Literature Support Spinal Cord Stimulation
Ann Thorac Surg. 2006 Nov;82(5):1704-8.
Spinal cord stimulation for patients with refractory angina and previous
coronary surgery.
Lapenna E, Rapati D, Cardano P, De Bonis M, Lullo F, Zangrillo A, Alfieri O.
Department of Cardiac Surgery, San Raffaele University Hospital, Milan, Italy.
lapenna.elisabetta@hsr.it
BACKGROUND: Refractory angina pectoris is an exceptionally debilitating condition affecting patients who
have typically failed multiple percutaneous and surgical revascularizations and optimal medical therapy and
who are not amenable for further revascularization procedures. Spinal cord stimulation (SCS) has been
adopted in this context at our institution and midterm mortality, anginal status, and quality of life have been
evaluated. METHODS: From 1998 to 2004, 51 patients with refractory class III-IV angina, who were not
considered candidates for revascularization procedures, underwent SCS. All patients had already
undergone previous surgical revascularization and a median of two percutaneous procedures.
Transmyocardial laser revascularization had been previously performed in 8 cases (15.6%). Most of the
patients (70.5%) had experienced a myocardial infarction. Mean ejection fraction was 0.42 +/- 0.121,
Canadian Cardiovascular Society class 3.5 +/- 0.5, quality of life (Spitzer index) 4.5 +/- 1.2, and the median
frequency of weekly angina episodes was 10. RESULTS: There were no SCS implantation-related
complications. At follow-up (100% complete, mean 24 +/- 18 months), a significant improvement of anginal
symptoms (>50% reduction of weekly anginal episodes) occurred in 45 patients (88.2%). In
those patients (Responders), the quality of life improved significantly (6.8 +/- 1.5; p < 0.0001), CCS class
decreased to 2 +/- 0.7 (p < 0.0001), and the median frequency of weekly angina episodes to 3 (p < 0.0001).
At 3 years, Responders' survival was 91.8 +/- 4.6% and the freedom from cardiac events 72.6 +/- 8.42%.
CONCLUSIONS: Spinal cord stimulation is a safe and effective procedure in truly no-option patients affected
by refractory angina. A midterm sustained improvement of symptoms and quality of life have been
documented with a satisfactory 3-year survival rate.
Pain Med. 2006 Sep-Oct;7(5):440-3.
Spinal cord stimulation is an effective treatment for the chronic intractable visceral pelvic pain.
Kapural L, Narouze SN, Janicki TI, Mekhail N.
Pain Management Department, The Cleveland Clinic Foundation, Cleveland, Ohio,
USA. Kapural@ccf.org OBJECTIVE: Recent studies have demonstrated significant involvement of dorsal
column pathways in transmission of visceral pelvic pain. Spinal cord stimulation (SCS) suppresses visceral
response to colon distension in an animal model and therefore may be an effective therapy for chronic pelvic
pain of visceral origin. We are reporting on the value of neurostimulation for chronic visceral
pelvic pain in six female patients with the diagnosis of long-standing pelvic pain (history of endometriosis,
multiple surgical explorations, and dyspareunia). DESIGN AND SETTINGS: Case-series report. All patients
received repeated hypogastric blocks (in an average of 5.3 blocks) with a significant
pain relief for a period ranging from 1 to 6 weeks. Three received neurolytic hypogastric block with the pain
relief of 3, 8, and 12 months, respectively. Following psychological evaluation and clearance by our
Multidisciplinary Committee on Implantable Devices, they all underwent SCS trial for 7-14 days.
All patients received SCS systems with dual leads (Compact or Quad leads, Medtronic Inc., Minneapolis, MN,
USA). RESULTS: The average follow-up was 30.6 months. Median visual analog scale pain score decreased
from 8 to 3. All patients had more than 50% of the pain relief. Pain Disability Index changed
from an average of 57.7 +/- 12 to 19.5 +/- 7. Opiate use decreased from an average 22.5 mg to 6.6 mg of
morphine sulfate milligram equivalents per day. CONCLUSION: It appears that SCS may have a significant
therapeutic potential for treatment of visceral pelvic pain.
Neurosurgery. 2005 Jan;56(1):98-107. Spinal Cord Stimulation versus Repeated Lumbosacral Spine Surgery
for Chronic Pain: A Randomized, Controlled
Trial. North RB, Kidd DH, Farrokhi F, Piantadosi SA. Department of Neurosurgery, Johns Hopkins University
School of Medicine, Baltimore, Maryland. OBJECTIVE: Persistent or recurrent radicular pain after lumbosacral
spine surgery is often associated with nerve root compression and is treated by
repeated operation or, as a last resort, by spinal cord stimulation (SCS). We conducted a prospective,
randomized, controlled trial to test our hypothesis that SCS is more likely than reoperation to result in a
successful outcome by standard measures of pain relief and treatment outcome, including subsequent use
of health care resources. >METHODS: For an average of 3 years postoperatively, disinterested third-party
interviewers followed 50 patients selected for reoperation by standard criteria and randomized to SCS or
reoperation. If the results of the randomized treatment were unsatisfactory, patients could cross
over to the alternative. Success was based on self-reported pain relief and patient satisfaction. Crossover to
the alternative procedure was an outcome measure. Use of analgesics, activities of daily living, and work
status were self-reported. RESULTS: Among 45 patients (90%) available for follow-up, SCS
was more successful than reoperation (9 of 19 patients versus 3 of 26 patients, P < 0.01). Patients initially
randomized to SCS were significantly less likely to cross over than were those randomized to reoperation (5
of 24 patients versus 14 of 26 patients, P = 0.02). Patients randomized to reoperation required
increased opiate analgesics significantly more often than those randomized to SCS (P < 0.025). Other
measures of activities of daily living and work status did not differ significantly. CONCLUSION: SCS is more
effective than reoperation as a treatment for persistent radicular pain after lumbosacral spine surgery, and
in the great majority of patients, it obviates the need for reoperation.
Minim Invasive Ther Allied Technol. 2004 Apr;13(2):124-8.
Epidural spinal cord stimulation in chronic non-reconstructible limb ischemia.
Neuhauser, Greiner, Kofler, Perkmann.
Department of Vascular Surgery University Hospital Innsbruck Innsbruck Austria.
For patients with chronic non-reconstructible limb ischemia (chronic CLI),
spinal-cord stimulation (SCS) has been advocated for the treatment of ischemic
pain and prevention of amputation. The present clinical report was performed to
evaluate the long-term effects of SCS on limb survival. A retrospective review
was performed of 21 patients who had undergone SCS between December 1997 and
July 2002 due to chronic CLI. The impulse generator used was the Itrel device
(Medtronic, Inc). All conventional methods for revascularization and improvement
of microcirculatory blood flow had been performed prior to SCS treatment.
Patient selection was performed by clinical examination, pulse volume records,
Doppler ankle/brachial measurements, angiography, and thoracic spine and lumbar
spine x-ray. Since July 2000, additional TcpO<SUB>2</SUB> measurements at the
dorsum of the foot have been performed. SCS implantation was performed as a
one-stage procedure in all cases. Patients are followed up to 57 months. Of 21
patients with chronic CLI, 20 (95%) were available for follow-up investigations.
