User Guide

Patient Trial Handbook
34
implanted with a SCS system. In this study, 27/41 patients, 66%, had permanent implants.
All patients were examined after 6 weeks. Pain measurements were assessed at 3-6 month
intervals for the first year and annually thereafter. The median long-term follow-up was 34
months. A total of 24/27 (89%), reported greater than 50% reduction in pain. Since the
majority of the patients were treated for FBSS, this article supports the use of SCS for the
treatment of FBSS.
In this study, one patient required a revision because of electrode fracture. One patient
required removal of the system due to local infection. One patient required replacement of
the IPG due to mechanical failure. Overall, 16 of 27 (59%) patients required a total of 36
repositioning procedures.
A retrospective analysis performed by Hassenbusch SJ et al. 1995 included patients with
chronic lower body pain, predominately neuropathic pain and pain either midline lower
back and/or unilateral or bilateral leg pain treated over a 5 year period. The study was a
comparison of SCS to spinal infusion of opiods. For patients with radicular pain involving
one leg with or without unilateral buttock pain, a trial of SCS was recommended first. For
patients with midline back pain and /or bilateral leg pain, a trial of long-term spinal infusion
was recommended first. If the patients failed screening with either of these modalities, the
other was then tested. If the treatment reduced the pain by 50%, the systems were