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Abstract

Postsurgical spine syndrome is becoming an increasingly common challenge for clinicians who deal with spinal disorders owing to the expanding indications for spinal surgery and the aging world population. A multidisciplinary approach is most appropriate for patients who are unlikely to benefit from further formal surgical intervention. Anticonvulsant medications are effective in managing neuropathic pain after surgery, whereas opioids are rarely beneficial. Neuromodulation via a surgically implanted dorsal column neurostimulator is gaining popularity owing to its substantial superiority over conventional medical management and/or further surgical intervention. However, considering that prevention is always better than cure, spinal surgeons need to be well aware of the many poor prognostic indicators for spinal surgery, particularly psychosocial overlay.
James R. Daniell et al.372 Asian Spine J 2018;12(2):372-379
Failed Back Surgery Syndrome: A Review Article
James R. Daniell1,2, Orso L. Osti1,2
1e University of Adelaide, Adelaide, SA, Australia
2Calvary Health Care, North Adelaide Campus, North Adelaide, SA, Australia
Postsurgical spine syndrome is becoming an increasingly common challenge for clinicians who deal with spinal disorders owing to the
expanding indications for spinal surgery and the aging world population. A multidisciplinary approach is most appropriate for patients
who are unlikely to benet from further formal surgical intervention. Anticonvulsant medications are effective in managing neuropath-
ic pain after surgery, whereas opioids are rarely benecial. Neuromodulation via a surgically implanted dorsal column neurostimulator
is gaining popularity owing to its substantial superiority over conventional medical management and/or further surgical intervention.
However, considering that prevention is always better than cure, spinal surgeons need to be well aware of the many poor prognostic
indicators for spinal surgery, particularly psychosocial overlay.
Keywords: Postsurgical spine syndrome; Failed back surgery syndrome; Repeat spinal surgery; Chronic pain management; Neuro-
modulation; Spinal cord stimulation
Copyright 2018 by Korean Society of Spine Surgery
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/)
which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Asian Spine Journal • pISSN 1976-1902 eISSN 1976-7846 • www.asianspinejournal.org
Received Mar 2, 2017; Revised Mar 3, 2017; Accepted May 28, 2017
Corresponding author: Orso L. Osti
Calvary Health Care, 89 Strangways Terrace, North Adelaide, SA 5006, Australia
E-mail: orsolosti@gmai l.com
ASJASJ
Review Article Asian Spine J 2018;12(2):372-379 • hps://doi.org/10.4184/asj.2018.12.2.372
Asian Spine JournalAsian Spine Journal
Introduction
Low back pain (LBP) has been estimated to have a lifetime
prevalence of 60%–80% among the global population,
making it one of the most common health complaints [1].
Approximately 10% of individuals suffering from LBP
have symptoms that persist for longer than 3 months [2].
As a consequence of the large number of patients with
LBP who have sought treatment, a substantial increase in
those undergoing surgery has been observed over the past
two decades.
Failed back surgery syndrome (FBSS) is a term used
to describe a clinical entity that has been acknowledged
since the advent of spinal surgery. It was perhaps best de-
scribed by Follett and Dirks [3] as the “surgical end stage
aer one or several interventions on the lumbar neuroaxis
indicated to relieve lower back pain, radicular pain or the
combination of both, without effect”. A more functional
denition is “when the outcome of lumbar spinal surgery
does not meet the pre-surgical expectations of the patient
and surgeon” [4].
The term FBSS has been criticized for being a clinical
misnomer for both patients and surgeons alike [5]. The
qualier “failed” does little to elucidate the entity, and it is
perhaps most appropriate to abandon this term entirely.
The diagnostic term “postsurgical spine syndrome” per-
haps more accurately describes the aforementioned clini-
cal entity [6].
Between 1998 and 2008, the yearly number of lumbar
fusion surgeries performed in the United States increased
from 77,682 to 210,407, with the total number of spinal
operations exceeding one million in 2002 [7,8]. e direct
yearly cost of spinal fusion surgery in the United States
was over US$ 16 billion in 2004 [9], whereas the overall
Failed Back Surgery Syndrome: A Review Article
Asian Spine JournalAsian Spine Journal
373
failure rate of lumbar spine surgery was estimated to be
10%–46% [10]. Given that these rates have not changed
substantially over the years despite advances in technol-
ogy and surgical technique, the number of patients devel-
oping FBSS can be expected to continually increase [11].
