Kimberly-Clark Health Care has announced positive outcomes of a randomised controlled trial on the use of its Sinergy cooled radiofrequency system to treat sacroiliac joint 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 enrolled 51 patients with 34 in the treatment group and 17 in the sham group. At the three-month follow-up, 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% of treated subjects achieved treatment success. Nilesh Patel, Advanced Pain Management, Green Bay, USA, led the study.
“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 Patel. “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.”
According to the National Institute of Neurological Disorders and Stroke, approximately four out of five adults in the United States will experience chronic axial low back pain and sacroiliac joint pain accounts for between 18 and 30%. This number converts to Americans spending at least US$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 Sinergy cooled radiofrequency system
Cooled radiofrequency is a minimally-invasive treatment for difficult-to-treat spine anatomy. The 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, radiofrequency 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.