Four patients died one to fifteen months after implantation due to acute renal
failure or myocardial infarction (19%). Major amputation could be avoided in 15
(71%) of 21 patients. Two electrode dislocation, one pulse-generator
dislocation, and one wire disconnection occurred; no other complications were
observed. SCS represents a safe and effective therapy for patients with chronic
non-reconstructible critical limb ischemia.
Ital Heart J Suppl. 2004 Jun;5(6):429-35. [Importance of spinal cord stimulation in the treatment of refractory
angina] [Article in Italian] Greco S,
Antonini L, Auriti A, Peverini M, Santini M. Dipartimento di Malattie del Cuore, Azienda Ospedaliera San Filippo
Neri, Roma. sa.gre@tiscali.it A small non-quantified number of patients is reported to be affected by forms of
angina pectoris already treated by traditional therapy but no longer able to achieve better results by drugs
or surgery: this is called "refractory angina". Treatments like external counterpulsation, transmyocardial laser
revascularization, stem cell transplantation or spinal cord stimulation may be suitable for these patients. The
analysis of major studies on spinal cord stimulation based on exercise ECG, Holter monitoring and positron
emission tomography, has shown a reduction in anginal attacks and in nitroglycerin pills. Though in small
figures, an improved perfusion of the ischemic areas, an increase in the time of ischemia and cardiac mortality
comparable to bypass surgery as well as a better quality of life and lower costs with respect to traditional
treatment are also evident. Patients who are at high risk of mortality for bypass surgery, and
who cannot receive significant benefits from revascularization or improved pharmacological therapy are
candidate to spinal cord stimulation. Spinal cord stimulation is safe and effective in about 70% of patients.
Some issues have not been investigated yet: the clinical characteristics of "non-responders" and
the possibility of avoiding sudden cardiac death in stimulated patients.
Br J Surg. 2004 Aug;91(8):948-55. Systematic review and meta-analysis of controlled trials assessing spinal
cord stimulation for inoperable critical leg
ischaemia. Ubbink DT, Vermeulen H, Spincemaille GH, Gersbach PA, Berg P, Amann W. Department of Surgery,
Academic Medical Centre, Amsterdam, The Netherlands. D.ubbink@amc.uva.nl BACKGROUND: Spinal cord
stimulation (SCS) may have a place in the treatment of patients with inoperable
chronic critical leg ischaemia. METHODS: A systematic review and meta-analysis was performed of all
controlled studies comparing SCS in addition to any form of conservative treatment for inoperable chronic
critical leg ischaemia. Main endpoints were limb salvage, pain relief and clinical situation. Systematic
methodological appraisal and data extraction were performed by independent reviewers. RESULTS: Of the 18
reports found, nine trials, comprising 444 patients, matched the selection criteria. After pooling, limb salvage
at 12 months appeared significantly greater in the SCS group (risk difference (RD) -0.13 (95 per cent
confidence interval (c.i.) -0.04 to -0.22)). Significant pain relief occurred in both treatment groups, but
patients who received SCS required significantly less analgesia and reached Fontaine stage 2 more often
than those who did not have SCS (RD 0.33 (95 per cent c.i. 0.19 to 0.47)). Complications of SCS were
problems of implantation (8.2 per cent), changes in stimulation requiring reintervention (14.8 per cent) and
infection (2.9 per cent). CONCLUSION: The addition of SCS to standard conservative treatment improves limb
salvage, ischaemic pain and the general clinical situation in patients with inoperable chronic critical leg
ischaemia. These benefits should be weighed against the cost and the (minor) complications associated with
the technique. Copyright 2004 British Journal of Surgery Society Ltd.
Ann Neurol. 2004 Jan;55(1):13-8. Comment in: Ann Neurol. 2004 Jan;55(1):5-6. The effect of spinal cord
stimulation in patients with chronic reflex sympathetic dystrophy: two years' follow-up of the randomized
controlled trial. Kemler MA, De Vet HC, Barendse GA, Van Den Wildenberg FA, Van Kleef
M. Department of Plastic Surgery, Medical Center Leeuwarden, Leeuwarden. Marius.Kemler@ZNB.nl Chronic
reflex sympathetic dystrophy is a painful, disabling disorder for which no treatment with proven effect is
available. We performed a randomized trial in a 2 to 1 ratio of patients, in which 36 patients
were treated with spinal cord stimulation and physical therapy (SCS+PT), and 18 patients received solely PT.
Twenty-four SCS+PT patients were given a permanent spinal cord stimulation system after successful test
stimulation; the remaining 12 patients received no permanent system. We assessed pain
intensity, global perceived effect, functional status, and health-related quality of life. Patients were examined
before randomization, before implantation, and also at 1, 3, 6, 12, and 24 months thereafter. At 2 years,
three patients were excluded from the analysis. The intention-to-treat analysis showed
improvements in the SCS+PT group concerning pain intensity (-2.1 vs 0.0 cm; p < 0.001) and global perceived
effect (43% vs 6% "much improved"; p = 0.001). There was no clinically important improvement of functional
status. Health-related quality of life improved only in the group receiving spinal cord
stimulation. After careful selection and successful test stimulation, spinal cord stimulation results in a
long-term pain reduction and health-related quality of life improvement in chronic reflex sympathetic
dystrophy.
Neurology. 2002 Oct 22;59(8):1203-9. Economic evaluation of spinal cord stimulation for chronic reflex
sympathetic dystrophy. Kemler MA, Furnee CA.
Department of Surgery, Maastricht University Hospital, Maastricht, The Netherlands. kemlerm@mzh.nl
OBJECTIVE: To evaluate the economic aspects of treatment of chronic reflex sympathetic dystrophy (RSD)
with spinal cord stimulation (SCS), using outcomes and costs of care before and after the start of
treatment. METHODS: Fifty-four patients with chronic RSD were randomized to receive either SCS together
with physical therapy (SCS+PT; n = 36) or physical therapy alone (PT; n = 18). Twenty-four SCS+PT patients
responded positively to trial stimulation and underwent SCS implantation. During 12
months of follow-up, costs (routine RSD costs, SCS costs, out-of-pocket costs) and effects (pain relief by
visual analogue scale, health-related quality of life [HRQL] improvement by EQ-5D) were assessed in both
groups. Analyses were carried out up to 1 year and up to the expected time of death. RESULTS:
SCS was both more effective and less costly than the standard treatment protocol. As a result of high initial
costs of SCS, in the first year, the treatment per patient is $4,000 more than control therapy. However, in the
lifetime analysis, SCS per patient is $60,000 cheaper than control therapy. In addition, at
12 months, SCS resulted in pain relief (SCS+PT [-2.7] vs PT [0.4] [p < 0.001]) and improved HRQL (SCS+PT
[0.22] vs PT [0.03] [p = 0.004]). CONCLUSIONS: The authors found SCS to be both more effective and less
expensive as compared with the standard treatment protocol for chronic RSD. Publication Types: Clinical Trial
Minerva Anestesiol. 2001 Nov;67(11):803-10. [Spinal cord stimulation and quality of life in patients with
refractory angina] [Article in Italian] Rapati D, Capucci R, Berti M, Danelli G, Torri G, Alfieri O. Servizio di
Anestesia e Rianimazione, Istituto Scientifico Ospedale S. Raffaele, Milan, Italy.
rapati.dino@hsr.it BACKGROUND: Spinal cord stimulation (SCS) is a treatment that exploits the antalgic and
vasodilatory effects on the microcirculation produced by a stimulating electrode positioned in the peridural
space. This therapy has been used for years in the treatment of refractory angina pectoris.