The potential widespread occurrence of this condi-
tion necessitates accurate assessment of this challenging
patient population to best address their symptoms and
deliver the most eective treatment.
The Problem
Repeat spinal surgery is a treatment option with dimin-
ishing returns. Although more than 50% of primary
spinal surgeries are successful, no more than 30%, 15%,
and 5% of the patients experience a successful outcome
aer the second, third, and fourth surgeries, respectively
[12]. e prevalence and incidence of patients with FBSS
are comparable with those of patients with rheumatoid
arthritis. However, patients with FBSS and neuropathic
pain experience higher levels of pain and a poorer quality
of life and physical function compared with those with os-
teoarthritis, rheumatoid arthritis, complex regional pain
syndrome, and bromyalgia [13].
Factors Leading to Failed Back
Surgery Syndrome
1. Patient factors
A number of patient-related factors may be associated
with higher rates of FBSS and should be considered when
discussing treatment options. A patient’s psychosocial
wellbeing has a significant effect on his/her treatment
outcome and pain experience such that Carragee et al.
[14] found poor psychosocial wellbeing to be the stron-
gest predictor of LBP disability in a study comparing
morphological and social risk factors. This is also true
when predicting poor outcomes aer spinal surgery [15].
A large number of patients assessed for spinal surgery
comprise those claiming workers’ compensation or re-
ceiving disability support pension. Both of these groups
have been found to be significantly more likely to have
poorer outcomes aer spinal surgery, with those claiming
workers’ compensation having the poorest outcomes. e
gures become even more alarming aer considering pre-
existing depression [16].
Furthermore, smokers are more likely to experience
poorer outcomes aer spinal surgery [17], and obesity is
an established predictor of higher rates of postoperative
complications [18].
2. Operative factors
A percentage of patients who had undergone spinal sur-
gery may have experienced poor outcomes due to an in-
appropriate surgical choice. As previously mentioned, the
number of prior spinal surgeries is a signicant predictor
of outcome of the following spinal surgery.
A single-level decompressive laminectomy in the pres-
ence of unknown multi-level spinal involvement is unlike-
ly to relieve the patient’s presenting symptoms. Similarly,
decompressive surgery in the presence of predominantly
axial/mechanical pain is unlikely to lead to a satisfactory
outcome. Furthermore, the most commonly reported er-
ror during spinal surgery was wrong-level decompression
[19].
Intraoperative errors during spinal surger y may not
only cause ongoing pain in the same preoperative distri-
bution site but also trigger new pain sources. Each surgery
has the potential to create new segmental instability and
generate further pain with misplaced interbody fusion
gras and implants, which may, for example, potentially
cause neural impingement [19]. In an analysis of 105
lumbar fusion cases with pedicle screw instrumentation,
the incidence rates of screw placement errors and implant
breakage at follow-up were 6.5% and 12.0%, respectively,
with potential for serious neurological complications [20].
Patients undergoing lumbar fusion are at risk of loss of
sagittal balance, particularly when more than one level is
involved. Furthermore, those with reduced sacral tilt aer
surgery have been found to exhibit loss of natural lumbar
lordosis with a resultant increase in stress transfer to the
sacroiliac joints [21].
3. Postoperative factors
1) Early
Immediately following surgery, a number of factors may
lead to operative failure. Procedural complications that
may have deleterious eects on the outcome include he-
matoma formation in the epidural or subdural space, in-
fection, pseudomeningocele, and nerve injury.
James R. Daniell et al.374 Asian Spine J 2018;12(2):372-379
2) Late
Altered biomechanics in the operated spine can potential-
ly shi segmental stress and cause “transition syndrome”.
Changes in load distribution may accelerate degeneration
in segments adjacent to the lumbar fusion, which could
lead to new sources of pain. One long-term radiological
study reported that 36% of the cases developed “transition
syndrome” 5 years after lumbar fusion [22,23] (Fig. 1).
Postlumbar discectomy patients with one-level disc her-
niation have been reported to have an overall recurrence
rate of 5%–25% within 5 years.
