Ultrasound-Guided Hydrodilatation and Release versus Conventional Corticosteroid Injection with Physical Therapy for Adhesive Capsulitis

Abstract

Background: Conventional treatments for adhesive capsulitis, including exercise therapy and intra-articular corticosteroid injection, are evidence-based approaches; however, their capacity to reverse the underlying capsular fibrosis remains uncertain. This study compares ultrasound-guided hydrodilatation and release (US-HR) against conventional exercise therapy plus intra-articular corticosteroid injection (ESP+IACI). Methods: In this prospective observational cohort study, 110 consecutive patients with adhesive capsulitis were allocated in a non-randomized manner, through shared decision-making between patient and physician, to US-HR (n=55) or ESP+IACI (n=55) and followed for 12 months. All outcome assessors, sonographers, and statistician were blinded to group assignment. The primary endpoint was shoulder function measured by the Constant–Murley Score (CMS) at six time points. Secondary endpoints included pain (VAS), function (FUSS), disability (SPADI), range of motion, sonographic capsular thickness, health-related quality of life (SF-36), and adverse events. In a prespecified responder analysis, individual percentage improvement in CMS at 12 weeks was classified as markedly effective (≥90%), effective (50–89%), or ineffective (<50%), with responders defined as ≥50% improvement. Results: Baseline characteristics were comparable, and outcome data were complete. At 12 months, the US-HR group reached a higher CMS than the ESP+IACI group (87.2 ± 6.5 vs. 75.1 ± 8.0; mean difference 12.1, 95% CI 9.4–14.8; P < 0.001; Cohen's d = 1.66). Between-group differences were apparent by 4 weeks. At 12 weeks, the distribution across response categories differed between groups (P = 0.007); the responder rate was higher with US-HR (94.5% vs. 78.2%; difference 16.4 percentage points, 95% CI 3.9–28.8; P = 0.012), as was the proportion with a markedly effective response (58.2% vs. 32.7%). US-HR was also associated with greater pain relief, lower disability, broader range of motion including external rotation, earlier reduction in axillary-recess and coracohumeral-ligament thickness, and better quality of life. Adverse events were infrequent and mild in both groups (7.3% vs. 3.6%; P = 0.679). Conclusion: In this non-randomized observational cohort, the multicomponent US-HR protocol was associated with more favorable and earlier functional, structural, and symptomatic recovery than ESP+IACI, with a comparable safety profile. Given the observational design, these findings are hypothesis-generating and require confirmation in randomized controlled trials.