• F T Wetzel, S Hassenbusch, J C Oakley, K D Willis, R K Simpson, and E L Ross.
• Department of Surgery, Section of Orthopedic Surgery and Rehabilitation, and Anesthesia and Critical Care, The University of Chicago Spine Center, Section of Orthopedic Surgery, Louis A. Weiss Memorial Hospital, Chicago, Illinois, USA.
• Neuromodulation. 2000 Apr 1;3(2):59-74.

AbstractObjective. The authors attempted to design and conduct a randomized, prospective study to investigate the efficacy of spinal cord stimulation (SCS) for patients with chronic back and leg pain following at least one previous surgery. While the scientific advantages of the randomized, prospective trial are considerable, the authors encountered numerous practical and ethical difficulties with conducting these trials. These are reviewed and an alternative investigative technique proposed. Materials and Methods. The literature on interventional and minimally invasive treatments for this population group is reviewed, and the strengths and weaknesses of different methodologies for conducting clinical research in an interventional setting are examined. Results. The difficulties inherent in a randomized, prospective study for an intervention vs. a nonintervention group are addressed, and an alternative methodology is proposed-that of a randomized interventional design. In this design, patients are assigned to a given treatment group, with each treatment exclusively available at different centers. Conclusions. By utilizing a randomized interventional study design, problems of comparability of procedures, provider reluctance to participate in randomized clinical trials, provider bias, detection bias, and transfer bias are eliminated. It is suggested that future investigations, particularly those which are interventionally or device-based, conform to this particular model.

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