Effectiveness of a high volume injection as treatment for chronic Achilles tendinopathy: randomised controlled trial

Abstract

ObjectiveTo study whether a high volume injection without corticosteroids improves clinical outcome in addition to usual care for adults with chronic midportion Achilles tendinopathy.DesignPatient and assessor blinded, placebo controlled randomised clinical trial.SettingSports medicine department of a large district general hospital, the Netherlands.Participants80 adults (aged 18-70 years) with clinically diagnosed chronic midportion Achilles tendinopathy and neovascularisation on ultrasonography. 39 were randomised to a high volume injection without corticosteroids and 41 to placebo.InterventionsParticipants were instructed to perform an exercise programme for 24 weeks (usual care) combined with 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.Main outcome measuresPrimary outcome was pain and function assessed using the validated Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire at 24 weeks (analysed using a generalised estimation equations model). Secondary outcomes were patient satisfaction, return to sport, degree of ultrasonographic Doppler flow, visual analogue scale on 10 hop test, power and flexibility of the gastrocnemius and soleus muscles, pain detect questionnaire for neuropathic pain, and pain coping inventory. Participants were evaluated at baseline and at 2, 6, 12, and 24 weeks.ResultsOnly 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.ConclusionsA 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.Trial registrationClinicalTrials.gov NCT02996409

Are pain coping strategies and neuropathic pain associated with a worse outcome after conservative treatment for Achilles tendinopathy? A prospective cohort study

“…The mean (standard deviation -SD) VISA-A score gradually increased from 43 (16) points at baseline to 63 (23) points at 24 weeks, with no difference between intervention groups. 17 The mean (SD) score for active coping was 0.53 (0.13) and 0.43 (0.10) for passive coping. A neuropathic pain component was likely in 12 patients (15%).…”

“…This study is part of a randomized clinical trial, the High-volume image-guided injections in chronic midportion Achilles Tendinopathy (HAT). 17 The RCT was approved by the Medical Research Ethics Committee Southwest Holland, Leiden, The Netherlands (MEC-14-100). Extensive description of the materials and methods are registered at clinicaltrials.gov (identifier: NCT02996409).…”

“…The HAT study evaluated the effect of high-volume image guided injection compared to a placebo injection in addition to eccentric exercises in patients with chronic midportion AT. 17 Written informed consent was acquired from all patients before inclusion. Patients were recruited in a large district hospital (Haaglanden Medical Center, The Hague, The Netherlands) between December 2016 and January 2019.…”

“…As reported in the study protocol, imputation was needed if the sensitivity analysis reported ≥5% missing data of the primary outcome. 17 We used SPSS software (V.24.0.0.1; SPSS, Chicago, Illinois, USA) for statistical analysis.…”

Impact of chronic Achilles tendinopathy on health-related quality of life, work performance, healthcare utilisation and costs

“…We estimated that 80 patients were needed to detect a clinically relevant between-group difference in the primary outcome. 19 As post hoc power analyses are discouraged and this is a descriptive study, we refrained from performing an additional power calculation.…”