The aim of this study was to monitor the clinical effectiveness of the technique in terms of symptomatic
benefits and, above all, improved quality of life in angina patients undergoing SCS. METHODS: From
November 1998 to December 2000 we used SCS to treat 17 patients with refractory angina (functional
class III or IV Canadian Cardiovascular Society) with onset more than one year earlier. All patients had
undergone one or more traditional revascularisation procedures and were receiving maximum drug therapy.
Patients were assigned to SCS because it was not technically possible to perform
other revascularisation procedures. Quality of life was measured before and after treatment using a
multidimensional index (QL Spitzer's index). We also noted the mortality, acceptance and morbidity of the
procedure during a follow-up lasting 10 months on average. Lastly, the number of weekly anginal pain
attacks, weekly nitrate consumption and CCS functional class were recorded before treatment and 1, 3 and
six months after therapy. RESULTS: SPC was effective in 13 patients out of 17 (76.47%). In responders the
quality of life improved by 70%: in these patients, the number of weekly angina attacks
reduced from 11.76+/-7.56 to 2.14+/-2.54, and the functional class from 3.30+/-0.75 to 1.5+/-0.53. No major
periprocedural complications were reported. The annual mortality rate was 6.6%. The technique was easy to
use. CONCLUSIONS: The results of this study show that SCS is effective, safe, easy to use and
well tolerated by patients with refractory angina who fail to respond to traditional revascularisation. This
technique substantially improves the quality of life of patients suffering from refractory angina.
J Diabetes Complications. 1999 Sep-Dec;13(5-6):293-9. Epidural spinal cord electrical stimulation in diabetic
critical lower limb ischemia. Petrakis IE,
Sciacca V. First Department of General Surgery, Policlinico Umberto I, University of Rome, La Sapienza,
Rome,Italy. Spinal cord stimulation (SCS) has been suggested to improve microcirculatory blood flow to
relieve ischemic pain and to reduce amputation rate in patients with peripheral arterial occlusive
disease (PAOD). The aim of this study was to evaluate the specific prognostic parameters in the prediction of
successful SCS, in diabetic patients, performing a retrospective data analysis. To perform this evaluation, 64
diabetic patients (39 men, 25 women; mean age, 69 years) classified as Fontaine's
stage III and IV, with PAOD, were treated with SCS for rest pain and trophic lesions with dry gangrene, after
failed conservative or surgical treatment. In clinical controls, pedal transcutaneous oxygen tension (TcPO(2)),
ankle/brachial blood pressure index (ABI), and toe pressure Doppler measurements were
utilized to select and follow-up the patients. After 58 months of follow-up (range, 20-128 months), pain relief
greater than 75% and limb salvage were achieved in 38 diabetic patients. A partial success was obtained in
nine patients with pain relief greater than 50% and limb salvage for at least 6 months.
The method failed in 17 patients or the device was removed due to technical problems, and the limb was
amputated in these patients. TcPO(2) was assessed on the dorsum of the foot. Clinical improvement and SCS
success were associated with increase of TcPO(2), before and after implantation. Limb salvage
was achieved in the patients who had significant TcPO(2) increase within the 2 weeks of the testing period,
independently of the stage of the disease. A TcPO(2) increase of more than 50% in the first 2 months after
implantation was predictive of success, and was related to the presence of adequate
paresthesias in the painful area during the trial period. TcPO(2) significantly increased after long-term
follow-up in all patients with limb salvage (from 22.1 to 43.1 mm Hg in the rest pain patients, from 15.8 to
36.4 mm Hg in those with trophic lesions of less than 3 cm(2), and from 12.1 to 28.1 in those with
trophic lesions of greater than 3 cm(2), (p < 0.01). ABI did not changed under stimulation. In diabetic patients
with PAOD, the SCS increases the skin blood flow, is associated with significant pain relief, and could be
proven an excellent alternative therapy, improving the life quality. Significant TcPO(2) increase
within the 2-week test period, is a predictive index of therapy success and should be considered before the
final decision in terms of cost effectiveness, before the permanent implantation.
Surg Neurol. 1998 Aug;50(2):110-20; discussion 120-1. Epidural spinal cord stimulation for treatment of
chronic pain--some predictors of success. A 15-year
experience. Kumar K, Toth C, Nath RK, Laing P. Department of Surgery, The Plains Health Centre, University of
Saskatchewan, Regina, Canada.
BACKGROUND: We have used epidural spinal cord stimulation (SCS) for pain control for the past 15 years. An
analysis of our series of 235 patients has clarified the value of specific prognostic parameters in the
prediction of successful SCS. METHODS: Patients were followed up for periods ranging from 6
months to 15 years with a mean follow-up of 66 months. The mean age of the 150 men and 85 women in the
study was 51.4 years. Indications for SCS included failed back syndrome (114 patients), peripheral vascular
disease (39 patients), peripheral neuropathy (30 patients), multiple sclerosis (13 patients),
reflex sympathetic dystrophy (13 patients), and other etiologies of chronic intractable pain (26 patients).
RESULTS: One hundred and eighty-nine patients received permanent devices; 111 (59%) of these patients
continue to receive satisfactory pain relief. Pain attributable to failed back syndrome, reflex
sympathetic dystrophy, peripheral vascular disease of lower limbs, multiple sclerosis, and peripheral
neuropathy responded favorably to spinal cord stimulation. In contrast, paraplegic pain, cauda equina
syndrome, stump pain, phantom limb pain, and primary bone and joint disease pain did not respond
as well. Cases of cauda equina injury had promising initial pain relief, but gradually declined after a few
years. After long-term follow-up, 47 of the 111 successfully implanted patients were gainfully employed,
compared with 22 patients before implantation. The successful patients reported improvements in
daily living as well as a decrease in analgesic usage. Multipolar stimulation systems were significantly more
reliable (p < 0.001) than unipolar systems. Complications included hardware malfunction, electrode
displacement, infection, and tolerance. CONCLUSION: Aside from etiologies of pain syndromes as
a prognostic factor, we have identified other parameters of success. In patients who have undergone
previous surgical procedures, the shorter the duration of time to implantation, the greater the rate of success
(p < 0.001). The diagnosis of failed back syndrome must be considered a confounding factor in our
analysis. Those patients whose pain did not follow a surgical procedure had better responses to SCS than
patients who had multiple surgical procedures prior to their first implant. The advent of multipolar systems
has significantly improved clinical reliability over unipolar systems. Age, sex, and laterality of pain
did not prove to be of significance.
