AOY: Intradiscal Oxygen-Ozone Chemonucleolysis versus Microdiscectomy for Lumbar Disc Herniation Radiculopathy: A Non-inferiority Randomized Control Trial
Interventional radiologists may provide a more effective and minimally invasive treatment for lumbar disc herniations typically treated by open surgery, according to data from a recent European multicenter pilot trial.
“Intradiscal oxygen-ozone chemonucleolysis versus microdiscectomy for lumbar disc herniation radiculopathy: A non-inferiority randomized control trial,” which was selected for one of the SIR 2022 Abstracts of the Year, investigated the clinical outcomes of intradiscal oxygen-ozone with microdiscectomy in patients with refractory radicular leg pain as a result of contained lumbar disc herniations. The trial indicated that ozone injection is as effective as microdiscectomy for pain relief and that a large percentage of patients receiving oxygen-ozone did not require microdiscectomy.
“This treatment can help about 70% of patients avoid open surgery,” says Kieran J. Murphy, MD, FSIR, lead author of the paper. “It will bring a lot of pain relief and reduction in suffering to patients around the world and will reduce opioid use in patients with disc herniations.”
According to Dr. Murphy, the therapy is performed by injecting O3 or ozone into the lumbar disc, which causes the disc to shrink slightly and decrease the pressure caused by the herniation. This is followed by another injection in the annulus and a nerve root block. “The whole thing takes about 15 minutes, and it’s an outpatient procedure so the patient can go home within an hour and a half,” Dr. Murphy said.
The minimally invasive nature of the therapy is cost effective and doesn’t require hospitalization or anesthesia. According to Dr. Murphy, there is a much lower risk of wound infections, complications or failed back syndromes that come with conventional spine surgery—but the therapy doesn’t preclude the possibility of open surgery in the future.
In addition to cost savings, the technique is accessible. “It crosses economic barriers between luxurious hospitals and community centers in developing nations,” Dr. Murphy says. “If you have a C-arm and a sterile needle, you can do ozone in the disc and treat a herniation.”
“This is a procedure that SIR members can do easily and will enjoy,” Dr. Murphy says. “Even though it sounds a little difficult because ozone sounds like a crazy gas and people may ask, ‘How can a gas dissolve a solid?’” But Dr. Murphy says he and the other investigators have a deep understanding of the mechanism of action, have developed an easily managed device and are creating a solid technique for the procedure. “If you have a rock-solid action, good device and solid procedure, you can teach a technique and have it be the same procedure every time,” Dr. Murphy says. “If people are tired or fatigued, they won’t make mistakes.”
Patients with large disc herniations, who cannot feel their legs, stand or control their bladders, were excluded from the trial, as well as those with herniations so large that the disc material is free within the epidural space. Dr. Murphy says that, at the current time, investigators will focus on patients with large disc bulges or annual tears, who have contained herniations—which is the majority of those with disc disease. “The study focused on those with a single level,” said Dr. Murphy. “In clinical practice, people have one or two levels treated at the same time, but we chose to focus on the lumbar spine, not the cervical spine or thoracic.”
Dr. Murphy believes that patients will drive the success of this therapy, once they understand it offers an option to treating chronic pain. “You get happy patients,” he says. “Happy outcomes are good for patients, and for us. IRs play a crucial role in serious interventions like oncological patients or gunshot wounds, but we need these happy cases to balance us out. And patients have procedures like this and then they bring you fruit cakes and woolen hats. It helps sustain us.”
The technique has been tested in mini pig sham-controlled studies in GLT laboratories with FDA-approved pathologists, gone through clinical trials in Europe and Canada, and now completed a prospective randomized trial against open surgery. According to Dr. Murphy, the next step is to approach the FDA and then conduct a U.S. trial. If any SIR members are interested in being involved in trials, Dr. Murphy encourages them to email or find him at SIR 2022.
