Boston Scientific Neuromodulation Corporation PSC5210W ユーザーズマニュアル
Introduction
3
for the same disease/conditions and patient population as the PRECI-
SION System.
SION System.
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 Profile),
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 significantly
improved from baseline. In this study, 25% of the implanted patients
had greater than 50% improvement in pain rating.
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 Profile),
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 significantly
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 reposi-
tioned due to pain at the original location. Three patients had reopera-
tions 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.
tioned due to pain at the original location. Three patients had reopera-
tions 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% 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
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