Assessment
In the workup of patients with FBSS, the principal clini-
cian involved should be able to utilize the services of a
multidisciplinary team.
1. History
First and foremost, the patient’s psychosocial wellbeing
should be thoroughly assessed. e presence of any psy-
chiatric comorbidity, workers’ compensation claims, or
personal disability claims should be noted. ese factors
should be addressed during treatment and should not be
used to exclude patients from further treatment.
An accurate and detailed pain history is crucial in delin-
eating the likely source of the patient’s pain. e dierence
between predominantly axial pain and neuropathic pain
or the presence of both should be understood. Similari-
ties in the distribution of prior and current pain are also
highly relevant given that new sources of pain may be an
indication of unrelated pathologies [24].
It is always of great importance to eliminate any “red
ags” in the history that may necessitate urgent interven-
tion and investigation, including signs of any bowel or
bladder disturbance, any new or progressive neurological
decit, signs of possible infection, and weight loss or other
symptoms that may indicate an undiagnosed malignancy.
orough documentation of previous treatments should
be included during history taking.
2. Physical examination
Physical examination of patients with FBSS is mainly
performed to eliminate the presence of any ominous di-
agnoses that may have been suggested in the past. In fact,
published studies show that very few clinical signs have a
high predictive value in identifying the source of pain [24].
Although paraspinal tenderness has been shown to be as-
sociated with facet arthropathy, the specicity of this test
is low [25]. A neurological examination should be per-
formed to conrm the absence of progressive neurologi-
cal decit and to establish a baseline prior to any further
intervention.
3. Investigations
e choice of an imaging modality for the FBSS cohort is
dependent on the underlying presumptive diagnosis and
previous treatments.
Plain erect radiographs are of use in the initial assess-
ment of vertebral alignment and the extent of previous
surgical intervention as well as in detecting substantial
and clinically signicant degenerative changes [19]. Plain
lateral dynamic erect radiographs (with extension/exion
views) have been shown to be superior to magnetic reso-
nance imaging (MRI) in detecting spondylolisthesis [26].
However, MRI remains the gold standard in FBSS
owing to its superior contrast enhancement sensitivity
Fig. 1. A typical radiological example of “failed back surgery syn-
drome”: previous L4 to S1 posterolateral fusion with adjacent (L3–L4)
segment degeneration, residual/recurrent neural involvement, broken
screw instrumentation, and loss of lumbar lordosis.
Failed Back Surgery Syndrome: A Review Article
Asian Spine JournalAsian Spine Journal
375
compared with computed tomography (CT) [27]. MRI
with gadolinium has the capacity to distinguish between
epidural brosis, perineural scar tissue, and recurrent disc
herniation as a source of pain [19,25] while being the best
imaging modality for detecting spondylodiscitis [27].
CT is used when MRI is contraindicated owing to the
presence of metalware or non-MRI-compatible cardiac
pacemakers, wherein old-fashioned water-soluble CT
myelography may be used [24]. CT may also be used in
identifying facet arthropathy and pseudoarthrosis owing
to its ne slice superiority in osseous imaging [28].
Management
1. Conservative
Conservative management should always be attempted
in patients with FBSS who do not require urgent surgery.
Moreover, it should always involve supervised exercise
programs with the dual purpose of improving patients’
core strength and spinal range of motion, which may in-
clude physical therapy and pharmacological management.
Pharmacological therapy may include paracetamol and
nonsteroidal anti-inammatory drugs for axial pain con-
sidering that they have both been shown to be superior to
placebo in reducing LBP [29]. Anticonvulsant drugs have
gained popularity for neuropathic pain, with gabapentin
(Neurontin) and pregabalin (Lyrica) being the most com-
monly used preparations. Gabapentin has been shown to
be superior to naproxen in alleviating back and leg pain
after spinal surgery [30]. Pregabalin plays a role in the
prevention of pain before and aer surgery, with its eect
apparently increasing with time [31].
e use of opioids in chronic LBP has become increas-
ingly controversial and is currently recommended for
only short-term therapy. In fact, opioid treatment should
be limited to a nite course over a few weeks given the ab-
sence of evidence to suggest any long-term pain improve-
ment from its use [32]. Furthermore, mounting evidence
has shown substantial morbidity risks associated with
long-term opioid use, including addiction, dependence,
overdose, and even death [25,32].
