• John C Oakley, Elliot S Krames, John Stamatos, and Allison M Foster.
• Yellowstone Neurosurgical Associates, Billings, MT, USA; Pacific Pain Treatment Center, San Francisco, CA, USA; North Shore University Hospital, Syosset, NY, USA; and Boston Scientific Neuromodulation, Valencia, CA, USA.
• Neuromodulation. 2008 Jan 1; 11 (1): 66-73.

AbstractObjectives.  In spinal cord stimulation (SCS) therapy, limited pain relief during the temporary trial period is generally considered to be predictive of poor long-term benefit. To validate or refute this perception, the long-term outcomes of subjects who reported less than 50% pain relief during a temporary SCS trial were examined. Materials and Methods.  Twelve subjects with intractable pain underwent implantation of trial SCS systems. After a trial period in which they reported less than 50% pain relief, they each received a permanent SCS implant. Pain ratings and complications were tracked for 6-18 months. Results.  At the end of the temporary trial period, the average pain relief was 21%; no subject reported 50% or better pain relief. More favorable outcomes were reported after activation of the permanent system, however. At all follow-up time points, at least a third of the subjects reported better than 50% pain relief, and the average pain relief varied over time between 44% and 83%. All complications were readily resolved and no subjects withdrew from the study. Conclusions.  Although SCS provided limited pain relief during the trial period, efficacy was more satisfactory after permanent implantation. Several subjects went on to experience nearly complete pain relief for up to 18 months (the maximum follow-up visit for study purposes), and no subject chose to discontinue SCS therapy. SCS appears to be a viable treatment option for patients who fail trials, raising some doubt as to the predictive sensitivity and specificity of the trial period. Thus, although outcome of a temporary trial period may be suggestive of later efficacy with SCS, it may not be the sole predictor of success. Alternatively, the arbitrary benchmark of 50% pain relief that is typically used to define the success of a temporary trial may be too stringent and unreliable.

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