User Manual

Introduction
5
required device removal; a new device was later implanted. Two
patients had the device removed due to unsatisfactory pain relief.
The prospective study performed by Villavicencio et al. 2000
included 41 patients with pain of various etiologies. The majority of
the patients, 24 (59%), had Failed Back Surgery Syndrome (FBSS), 7
(17%) had Complex Regional Pain Syndrome (CRPS I and II), 4
(10%) had neuropathic pain syndrome, and 6 (15%) were diagnosed
as stroke or other. Patients underwent an initial trial period for SCS
with temporary leads. If the trial resulted in greater than 50% reduc-
tion in the patient’s pain, as measured by the VAS, the patient was
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 frac-
ture. One patient required removal of the system due to local infec-
tion. One patient required replacement of the IPG due to mechanical
failure. Overall, 16 of 27 (59%) patients required a total of 36 reposi-
tioning procedures.
A retrospective analysis performed by Hassenbusch SJ et al. 1995
included patients with chronic lower body pain, predominately neuro-
pathic pain and pain either midline lower back and/or unilateral or
bilateral leg pain treated over a 5 year period. The study was a com-
parison of SCS to spinal infusion of opiods. For patients with radicu-
lar 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 internalized. A retrospective analysis of