Spine. 1996 Dec 1;21(23):2786-94. Prospective, multicenter study of spinal cord stimulation for relief of
chronic back and extremity pain. Burchiel KJ,
Anderson VC, Brown FD, Fessler RG, Friedman WA, Pelofsky S, Weiner RL, Oakley J, Shatin D. Division of
Neurosurgery, Oregon Health Sciences University, Portland. STUDY DESIGN: This prospective, multicenter
study was designed to investigate the efficacy and outcome of spinal cord stimulation
using a variety of clinical and psychosocial outcome measures. Data were collected before implantation and
at regular intervals after implantation. This report focuses on 70 patients who had undergone 1 year of
follow-up treatment at the time of data analysis. OBJECTIVES: To provide a more generalizable
assessment of long-term spinal cord stimulation outcome by comparing a variety of pain and
functional/quality-of-life measures before and after management. This report details results after 1 year of
stimulation. SUMMARY OF BACKGROUND DATA: The historically diverse methods, patient
selection criteria, and outcome measures reported in the spinal cord stimulation literature have made
interpretation and comparison of results difficult. Although short-term outcomes are generally consistent,
long-term outcomes of spinal cord stimulation, as determined by prospective studies that assess
multidimensional aspects of the pain complaint among a relatively homogeneous population, are not well
established. METHODS: Two hundred nineteen patients were entered at six centers throughout the United
States. All patients underwent a trial of stimulation before implant of the permanent system.
Most were psychologically screened. One hundred eighty-two patients were implanted with a permanent
stimulating system. At the time of this report, complete 1-year follow-up data were available on 70 patients,
88% of whom reported pain in the back or lower extremities. Patient evaluation of pain and
functional levels was completed before implantation and 3, 6, 12, and 24 months after implantation.
Complications, medication usage, and work status also were monitored. RESULTS: All pain and quality-of-life
measures showed statistically significant improvement during the treatment year. These included
the average pain visual analogue scale, the McGill Pain Questionnaire, the Oswestry Disability Questionnaire,
the Sickness Impact Profile, and the Back Depression Inventory. Overall success of the therapy was defined
as at least 50% pain relief and patient assessment of the procedure as fully or partially
beneficial and worthwhile. Using this definition, spinal cord stimulation successfully managed pain in 55% of
patients on whom 1-year follow-up is available. Complications requiring surgical intervention were reported
by 17% (12 of 70) of patients. Medication usage and work status were not changed
significantly. CONCLUSIONS: This prospective, multicenter study confirms that spinal cord stimulation can be
an effective therapy for management of chronic low back and extremity pain. Significant improvements in
many aspects of the pain condition were measured, and complications were minimal.
Spine. 1996 Jun 1;21(11):1344-50; discussion 1351. Prospective outcome evaluation of spinal cord
stimulation in patients with intractable leg pain. Ohnmeiss
DD, Rashbaum RF, Bogdanffy GM. Institute for Spine and Biomedical Research, Plano, Texas, USA. STUDY
DESIGN. The results of spinal cord stimulation were prospectively evaluated using both subjective patient
self-report measures and objective physical functional testing. OBJECTIVES. The purpose of this
study was to evaluate prospectively the effects of spinal cord stimulation implantation, performed with the
patient awake and providing feedback, in patients with primary reports of intractable leg pain. SUMMARY OF
BACKGROUND DATA. Spinal cord stimulation has been used for treating chronic pain
of many types. However, even among those with intractable lower extremity pain, the outcome results have
shown great variability. METHODS. The surgical procedure was performed with the patient awake and
providing feedback to ensure optimal pain relief from the lead placement. The study group
comprised 40 patients, ranging in age from 28 to 86 years. The average symptom duration was 65.4 months,
and the average number of prior lumbar spine surgeries was 2.3 (range, 1 to 8). The primary data collection
periods were preoperative, 6 weeks after, and 12 and 24 months after surgery. RESULTS.
Statistically significant improvement in isometric lower extremity function was demonstrated 6 weeks after
the spinal cord stimulation implantation. In the more painful leg, the performance increased from 457.5
ft-lb-sec to 629.8 ft-lb-sec (P < 0.01). The performance remained significantly improved at the 12-
and 24-month follow-ups. Significant improvement was demonstrated on the physical scale of the Sickness
Impact Profile at 6 weeks. At 24 months, all three scales (physical, psychological, and other) as well as the
total score were significantly improved. Statistically significant decreases in pain, assessed by
changes in visual analog scale scores, were noted in the legs, when walking, and in overall lifestyle. The use
of narcotic medication decreased at all follow-up periods. At least 66% of the patients who were taking
narcotics before spinal cord stimulation were taking reduced amounts or no narcotics 2
years later. At the time of the 24-month follow-up, at least 70% of patients reported that the procedure
helped them, and would recommend it to someone with similar symptoms. CONCLUSIONS. Spinal cord
stimulation implantation can result in improved physical function and decreased pain in patients who
are carefully screened and in whom the implantation is performed with the patient awake to help ensure
optimal pain-relieving lead placement.
Neurochirurgie. 1995;41(2):73-86; discussion 87-8. [Chronic spinal cord stimulation in the treatment of
neurogenic pain. Cooperative and retrospective
study on 20 years of follow-up] [Article in French] Lazorthes Y, Siegfried J, Verdie JC, Casaux J. Service de
Neurochirurgie, CHU Rangueil, Faculte de Medecine Rangueil, Toulouse. The aim of this investigation is to
evaluate the long-term spinal cord stimulation (SCS) efficacy and safety, with a 20-years study concerning
692 patients (series I: 279, series II: 413). The series concern 304 arachno-epidural fibrosis, 152 peripheral
nerve lesions, 25 amputations pain, 17 plexus brachial lesions, 101 spinal cord lesions, 22 cancer pain, and
71 vascular pain. A multidisciplinary chronic pain evaluation must exclude contra-indications (nociceptive pain,
serious drug habituations, psychological problems, unresolved issues or secondary pain). Percutaneous
epidural SCS is a screening method if the trial is sufficiently prolonged (3 to 14 days) and if the pain
topography is overlapped by induced paresthesias. The immediate global results of the 2 series are similar:
respectively 86% and 85% of success one month after implantation. With the same longterm follow-up
(mean: 10 yrs, range: 2-20), and the same evaluation criteria, the percentage of long-term global success
rate is 54% in series I, and 52% in series II. In the most recent period (1984-1990) concerning 301 patients,
the success rate are respectively 68% and 60%. Analysing the results etiologically confirms the
therapeutic value of SCS for neurogenic pain secondary to partial deafferentation. For upper limb pain,
ipsilateral radicular stimulation is preferable. When the nerve lesion extends to the pre-ganglionic portion
(brachial plexus avulsion, herpes zoster) or in cases of pain of spinal or cerebral origin, thalamic
stimulation must be considered, after failure of SCS.
