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March 1, 2013 /PRNewswire/ -- Kimberly-Clark today announced the publication of two separate studies that achieved positive outcomes following use of
cooled radiofrequency (RF) to treat discogenic and sacroiliac joint (SIJ) pain in the low back. The studies evaluated
Clark's TransDiscal Cooled Radiofrequency System and SInergy Cooled Radiofrequency System and demonstrated that both treatment options provided patients who suffer from chronic low back pain with much-needed pain relief and improved quality of life benefits. Results were published in
Pain Medicine, the official journal of the American Academy of Pain Medicine, the Faculty of Pain Medicine of the Australian and
New Zealand College of Anesthetists, and the International Spine Intervention Society.
Leonardo Kapural of Carolinas Pain Institute and Wake Forest Brookstown Pain Center in
Winston-Salem, N.C., led the first-of-its-kind
double-blinded randomized controlled trial study of 59 patients with 29 randomized to intradiscal biacuplasty (IDB) and 30 to the control group. Participating patients had a history of chronic low back pain persisting six months or longer. This type of pain is extremely debilitating, and it dramatically limits an individual's everyday activities such as sitting and driving. At the six-month follow-up, patients treated with
Clark's TransDiscal Cooled RF System reported significantly greater improvements in restoration of physical function, and a decrease in pain, disability and opioid usage compared to patients in the control group. The study was conducted at the Department of Pain Management at the Cleveland Clinic in
Cleveland, Ohio, and the Center for Clinical Research at Carolina's Pain Institute in
"Discogenic low back pain accounts for the majority of chronic low back pain. Traditional treatment options include pharmacologic, physiotherapy and surgical options such as spinal fusion or artificial disc replacement. These data are particularly encouraging because there is now additional, compelling evidence to suggest a minimally-invasive approach, such as cooled radiofrequency, can provide sustained relief to a carefully selected group of patients," said lead clinical investigator
Leonardo Kapural, M.D., Ph.D. "In this study, patients treated with the TransDiscal Cooled RF System experienced clinically significant improvements in physical function compared to those in the control group."
In the same edition of
Pain Medicine, a retrospective chart review found the use of cooled RF to be significantly effective for the treatment of SIJ low back pain. The European
study, led by Dr.
Wolfgang Stelzer of the Medical University of
Vienna, Austria, examined the electronic records of 126 patients treated with
Clark's SInergy Cooled RF System for SIJ pain. The retrospective chart review showed promising, durable improvements in pain, quality of life and reduction in medication usage.
At the one-year follow-up, 67 percent of patients stopped or decreased use of opioids, 48 percent of patients reported significant reduction in pain scores and 85 percent stated quality of life was improved or much improved. In some patients, relief was maintained up to 20 months.