Comparison of peritendinous hyaluronan injections versus extracorporeal shock wave therapy in the treatment of painful Achilles tendinopathy: A randomized clinical efficacy and safety study

Publication date: Available online 14 September 2016
Source:Archives of Physical Medicine and Rehabilitation
Author(s): Nils Lynen, Thierry De Vroey, Imke Spiegel, Frederik Van Ongeval, Niels-Jan Hendrickx, Gaëtane Stassijns
ObjectiveTo compare the safety and efficacy of hyaluronan (HA) injections with standard extracorporeal shock wave therapy (ESWT) in the treatment of painful midportion Achilles tendinopathy.DesignMultinational, prospective, randomized controlled, blinded-observer trial.SettingAmbulatory care.ParticipantsAdults presenting Achilles midportion tendinopathy for at least 6 weeks and a pain score of at least 40 mm (Huskisson, visual analogue scale (VAS), 100 mm). 62 participants were randomized and 59 analyzed in the ITT-data set. No withdrawals due to adverse effects.InterventionsTwo peritendinous HA injections versus three ESWT applications at weekly intervals.Main Outcome MeasuresPrimary efficacy criterion was changed from VISA-A score to percent change in pain (VAS) at 3 months post-treatment, compared to baseline values. Main secondary parameters were VISA-A, Clinical Global Impression (CGI) and clinical parameters.ResultsHA treatment provided a clinically relevant improvement in Achilles midportion tendinopathy. A large superiority of the HA-group, compared to ESWT application, was observed for percent change in pain (VAS) and this superiority was proven to be statistically significant (Mann-Whitney statistic (MW) = 0.7507 with p = 0.0030 lower than required alpha = 0.025 significance level one-sided; Mann-Whitney-U test) at 3 months post-treatment. Similar findings for HA were also observed at 4 weeks (MW = 0.6425, p = 0.0304) and 6 months (MW = 0.7172, p = 0.0018). Advantage of HA treatment was confirmed by VISA-A, CGI and clinical parameters. Ten adverse events, 4 in HA-group and 6 in ESWT-group were reported, but none were classified as serious.ConclusionsTwo peritendinous HA injections showed greater treatment success in Achilles midportion tendinopathy compared to standard ESWT.



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