Point of view.

Five years after initial reports and several years after widespread use of intradiscal electrothermal therapy (IDET) for chronic discogenic pain, providers and patients now have two randomized trials to inform decision-making. Both are impressive in that they are placebo-controlled; patients underwent either full catheter insertion in the Freeman et al study or a sham needle insertion in the previously published study by Pauza et al. The Pauza et al study showed modest overall benefit, although many patients did not seem to improve at all. The study by Freeman et al in this issue of Spine showed no substantial benefit from the IDET procedure. Freeman et al are to be congratulated on a very transparent study; readers should note that the 2 patients who withdrew from the intervention group for “protocol violations,” including 1 patient who underwent an operative fusion, are not included in the analysis. Inclusion of these patients in the active treatment group would likely have made the active treatment group perform even more poorly than reported. Thousands of IDET procedures have been performed, yet only 121 patients have been enrolled in randomized trials in these two studies. The Freeman et al study had only 19 patients enrolled in the sham group. What should clinicians tell their patients with chronic back pain when they ask about the advisability of this procedure? Although the two randomized trials had somewhat different sham techniques and somewhat different severity of patient disease, even the most optimistic interpretation of these two studies should induce caution in discussing this treatment with patients. Case series of several hundred patients reported by other authors (including the inventors of the procedure) have been much more optimistic, but this is almost always the case with a novel treatment. A more recent case series has shown much less optimistic results. Randomized trials, especially with a placebo-control group, remain the gold standard for demonstration of clinical efficacy. Given the additional results reported in this issue, caution should be advised to patients and providers considering IDET treatment. Of course, many other surgical or invasive injection therapies are in everyday practice without rigorous evaluation, but the claims for the remarkable results of intradiscal therapy published several years ago do not appear to be maintained. Patients contemplating this therapy should be informed of the equivocal nature of evidence regarding long-term benefit and recognize that the treatment has not passed standards of scientific proof. Is the case closed on this technology? Both randomized trials are single-site studies, and the number of patients in the sham “placebo” group is very small. To provide patients with better advice on the advisability of this procedure, a multisite randomized trial is indicated. The trial should be sufficiently powered to detect a clinically significant effect size for the procedure. Patients, insurers, and providers require this information if this procedure is to continue to be offered to patients. The clear message for other novel therapies for spine disease is that earlier utilization of randomized trials is ethical and essential.