ROCKVILLE, Md., July 2, 2014 /PRNewswire-USNewswire/ -- The addition of a corticosteroid to epidural injections of an anesthetic does not enhance pain reduction in patients with lumbar spinal stenosis, a common cause of lower back and leg pain, according to a study in the July 3 issue of New England Journal of Medicine. The findings come from the first major clinical trial comparing epidural injections of anesthetic with and without corticosteroids for spinal stenosis.
Researchers funded by the Agency for Healthcare Research and Quality (AHRQ) studied patients six weeks after treatment and found those whose lidocaine anesthetic was supplemented with a corticosteroid—a steroid medication often used to relieve swelling—experienced minimal to no additional benefit compared with patients who received injections of anesthetic alone.
"The pain associated with lumbar stenosis can be excruciating, and patients are understandably looking for relief," said AHRQ Director Richard Kronick, Ph.D. "This study raises questions about the benefits of combining corticosteroids with an anesthetic for patients with lumbar stenosis, and it will help patients and their physicians make better informed decisions about treatment options."
Lumbar spinal stenosis is a common cause of back-related disability. It is caused by gradual changes, often age related, that cause the spinal canal to narrow and press against nerves. This leads to back and leg pain, a tingling sensation in the legs and weakness. It is the leading reason for back surgery in older adults.
Epidural injection of anesthetic with corticosteroid is a common treatment for lumbar spinal stenosis. The combination has been hypothesized to relieve pain by reducing nerve swelling and increasing blood flow. It is estimated that more than 2.2 million lumbar epidural steroid injections are performed each year among Medicare patients. Rates and associated costs of the procedure have increased nearly 300 percent over the last two decades.
This study, the Lumbar Epidural steroid injections for Spinal Stenosis (LESS) trial, was led by Janna L. Friedly, M.D., assistant professor in the Department of Rehabilitation Medicine at the
University of Washington in Seattle. It was conducted at 16 hospitals in the United States and included 400 patients aged 50 and older with evidence of lumbar stenosis and at least moderate pain. Half of the patients in the trial received epidural injections of anesthetic with corticosteroid, the other half received injections without corticosteroid.
The researchers found that patients combining corticosteroids and lidocaine were more likely to report side effects, and were more likely to absorb the corticosteroid into their bloodstream. Taken over time, corticosteroids can result in reduce bone density, increased risk of bone fracture and immunosuppression. Steroids also are a common cause of adverse drug events, according to AHRQ's Healthcare Cost and Utilization Project data.
"This is the first large, multicenter randomized trial to look at epidural steroid injections for spinal stenosis, and we found that injection with corticosteroids and lidocaine provided these patients with minimal or no additional benefit over lidocaine injections," Dr. Friedly said. "If patients are considering an epidural injection, they should talk to their doctor about the benefits and risks of the options available.
The article, "A Randomized Trial of Epidural Steroid Injections for Spinal Stenosis," was funded through an AHRQ Clinical and Health Outcomes in Comparative Effectiveness grant with money from the American Recovery and Reinvestment Act of 2009. AHRQ, a research agency within the U.S. Department of Health and Human Services, is the lead federal agency charged with producing evidence to make health care safer, higher quality, more accessible, equitable and affordable, and to work with HHS and other partners to make sure that the evidence is understood and used. For more information, visit www.ahrq.gov.
Editor's Note: In April 2014, the Food and Drug Administration issued a MedWatch alert on corticosteroid injections in the neck. That alert can be found at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm394530.htm.
SOURCE Agency for Healthcare Research & Quality