Investigating the Effect of RACZ Epidural Neuroplasty With Ozone Injection in Patients With Chronic Radicular Lumbar Pain: A Randomized Controlled Clinical Trial

Background

Although the exact causes of chronic lumbar radicular pain are still unknown, potential causes include epidural fibrosis, arachnoiditis, mechanical failure, nerve root inflammation, and structural and degenerative changes to the spine.

Objective

This study was conducted to assess the analgesic effect of using epidural ozone injection along with routine RACZ neuroplasty in patients with low back pain.

Methods

This is a prospective randomized clinical trial conducted on 40 patients with chronic radicular lumbar pain allocated into two equal groups of RACZ caudal neuroplasty with and without ozone injection. Two groups of twenty people each were created from forty patients with chronic radicular lumbar pain who did not improve with conservative measures. In Group B, RACZ neuroplasty was performed, while in Group A, RACZ neuroplasty was administered along with epidural ozone injection. Before the intervention, baseline pain intensity and the degree of back pain‐related disability were determined using the Numeric Rating Scale (NRS) and Oswestry Disability Index (ODI), respectively. Twenty‐four hours, 1 month, and 3 months after the procedure, the NRS was recorded again. ODI was also assessed 1 month and 3 months after the procedure.

Results

The mean NRS scores in the intervention group before, and 24 h, 1 month, and 3 months after the procedure were 8.80 ± 1.47, 4.45 ± 2.01, 5.25 ± 1.25, and 5.40 ± 2.16, respectively, and corresponding values in the control group were 8.70 ± 1.30, 4.60 ± 1.60, 5.70 ± 1.66, and 6.40 ± 1.64, respectively (Group effect: F = 0.784, p  = 0.381 and Time effect: F  = 81.910, p  < 0.001). The mean scores of the ODI before, 1 month, and 3 months after the procedure were 48.60 ± 17.65, 40.75 ± 15.38, and 43.70 ± 18.50, respectively, in the intervention group, while in the control group, the respective values were 57.20 ± 15.67, 43.90 ± 19.92, and 48.75 ± 12.83. (Group effect: F = 1.246, p  = 0.271 and Time effect: F  = 24.496, p  < 0.001).

Conclusion

While the addition of ozone to RACZ neuroplasty showed no significant benefit in this study, these findings are limited by the modest sample size and short follow‐up. Further large‐scale, well‐powered trials are required to definitively establish the therapeutic role of ozone in this population.

Trial Registration: Iranian Registry of Clinical Trials (IRCT): IRCT20150724023315N3