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INTRODUCTION

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This chapter deals with screening trials for the use of spinal cord stimulation (SCS) to treat otherwise intractable pain. The same general principles, however, apply to other types of neuromodulation for pain, such as peripheral, cortical, and deep brain stimulation, and stimulation for conditions other than pain.

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SPECIFIC PURPOSES OF AN SCS SCREENING TRIAL

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  • To identify candidates for successful therapeutic chronic use of a stimulator and save the expense and morbidity of implantation in patients likely to be therapy failures.

  • To predict the technical success of SCS (overlap of pain with a comfortable level of paresthesia and no motor reaction).

  • To predict the clinical success of SCS (usually defined as ≥ 50% pain relief despite provocative activities, patient satisfaction with the treatment, and no increase in adjunct pain therapy).

  • To determine if the patient can tolerate the sensation of paresthesia and can use the equipment successfully.

  • To confirm patient compliance and validate patient reports by tracking usage.

  • To reveal the electrode level and stimulation configuration that will optimize technical and clinical success.

  • To gain information that will influence the choice of electrode(s) and the choice (rechargeable versus non-rechargeable) and location of the pulse generator in patients who proceed to implantation.

  • To comply with the requirements of Medicare and many third-party payers.

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APPROPRIATE PATIENT DIAGNOSES

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  • In many cases, the diagnosis underlying a chronic pain problem, and thus its prognosis and optimum treatment, is unclear.

  • Experimental animal1 and human2 models indicate that SCS is more effective for neuropathic than for nociceptive pain.

  • Animal models3 and clinical results point to the effectiveness of SCS for certain types of ischemic and visceral4 pain.

  • We consider an SCS trial in a patient who has persistent or recurrent, otherwise intractable pain of the trunk and/or limbs. To the extent that a screening trial is a relatively low-risk, low-cost procedure, it is reasonable to offer screening liberally, ie, in cases in which the expected yield of success might be relatively low—in conjunction with critical interpretation of the results of the trial.

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OFF-LABEL INDICATIONS OF SCS FOR PAIN

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  • Angina pectoris has been a popular indication for SCS in Europe,5 but is considered off-label by US manufacturers of SCS equipment. The yield of SCS screening trials in patients with angina pectoris is so high that the trial is often abbreviated or eliminated.

  • Peripheral vascular disease causing limb pain, although clearly involving the areas covered by the US labeling language (pain of the trunk and limbs), is viewed conservatively as well. SCS can have a positive affect on blood flow, but this is not among the US label indications.

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RELEVANT ANATOMY

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  • The effects of SCS vary according to which neural structures are stimulated.

  • The location of the electrode (vertebral level6 and distance from the physiologic midline of the ...

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