Comparative Effectiveness of Ultrasound Guided Ozone (O2-O3) and Corticosteroid Injections for Sacroiliac Joint Dysfunction: A Multicenter Clinical Trial.

Background/

Objectives

Sacroiliac joint (SIJ) dysfunction is a common yet frequently underdiagnosed cause of chronic low back pain. This study aimed to compare the clinical effectiveness of ultrasound-guided corticosteroid and ozone injections in patients with chronic low back pain due to SIJ dysfunction.

Methods

This comparative clinical study included 64 patients with chronic sacroiliac joint (SIJ) dysfunction who received ultrasound-guided SIJ injections with either corticosteroid (n = 31) or ozone (n = 33). Participants had a mean age of 45.0 ± 7.7 years, and the sex distribution was 42/22 (female/male). Pain intensity was assessed using the Numeric Rating Scale (NRS), disability using the Oswestry Disability Index (ODI), and quality of life using the Short Form-12 Physical (PCS) and Mental (MCS) Component Summary scores. Outcomes were evaluated at baseline, 3 months, and 6 months. Longitudinal changes were analyzed using two-way repeated-measures ANOVA (group × time) with Bonferroni-adjusted post hoc comparisons. Effect sizes were calculated using Cohen's d. Normality and homoscedasticity were assessed (Shapiro-Wilk and Levene tests), and baseline comparisons were performed using appropriate parametric or non-parametric tests.

Results

Both treatments significantly improved pain, disability, and quality of life at 3 months (p < 0.01). However, improvements were significantly greater and more durable in the ozone group across all outcomes at both 3 and 6 months (p < 0.01). At 6 months, between-group differences favored ozone for NRS (mean difference -2.81; Cohen's d = -2.36), ODI (-6.05; d = -1.46), SF-12 PCS (+4.24; d = 1.24), and SF-12 MCS (+4.22; d = 0.83). A ≥50% pain reduction was achieved at 3 months in 97.0% of ozone-treated patients versus 45.2% of corticosteroid-treated patients (p < 0.01) and persisted at 6 months in 18.2% and 0% of patients, respectively (p < 0.05). The magnitude of improvement in the ozone group exceeded commonly reported Minimal Clinically Important Difference (MCID) thresholds for chronic low back pain outcomes, supporting clinical relevance.

Conclusions

Ultrasound-guided ozone injection provided greater and more durable improvements in pain relief, functional status, and quality of life compared with corticosteroid injection in patients with SIJ dysfunction.