As part of the treatment regimen, some evidence sug-
gests that cognitive behavioral therapy leads to a reduc-
tion in pain scores in the immediate postoperative period
and during long-term disability [33]. Physical therapy
may be used as part of a multimodal approach for pain
management given its mild eectiveness in patients with
chronic LBP. However, no consensus exists on the best
type of therapy [34].
2. Repeat surgery
Choosing the most appropriate management modality
should be based on the type and pattern of pain syndrome
experienced by the patient: those suering from predomi-
nantly axial or mechanical pain and those with predomi-
nantly neuropathic lower limb pain.
As mentioned earlier, very few absolute indications ex-
ist for repeat spinal surgery. ese include any disabling
and progressive neurological decit, be it association with
bowel or bladder function impairment, cauda equina syn-
drome, or established spinal instability requiring reopera-
tion [35].
Removal of pedicle screw instrumentation may be con-
sidered during predominantly axial or midline pain aer
lumbar fusion. In fact, a number of such cases showed a
significant reduction in pain scores and opioid require-
ment after implant removal [36]. It is also important to
consider the presence of significant adjacent segment
disease or periprosthetic loosening, which may contribute
to the pain, as well as underlying osteoporosis requiring
appropriate medical management (Fig. 2).
3. Neuromodulation
Spinal cord stimulation (SCS) has been proven to be the
most effective form of semi-invasive treatment in pa-
tients with predominantly neuropathic limb pain. The
PROCESS study, published by Kumar et al. [37] in 2007,
compared conventional medical management (CMM)
alone with SCS+CMM in patients with radicular pain for
6 months following a minimum of one anatomically suc-
cessful procedure for herniated lumbar nucleus pulposus.
Aer 6 months, the percentage of patients experiencing at
least a 50% reduction in pain scores was 9% in the CMM
alone group against 48% in the CMM+SCS group [37].
North et al. [38] in 2005 conducted a randomized study
comparing SCS with reoperation in patients experienc-
ing radicular pain with or without LBP. In the study, suc-
cess was dened as a greater than 50% reduction in pain
and satisfaction with treatment; these endpoints were the
same as those used in previous similar studies. SCS was
more successful than reoperation (nine of 19 patients ver-
James R. Daniell et al.376 Asian Spine J 2018;12(2):372-379
sus three of 26, p<0.01), whereas fewer patients changed
groups from SCS to reoperation [38]. A retrospective
analysis of 16,455 patients with FBSS who underwent ei-
ther reoperation or SCS implantation demonstrated that
those with SCS implantation experienced less than half
the complications compared with those who underwent
reoperation aer 90 days (6.5% versus 14.4%) [39].
The role of SCS in patients with predominantly axial
pain has previously been considered much less promising
than that in patients with radicular pain. A recent multi-
center randomized controlled trial conducted by Kapural
et al. [40] randomized patients with chronic LBP and/
or limb pain to high-frequency SCS (10,000 Hz) (HF10)
or traditional low-frequency SCS (50 Hz). Majority of
these patients (87% and 86.2%, respectively) had under-
gone previous spinal surgery. The primary endpoint of
the study was a minimum pain reduction of 50% without
stimulation-related neurological deficits [40]. The trial
showed that HF10 was superior to traditional SCS in the
treatment of both axial and radicular pain, with HF10
having a better response rate (84.3%) compared with
traditional SCS (43.8%) in patients with axial pain after
3 months. Among those with radicular pain, HF10 and
traditional SCS had response rates of 83.1% and 55.0% af-
ter 3 months of follow-up, respectively [40]. e superior
outcomes of HF10 therapy continued until 24 months in
those with both back and leg pain [41]. e ecacy of the
HF10 therapy has also been confirmed in an Australian
cohort, with high trial success rates and significant pain
reduction among patients who failed to respond to tradi-
tional SCS [42].
A number of other neuromodulation techniques have
also been attempted, including burst, adaptive, dorsal root
Fig. 3. Example of percutaneous placement of electrodes for the man-
agement of persisting axial and neuropathic pain with direct stimula-
tion of the L4 dorsal root ganglion.
