Intradiscal oxygen-ozone therapy had similar clinical improvements vs. microdiscectomy
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Intradiscal oxygen-ozone chemonucleolysis met non-inferiority criteria and achieved similar rapid, significant clinical improvements as microdiscectomy in patients with single-level lumbar disc herniations, according to results.
“[Intradiscal oxygen-ozone] is a simple procedure that is good for patients, that gives them pain relief upfront [and] that avoids the long-term degenerative consequences of open surgery, but it does not preclude surgery if they need it,” Kieran Murphy, MD, FRCPC, co-author of the study and professor of interventional neuroradiology at the University of Toronto, told Healio about results presented at the Society of Interventional Radiology Annual Meeting.
Intradiscal oxygen-ozone vs. microdiscectomy
Murphy and colleagues randomly assigned 49 patients with a single-level contained lumbar disc herniation, radicular leg pain for more than 6 weeks and who were resistant to medical management to undergo either intradiscal oxygen-ozone chemonucleolysis (n=25) or microdiscectomy (n=24). Researchers considered overall 6-month improvement over baseline in leg pain as the primary outcome, while back numerical rating pain scores, Roland Morris Disability Index and EuroQol-5D were considered other validated clinical outcomes. Outcomes were collected at baseline and postoperatively at 1 week and at 1, 3 and 6 months.
Murphy noted 71% of patients in the oxygen-ozone group avoided microdiscectomy. Compared with baseline, both the intradiscal oxygen-ozone and microdiscectomy groups had rapid and statistically significant improvements in leg pain, back pain, Roland Morris Disability Index and EQ-5D that persisted in follow-up, according to results.
“What we saw was a gradual reduction in disc volume and the ozone group did not develop post-surgical degenerative changes, whereas the surgical group developed facet hypertrophy and endplate degenerative changes,” Murphy said. “So, there is a significant clinical impact from the procedure and upfront pain relief, but then you avoid the long-term degenerative complications of discectomy.”
Future approval
Results also showed the two groups had no significant between-group differences for any outcomes, and the difference between the two groups did not exceed the non-inferiority 95% confidence lower limit of treatment difference at either the as-treated or intention-to-treat populations.
While currently used to treat patients on a special access approval in Canada, Murphy noted researchers will apply for approval from the FDA and Health Canada soon.
“For me, what I like is [the intradiscal oxygen-ozone therapy] can be done anywhere. It can be done in a developing country, or it can be done in New York City,” Murphy said. “The amount of infrastructure needed to do this is little. If you have the equipment to do an image-guided nerve root block, you can do this.”
References
Kelekis A, et al. Spine J. 2022;doi:10.1016/j.spinee.2021.11.017.
Murphy K, et al. Intradiscal oxygen-ozone chemonucleolysis versus microdiscectomy for lumbar disc herniation radiculopathy: A non-inferiority randomized controlled trial. Presented at: Society of Interventional Radiology Annual Meeting. June 11-16, 2022; Boston.
SpinaFX Medical to exhibit at Society of Interventional Radiology Annual Scientific Meeting. https://www.prnewswire.com/news-releases/spinafx-medical-to-exhibit-at-society-of-interventional-radiology-annual-scientific-meeting-301565649.html. Published June 10, 2022. Accessed June 17, 2022.
Perspective
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Each arm of the study had a drop-out rate that exceeded the 10% predicted. Only 19 of 25 patients in the oxygen therapy group had a data set available for 6-month evaluation. Of those 19 patients, eight patients had undergone surgical intervention by 6 months. In the open discectomy group, 18 of 24 patients were available for 6-month follow-up. Of those patients, two had undergone secondary procedures.
There was no nonoperative arm provided for comparison to evaluate the natural history. A limited 6-month post-treatment analysis is provided. The authors state that 71% of the oxygen treatment group were able to avoid a discectomy. This seems to assume that none of the 24% of the patients unavailable for 6-month follow-up underwent a discectomy.
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Murphy K, et al. Intradiscal oxygen-ozone chemonucleolysis versus microdiscectomy for lumbar disc herniation radiculopathy: A non-inferiority randomized controlled trial. Presented at: Society of Interventional Radiology Annual Meeting. June 11-16, 2022; Boston.
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