Kimberly-Clark Health Care today announced the results of a randomized controlled trial on the use of cooled radiofrequency (RF) to treat sacroiliac joint (SIJ) pain in the lower back. The results were published in the March edition of Pain Medicine, 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.

The study used the SInergy Cooled Radiofrequency System manufactured by Kimberly-Clark Health Care. At the three-month follow-up, those patients treated with cooled radiofrequency showed significant improvements in pain, disability and quality of life outcomes. The durability of the relief was maintained at the nine-month follow-up where 59 percent of treated subjects achieved treatment success. Cooled radiofrequency is a minimally-invasive treatment for difficult-to-treat spine anatomy. SInergy Cooled Radiofrequency System is intended to target and treat the pain-generating nerves in the lower back and buttock region that may be responsible for sacroiliac joint pain. Internally cooled, RF electrodes have been applied in pain medicine to overcome the challenges of capturing diffused or inconsistently located target structures through larger lesion formation. The treatment approach can greatly reduce low back pain and potentially even eliminate it.

Dr. Nilesh Patel of Advanced Pain Management in Green Bay, Wis., led the study which enrolled 51 patients with 34 in the treatment group and 17 in the sham group.

"Chronic sacroiliac joint pain is a debilitating and painful condition and treatment-as-usual has failed many of these patients. The trial results indicate cooled radiofrequency is a much-needed interventional treatment that offers a safe and effective option for alleviating chronic, difficult-to-treat low back pain," said lead clinical investigator Nilesh Patel, M.D. "It is significant to find that, over time, patients report less pain and discomfort and are able to resume a more active lifestyle and do the things they love. The duration and magnitude of relief with the SInergy Cooled Radiofrequency System was consistent with previous conducted studies with beneficial results extending well beyond nine months."

Approximately four out of five adults in the United States will experience chronic axial low back pain and SIJ pain accounts for between 18 and 30 percent. This number converts to Americans spending at least $50 billion each year on low back pain, making it the most common cause of job-related disability and a leading contributor to missed work. 

About the Clinical Trial

Baylis Medical Company sponsored the trial and was the original developer of the SInergy System, which was acquired by Kimberly-Clark Health Care in 2009.

Kimberly-Clark in the Healthcare Environment

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