A widely used method of treating a common cause of back and leg pain, steroid injections for spinal stenosis may provide little benefit for many patients, according to a new study that experts said should make doctors and patients think twice about the treatment.
The addition of a corticosteroid to epidural injections of an anesthetic does not enhance pain reduction in patients with lumbar spinal stenosis, 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.
Hundreds of thousands of injections are given for stenosis each year in the United States, experts say, costing hundreds of millions of dollars.
But the study, the largest randomized trial evaluating the treatment, found that patients receiving a standard stenosis injection, which combine a steroid and a local anesthetic, had no less pain and virtually no greater function after six weeks than patients injected with anesthetic alone.
“Certainly there are more injections than actually should happen,” said Dr. Gunnar Andersson, the chairman emeritus of orthopedic surgery at Rush University Medical Center in Chicago, who was not involved in the research. “It’s sort of become the thing you do. You see this abnormality on the M.R.I. and the patient complains, and immediately, you send the patient for an epidural injection.”
Mostly, steroid injections are safe, carrying small risks of infection, headaches and sleeplessness. But in April, the Food and Drug Administration warned that they may, in rare cases, cause blindness, stroke, paralysis or death, noting that injections have not been F.D.A. approved for back pain and their effectiveness has not been established.
“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.”
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.