Ann Thorac Surg. 2006 Nov;82(5):1704-8.
Spinal cord stimulation for patients with refractory angina and previous
coronary surgery.
Lapenna E, Rapati D, Cardano P, De Bonis M, Lullo F, Zangrillo A, Alfieri O.
Department of Cardiac Surgery, San Raffaele University Hospital, Milan, Italy.
lapenna.elisabetta@hsr.it
BACKGROUND: Refractory angina pectoris is an exceptionally debilitating condition affecting patients who
have typically failed multiple percutaneous and surgical revascularizations and optimal medical therapy and
who are not amenable for further revascularization procedures. Spinal cord stimulation (SCS) has been
adopted in this context at our institution and midterm mortality, anginal status, and quality of life have been
evaluated. METHODS: From 1998 to 2004, 51 patients with refractory class III-IV angina, who were not
considered candidates for revascularization procedures, underwent SCS. All patients had already
undergone previous surgical revascularization and a median of two percutaneous procedures.
Transmyocardial laser revascularization had been previously performed in 8 cases (15.6%). Most of the
patients (70.5%) had experienced a myocardial infarction. Mean ejection fraction was 0.42 +/- 0.121,
Canadian Cardiovascular Society class 3.5 +/- 0.5, quality of life (Spitzer index) 4.5 +/- 1.2, and the median
frequency of weekly angina episodes was 10. RESULTS: There were no SCS implantation-related
complications. At follow-up (100% complete, mean 24 +/- 18 months), a significant improvement of anginal
symptoms (>50% reduction of weekly anginal episodes) occurred in 45 patients (88.2%). In
those patients (Responders), the quality of life improved significantly (6.8 +/- 1.5; p < 0.0001), CCS class
decreased to 2 +/- 0.7 (p < 0.0001), and the median frequency of weekly angina episodes to 3 (p < 0.0001).
At 3 years, Responders' survival was 91.8 +/- 4.6% and the freedom from cardiac events 72.6 +/- 8.42%.
CONCLUSIONS: Spinal cord stimulation is a safe and effective procedure in truly no-option patients affected
by refractory angina. A midterm sustained improvement of symptoms and quality of life have been
documented with a satisfactory 3-year survival rate.
Pain Med. 2006 Sep-Oct;7(5):440-3.
Spinal cord stimulation is an effective treatment for the chronic intractable visceral pelvic pain.
Kapural L, Narouze SN, Janicki TI, Mekhail N.
Pain Management Department, The Cleveland Clinic Foundation, Cleveland, Ohio,
USA. Kapural@ccf.org OBJECTIVE: Recent studies have demonstrated significant involvement of dorsal
column pathways in transmission of visceral pelvic pain. Spinal cord stimulation (SCS) suppresses visceral
response to colon distension in an animal model and therefore may be an effective therapy for chronic pelvic
pain of visceral origin. We are reporting on the value of neurostimulation for chronic visceral
pelvic pain in six female patients with the diagnosis of long-standing pelvic pain (history of endometriosis,
multiple surgical explorations, and dyspareunia). DESIGN AND SETTINGS: Case-series report. All patients
received repeated hypogastric blocks (in an average of 5.3 blocks) with a significant
pain relief for a period ranging from 1 to 6 weeks. Three received neurolytic hypogastric block with the pain
relief of 3, 8, and 12 months, respectively. Following psychological evaluation and clearance by our
Multidisciplinary Committee on Implantable Devices, they all underwent SCS trial for 7-14 days.
All patients received SCS systems with dual leads (Compact or Quad leads, Medtronic Inc., Minneapolis, MN,
USA). RESULTS: The average follow-up was 30.6 months. Median visual analog scale pain score decreased
from 8 to 3. All patients had more than 50% of the pain relief. Pain Disability Index changed
from an average of 57.7 +/- 12 to 19.5 +/- 7. Opiate use decreased from an average 22.5 mg to 6.6 mg of
morphine sulfate milligram equivalents per day. CONCLUSION: It appears that SCS may have a significant
therapeutic potential for treatment of visceral pelvic pain.
Neurosurgery. 2005 Jan;56(1):98-107. Spinal Cord Stimulation versus Repeated Lumbosacral Spine Surgery
for Chronic Pain: A Randomized, Controlled
Trial. North RB, Kidd DH, Farrokhi F, Piantadosi SA. Department of Neurosurgery, Johns Hopkins University
School of Medicine, Baltimore, Maryland. OBJECTIVE: Persistent or recurrent radicular pain after lumbosacral
spine surgery is often associated with nerve root compression and is treated by
repeated operation or, as a last resort, by spinal cord stimulation (SCS). We conducted a prospective,
randomized, controlled trial to test our hypothesis that SCS is more likely than reoperation to result in a
successful outcome by standard measures of pain relief and treatment outcome, including subsequent use
of health care resources. >METHODS: For an average of 3 years postoperatively, disinterested third-party
interviewers followed 50 patients selected for reoperation by standard criteria and randomized to SCS or
reoperation. If the results of the randomized treatment were unsatisfactory, patients could cross
over to the alternative. Success was based on self-reported pain relief and patient satisfaction. Crossover to
the alternative procedure was an outcome measure. Use of analgesics, activities of daily living, and work
status were self-reported. RESULTS: Among 45 patients (90%) available for follow-up, SCS
was more successful than reoperation (9 of 19 patients versus 3 of 26 patients, P < 0.01). Patients initially
randomized to SCS were significantly less likely to cross over than were those randomized to reoperation (5
of 24 patients versus 14 of 26 patients, P = 0.02). Patients randomized to reoperation required
increased opiate analgesics significantly more often than those randomized to SCS (P < 0.025). Other
measures of activities of daily living and work status did not differ significantly. CONCLUSION: SCS is more
effective than reoperation as a treatment for persistent radicular pain after lumbosacral spine surgery, and
in the great majority of patients, it obviates the need for reoperation.
Minim Invasive Ther Allied Technol. 2004 Apr;13(2):124-8.
Epidural spinal cord stimulation in chronic non-reconstructible limb ischemia.
Neuhauser, Greiner, Kofler, Perkmann.
Department of Vascular Surgery University Hospital Innsbruck Innsbruck Austria.
For patients with chronic non-reconstructible limb ischemia (chronic CLI),
spinal-cord stimulation (SCS) has been advocated for the treatment of ischemic
pain and prevention of amputation. The present clinical report was performed to
evaluate the long-term effects of SCS on limb survival. A retrospective review
was performed of 21 patients who had undergone SCS between December 1997 and
July 2002 due to chronic CLI. The impulse generator used was the Itrel device
(Medtronic, Inc). All conventional methods for revascularization and improvement
of microcirculatory blood flow had been performed prior to SCS treatment.
Patient selection was performed by clinical examination, pulse volume records,
Doppler ankle/brachial measurements, angiography, and thoracic spine and lumbar
spine x-ray. Since July 2000, additional TcpO<SUB>2</SUB> measurements at the
dorsum of the foot have been performed. SCS implantation was performed as a
one-stage procedure in all cases. Patients are followed up to 57 months. Of 21
patients with chronic CLI, 20 (95%) were available for follow-up investigations.
