Comparative Study of Corticosteroid Injection in the Caudal Epidural Space under Fluoroscopy Guidance with or without Ozone Injection in Lumbosacral Radiculopathy: A Single-Blind Clinical Trial

Abstract

Background: Lumbosacral radiculopathy due to disc herniation is a leading cause of chronic pain and disability worldwide. While fluoroscopic-guided epidural steroid injections (ESIs) are widely used for symptom relief, their efficacy is variable, and the long-term benefits remain controversial. Ozone therapy has emerged as a promising adjunct to steroid injections due to its anti-inflammatory, analgesic, and oxygenating effects. This study aimed to compare the efficacy and safety of fluoroscopic-guided caudal epidural steroid injections with and without ozone therapy in patients with lumbosacral radiculopathy.
Methods: A randomized, single-blind clinical trial was carried out with 40 adults diagnosed with radicular pain from lumbar disc protrusion at L4-L5 or L5-S1. They were randomly placed into two equal-sized groups. The first group (n=20) received a caudal injection containing dexamethasone (8 mg), lidocaine (5 mL, 1%), and saline (3 mL). The second group (n=20) received the same injection along with 5 mL of ozone (10 µg/cc). Fluoroscopy was used to guide all procedures. Pain and physical function were tracked using the Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI), both before treatment and again after one, three, and six months.
Results: Improvements were seen in both groups over time. Still, the ozone group reported stronger pain relief and better functional scores at every follow-up. At one month, VAS and ODI scores were significantly lower in the ozone group (VAS: 1.85 ± 0.75 vs. 2.40 ± 0.90, p = 0.029; ODI: 22.3 ± 4.5 vs. 26.7 ± 5.1, p = 0.025). The difference held steady at three months (VAS: p = 0.022; ODI: p = 0.021) and at six months (VAS: p = 0.017; ODI: p = 0.015). No major side effects occurred, and mild ones cleared up on their own.
Conclusion: The addition of ozone therapy to fluoroscopic-guided caudal epidural steroid injections significantly enhances pain relief and functional recovery in patients with lumbosacral radiculopathy compared to steroid injections alone. This combination therapy represents a safe, minimally invasive, and effective treatment option for individuals with refractory radicular pain. Further large-scale, multicenter trials with long-term follow-up are warranted to validate these findings and optimize treatment protocols.