New treatment uses ozone and oxygen in hand-held device to treat herniated discs
Patients and radiologists at Vancouver General Hospital are the first in North America to test an ozone/oxygen injection treatment to alleviate the pain from herniated discs in the lower back, a condition affecting at least five per cent of adults.
The treatment uses a combination of oxygen and ozone gas because its oxidating effect has been shown to shrink bulging discs, reducing compression by pulling the herniated part away from nerve roots.
Dr. Peter Munk, the Vancouver radiologist who’s leading the local study and is head of the musculoskeletal division at the University of B.C. and VGH, said a 2010 meta-analysis looked at results from about a dozen studies involving 8,000 European patients.
“There was a strong suggestion that patients got better more rapidly with the treatment. What we’re hoping to see here is that through the ozone process, healing will occur rapidly and patients won’t need other interventions like repeated steroid (cortisone) injections and surgery,” said Munk, who is also editor of the Canadian Association of Radiology journal and has no financial interest in the new therapy.
“The disc is like a fibrous doughnut and you get a herniation when an inner part of the disc bulges out through a weakened area,” Munk said, adding that the vast majority (95 per cent) of herniations occur in the lower back (lumbar) area, where they cause pain in the back and legs by pinching on spinal nerves.
The main objective of the clinical trial, now recruiting 25 participants, is to assess the safety of a new Canadian-engineered injection delivery system for the ozone-oxygen therapy. Discs are like the shock absorbers between the vertebrae; the experimental treatment requires radiologists to use CT imaging so they can guide the needle precisely into the centre of the herniated disc.
The procedure takes 20 minutes and, as an outpatient service, should cost the health care system far less than surgery, according to Active-O, Inc., the company which is sponsoring the trial and owns rights to the AO-1000 treatment, developed by Toronto radiologist, Dr. Kieran Murphy, of the University Health Network.
The injectable gas treatment is widely used in Asia and Europe but Murphy’s invention is a new hand-held device which utilizes a special syringe to deliver the treatment. The conventional system is more cumbersome as it uses ozone from massive machines that can only be located in certain hospital settings. The new system involves an oxygen supply from a small canister. Oxygen is drawn into the syringe and with the flick of a button on the hand-held device, an electrical charge generates ozone that is then injected into the lower back area.
Surgery is usually reserved for the worst cases, and involves removal of a portion of the diseased disc and fusion of the vertebrae. Munk said the ozone-oxygen treatment is not meant for the worst cases. it’s intended for the most common types — bulging (contained) herniated discs.
Although infection, bleeding and embolisms are worst-case complications of the ozone treatment, previous studies have shown such risks are less than one per cent or one in 1,500 patients. Even though the new device is being used on humans for the first time (it was previously tested in animals) ActiveO says the design of the device and the use of imaging guidance should all but eliminate risks.
According to the meta-analysis of ozone treatments for herniated lumbar discs, published in the Journal of Interventional Radiology, Italians were the first to inject one to three ml of ozone/oxygen into herniated discs in the 1990s. The study was partly funded by ActiveO, and authors, including Murphy, declared direct or indirect financial relationships with the company.
While ozone therapy has been used extensively in other parts of the world for disc herniation treatment, it is still considered a toxic gas when inhaled and it is controversial as an alternative treatment for other diseases.
Alternative health practitioners have touted it as a remedy because it has been shown to deactivate disease particles in laboratory situations. But there’s a paucity of evidence to support the theory that ozone increases oxygen in the body and that cancer or other diseases won’t thrive in a high oxygen environment.
For more information on enrolment in the VGH disc herniation trial, call 604-875-4612. Munk said hospitals in Alberta and Ontario are also expected to participate in the trial.