Four patients died one to fifteen months after implantation due to acute renal
failure or myocardial infarction (19%). Major amputation could be avoided in 15
(71%) of 21 patients. Two electrode dislocation, one pulse-generator
dislocation, and one wire disconnection occurred; no other complications were
observed. SCS represents a safe and effective therapy for patients with chronic
non-reconstructible critical limb ischemia.
Ital Heart J Suppl. 2004 Jun;5(6):429-35. [Importance of spinal cord stimulation in the treatment of refractory
angina] [Article in Italian] Greco S,
Antonini L, Auriti A, Peverini M, Santini M. Dipartimento di Malattie del Cuore, Azienda Ospedaliera San Filippo
Neri, Roma. sa.gre@tiscali.it A small non-quantified number of patients is reported to be affected by forms of
angina pectoris already treated by traditional therapy but no longer able to achieve better results by drugs
or surgery: this is called "refractory angina". Treatments like external counterpulsation, transmyocardial laser
revascularization, stem cell transplantation or spinal cord stimulation may be suitable for these patients. The
analysis of major studies on spinal cord stimulation based on exercise ECG, Holter monitoring and positron
emission tomography, has shown a reduction in anginal attacks and in nitroglycerin pills. Though in small
figures, an improved perfusion of the ischemic areas, an increase in the time of ischemia and cardiac mortality
comparable to bypass surgery as well as a better quality of life and lower costs with respect to traditional
treatment are also evident. Patients who are at high risk of mortality for bypass surgery, and
who cannot receive significant benefits from revascularization or improved pharmacological therapy are
candidate to spinal cord stimulation. Spinal cord stimulation is safe and effective in about 70% of patients.
Some issues have not been investigated yet: the clinical characteristics of "non-responders" and
the possibility of avoiding sudden cardiac death in stimulated patients.
Br J Surg. 2004 Aug;91(8):948-55. Systematic review and meta-analysis of controlled trials assessing spinal
cord stimulation for inoperable critical leg
ischaemia. Ubbink DT, Vermeulen H, Spincemaille GH, Gersbach PA, Berg P, Amann W. Department of Surgery,
Academic Medical Centre, Amsterdam, The Netherlands. D.ubbink@amc.uva.nl BACKGROUND: Spinal cord
stimulation (SCS) may have a place in the treatment of patients with inoperable
chronic critical leg ischaemia. METHODS: A systematic review and meta-analysis was performed of all
controlled studies comparing SCS in addition to any form of conservative treatment for inoperable chronic
critical leg ischaemia. Main endpoints were limb salvage, pain relief and clinical situation. Systematic
methodological appraisal and data extraction were performed by independent reviewers. RESULTS: Of the 18
reports found, nine trials, comprising 444 patients, matched the selection criteria. After pooling, limb salvage
at 12 months appeared significantly greater in the SCS group (risk difference (RD) -0.13 (95 per cent
confidence interval (c.i.) -0.04 to -0.22)). Significant pain relief occurred in both treatment groups, but
patients who received SCS required significantly less analgesia and reached Fontaine stage 2 more often
than those who did not have SCS (RD 0.33 (95 per cent c.i. 0.19 to 0.47)). Complications of SCS were
problems of implantation (8.2 per cent), changes in stimulation requiring reintervention (14.8 per cent) and
infection (2.9 per cent). CONCLUSION: The addition of SCS to standard conservative treatment improves limb
salvage, ischaemic pain and the general clinical situation in patients with inoperable chronic critical leg
ischaemia. These benefits should be weighed against the cost and the (minor) complications associated with
the technique. Copyright 2004 British Journal of Surgery Society Ltd.
Ann Neurol. 2004 Jan;55(1):13-8. Comment in: Ann Neurol. 2004 Jan;55(1):5-6. The effect of spinal cord
stimulation in patients with chronic reflex sympathetic dystrophy: two years' follow-up of the randomized
controlled trial. Kemler MA, De Vet HC, Barendse GA, Van Den Wildenberg FA, Van Kleef
M. Department of Plastic Surgery, Medical Center Leeuwarden, Leeuwarden. Marius.Kemler@ZNB.nl Chronic
reflex sympathetic dystrophy is a painful, disabling disorder for which no treatment with proven effect is
available. We performed a randomized trial in a 2 to 1 ratio of patients, in which 36 patients
were treated with spinal cord stimulation and physical therapy (SCS+PT), and 18 patients received solely PT.
Twenty-four SCS+PT patients were given a permanent spinal cord stimulation system after successful test
stimulation; the remaining 12 patients received no permanent system. We assessed pain
intensity, global perceived effect, functional status, and health-related quality of life. Patients were examined
before randomization, before implantation, and also at 1, 3, 6, 12, and 24 months thereafter. At 2 years,
three patients were excluded from the analysis. The intention-to-treat analysis showed
improvements in the SCS+PT group concerning pain intensity (-2.1 vs 0.0 cm; p < 0.001) and global perceived
effect (43% vs 6% "much improved"; p = 0.001). There was no clinically important improvement of functional
status. Health-related quality of life improved only in the group receiving spinal cord
stimulation. After careful selection and successful test stimulation, spinal cord stimulation results in a
long-term pain reduction and health-related quality of life improvement in chronic reflex sympathetic
dystrophy.
Neurology. 2002 Oct 22;59(8):1203-9. Economic evaluation of spinal cord stimulation for chronic reflex
sympathetic dystrophy. Kemler MA, Furnee CA.
Department of Surgery, Maastricht University Hospital, Maastricht, The Netherlands. kemlerm@mzh.nl
OBJECTIVE: To evaluate the economic aspects of treatment of chronic reflex sympathetic dystrophy (RSD)
with spinal cord stimulation (SCS), using outcomes and costs of care before and after the start of
treatment. METHODS: Fifty-four patients with chronic RSD were randomized to receive either SCS together
with physical therapy (SCS+PT; n = 36) or physical therapy alone (PT; n = 18). Twenty-four SCS+PT patients
responded positively to trial stimulation and underwent SCS implantation. During 12
months of follow-up, costs (routine RSD costs, SCS costs, out-of-pocket costs) and effects (pain relief by
visual analogue scale, health-related quality of life [HRQL] improvement by EQ-5D) were assessed in both
groups. Analyses were carried out up to 1 year and up to the expected time of death. RESULTS:
SCS was both more effective and less costly than the standard treatment protocol. As a result of high initial
costs of SCS, in the first year, the treatment per patient is $4,000 more than control therapy. However, in the
lifetime analysis, SCS per patient is $60,000 cheaper than control therapy. In addition, at
12 months, SCS resulted in pain relief (SCS+PT [-2.7] vs PT [0.4] [p < 0.001]) and improved HRQL (SCS+PT
[0.22] vs PT [0.03] [p = 0.004]). CONCLUSIONS: The authors found SCS to be both more effective and less
expensive as compared with the standard treatment protocol for chronic RSD. Publication Types: Clinical Trial
Minerva Anestesiol. 2001 Nov;67(11):803-10. [Spinal cord stimulation and quality of life in patients with
refractory angina] [Article in Italian] Rapati D, Capucci R, Berti M, Danelli G, Torri G, Alfieri O. Servizio di
Anestesia e Rianimazione, Istituto Scientifico Ospedale S. Raffaele, Milan, Italy.
rapati.dino@hsr.it BACKGROUND: Spinal cord stimulation (SCS) is a treatment that exploits the antalgic and
vasodilatory effects on the microcirculation produced by a stimulating electrode positioned in the peridural
space. This therapy has been used for years in the treatment of refractory angina pectoris.
