Focused extracorporeal shockwave therapy (f-ESWT) for knee osteoarthritis: a double-blind randomized clinical trial
DOI:
https://doi.org/10.5935/0104-7795.20170033Keywords:
High-Energy Shock Waves, Osteoarthritis, Knee, Disability EvaluationAbstract
Objective: To assess the efficacy of focused extracorporeal shockwave therapy (f-ESWT) when compared to placebo for pain and disability in patients with knee osteoarthritis (OA). Methods: Randomized, parallel, double-blind, placebo-controlled clinical trial. Patients with primary knee OA were given a set of exercises (hamstring stretching and quadriceps strengthening) and randomized into f-ESWT or placebo (sham probe). All patients were submitted to 4 weekly sessions of 7,000 pulses, and in the f-ESWT group energy was up to 0.15mJ/mm2. Primary outcome was visual analog scale (VAS) for pain at 1 month. Secondary outcomes were WOMAC, TUG, Lequesne's index and OMERACT-OARSI responder index at 1 and 3 months; as well as VAS at 3 months and adverse events (AEs). Both patients and outcome assessors were blinded. Mann-Whitney U test and Fisher's exact test were used with alpha=5% and power=80% in an intention-to-treat analysis. Continuous outcomes were reported as mean± standard deviation. Results: 18 patients were included (9 in each group), aging 60.6±8.7, with 33.3% males. There was no significant difference at baseline across groups in any variables. f-ESWT was not superior to placebo at 1 month: VAS=-2.97±3.18 and -2.68±2.33cm, respectively, p=0.96. TUG at 1 month had significant differences: 9.09±2.30 and 11.01±2.85sec, p=0.01. No serious AEs were observed. Conclusions: f-ESWT was not superior to placebo for knee OA. This RCT was underpowered to detect differences in this study. New RCTs should use WOMAC A (pain subscale) as primary outcome and recruit at least 92 patients.
Downloads
References
Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, et al. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014;73(7):1323-30. DOI: http://dx.doi.org/10.1136/annrheumdis-2013-204763
McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014;22(3):363-88. DOI: http://dx.doi.org/10.1016/j.joca.2014.01.003
Crum LA. Cavitation microjets as a contributory mechanism for renal calculi disintegration in ESWL. J Urol. 1988;140(6):1587-90. DOI: http://dx.doi.org/10.1016/S0022-5347(17)42132-X
Chen TW, Lin CW, Lee CL, Chen CH, Chen YJ, Lin TY, et al. The efficacy of shock wave therapy in patients with knee osteoarthritis and popliteal cyamella. Kaohsiung J Med Sci. 2014;30(7):362-70. DOI: http://dx.doi.org/10.1016/j.kjms.2014.03.006
Gerdesmeyer L, Wagenpfeil S, Haake M, Maier M, Loew M, Wortler K, et al. Extracorporeal shock wave therapy for the treatment of chronic calcifying tendonitis of the rotator cuff: a randomized controlled trial. JAMA. 2003;290(19):2573-80. DOI: http://dx.doi.org/10.1001/jama.290.19.2573
Mariotto S, Cavalieri E, Amelio E, Ciampa AR, de Prati AC, Marlinghaus E, et al. Extracorporeal shock waves: from lithotripsy to anti-inflammatory action by NO production. Nitric Oxide. 2005;12(2):89-96. DOI: http://dx.doi.org/10.1016/j.niox.2004.12.005
Pettrone FA, McCall BR. Extracorporeal shock wave therapy without local anesthesia for chronic lateral epicondylitis. J Bone Joint Surg Am. 2005;87(6):1297-304.
Vulpiani MC, Vetrano M, Trischitta D, Scarcello L, Chizzi F, Argento G, et al. Extracorporeal shock wave therapy in early osteonecrosis of the femoral head: prospective clinical study with long-term follow-up. Arch Orthop Trauma Surg. 2012;132(4):499-508. DOI: http://dx.doi.org/10.1007/s00402-011-1444-9
Zhao Z, Ji H, Jing R, Liu C, Wang M, Zhai L, et al. Extracorporeal shock-wave therapy reduces progression of knee osteoarthritis in rabbits by reducing nitric oxide level and chondrocyte apoptosis. Arch Orthop Trauma Surg. 2012;132(11):1547-53. DOI: http://dx.doi.org/10.1007/s00402-012-1586-4
Zhao Z, Jing R, Shi Z, Zhao B, Ai Q, Xing G. Efficacy of extracorporeal shockwave therapy for knee osteoarthritis: a randomized controlled trial. J Surg Res. 2013;185(2):661-6. DOI: http://dx.doi.org/10.1016/j.jss.2013.07.004
Lohrer H, Nauck T, Korakakis V, Malliaropoulos N. Historical ESWT paradigms are overcome: a narrative review. Biomed Res Int. 2016;2016:3850461. DOI: http://dx.doi.org/10.1155/2016/3850461
Shimpi RK, Jain RJ. Role of extracorporeal shock wave therapy in management of Peyronie's disease: a preliminary report. Urology annals. 2016;8(4):409-17. DOI: http://dx.doi.org/10.4103/0974-7796.192100
Yahata K, Kanno H, Ozawa H, Yamaya S, Tateda S, Ito K, et al. Low-energy extracorporeal shock wave therapy for promotion of vascular endothelial growth factor expression and angiogenesis and improvement of locomotor and sensory functions after spinal cord injury. J Neurosurg Spine. 2016;25(6):745-55. DOI: http://dx.doi.org/10.3171/2016.4.SPINE15923
Peng YZ, Zheng K, Yang P, Wang Y, Li RJ, Li L, et al. Shock wave treatment enhances endothelial proliferation via autocrine vascular endothelial growth factor. Genetics and molecular research: GMR. 2015;14(4):19203-10. DOI: http://dx.doi.org/10.4238/2015.December.29.30
Goertz O, von der Lohe L, Lauer H, Khosrawipour T, Ring A, Daigeler A, et al. Repetitive extracorporeal shock wave applications are superior in inducing angiogenesis after full thickness burn compared to single application. Burns. 2014;40(7):1365-74. DOI: http://dx.doi.org/10.1016/j.burns.2014.01.019
Hatanaka K, Ito K, Shindo T, Kagaya Y, Ogata T, Eguchi K, et al. Molecular mechanisms of the angiogenic effects of low-energy shock wave therapy: roles of mechanotransduction. Am J Physiol Cell Physiol. 2016;311(3):C378-85.
