maria Galán-Díaz, Ana Vanessa Bataller-Cervero, Zaid Al-Boloushi, Yasmina Hamam-Alcober, Pablo Herrero, Maria Pilar López-Royo, Eva Maria Gómez-Trullén, Maria Ortiz-Lucas, Rita Maria Galán-Díaz, Ana Vanessa Bataller-Cervero, Zaid Al-Boloushi, Yasmina Hamam-Alcober, Pablo Herrero

Abstract

Introduction: Patellar tendinopathy is a degenerative disease of the patellar tendon, which affects athletes from a variety of sports, and is especially predominant in sports involving high-impact jumping. The aim of this study is to determine the additional effect of two interventions combined with eccentric exercise and compare which one is the most effective at short-term and long-term follow-up for patients with patellar tendinopathy.

Methods and analysis: This study is a randomised controlled trial with blinded participants. Measurements will be carried out by a specially trained blinded assessor. A sample of 57 patients with a medical diagnosis of patellar tendinopathy will participate in this study and will be divided into three treatment groups. Eligible participants will be randomly allocated to receive either: (a) treatment group with percutaneous needle electrolysis, (b) treatment group with dry needling or (c) treatment group with placebo needling. In addition, all groups will perform eccentric exercise. Functionality and muscle strength parameters, pain, ultrasound appearances and patient perceived quality of life shall be evaluated using the Victorian Institute of Sports Assessment for patellar (VISA-P), jump tests, Visual Analogue Scale, ultrasound images and Short Form-36 (SF-36), respectively. Participants will be assessed at baseline, at 10 weeks and at 22 weeks after baseline. The expected findings will allow us to advance in the treatment of this injury, as they will help determine whether a needling intervention has additional effects on an eccentric exercise programme and whether any of the needling modalities is more effective than the other.

Ethics and dissemination: This protocol has been approved by the Ethics Committee of Aragon (N° PI15/0017). The trial will be conducted in accordance with the Declaration of Helsinki.

Trial registration number: NCT02498795.

Keywords: dry needling; eccentric exercise; percutaneous needle electrolysis; tendinopathy.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flow diagram. Randomised controlled trial design. G-DN, dry needle group; G-PNE, percutaneous needle electrolysis group.
Figure 2
Figure 2
Schedule for the enrolment and intervention. Schedule for enrolment and intervention per cluster. G-DN, dry needle group; G-PNE, percutaneous needle electrolysis group; -t1, baseline; t1–t2, intervention period; T2, 8 weeks after baseline; t3, after baseline; T3, 10 weeks after baseline; t4, after baseline; T4, 3 months after baseline; US, ultrasound; VAS, Visual Analogue Scale.

