HAT-project

About our project 

A research team, led by Dr. Robert-Jan de Vos (sports physician) and coordinated by Dr. Arco van der Vlist (PhD student) at Erasmus MC, completed a randomized clinical trial for patients with chronic midportion Achilles tendinopathy. 

This large project took more than 4 years to complete, and was funded by the Dutch Arthritis Association and the Anna Foundation. 

Chronic disorders of the Achilles tendon (tendinopathy) are a common overuse injury seen in general practice. Most of these patients (74%) have midportion Achilles tendinopathy. Runners are most at risk of developing symptoms, with a lifetime risk of 52%. 

The initial treatment of Achilles tendinopathy is exercise combined with load management. Despite initiation of treatments, two thirds of patients continue to have symptoms at one year follow-up. 

The formation of blood vessels (neovascularisation) around and within the tendon is one of the features of chronic Achilles tendinopathy. Our large cohort study showed an association between the degree of ultrasonographic Doppler flow and patient reported severity of symptoms. Consequently, treatments have been developed to target neovascularisation. A novel technique is high volume injection, in which a large amount of fluid is injected into the area surrounding the tendon with the aim of obliterating peritendinous and intratendinous neovascularisation from high mechanical pressure. 

Our aim was to compare the effect of a high volume injection without corticosteroids with a placebo injection (both combined with an exercise program) on pain and functional outcome at 24 weeks in patients with chronic midportion Achilles tendinopathy. 

Methods 

In a stratified, investigator- and patient-blinded, block-randomised trial, patients with clinically diagnosed and ultrasound-confirmed Achilles tendinopathy were included. 

Of the 80 included adults, 39 were randomised to a high volume injection without corticosteroids and 41 to placebo. The patients received either one 50 mL high volume injection of saline and lidocaine (intervention group) or one 2 mL placebo injection of saline and lidocaine (placebo group) at baseline. All patients were instructed to perform a progressive exercise program for 24 weeks (usual care). 

Primary outcome was pain and function assessed using the validated Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire at 24 weeks. Secondary outcomes were patient satisfaction and return to sports. 

Results 

Between December 2016 and January 2019, a total of 185 applications from potentially eligible patients with suspected Achilles tendinopathy were screened. After exclusions 80 participants were included in the study. eligible patients remaining for inclusion. Only one participant (1%) was lost to follow-up. The estimated mean VISA-A score improved significantly, from 40.4 (95% confidence interval 32.0 to 48.7) at baseline to 59.1 (50.4 to 67.8) at 24 weeks in the high volume injection group and from 36.9 (27.1 to 46.8) to 58.5 (47.9 to 69.1) in the placebo group. The VISA-A score over time did not differ between the groups (adjusted between group difference at 24 weeks 0.5 points, 95% confidence interval −17.8 to 18.8). No significant between group differences were found for patient satisfaction (21/37 (57%) v 19/39 (49%) patients, P=0.50) and return to desired sport (15/29 (52%) v 19/31 (61%) patients active in sports, P=0.65) at 24 weeks. None of the other secondary outcomes differed between the two groups. 

Conclusions 

A high volume injection without corticosteroids in addition to usual care is not effective for symptom reduction in patients with chronic midportion Achilles tendinopathy. On the basis of our findings, we cannot recommend the use of a high volume injection in this patient group.