Article Text
Abstract
Background Chronic tendinopathy is a significant burden in physically active populations. High-volume image-guided injection (HVIGI) proposes to strip away associated neovascularity, disrupt painful nerve ingrowth and facilitate rehabilitation.
Methods The objective was to investigate the efficacy of HVIGI with and without steroid relative to placebo. The study design was a three-arm block randomised control trial in a tertiary rehabilitation centre. Sixty-two participants were recruited between 25 May 2016 and 5 March 2020. Participants were men aged 18–55 with, Achilles or patellar tendinopathy of at least 6-months chronicity who had not improved with conservative management including shockwave, Ultrasound (US) evidence of neovascularisation, tendon thickening and echogenic changes.
Participants were randomly assigned to control (3ml subcutaneous 0.5% Bupivacaine) or HVIGI (10 ml 0.5% Bupivacaine and 30 ml normal saline US guided between tendon and underlying fatpad) or HVIGI with steroid (0.25 ml 100 mg/ml hydrocortisone). Clinicians and assessors were blinded. All participants were supervised through a pain-guided progressive loading programme for 6-months post injection. The primary outcome measures were the Victoria institute of sport assessments for Achilles and patellar tendinopathy (VISA-A and VISA-P) and visual analogue scale (VAS)-pain at 6-months.
Results VISA improved by 22.8 ((95% CI) 10.4 to 35.3, effect size (ES) 1.51) in control (n=21), 18.6 (9.1 to 28.0, ES 1.31) in HVIGI (n=21) and 18.5 (3.4 to 33.6, ES 0.88) in HVIGI with steroid (n=20) groups. VAS-pain improved by 15 ((IQR) -38.75 to 8, ES 0.39) in control, 13 in HVIGI (-34.0 to 3.75, ES 0.47) and 27 (-38.0 to-1.0, ES 0.54) in HVIGI with steroid groups. Main effects for time were significant (p<0.001) but not group (p≥0.48) with no group-time interaction (p=0.71). One participant was lost to follow-up from each group for whom multiple imputation was used. No adverse events occurred.
Conclusions Data does not demonstrate superiority of HVIGI over control injection. Pain-guided progressive loading remains the mainstay of treatment.