Boston Scientific Neuromodulation Corporation SC5132 Manual De Usuario
Information for Prescribers
Precision Spectra™ System Information for Prescribers
90668515-01 Rev A 2 of 15
90668515-01 Rev A 2 of 15
The prospective study by Ohnmeiss et al. 1996, examined the long-term effectiveness of SCS
in patients with intractable leg pain. Forty patients were implanted with SCS systems and
evaluated at 6 weeks, 12 months, and 24 months follow-up. Outcome measures included the
VAS, pain drawings, medication use, SIP (Sickness Impact Profi le), isometric lower extremity
testing, and patient questionnaires. An intent-to-treat analysis was performed. After patients
had SCS for 24 months, leg pain, pain when walking, standing pain, pain’s effect on overall
lifestyle, and the total analog scale scores were signifi cantly improved from baseline. In this
study, 25% of the implanted patients had greater than 50% improvement in pain rating.
In addition, 3 patients from this study had their stimulators repositioned due to pain at the
original location. Three patients had reoperations to adjust lead position; 1 patient required
2 reoperations, 1 patient had the device removed due to infection and later to have a new
device implanted. A diabetic patient had skin problems which 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% reduction 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
fi rst 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 opioids. For patients with radicular pain involving one leg with or
without unilateral buttock pain, a trial of SCS was recommended fi rst. For patients with midline
back pain and /or bilateral leg pain, a trial of long-term spinal infusion was recommended fi rst.
If the patients failed screening with either of these modalities, the other was then tested. If the
in patients with intractable leg pain. Forty patients were implanted with SCS systems and
evaluated at 6 weeks, 12 months, and 24 months follow-up. Outcome measures included the
VAS, pain drawings, medication use, SIP (Sickness Impact Profi le), isometric lower extremity
testing, and patient questionnaires. An intent-to-treat analysis was performed. After patients
had SCS for 24 months, leg pain, pain when walking, standing pain, pain’s effect on overall
lifestyle, and the total analog scale scores were signifi cantly improved from baseline. In this
study, 25% of the implanted patients had greater than 50% improvement in pain rating.
In addition, 3 patients from this study had their stimulators repositioned due to pain at the
original location. Three patients had reoperations to adjust lead position; 1 patient required
2 reoperations, 1 patient had the device removed due to infection and later to have a new
device implanted. A diabetic patient had skin problems which 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% reduction 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
fi rst 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 opioids. For patients with radicular pain involving one leg with or
without unilateral buttock pain, a trial of SCS was recommended fi rst. For patients with midline
back pain and /or bilateral leg pain, a trial of long-term spinal infusion was recommended fi rst.
If the patients failed screening with either of these modalities, the other was then tested. If the