Fig. 2. (A, B) Lucency and loosening surrounding both L4 pedicle screw implants 18 months postsurgery with the diagnostic ap-
pearance on bone scan likely to be linked to failure of bony ingrowth into the carbon ber interbody cage used to replace the L4–L5
disc.
AB
Failed Back Surgery Syndrome: A Review Article
Asian Spine JournalAsian Spine Journal
377
ganglion, and peripheral nerve eld stimulation. Based on
one study conducted by Schu et al. [43], only moderate
evidence exists for burst stimulation, which demonstrated
lower pain scores and higher patient satisfaction over 1
week compared with traditional tonic–clonic stimulation
[44]. A prospective study by Liem et al. [45] showed that
dorsal root ganglion stimulation had similar efficacy for
both leg and back pain in patients with FBSS, although
the most signicant reduction was observed for foot pain
(Fig. 3).
Screening patient s for SCS implant ation re quires
comprehensive consultation wherein formal surgery is
conrmed to have no further benet and the patient re-
ceives optimal medical management, has realistic insight
into their condition, and has no evidence of infection. In
general, most trials involving SCS include a trial period
of minimum 10 days with at least a 50% reduction in
pain scores. e surgical implantation of leads is associ-
ated with greater ecacy during the trial period. It is also
worth considering that signicantly higher rates of infec-
tion have been observed when using externalized leads
during the trial.
Conclusions
Our approach to manage FBSS considers the limitations
of surgical intervention on the spine, as well as the vari-
ous patient-related factors that may lead to unsuccessful
outcomes besides the presence of surgically ameliorable
pathology. The decision to perform surgery in patients
with predominantly axial pain should be made with the
understanding that many patients may not respond to the
treatment.
e importance of a competent multidisciplinary team
in FBSS cannot be overstated. Engagement between phy-
sicians, psychologists, physiotherapists, and other allied
health professionals is essential in improving outcomes
for patients with FBSS.
SCS continues to establish itself as the preferred treat-
ment option for patients with FBSS in the absence of a
viable surgical alternative, particularly when radicular/
neuropathic pain, as well as oen when substantial axial
pain, is the main source of disability.
Conict of Interest
No potential conict of interest relevant to this article was
reported.
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pain. Neuromodulation 2015;18:41-8.
... This leads to chronic disabling pain with poor quality of life and function for the patient. [2,6] Carragee et al. associated increased rates of FBSS with psychosocial health of patients. It is correlated proportionally with predicting poor outcomes after spine surgery. ...
... This stresses on importance of surgeon patient communication with psychiatric counseling, both pre and postoperatively. [2,7] Failure rates are also majorly based on the choice and technique of operation. Errors while operating does not help the patient and also worsen the present condition of the patient triggering new complications. ...
... Errors while operating does not help the patient and also worsen the present condition of the patient triggering new complications. [2] The incidence of faulty screw insertion and implant breakage ranges up to 6.5-12% in patients undergoing lumbar spinal fusion using pedicle screws, with the risk of serious neurological damage and loss of sagittal balance when more than one level is fused. [2] Conservative management with analgesics, anti-convulsant such as pregabalin and gabapentin, cognitive behavioral therapy, and physiotherapy is the first line of treatment. ...
... In the current study, majority of the patients were older than 40 years, and more than half of them were males, which agreed the epidemiological picture of LBP and FBSS (28)(29)(30). On the other hand, all patients in our study presented with low back pain for different duration ranged 1 -14 months, Multiple disc prolapses and foot drop were the next more frequent presenting feature , while other features like Spinal canal stenosis and Cauda equina syndrome reported in 25% and 15%, respectively, these findings were not unexpected due to the nature of the study population , these findings also reported in previous studies (29,(31)(32)(33). ...
... In the current study, majority of the patients were older than 40 years, and more than half of them were males, which agreed the epidemiological picture of LBP and FBSS (28)(29)(30). On the other hand, all patients in our study presented with low back pain for different duration ranged 1 -14 months, Multiple disc prolapses and foot drop were the next more frequent presenting feature , while other features like Spinal canal stenosis and Cauda equina syndrome reported in 25% and 15%, respectively, these findings were not unexpected due to the nature of the study population , these findings also reported in previous studies (29,(31)(32)(33). ...
