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
Around the world, medical professionals turn to Kimberly-Clark for a wide
portfolio of solutions that improve the health, hygiene and well-being of
patients and hospital staff. As part of their healing mission, caregivers rely
on Kimberly-Clark to deliver clinical solutions and educational resources that
they can depend on to prevent, diagnose and manage a wide variety of
healthcare-associated infections. As a global enterprise with more than $1
billion in annual sales, Kimberly-Clark Health Care holds the No. 1 and No. 2
market share positions in several categories including; infection control
solutions, surgical solutions, pain management and digestive health. Throughout
the care continuum, patients and staff alike trust Kimberly-Clark medical
supplies and devices, KLEENEX tissues, Kimberly-Clark Professional skin care
products and SCOTT towels for day-to-day needs. For more information, please
visit http://www.kchealthcare.com