Gao F, Sun W, Li Z, Guo W, Wang W, Cheng L, et al. Extracorporeal shock wave therapy in the treatment of primary bone marrow edema syndrome of the knee: a prospective randomised controlled study. BMC Musculoskelet Disord. 2015;16:379. DOI: http://dx.doi.org/10.1186/s12891-015-0837-2
Sansone V, Romeo P, Lavanga V. Extracorporeal Shock Wave Therapy Is Effective in the Treatment of Bone Marrow Edema of the Medial Compartment of the Knee: A Comparative Study. Med Princ Pract. 2017;26(1):23-9. DOI: http://dx.doi.org/10.1159/000452836
Cheng JH, Wang CJ, Su SH, Huang CY, Hsu SL. Next-generation sequencing identifies articular cartilage and subchondral bone miRNAs after ESWT on early osteoarthritis knee. Oncotarget. 2016;7(51):84398-407. DOI: http://dx.doi.org/10.18632/oncotarget.11331
Murata R, Nakagawa K, Ohtori S, Ochiai N, Arai M, Saisu T, et al. The effects of radial shock waves on gene transfer in rabbit chondrocytes in vitro. Osteoarthritis Cartilage. 2007;15(11):1275-82. DOI: http://dx.doi.org/10.1016/j.joca.2007.04.001
Takahashi N, Ohtori S, Saisu T, Moriya H, Wada Y. Second application of low-energy shock waves has a cumulative effect on free nerve endings. Clin Orthop Relat Res. 2006;443:315-9. DOI: http://dx.doi.org/10.1097/01.blo.0000188064.56091.a7
Wu YH, Lun JJ, Chen WS, Chong FC. The electrophysiological and functional effect of shock wave on peripheral nerves. Conf Proc IEEE Eng Med Biol Soc. 2007;2007:2369-72.
Ohtori S, Inoue G, Mannoji C, Saisu T, Takahashi K, Mitsuhashi S, et al. Shock wave application to rat skin induces degeneration and reinnervation of sensory nerve fibres. Neurosci Lett. 2001;315(1-2):57-60.
Bolt DM, Burba DJ, Hubert JD, Strain GM, Hosgood GL, Henk WG, et al. Determination of functional and morphologic changes in palmar digital nerves after nonfocused extracorporeal shock wave treatment in horses. Am J Vet Res. 2004;65(12):1714-8. DOI: http://dx.doi.org/10.2460/ajvr.2004.65.1714
Imamura M, Alamino S, Hsing WT, Alfieri FM, Schmitz C, Battistella LR. Radial extracorporeal shock wave therapy for disabling pain due to severe primary knee osteoarthritis. J Rehabil Med. 2017;49(1):54-62. DOI: http://dx.doi.org/10.2340/16501977-2148
Lee JH, Lee S, Choi S, Choi YH, Lee K. The effects of extracorporeal shock wave therapy on the pain and function of patients with degenerative knee arthritis. Journal of physical therapy science. 2017;29(3):536-8. DOI: http://dx.doi.org/10.1589/jpts.29.536
Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015;49(24):1554-7. DOI: http://dx.doi.org/10.1136/bjsports-2015-095424
Lluch Girbes E, Duenas L, Barbero M, Falla D, Baert IA, Meeus M, et al. Expanded Distribution of Pain as a Sign of Central Sensitization in Individuals With Symptomatic Knee Osteoarthritis. Phys Ther. 2016;96(8):1196-207. DOI: http://dx.doi.org/10.2522/ptj.20150492
Edwards RR, Dolman AJ, Martel MO, Finan PH, Lazaridou A, Cornelius M, et al. Variability in conditioned pain modulation predicts response to NSAID treatment in patients with knee osteoarthritis. BMC Musculoskelet Disord. 2016;17:284. DOI: http://dx.doi.org/10.1186/s12891-016-1124-6
Downloads
Published
Issue
Section
License
Copyright (c) 2017 Acta Fisiátrica
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