... 10 Neuromodulation and implantable 1 technologies are the most effective interventions for long-term pain management for patients with FBSS. 11 Spinal cord stimulation (SCS) is a widely used, minimally invasive, surgical intervention for various chronic pain syndromes, including FBSS. 12 Several studies showed that SCS is a safe and effective alternative to opioids in a variety of pain syndromes. 13 Because of this clinical effectiveness, the number of patients that undergo SCS implantation each year approximates 34,000 globally and shows to be continuously growing. ...
Article
Background Spinal cord stimulation (SCS) is an established therapy of failed back surgery syndrome (FBSS), although the effects on daily functioning, quality of life (QoL), and patients’ expectations, experiences, and satisfaction remain elusive. The current integrative review aimed to summarize the overall effects of SCS in patients with FBSS on pain relief, health-related QoL, and daily activities. Materials and Methods PubMed, CINAHL, Embase, ClinicalTrials.gov, gray literature, and reference lists of relevant articles were searched for additional papers. All included studies were assessed for risk of bias using the Mixed Methods Appraisal Tool. Following the methods of Whittemore and Knafl, an integrative review and a meta-analysis were performed. Results In total, 16 articles were included; 11 articles presented quantitative outcomes, and five articles presented qualitative data. Lower back pain, leg pain, overall pain, Oswestry Disability Index, EuroQol Five Dimensions Health Questionnaire three-level/five-level, and the physical component score of Short Form Health Survey (SF-36) significantly improved during all follow-up moments. Only the mental component score of the SF-36 did not significantly improve, compared with baseline. Heterogeneity was diversely present among the studies. Patients’ expectations and goals were disparate, although patients seemed to desire a return to their pre-FBSS state. Experiences with regard to the outcomes showed that patients largely recuperated after SCS, although limitations were still present. Patients also expressed inconvenience with regard to the trial period, implantation location, and recharging of the implantable pulse generator. Conclusions SCS showed beneficial effects on different domains of life in patients with FBSS. The quantitative analyses suggest an overall improvement in most domains, although patients’ experiences show that limitations in daily life and living with the SCS system persist. Multiple extensive preoperative counseling sessions and discussions with patients are deemed necessary to improve patient satisfaction and meet their expectations. Shared decision-making and provision of complete information are key factors for success.
Article
Zusammenfassung Die Bildgebung der postoperativen Wirbelsäule hat im Wesentlichen zwei Aufgaben: Sie dient der Kontrolle des operativen Erfolgs und der Identifikation von Komplikationen. Dafür stehen die konventionelle Röntgenaufnahme, Computertomographie (CT), Myelographie und Magnetresonanztomographie (MRT) zur Verfügung. Unter Berücksichtigung der präoperativen Situation, der durchgeführten Operation und der postoperativen Beschwerdekonstellation ist es Aufgabe der Radiologinnen und Radiologen, die passende Modalität für eine suffiziente Diagnostik zu wählen. Insbesondere der Zustand nach Implantation von Fremdmaterial bedeutet eine technische Herausforderung im Rahmen der Bildakquisition. In der Befundung sehen sich die Radiologinnen und Radiologen mit der Aufgabe konfrontiert, zwischen natürlichen, zu erwartenden postoperativen Veränderungen und relevanten Komplikationen zu differenzieren. Ein reger Austausch mit Patientinnen und Patienten und zuweisenden Klinikerinnen und Klinikern ist dabei unerlässlich. Insbesondere klinische Hinweise auf einen Infekt, neue oder deutliche progrediente neurologische Ausfallserscheinungen und das Konus-Kauda-Syndrom erfordern eine zeitnahe Diagnosestellung, um eine rasche Therapieeinleitung zu gewährleisten.
