Efficacy and cost effectiveness of high volume injections with and without corticosteroid compared with sham for midportion Achilles tendinopathy (Inject trial): randomised controlled trial
Peter Malliaras, David Connell, Anders Ploug Boesen, Rebecca S Kearney, Hylton B Menz, Dylan Morrissey, Shannon E Munteanu, Karin Gravare Silbernagel, Martin Underwood, Andrew Forbes, Terry P HainesAbstract
Objective
To test the efficacy and cost effectiveness of high volume injections with and without corticosteroid versus sham injection for midportion Achilles tendinopathy.
Design
Single centred, participant and assessor masked, three arm randomised controlled trial (Inject trial).
Setting
Community.
Participants
From 5 December 2019 and 24 July 2022, 192 adults (18 years or older) diagnosed with midportion Achilles tendinopathy were randomly assigned (1:1:1) to sham (n=64), high volume injection without corticosteroid (n=63), or high volume injection with corticosteroid (n=65).
Interventions
Participants were allocated to sham injection (2-3 mL 0.5% bupivacaine hydrochloride), high volume injection with corticosteroid (50 mL saline and 0.5% bupivacaine with 25 mg hydrocortisone in the first 10 mL), or high volume injection with no corticosteroid (same solution but without hydrocortisone). They received the same exercise programme, education, and activity modification advice.
Main outcome measures
The primary clinical outcome was pain and disability using the validated VISA-A and the primary endpoint was at 52 weeks. The economic outcome was cost per quality-adjusted life-years from a societal perspective.
Results
VISA-A data were obtained from 181 (94%) of 192 participants at 12 months. No clear differences were noted between sham and high volume injection either with (-3.5 (98.33% confidence interval -12.0 to 5.0)) or without corticosteroid (4.0 (-4.2 to 12.3)), and between the two injections (-7.5 (-15.3 to 0.3)), at 12 months. The point estimate was closest to the target difference for the comparison between injections and favoured the arm without steroid. The only differences observed on VISA-A at intermediate time points were a benefit for high volume with corticosteroid versus sham at six weeks (9.2 (1.5 to 16.9)) but worse outcomes for high volume injection with corticosteroid versus high volume injection with no corticosteroid at 26 weeks (-8.6 (-16.4 to -0.7)). The health economic analysis found high volume injection with corticosteroid to be less costly than the sham with similar effectiveness based on quality-adjusted life-years (>0.90 probability of being cost effective at $AUD50 000 and $100 000 willingness-to-pay thresholds). No serious trial related adverse events were recorded.
Conclusion
High volume injections with or without corticosteroids did not improve pain or disability compared with sham at 12 months. Although high volume injections with corticosteroid showed short term clinical benefit and potential reduction in healthcare costs over a year, they were associated with worse longer term clinical outcomes. The clinical data do not support routine use for high volume injections with corticosteroid for midportion Achilles tendinopathy.
Trial registration
Australian New Zealand Clinical Trials Registry