The aim of this study was to monitor the clinical effectiveness of the technique in terms of symptomatic
benefits and, above all, improved quality of life in angina patients undergoing SCS. METHODS: From
November 1998 to December 2000 we used SCS to treat 17 patients with refractory angina (functional
class III or IV Canadian Cardiovascular Society) with onset more than one year earlier. All patients had
undergone one or more traditional revascularisation procedures and were receiving maximum drug therapy.
Patients were assigned to SCS because it was not technically possible to perform
other revascularisation procedures. Quality of life was measured before and after treatment using a
multidimensional index (QL Spitzer's index). We also noted the mortality, acceptance and morbidity of the
procedure during a follow-up lasting 10 months on average. Lastly, the number of weekly anginal pain
attacks, weekly nitrate consumption and CCS functional class were recorded before treatment and 1, 3 and
six months after therapy. RESULTS: SPC was effective in 13 patients out of 17 (76.47%). In responders the
quality of life improved by 70%: in these patients, the number of weekly angina attacks
reduced from 11.76+/-7.56 to 2.14+/-2.54, and the functional class from 3.30+/-0.75 to 1.5+/-0.53. No major
periprocedural complications were reported. The annual mortality rate was 6.6%. The technique was easy to
use. CONCLUSIONS: The results of this study show that SCS is effective, safe, easy to use and
well tolerated by patients with refractory angina who fail to respond to traditional revascularisation. This
technique substantially improves the quality of life of patients suffering from refractory angina.
J Diabetes Complications. 1999 Sep-Dec;13(5-6):293-9. Epidural spinal cord electrical stimulation in diabetic
critical lower limb ischemia. Petrakis IE,
Sciacca V. First Department of General Surgery, Policlinico Umberto I, University of Rome, La Sapienza,
Rome,Italy. Spinal cord stimulation (SCS) has been suggested to improve microcirculatory blood flow to
relieve ischemic pain and to reduce amputation rate in patients with peripheral arterial occlusive
disease (PAOD). The aim of this study was to evaluate the specific prognostic parameters in the prediction of
successful SCS, in diabetic patients, performing a retrospective data analysis. To perform this evaluation, 64
diabetic patients (39 men, 25 women; mean age, 69 years) classified as Fontaine's
stage III and IV, with PAOD, were treated with SCS for rest pain and trophic lesions with dry gangrene, after
failed conservative or surgical treatment. In clinical controls, pedal transcutaneous oxygen tension (TcPO(2)),
ankle/brachial blood pressure index (ABI), and toe pressure Doppler measurements were
utilized to select and follow-up the patients. After 58 months of follow-up (range, 20-128 months), pain relief
greater than 75% and limb salvage were achieved in 38 diabetic patients. A partial success was obtained in
nine patients with pain relief greater than 50% and limb salvage for at least 6 months.
The method failed in 17 patients or the device was removed due to technical problems, and the limb was
amputated in these patients. TcPO(2) was assessed on the dorsum of the foot. Clinical improvement and SCS
success were associated with increase of TcPO(2), before and after implantation. Limb salvage
was achieved in the patients who had significant TcPO(2) increase within the 2 weeks of the testing period,
independently of the stage of the disease. A TcPO(2) increase of more than 50% in the first 2 months after
implantation was predictive of success, and was related to the presence of adequate
paresthesias in the painful area during the trial period. TcPO(2) significantly increased after long-term
follow-up in all patients with limb salvage (from 22.1 to 43.1 mm Hg in the rest pain patients, from 15.8 to
36.4 mm Hg in those with trophic lesions of less than 3 cm(2), and from 12.1 to 28.1 in those with
trophic lesions of greater than 3 cm(2), (p < 0.01). ABI did not changed under stimulation. In diabetic patients
with PAOD, the SCS increases the skin blood flow, is associated with significant pain relief, and could be
proven an excellent alternative therapy, improving the life quality. Significant TcPO(2) increase
within the 2-week test period, is a predictive index of therapy success and should be considered before the
final decision in terms of cost effectiveness, before the permanent implantation.
Surg Neurol. 1998 Aug;50(2):110-20; discussion 120-1. Epidural spinal cord stimulation for treatment of
chronic pain--some predictors of success. A 15-year
experience. Kumar K, Toth C, Nath RK, Laing P. Department of Surgery, The Plains Health Centre, University of
Saskatchewan, Regina, Canada.
BACKGROUND: We have used epidural spinal cord stimulation (SCS) for pain control for the past 15 years. An
analysis of our series of 235 patients has clarified the value of specific prognostic parameters in the
prediction of successful SCS. METHODS: Patients were followed up for periods ranging from 6
months to 15 years with a mean follow-up of 66 months. The mean age of the 150 men and 85 women in the
study was 51.4 years. Indications for SCS included failed back syndrome (114 patients), peripheral vascular
disease (39 patients), peripheral neuropathy (30 patients), multiple sclerosis (13 patients),
reflex sympathetic dystrophy (13 patients), and other etiologies of chronic intractable pain (26 patients).
RESULTS: One hundred and eighty-nine patients received permanent devices; 111 (59%) of these patients
continue to receive satisfactory pain relief. Pain attributable to failed back syndrome, reflex
sympathetic dystrophy, peripheral vascular disease of lower limbs, multiple sclerosis, and peripheral
neuropathy responded favorably to spinal cord stimulation. In contrast, paraplegic pain, cauda equina
syndrome, stump pain, phantom limb pain, and primary bone and joint disease pain did not respond
as well. Cases of cauda equina injury had promising initial pain relief, but gradually declined after a few
years. After long-term follow-up, 47 of the 111 successfully implanted patients were gainfully employed,
compared with 22 patients before implantation. The successful patients reported improvements in
daily living as well as a decrease in analgesic usage. Multipolar stimulation systems were significantly more
reliable (p < 0.001) than unipolar systems. Complications included hardware malfunction, electrode
displacement, infection, and tolerance. CONCLUSION: Aside from etiologies of pain syndromes as
a prognostic factor, we have identified other parameters of success. In patients who have undergone
previous surgical procedures, the shorter the duration of time to implantation, the greater the rate of success
(p < 0.001). The diagnosis of failed back syndrome must be considered a confounding factor in our
analysis. Those patients whose pain did not follow a surgical procedure had better responses to SCS than
patients who had multiple surgical procedures prior to their first implant. The advent of multipolar systems
has significantly improved clinical reliability over unipolar systems. Age, sex, and laterality of pain
did not prove to be of significance.
