The efficacy of ultrasound and fluoroscopy-guided caudal epidural prolotherapy versus steroids for chronic pain management in failed back surgery syndrome

Abstract

ABSTRACT Background Caudal epidural prolotherapy injection has emerged as a successful treatment for managing chronic pain. This study is a prospective randomized, double-blinded clinical trial. It assesses and compares the effectiveness of prolotherapy versus steroid injection for pain relief in cases of failed back surgery syndrome (FBSS). It involved randomly assigning 90 patients with FBSS to one of two equal groups: steroids or prolotherapy. The VAS was used to measure pain as the primary outcome, while disability was measured by the Oswestry disability index (ODI). McGill Pain Questionnaire (MPQ) and complications were recorded as secondary outcomes. Results The VAS improved significantly from the baseline in both groups at all follow-up periods (p < 0.001). Nonetheless, after 2, 4, and 6 weeks post-injection, there was no statistically significant difference between the two groups, while at 8 weeks, 3, and 6 months, the VAS was statistically significantly lower in the steroids group than in the prolotherapy group (p < 0.001). The ODI and MPQ improved significantly from the baseline in both groups at all follow-up periods (p < 0.001). However, after 2 and 4 weeks post-injection, there was no statistically significant difference between the two groups; but, at 6 and 8 weeks, 3, and 6 months, the ODI and MPQ were statistically significantly lower in the steroid group compared to the prolotherapy group (p < 0.001). Only one patient in the steroid group suffered from pain and swelling at the injection site without a statistically significant difference between the two groups. Conclusion Caudal epidural prolotherapy injection has good efficacy in managing pain that can be similar to steroid injection but shorter in duration in cases of FBSS with comparable safety profile.