References

    1. Knobloch K. The role of tendon microcirculation in Achilles and Patellar tendinopathy. J Orthop Surg Res 2008;3:18 10.1186/1749-799X-3-18
    1. Zwerver J, Bredeweg SW, van den Akker-Scheek I. Prevalence of jumper's knee among nonelite athletes from different sports: a cross-sectional survey. Am J Sports Med 2011;39:1984–8. 10.1177/0363546511413370
    1. Stenroth L, Sefa S, Arokoski J, et al. . Does magnetic resonance imaging provide superior reliability for Achilles and Patellar tendon cross-sectional area measurements compared with ultrasound imaging? Ultrasound Med Biol 2019;45:3186–98. 10.1016/j.ultrasmedbio.2019.08.001
    1. Taylor DW, Petrera M, Hendry M, et al. . A systematic review of the use of platelet-rich plasma in sports medicine as a new treatment for tendon and ligament injuries. Clin J Sport Med 2011;21:344–52. 10.1097/JSM.0b013e31821d0f65
    1. Andres BM, Murrell GAC. Treatment of tendinopathy: what works, what does not, and what is on the horizon. Clin Orthop Relat Res 2008;466:1539–54. 10.1007/s11999-008-0260-1
    1. Larsson MEH, Käll I, Nilsson-Helander K. Treatment of Patellar tendinopathy—a systematic review of randomized controlled trials. Knee Surg Sports Traumatol Arthrosc 2012;20:1632–46. 10.1007/s00167-011-1825-1
    1. Kongsgaard M, Kovanen V, Aagaard P, et al. . Corticosteroid injections, eccentric decline squat training and heavy slow resistance training in patellar tendinopathy. Scand J Med Sci Sports 2009;19:790–802. 10.1111/j.1600-0838.2009.00949.x
    1. Murtaugh B, Ihm JM. Eccentric training for the treatment of tendinopathies. Curr Sports Med Rep 2013;12:175–82. 10.1249/JSR.0b013e3182933761
    1. Young MA, Cook JL, Purdam CR. Eccentric decline squat protocol offers superior results at 12 months compared with traditional eccentric protocol for patellar tendinopathy in volleyball players. Br J Sports Med 2005;39:102–5. 10.1136/bjsm.2003.010587
    1. Ortega-Castillo M, Medina-Porqueres I. Effectiveness of the eccentric exercise therapy in physically active adults with symptomatic shoulder impingement or lateral epicondylar tendinopathy: a systematic review. J Sci Med Sport 2016;19:438–53. 10.1016/j.jsams.2015.06.007
    1. James SLJ, Ali K, Pocock C, et al. . Ultrasound guided dry needling and autologous blood injection for Patellar tendinosis * commentary. Br J Sports Med 2007;41:518–21. 10.1136/bjsm.2006.034686
    1. Abat FDW, Gelber PE, Polidori F, et al. . Effectiveness of the Intratissue percutaneous electrolysis (EPI®) technique and isoinertial eccentric exercise in the treatment of Patellar tendinopathy at two years follow-up. Muscles Ligaments Tendons J 2014;14:188–93.
    1. Valera Garrido F, Minaya Muñoz F, SI JM. Effectiveness of electrolysis percutaneous intratisular (EPI®) in chronic insertional Patellar tendinopathy. Muscles Ligaments Tendons J 2010;21:227–36.
    1. Sánchez-Ibáñez JM, Alves R, Polidori F, et al. . Effectiveness of ultrasound-guided percutaneous electrolysis intratendon (EpI) in the treatment of insertional Patellar tendinopathy in soccer players. Br J Sports Med 2013;47:e2.17–e2. 10.1136/bjsports-2013-092459.24
    1. Zwerver J, Verhagen E, Hartgens F, et al. . The TOPGAME-study: effectiveness of extracorporeal shockwave therapy in jumping athletes with Patellar tendinopathy. design of a randomised controlled trial. BMC Musculoskelet Disord 2010;11:6 10.1186/1471-2474-11-28
    1. Riggin CN, Chen M, Gordon JA, et al. . Ultrasound-Guided dry Needling of the healthy rat supraspinatus tendon elicits early healing without causing permanent damage. J Orthop Res 2019;37:2035–42. 10.1002/jor.24329
    1. Krey D, Borchers J, McCamey K. Tendon needling for treatment of tendinopathy: a systematic review. Phys Sportsmed 2015;43:80–6. 10.1080/00913847.2015.1004296
    1. Abat F, Valles S-L, Gelber P-E, et al. . An experimental study of muscular injury repair in a mouse model of notexin-induced lesion with EPI® technique. BMC Sports Sci Med Rehabil 2015;7:7 10.1186/s13102-015-0002-0
    1. Valera-Garrido F, Minaya-Muñoz F, Sánchez-Ibáñez JM, et al. . Comparison of the acute inflammatory response and proliferation of dry needling and electrolysis percutaneous intratissue (EpI) in healthy rat Achilles tendons. Br J Sports Med 2013;47:e2.52–e2. 10.1136/bjsports-2013-092459.56
