A landmark double-blind, placebo controlled medical device study, "Randomized Placebo-Controlled Trial of Intradiscal Electrothermal Therapy (IDET™) for Treatment of Discogenic Low Back Pain," Kevin Pauza, M.D., et al., was one of only three clinical studies to receive an Outstanding Paper Award during today's North American Spine Society (NASS) 2003 Annual Meeting.
The IDET™ Procedure is a minimally invasive procedure for chronic low back pain patients that have failed to respond to aggressive, non-operative therapies. It is a product of Smith & Nephew, Inc., Endoscopy Division, a subsidiary of Smith & Nephew plc (NYSE: SNN) (London Stock Exchange: SN).
In the study, conducted by Kevin Pauza, M.D., at the Texas Spine and Joint Hospital, Tyler, Texas, 65 patients either received The IDET™ Procedure or a placebo procedure. The principal investigator (Dr. Pauza) remained blinded to the subject's randomization until after the patient was sedated. Identical post-procedural protocols were followed by both groups, including wearing a lumbar brace for six weeks and performing monitored exercise therapy. The subjects, therapists and an independent outcome evaluator remained blinded during the procedure and for six months post-procedure.
The study concluded that a statistically significant improvement in pain levels six months after The IDET™ Procedure was observed in patients who received The IDET™ Procedure when compared to the placebo group. Following the study, patients in the placebo group were offered The IDET™ Procedure as treatment.
"We offer our congratulations to Dr. Kevin Pauza and other members of the clinical research team on this significant accomplishment," commented John Konsin, vice president, Smith & Nephew Endoscopy. "The resources, determination and attention to detail required to execute a clinical study of this caliber is almost unheard of within the medical device industry."
Outstanding Paper recipients will also have their studies published in the peer-reviewed and official journal of NASS, The Spine Journal, in an early 2004 issue.