Randomized controlled trials in interventional spine: perils and pitfalls.

It is the responsibility of clinician investigators to advance clinical knowledge and specifically its application to patient care. Randomized controlled trials remain near the top of the hierarchy of evidence based medicine. The acquisition of evidence based medicine by means of randomized controlled trials presents general difficulties and additional pitfalls specific to interventional treatments. The nature of interventional procedures makes the performance of these studies more difficult to plan and execute. To generate clinically useful research results requires an understanding of the mechanics of performing studies and the reporting of methodologies to ensure appropriate interpretation. Placebo arms and sham interventions present serious ethical issues, which must be analyzed on a case by case basis. The conscientious researcher must always abide by the principles of ethical research and the tenets of human subject protection.