Preliminary results in comparison of caudal epidural injection of hyaluronidase versus hypertonic saline in managing lumbosacral canal stenosis: A randomized clinical trial

Abstract

Background: Lumbosacral spinal stenosis (LSS) is one of the most common causes of back pain and disability. Its treatment varies from conservative and medical to surgical treatment, and the indications for its optimal management are not obviously defined. Epidural steroid injection is commonly used for pain relief in LSS. This study aims to compare the adjuvant efficacy of caudal epidural injection (CEI) of hyaluronidase with steroid versus hypertonic saline with steroid in patients with LSS. Methods: This clinical trial was done in a prospective, randomized, double-blind approach; it was conducted among 30 patients aged between 45 – 75 years who suffered from low back and leg pain in recent 6 months due to LSS. The patients were randomly allocated to two groups. Group A included 15 patients who received fluoroscopically guided CEI containing steroid, local anesthetic, and hyaluronidase, and Group B consisted of 15 patients who received fluoroscopically guided CEI containing steroid, local anesthetic, and hypertonic saline. The outcome measures included the Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Quebec Back Pain Disability Scale (QBPDS), which were obtained from patients before the CEI as a baseline and after the second, fourth, and eighth weeks. Results: Before injection, there were no statistically significant differences between the two studied groups, neither in demographic characteristics nor in VAS, ODI, and QBPDS parameters. After injection, the mean of ODI and QBPDS improved from the baseline to the 2nd, 4th, and the 8th weeks in both groups (p < 0.001) without any superiority between the two groups (p > 0.05). However, there was a significant improvement of the mean VAS score through the second and fourth weeks in Group A (p = 0.032, 0.050). VAS score in the eighth week was equal without any superiority in both groups (p > 0.05). Additionally, the mean social life status was significantly improved in group A in the 4th and 8th weeks after the intervention. Conclusions: In short-term follow-up, Caudal epidural injection of hyaluronidase, as well as hypertonic saline, seems to be effective in the management of LSS without any superiority in both materials. However, in the 2nd and 4th weeks after the procedure, better improvement of means VAS score was observed in the hyaluronidase group.