If nothing else cures your back pain, would barbecuing a spinal disk help?
In the endless battle against back ailments, some 35,000 to 40,000 patients have turned to a new procedure that uses heated probes to try and heal painful spinal disks. About 3,500 doctors have already been trained in the procedure, known as IDET for Intradiscal Electrothermal Therapy, since its introduction in 1998.
But so far there is no compelling, published evidence that it can relieve back pain. Although the approach has been marketed as an alternative to expensive and risky spinal-fusion surgery, some doctors say that’s not appropriate and believe that IDET has spread too fast, due in part to aggressive marketing.
Back pain is a particularly fertile field for new procedures because it remains so difficult to treat. One study says that 1% of Americans are chronically disabled by back pain. And about 80% of the time patients report pain to doctors, there isn’t clear agreement in medical literature about what the treatment should be.
For years, patients with chronic pain that hasn’t responded to other treatments have turned to fusion surgery, an invasive procedure in which spinal vertebrae are fused together. Some 250,000 or more fusion operations are done a year.
But outside of very specific situations, involving “spinal instability,” for instance, research hasn’t definitively established much of a benefit. In fact, a significant number of patients will actually be worse off after fusion surgery, which can trigger a painful phenomenon known as “failed back syndrome.”
IDET was developed as an alternative to fusion, says Jeffrey Saal, one of the inventors. The idea is to seal cracks and stiffen the disk by means of heat, while also killing off (perhaps temporarily) nerves that are hurting. IDET is an outpatient procedure done through a small incision in the back.
Early studies suggested that it might work in certain circumstances. But many researchers and analysts say those studies didn’t meet the highest research standards. Moreover, most of the positive early studies of IDET were done by researchers with financial ties to Oratec Interventions, the company selling the equipment used in the procedure. This isn’t unusual, but it does indicate that more independent research is necessary.
In the absence of a critical mass of independent research, most insurers don’t routinely cover the procedure. Prices range widely, but IDET can cost up to about $10,000 including physical therapy. While spinal-fusion surgery costs more at $45,000 to $100,000, fusion is covered by insurance.
Still, despite the questions surrounding the research, IDET has grown. That’s in part because doctors have been eager to find new treatments for back pain. But there is also evidence that the procedure was marketed to doctors too widely. Oratec received warning letters from the Food and Drug Administration in recent years for promoting the procedure for unapproved uses, such as “chronic lower back pain,” when the device had been approved for narrower uses such as treating herniated disks.
Some doctors say IDET has been used on many patients who don’t fit the original criteria, and as a result, too many patients are undergoing procedures for which they receive no benefit.
The procedure was marketed “as an alternative to spinal fusion,” says Richard Deyo, a physician and professor at the University of Washington. But the treatments aren’t interchangeable, he says. IDET could have been appropriately marketed as an alternative to painkilling drugs such as aspirin or Aleve, says Dr. Deyo. “But marketing IDET as alternative to fusion makes it sound more major and more important.”
A spokesman for Smith & NephewPLC, which bought Oratec early last year, says that Oratec didn’t promote the use of IDET beyond the intended use. He says that while prior research hasn’t won over insurers, the company hopes new research will establish IDET as an accepted back treatment.
In fact, some new research in the works does suggest that IDET may be helpful for certain patients — those who have a tear on the outside of a disk and feel pain at the site of the damage, but who don’t have major disk degeneration. That’s a much narrower set of patients than have been offered the procedure, and not necessarily the same patients who should be considered for fusion surgery.
The study, which hasn’t been published yet in a peer-reviewed medical journal, says that of the 32 people who received the procedure, 79% reported improvement in their pain six months later, including 38% whose pain improved by more than 50%. The author, Kevin Pauza of the Texas Spine and Joint Hospital in Tyler, Texas, has no financial ties to Oratec, though one of his statisticians was once employed by the company.
Dr. Pauza says the study is statistically valid, though he notes that the placebo effect was “substantial.” There were 24 patients randomly selected to get a sham placebo surgery, and 45% of those reported their pain got better — including 33% whose pain improved by more than 50%.
The bottom line for patients: Consider carefully whether the procedure is right for you. Vijay Vad, a sports-medicine doctor at Cornell University Medical Center’s Hospital for Special Surgery, says that IDET can be helpful for perhaps only one in 10 patients, often younger than 45 and without major disk degeneration, who haven’t responded to exercise.
“The reason IDET has gotten a bad name in the community is that people are doing it on everyone,” Dr. Vad says.