Highlights
- •Two peritendinous hyaluronan (HA) injections are safe and effective in treating symptomatic Achilles' midportion tendinopathy.
- •HA injections are superior to standard extracorporeal shock wave therapy (ESWT) application and result in clinically relevant findings.
- •Administration of HA was less painful to the patients compared with ESWT.
Abstract
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.
Keywords
List of abbreviations:
CGI (Clinical Global Impression), CI (confidence interval), ESWT (extracorporeal shock wave therapy), HA (hyaluronan), ITT (intention to treat), min-max (minimum-maximum), MW (Mann-Whitney), MW-U (Mann-Whitney U), VAS (visual analog scale), VISA-A (Victorian Institute of Sports Assessment–Achilles' questionnaire)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: September 14, 2016
Footnotes
Supported by TRB Chemedica AG.
Clinical Trial Registration No.: NCT01954108.
Disclosures: none.
Identification
Copyright
© 2016 by the American Congress of Rehabilitation Medicine
