AUTHOR=Yang Xiao-hui , Liu Xiao-hui , Ma Yun-gai , Fan Jia-xing , Ma Xiao-long , Zhuang Guan-ying , Yang Zhan-min 

TITLE=The clinical efficacy of ozone combined with steroid in the treatment of discogenic low back pain: a randomized, double-blinded clinical study

JOURNAL=Frontiers in Neurology

VOLUME=14

YEAR=2023

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1078111

DOI=10.3389/fneur.2023.1078111

ISSN=1664-2295

ABSTRACT=<sec id="sec1"><title>Objective</title><p>This randomized double-blinded clinical study is to investigate the clinical efficacy of per-paravertebral disk ozone injection combined with steroids in the treatment of patients with chronic discogenic low back pain (CDLBP).</p></sec><sec id="sec2"><title>Methods</title><p>Group A (<italic>N</italic> = 60) received a per-paravertebral injection of a steroid mixture of 10 mL with pure oxygen 20 mL, while group B (<italic>N</italic> = 60) received a per-paravertebral injection of a steroid mixture of 10 mL combined with ozone 20 mL (30 μg/mL). Injections were administered once a week for 3 weeks, with a follow-up of 6 months. Clinical outcomes were assessed at week 1, month 3, and month 6 with the help of Visual Analog Scale (VAS) scores and Macnab efficacy evaluation.</p></sec><sec id="sec3"><title>Results</title><p>The VAS score of both group A (1.65 vs. 6.87, <italic>p</italic> = 0.000) and group B (1.25 vs. 6.85, <italic>p</italic> = 0.000) at week 1 was significantly reduced compared to baseline. The effect was sustained at the 3- and 6-month follow-up periods (<italic>p</italic> &lt; 0.05). Group B had significantly lower VAS scores at month 3 (1.53 vs. 3.82, <italic>p</italic> = 0.000) and month 6 (2.80 vs. 5.05, <italic>p</italic> = 0.000) compared to group A, respectively. Based on Macnab criteria, 95 and 96.7% of patients in groups A and B had good rates “excellent plus good” at week 1, respectively. Good rates were significantly higher in group B at month 3 (91.7 vs. 78.3%, <italic>p</italic> = 0.041) and month 6 (85.0 vs. 68.3%, <italic>p</italic> = 0.031) compared to group A, respectively. No serious adverse events were noted in both groups.</p></sec><sec id="sec4"><title>Conclusion</title><p>Per-paravertebral injection of steroid and ozone combination resulted in better relief of CDLBP compared to pure oxygen plus steroid.</p></sec><sec id="sec401"><title>Clinical Trial Registration</title><p>ChiCTR2100044434 <ext-link xlink:href="https://www.chictr.org.cn/showproj.html?proj=121571" ext-link-type="uri" xmlns:xlink="http://www.w3.org/1999/xlink">https://www.chictr.org.cn/showproj.html?proj=121571</ext-link>.</p></sec>