Study comparing Plasma Disc Decompression with epidural steroid injections for lumbar disc herniation

Mar 31 2010

ArthroCare Corp. (NASDAQ: ARTC), a leader in developing state-of-the-art, minimally invasive surgical products, announced today the publication of an important clinical trial demonstrating that patients treated with ArthroCare's Plasma Disc Decompression (PDD) products experienced reduced pain and better quality of life scores compared to patients treated with the current standard care, epidural steroid injections.

“Plasma Disc Decompression compared with fluoroscopy-guided transforaminal epidural steroid injections for symptomatic contained lumbar disc herniation: A prospective, randomized, controlled trial”

The multi-center study, which is titled "Plasma Disc Decompression compared with fluoroscopy-guided transforaminal epidural steroid injections for symptomatic contained lumbar disc herniation: A prospective, randomized, controlled trial," was published in the April 2010 issue of the Journal of Neurosurgery: Spine.

This prospective, controlled and randomized study enrolled 90 patients (18 to 66 years old) with low back pain associated with contained herniated discs and who had previously failed conservative care and one epidural steroid injection. Low back pain can be caused when a disc becomes injured and bulges into adjacent nerves in the spine. These patients are usually treated with a regimen of medical care and physical therapy which will reduce the pain for many. However for a significant portion of patients, the pain will persist and is later treated with injection of steroids or surgery. Epidural steroid injections are considered to be the standard care for patients experiencing low back pain caused by contained herniated discs.

Patients were placed randomly into two groups, a PDD arm and an epidural steroid injection arm and were later evaluated for pain reduction and quality of life over a two-year period. The study concluded that patients in the PDD group experienced clinically important improvements compared to patients in the epidural steroid injection group. After a two-year follow-up period, 56 percent of patients in the PDD group did not have a subsequent secondary procedure, compared with only 28 percent of the patients in the epidural steroid group.

Peter C. Gerszten, MD, MPH, Associate Professor of Neurological Surgery, at the University of Pittsburgh Medical Center, and principal investigator of the clinical study commented, "This study provides evidence that patients with low back pain associated with a contained disc herniation achieve better outcomes with Plasma Disc Decompression as compared to conventional treatment with epidural steroid injections."

ArthroCare's PDD products are minimally invasive and can be used in an out-patient basis. The products are used surgically to remove a tiny portion of a contained herniated disc. The products are recommended for those patients with contained herniated discs that have not ruptured. More aggressive surgical options have included laminectomy where portions of a vertebra are removed, or discectomy where most or the entire disc is removed.