Kieran Murphy1, Mario Muto2, Jim Steppan3, Thomas Meaders3, Chett Boxley3. 1. Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada. Electronic address: Kieran.Murphy@uhn.on.ca. 2. A. Cardarelli Hospital, Napoli, Italy. 3. ActiveO, Salt Lake City, Utah, USA.
Abstract
PURPOSE: The primary objective of this pilot study was to compare pain and function scores from patients before and after an ozone injection in combination with steroids and bupivacaine to treat herniated discs. A secondary objective was to correct some of the methodological weaknesses of some previously published ozone studies. METHODS: Fifty patients were enrolled; 1-3 mL of 2 wt% ozone in 98 wt% oxygen was delivered into the nucleus pulposus, and 7-9 mL into the adjacent paravertebral tissues. The oxygen/ozone treatment was followed by a periganglionic injection of corticosteroid and bupivacaine. All patients were evaluated 1 month after the treatment to quantify improvement in pain and function, and to monitor for potential adverse events. RESULTS: Forty-four patients had intradiscal injections and were included in the analysis. After 1 treatment, 75.0% showed significant improvement in pain based on the visual analog scale (improvement >1.8), 72.7% showed significant improvement in function based on the Oswestry disability index (improvement >15%), and 79.5% showed improvement based on the modified MacNab criteria. There were no adverse events associated with the treatment. CONCLUSIONS: Patients showed significant improvement in pain and function after receiving ozone injections in combination with steroids and bupivacaine for the treatment of herniated discs. Because of the lack of a control group and short follow-up times, conclusions about the safety and efficacy of ozone injections for the treatment of herniated discs are not warranted. However, the results provide sufficient evidence that the risk and expense of an additional randomized controlled study is merited.
PURPOSE: The primary objective of this pilot study was to compare pain and function scores from patients before and after an ozone injection in combination with steroids and bupivacaine to treat herniated discs. A secondary objective was to correct some of the methodological weaknesses of some previously published ozone studies. METHODS: Fifty patients were enrolled; 1-3 mL of 2 wt% ozone in 98 wt% oxygen was delivered into the nucleus pulposus, and 7-9 mL into the adjacent paravertebral tissues. The oxygen/ozone treatment was followed by a periganglionic injection of corticosteroid and bupivacaine. All patients were evaluated 1 month after the treatment to quantify improvement in pain and function, and to monitor for potential adverse events. RESULTS: Forty-four patients had intradiscal injections and were included in the analysis. After 1 treatment, 75.0% showed significant improvement in pain based on the visual analog scale (improvement >1.8), 72.7% showed significant improvement in function based on the Oswestry disability index (improvement >15%), and 79.5% showed improvement based on the modified MacNab criteria. There were no adverse events associated with the treatment. CONCLUSIONS:Patients showed significant improvement in pain and function after receiving ozone injections in combination with steroids and bupivacaine for the treatment of herniated discs. Because of the lack of a control group and short follow-up times, conclusions about the safety and efficacy of ozone injections for the treatment of herniated discs are not warranted. However, the results provide sufficient evidence that the risk and expense of an additional randomized controlled study is merited.
Authors: Federico Bruno; Nicola Carboni; Pierpaolo Palumbo; Francesco Arrigoni; Marco Varrassi; Antonio Izzo; Nadia Catallo; Ernesto Di Cesare; Carlo Masciocchi; Alessandra Splendiani; Andrea Giovagnoni; Antonio Barile Journal: Interv Neuroradiol Date: 2021-09-13 Impact factor: 1.764