Dextrose Prolotherapy injection improves dynamic postural balance and reduces risk of recurrent sprains in Chronic Ankle Instability: A one-year randomized placebo-controlled trial.

Abstract

to investigate whether dextrose prolotherapy (DPT) injections to the anterior talofibular ligament (ATFL) improves Chronic ankle instability (CAI). A 52-week, two-arm, parallel, superiority, triple-blinded randomized-controlled trial. The study was performed at a university-affiliated primary care clinic. 114 participants with CAI were randomly assigned to DPT and normal saline (NS) group in a 1:1 ratio. The DPT group and the NS group and received 5 ml of 15 % dextrose (D15) and 5 ml of normal saline injection to the ATFL on week 0, 4, 8, and 16, respectively. Primary outcome was the Cumberland Ankle Instability Tool (CAIT 0-30 points) at 52 weeks. Secondary outcomes included the Star Excursion Balance Test (SEBT), number of ankle re-sprains, health-related quality of life (measured by EQ-5D) and treatment satisfaction. All outcomes were assessed at baseline, 16, 26 and 52 weeks. Randomization produced two groups of 57 participants, (57 % female; 49.9±14.8 years). Although no statistically significant between-group difference was detected for CAIT, DPT participants demonstrated a statistically significant improvement in SEBT compared to NS, with a difference-in-difference estimate of 4.46 points (confidence interval [CI] 0.51 to 8.41, P=0.027) at 26 weeks, and 4.27 points (CI 0.26 to 8.29, P=0.037) at 52 weeks. Participants in the DPT group had a lower risk of re-sprains (adjusted odds ratio 2.88 (CI 1.21 to 6.89, P=0.017). No procedure-related adverse events were reported. DPT is superior than NS injections in improving postural dynamic balance at 26 and 52 weeks, and experienced fewer re-sprains at 52 weeks.