    1. Alfredson H, Pietilä T, Jonsson P, et al. . Heavy-load eccentric calf muscle training for the treatment of chronic Achilles tendinosis. Am J Sports Med 1998;26:360–6. 10.1177/03635465980260030301
    1. Grävare Silbernagel K, Crossley KM. A proposed Return-to-Sport program for patients with Midportion Achilles tendinopathy: rationale and implementation. J Orthop Sports Phys Ther 2015;45:876–86. 10.2519/jospt.2015.5885
    1. Padrón-Benítez A, Rojas-Mederos S. A comparative study between low and high intensity percutaneous needle electrolysis in patients with Patellar tendinopathy: a structural and functional analysis. J Invasive Tech Phys Ther 2016;1:10–17.
    1. Hernandez-Sanchez S, Hidalgo MD, Gomez A. Cross-Cultural adaptation of VISA-P score for Patellar tendinopathy in Spanish population. J Orthop Sports Phys Ther 2011;41:581–91. 10.2519/jospt.2011.3613
    1. Alonso J, Prieto L, Anto JM. The Spanish version of the SF-36 health survey- a measure of clinical outcomes. Medicina Clinica 1995;104:771–6.
    1. Martinoli C. Musculoskeletal ultrasound: technical guidelines. Insights Imaging 2010;1:99–141. 10.1007/s13244-010-0032-9
    1. Rodríguez-Rosell D, Mora-Custodio R, Franco-Márquez F, et al. . Traditional vs. Sport-Specific vertical jump tests: reliability, validity, and relationship with the legs strength and sprint performance in adult and teen soccer and Basketball players. J Strength Cond Res 2017;31:196–206. 10.1519/JSC.0000000000001476
    1. Helland C, Bojsen-Møller J, Raastad T, et al. . Mechanical properties of the patellar tendon in elite volleyball players with and without patellar tendinopathy. Br J Sports Med 2013;47:862–8. 10.1136/bjsports-2013-092275
    1. Gual G, Fort-Vanmeerhaeghe A, Romero-Rodríguez D, et al. . Effects of In-Season inertial resistance training with eccentric overload in a sports population at risk for Patellar tendinopathy. J Strength Cond Res 2016;30:1834–42. 10.1519/JSC.0000000000001286
    1. Scott A, LaPrade RF, Harmon KG, et al. . Platelet-Rich plasma for Patellar tendinopathy: a randomized controlled trial of Leukocyte-Rich PRP or Leukocyte-Poor PRP versus saline. Am J Sports Med 2019;363546519837954.
    1. Figueroa D, Figueroa F, Calvo R. Patellar tendinopathy: diagnosis and treatment. J Am Acad Orthop Surg 2016;24:e184–92.
    1. Lian Østein B., Engebretsen L, Bahr R. Prevalence of jumper's knee among elite athletes from different sports: a cross-sectional study. Am J Sports Med 2005;33:561–7. 10.1177/0363546504270454
    1. Visnes H, Bahr R. The evolution of eccentric training as treatment for patellar tendinopathy (jumper's knee): a critical review of exercise programmes. Br J Sports Med 2007;41:217–23. 10.1136/bjsm.2006.032417
    1. Abat F, Gelber PE, Polidori F, et al. . Clinical results after ultrasound-guided intratissue percutaneous electrolysis (EPI®) and eccentric exercise in the treatment of Patellar tendinopathy. Knee Surg Sports Traumatol Arthrosc 2015;23:1046–52. 10.1007/s00167-014-2855-2
    1. Dragoo JL, Wasterlain AS, Braun HJ, et al. . Platelet-Rich plasma as a treatment for Patellar tendinopathy: a double-blind, randomized controlled trial. Am J Sports Med 2014;42:610–8. 10.1177/0363546513518416
    1. Warden SJ, Kiss ZS, Malara FA, et al. . Comparative accuracy of magnetic resonance imaging and ultrasonography in confirming clinically diagnosed Patellar tendinopathy. Am J Sports Med 2007;35:427–36. 10.1177/0363546506294858
    1. Hernandez-Sanchez S, Hidalgo MD, Gomez A. Cross-cultural adaptation of VISA-P score for patellar tendinopathy in Spanish population. J Orthop Sports Phys Ther 2011;41:581–91. 10.2519/jospt.2011.3613
    1. Andriolo L, Altamura SA, Reale D, et al. . Nonsurgical treatments of Patellar tendinopathy: multiple injections of platelet-rich plasma are a suitable option: a systematic review and meta-analysis. Am J Sports Med 2019;47:1001–18. 10.1177/0363546518759674
    1. de Vries A, Zwerver J, Diercks R, et al. . Effect of patellar strap and sports tape on pain in patellar tendinopathy: a randomized controlled trial. Scand J Med Sci Sports 2016;26:1217–24. 10.1111/sms.12556
    1. Markovic G, Dizdar D, Jukic I, et al. . Reliability and factorial validity of squat and countermovement jump tests. J Strength Cond Res 2004;18:551–5. 10.1519/1533-4287(2004)18<551:RAFVOS>;2

Source: PubMed

3
Iratkozz fel