Spine. 1996 Dec 1;21(23):2786-94. Prospective, multicenter study of spinal cord stimulation for relief of
chronic back and extremity pain. Burchiel KJ,
Anderson VC, Brown FD, Fessler RG, Friedman WA, Pelofsky S, Weiner RL, Oakley J, Shatin D. Division of
Neurosurgery, Oregon Health Sciences University, Portland. STUDY DESIGN: This prospective, multicenter
study was designed to investigate the efficacy and outcome of spinal cord stimulation
using a variety of clinical and psychosocial outcome measures. Data were collected before implantation and
at regular intervals after implantation. This report focuses on 70 patients who had undergone 1 year of
follow-up treatment at the time of data analysis. OBJECTIVES: To provide a more generalizable
assessment of long-term spinal cord stimulation outcome by comparing a variety of pain and
functional/quality-of-life measures before and after management. This report details results after 1 year of
stimulation. SUMMARY OF BACKGROUND DATA: The historically diverse methods, patient
selection criteria, and outcome measures reported in the spinal cord stimulation literature have made
interpretation and comparison of results difficult. Although short-term outcomes are generally consistent,
long-term outcomes of spinal cord stimulation, as determined by prospective studies that assess
multidimensional aspects of the pain complaint among a relatively homogeneous population, are not well
established. METHODS: Two hundred nineteen patients were entered at six centers throughout the United
States. All patients underwent a trial of stimulation before implant of the permanent system.
Most were psychologically screened. One hundred eighty-two patients were implanted with a permanent
stimulating system. At the time of this report, complete 1-year follow-up data were available on 70 patients,
88% of whom reported pain in the back or lower extremities. Patient evaluation of pain and
functional levels was completed before implantation and 3, 6, 12, and 24 months after implantation.
Complications, medication usage, and work status also were monitored. RESULTS: All pain and quality-of-life
measures showed statistically significant improvement during the treatment year. These included
the average pain visual analogue scale, the McGill Pain Questionnaire, the Oswestry Disability Questionnaire,
the Sickness Impact Profile, and the Back Depression Inventory. Overall success of the therapy was defined
as at least 50% pain relief and patient assessment of the procedure as fully or partially
beneficial and worthwhile. Using this definition, spinal cord stimulation successfully managed pain in 55% of
patients on whom 1-year follow-up is available. Complications requiring surgical intervention were reported
by 17% (12 of 70) of patients. Medication usage and work status were not changed
significantly. CONCLUSIONS: This prospective, multicenter study confirms that spinal cord stimulation can be
an effective therapy for management of chronic low back and extremity pain. Significant improvements in
many aspects of the pain condition were measured, and complications were minimal.
Spine. 1996 Jun 1;21(11):1344-50; discussion 1351. Prospective outcome evaluation of spinal cord
stimulation in patients with intractable leg pain. Ohnmeiss
DD, Rashbaum RF, Bogdanffy GM. Institute for Spine and Biomedical Research, Plano, Texas, USA. STUDY
DESIGN. The results of spinal cord stimulation were prospectively evaluated using both subjective patient
self-report measures and objective physical functional testing. OBJECTIVES. The purpose of this
study was to evaluate prospectively the effects of spinal cord stimulation implantation, performed with the
patient awake and providing feedback, in patients with primary reports of intractable leg pain. SUMMARY OF
BACKGROUND DATA. Spinal cord stimulation has been used for treating chronic pain
of many types. However, even among those with intractable lower extremity pain, the outcome results have
shown great variability. METHODS. The surgical procedure was performed with the patient awake and
providing feedback to ensure optimal pain relief from the lead placement. The study group
comprised 40 patients, ranging in age from 28 to 86 years. The average symptom duration was 65.4 months,
and the average number of prior lumbar spine surgeries was 2.3 (range, 1 to 8). The primary data collection
periods were preoperative, 6 weeks after, and 12 and 24 months after surgery. RESULTS.
Statistically significant improvement in isometric lower extremity function was demonstrated 6 weeks after
the spinal cord stimulation implantation. In the more painful leg, the performance increased from 457.5
ft-lb-sec to 629.8 ft-lb-sec (P < 0.01). The performance remained significantly improved at the 12-
and 24-month follow-ups. Significant improvement was demonstrated on the physical scale of the Sickness
Impact Profile at 6 weeks. At 24 months, all three scales (physical, psychological, and other) as well as the
total score were significantly improved. Statistically significant decreases in pain, assessed by
changes in visual analog scale scores, were noted in the legs, when walking, and in overall lifestyle. The use
of narcotic medication decreased at all follow-up periods. At least 66% of the patients who were taking
narcotics before spinal cord stimulation were taking reduced amounts or no narcotics 2
years later. At the time of the 24-month follow-up, at least 70% of patients reported that the procedure
helped them, and would recommend it to someone with similar symptoms. CONCLUSIONS. Spinal cord
stimulation implantation can result in improved physical function and decreased pain in patients who
are carefully screened and in whom the implantation is performed with the patient awake to help ensure
optimal pain-relieving lead placement.
Neurochirurgie. 1995;41(2):73-86; discussion 87-8. [Chronic spinal cord stimulation in the treatment of
neurogenic pain. Cooperative and retrospective
study on 20 years of follow-up] [Article in French] Lazorthes Y, Siegfried J, Verdie JC, Casaux J. Service de
Neurochirurgie, CHU Rangueil, Faculte de Medecine Rangueil, Toulouse. The aim of this investigation is to
evaluate the long-term spinal cord stimulation (SCS) efficacy and safety, with a 20-years study concerning
692 patients (series I: 279, series II: 413). The series concern 304 arachno-epidural fibrosis, 152 peripheral
nerve lesions, 25 amputations pain, 17 plexus brachial lesions, 101 spinal cord lesions, 22 cancer pain, and
71 vascular pain. A multidisciplinary chronic pain evaluation must exclude contra-indications (nociceptive pain,
serious drug habituations, psychological problems, unresolved issues or secondary pain). Percutaneous
epidural SCS is a screening method if the trial is sufficiently prolonged (3 to 14 days) and if the pain
topography is overlapped by induced paresthesias. The immediate global results of the 2 series are similar:
respectively 86% and 85% of success one month after implantation. With the same longterm follow-up
(mean: 10 yrs, range: 2-20), and the same evaluation criteria, the percentage of long-term global success
rate is 54% in series I, and 52% in series II. In the most recent period (1984-1990) concerning 301 patients,
the success rate are respectively 68% and 60%. Analysing the results etiologically confirms the
therapeutic value of SCS for neurogenic pain secondary to partial deafferentation. For upper limb pain,
ipsilateral radicular stimulation is preferable. When the nerve lesion extends to the pre-ganglionic portion
(brachial plexus avulsion, herpes zoster) or in cases of pain of spinal or cerebral origin, thalamic
stimulation must be considered, after failure of SCS.
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