Nevada-Based Active O, Inc. Kicks off New Clinical Trial Studying Non-Surgical Treatment for Lower Back Pain

A clinical trial being conducted at several high-profile centers in Canada, sponsored by Incline Village-based Active O, Inc., has begun recruiting patients to investigate a new, non-surgical treatment for lower back pain caused by a contained herniated disc.

The trial is studying a minimally invasive injection of natural gases designed to dissolve a small amount of disc tissue in order to resolve the disc herniation. The treatment does not use a high-temperature device and avoids surgical removal of the tissue.

The first sites in North America to study this novel treatment are the University of British Columbia in Vancouver, Toronto Western Hospital for the University Health Network, University of Toronto, and the London Health Sciences Centre, University Hospital, in London, Ontario.

A meta-analysis of 8,000 patients undergoing this treatment in Europe showed that more than 70 percent experienced improvement in their pain, with a very low rate of complications1.

“For patients that have failed conservative therapy and steroid injections, their only options today are prescription medication or surgery,” said James Rybicki, Chief Executive Officer of ActiveO. “In this clinical trial, the Canadian investigators are exploring a promising, less invasive option to fill this treatment gap that is designed to provide patients with resolution of their back pain.”

Contained herniated discs, often called “bulging discs,” occur when the outer layer of the disc weakens and the inner core of the disc bulges into the area where the nerves are located. This common condition can cause pain down the leg or in the lower back.

This treatment is considered investigational and is not authorized for sale in the United States or Canada.

1Steppan J, Meaders T, Muto M, Murphy KJ. A meta-analysis of the effectiveness and safety of ozone treatments for herniated lumbar discs. JVIR 2010;21(4):534-548.