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Comparison of Peritendinous Hyaluronan Injections Versus Extracorporeal Shock Wave Therapy in the Treatment of Painful Achilles' Tendinopathy: A Randomized Clinical Efficacy and Safety Study

Nils Lynen Thierry De Vroey Imke Spiegel Frederik Van Ongeval Niels-Jan Hendrickx Gaëtane Stassijns 《Archives of physical medicine and rehabilitation》2017,98(1):64-71

Objective

To compare the safety and efficacy of hyaluronan (HA) injections with standard extracorporeal shock wave therapy (ESWT) in the treatment of painful midportion Achilles' tendinopathy.

Design

Multinational, prospective, randomized controlled, blinded-observer trial.

Setting

Ambulatory care.

Participants

Adults (N=62) with Achilles' midportion tendinopathy for ≥6 weeks and a pain score of at least 40mm (Huskisson visual analog scale [VAS], 100mm) were randomized, and 59 were analyzed in the intention-to-treat data set. There were no withdrawals because of adverse effects.

Interventions

Two peritendinous HA injections versus 3 ESWT applications at weekly intervals.

Main Outcome Measures

Primary efficacy criterion was changed from the Victorian Institute of Sports Assessment–Achilles' questionnaire (VISA-A) score to the percent change in pain (VAS) at 3 months posttreatment, compared with baseline values. Main secondary parameters were VISA-A, Clinical Global Impression (CGI), and clinical parameters.

Results

HA treatment provided a clinically relevant improvement in Achilles' midportion tendinopathy. A large superiority of the HA group, compared with ESWT application, was observed for percent change in pain (VAS), and this superiority was proven to be statistically significant (Mann-Whitney statistic [MW]=.7507 with P=.0030 lower than required α=.025 significance level 1-sided; Mann-Whitney U test) at 3 months posttreatment. Similar findings for HA were also observed at 4 weeks (MW=.6425, P=.0304) and 6 months (MW=.7172, P=.0018). Advantage of HA treatment was confirmed by VISA-A questionnaire, CGI, and clinical parameters. Ten adverse events, 4 in the HA group and 6 in the ESWT group, were reported, but none were classified as serious.

Conclusions

Two peritendinous HA injections showed greater treatment success in Achilles' midportion tendinopathy compared with standard ESWT. 相似文献