Comparative effectiveness of paravertebral Ozone injection and caudal epidural steroid-hyaluronidase injection in lumbosacral spinal stenosis

Abstract

Background

Lumbosacral spinal stenosis (LSS) is the narrowing of the lumbar spinal canal. LSS usually happens in older people who do not have the proper physical condition to undergo surgery. Therefore, minimally invasive methods such as Ozone therapy and epidural injection can be used in these patients.

Objective

The objective this study was to compare the effect of caudal epidural steroid-hyaluronidase injection with paravertebral intramuscular Ozone injection on reducing pain in patients with LSS.

Methods

A total of 30 patients suffering from LSS randomized to two groups. Group A (n = 15) received three paravertebral intramuscular infiltrations of the Ozone, Group B (n = 15) received a caudal epidural injection of steroid-hyaluronidase. The effects of the interventions were evaluated by measuring Visual analog scale (VAS), Oswestry Disability index (ODI), Quebec Back Pain Disability (QBPDS) and Roland Morris low back pain questionnaire (RMQ) before the interventions and at 2 weeks, 4 weeks, and 8 weeks after the interventions.

Results

Within-group changes showed significant improvement in VAS, ODI, RMQ, and QBPDS scores in both groups from pre-treatment to end of follow-up (all p < 0.05). The mean VAS score at all follow-up had significant differences between the two groups (p < 0.01). The mean ODI, RMQ, and QBPDS scores at 2-week and 4-week had significant differences between the two groups (p < 0.01). At the 8-week follow-up, there was no significant difference between groups concerning mean ODI, RMQ, and QBPDS scores (p > 0.05).

Conclusion

Both intramuscular injection Ozone and caudal epidural injection steroid- hyalaz significantly reduce pain. The existing data suggested 8 weeks improvements in pain severity are more significant for paravertebral Ozone injection, compared to caudal epidural steroid-hyaluronidase injection.

Keywords:

• Lumbosacral spinal stenosis
• epidural injection
• steroid
• hyaluronidase
• ozone

Acknowledgments

This manuscript was a part of the thesis of Reyhaneh Parvin (NO. 16772) that was approved by the vice-chancellor of research, Shiraz University of medical sciences, Shiraz, Iran. The study method was approved by the Medial Ethics Committee of Shiraz University of Medical Sciences (SUMS) with the reference number ‘IR.SUMS.MED.REC.1397.283’. The authors would like to thank center for development of clinical research of Nemazee hospital and Dr. Nasrin Shokrpour, Dr. Parisa Chamanpara and the research consultation center (RCC) of Shiraz University of medical sciences, Shiraz, Iran for editorial assistance also thank Dr. Hasan Moradian for his cooperation in Final editing and re-analysis of data.

Trial registration

The study protocol was registered as a clinical trial under registration IRCT20191004044980N1 at the Iranian Registry of Clinical Trials (http://www.irct.ir).

Disclosure statement

No potential conflict of interest was reported by the author(s).