SIR Abstract of the Year study highlights promising treatment option for lumbar disc herniation with radiculopathy
TORONTO, ONTARIO, January 17, 2023—Minimally invasive image-guided therapy company, SpinaFX Medical Inc. (SpinaFX), applauds the results of a randomized control trial conducted in Europe that demonstrated non-inferiority of intradiscal oxygen-ozone therapy to microdiscectomy for lumbar disc herniation symptom relief.
The study, published in Volume 22, Issue 6 of The Spine Journal, was recognized as a 2022 Abstract of the Year at the Society of Interventional Radiology Annual Meeting in June 2022.
“The study’s findings hold great promise for closing the therapeutic gap in the continuum of care for those suffering with pain due to contained lumbar disc herniation,” said SpinaFX Medical CEO Jeff Cambra. “Back pain is a pervasive issue and expanding use of this treatment option provides hope for millions of sufferers.”
Key findings of the study include:
- Both intradiscal oxygen-ozone and microdiscectomy for lumbar disc herniation produced rapid and statistically significant improvements in leg pain, functional disability and quality of life that persisted in follow-up care.
- Intradiscal oxygen-ozone was non-inferior to microdiscectomy based on overall six-month improvements in mean leg pain scores.
- Lumbar disc herniation leg pain can be effectively treated with a single intradiscal oxygen-ozone injection.
- Intradiscal oxygen-ozone procedures are quicker than microdiscectomy and patients are discharged significantly sooner.
- Intradiscal oxygen-ozone therapy can potentially reduce the number of those requiring microdiscectomy for lumbar disc herniation leg pain.
“I have studied intradiscal ozone for the treatment of herniated lumbar discs for 17 years and believe in the treatment’s potential to fundamentally change the treatment journey of a patient with a herniated disc,” said Dr. Kieran Murphy, SpinaFX Chief Medical Officer and co-author of the study. “This first-of-its-kind study has exciting implications for the future of treatment for suffering patients.”
The multicenter randomized control trial was administered at three European hospital spine centers. The 49 participants had single level contained lumbar disc herniation with radicular leg pain for more than six weeks that was resistant to medical management. Of the 49 participants, 25 patients were randomly assigned to receive intradiscal oxygen ozone, and 24 were randomly assigned to undergo microdiscectomy. Forty-three patients, or 88 percent of study participants received the treatment assigned to them. The primary outcome that investigators evaluated was six-month improvement over baseline leg pain.