Article
Background: Lower back pain is often evaluated using magnetic resonance imaging (MRI) and conventional imaging, which provide incomplete information about the etiology of pain and lead to less than optimal management. Hypothesis: MR neurography (MRN) of the lumbosacral (LS) plexus renders a more accurate diagnosis, alters the management strategy, and clinical outcomes of radiculopathy or failed back surgery Syndrome (FBSS) patients when compared to the conventional imaging modalities. Study type: Retrospective, cross-sectional. Population: A total of 356 patients (mean age 65.8 ± 12.3; 48.9% female) from single university hospital over 6 years with MRN of LS plexus were included from a cohort of 14,775 total patients with lumbar spine MR imaging. Assessment: Conventional imaging obtained before and after MRN of LS plexus was reevaluated and categorized into three levels based on extent of imaging findings' correlation to presenting clinical symptoms (contributory levels). Clinical notes were reviewed for changes in ordering provider's recommended management and subsequent patients' symptom level pre-MRN to post-MRN. Field strength/sequence: A 5 T and 3.0 T. T1-weighted (T1W), T2-weighted (T2W), short T1 inversion recovery (STIR), T1 turbo spin echo (T1 TSE), T2 spectral attenuated inversion recovery (T2 SPAIR). Statistical tests: Chi-squared test. Statistical significance was set at P < 0.05. Results: A total of 356 total patients (174 females) with mean age ± SD was 65.8 ± 12.3 years, 4.2% of patients imaged with lumbar spine MRI. Definitely contributory studies among X-rays, computed tomography, MRI, and MRN were 3 of the 129 (2.3%), 3 of the 48 (6.2%), 35 of the 184 (19.0%), and 283 of the 356 (79.8%), respectively. Pre-MRN vs. post-MRN led to change in recommendation in 219 of the 356 (61.5%) patients and 71 of the 99 (71.7%) patients had improved symptoms. Conclusion: MRN of the LS plexus can provide more corroborative image findings for symptom correlation compared to other imaging modalities for accurate diagnosis, effects patient management and leads to positive clinical outcomes in a small subset of patients with radiculopathy or FBSS. Evidence level: 4 TECHNICAL EFFICACY: Stage 5.
Article
In most patients after lumbar discoectomy, despite the elimination of root compression, the manifestations of chronic radiculopathy continue. Pain syndrome persists in 85.8% of patients, numbness in 74.1%, and paresthesia in 44.7%. Objective:to study the efficacy of transcutaneous electroneurostimulation (TENS) of the peroneal and tibial nerves in the treatment of patients with neurological deficit after undergoing discoectomy at the L4–S1 level. Materials and methods. After a course of pharmacotherapy, 15 patients underwent a course of direct stimulation of the peroneal and tibial nerves using transcutaneous electroneurostimulation, and 15 patients underwent a course of sham stimulation. Conclusion. Direct labile stimulation of the peroneal and tibial nerves using a monopolar current with a frequency of 1Hz, a duration of 200 μs and an amplitude that induces a painless motor response is a highly effective method of treating patients with residual clinical neurological manifestations after undergoing discoectomy at the L4–S1 level. Against the background of this method, the symptoms of tension, motor deficit, gait disturbance, impaired аchilles reflex and pain syndrome in the sensory and affective aspects are reliably regressed.
Article
Background It is unknown whether online information about the benefits and harms of surgery contains an accurate description of evidence. Objective To describe the proportion of webpages containing information about surgery for spinal pain (decompression and fusion) that accurately described the evidence on the benefits of surgery, described harms, and provided quantitative estimates of these harms. Methods We performed a content analysis of webpages containing information about spine surgery. Two reviewers identified webpages and extracted data. Primary outcomes were the proportion of webpages that accurately described the evidence on the benefits, described harms, and provided quantitative estimates of these harms. Results We included 117 webpages. Only 29 (25%) webpages accurately described the evidence on the benefits of spine surgery, and more webpages on decompression accurately described the evidence compared to webpages on fusion (31% vs 15%, difference in proportions = 16%; 95% CI: 2%, 31%). Harms of surgery were described in most webpages (n = 76, 65%), but a much smaller proportion of webpages (n = 18, 15%) provided a quantitative estimate for the mentioned harms. Conclusions Most webpages failed to accurately describe the benefits and harms of decompression and fusion surgeries for spinal pain. Unbiased consumer resources and educating the public on how to critically evaluate health claims are important steps to improve knowledge on the benefits and harms of spine surgery.
Article
Цель. Оценить выраженность и характеристики болевого синдрома у пациентов без и после оперативного лечения болей в нижней части позвоночника, а также его связь с уровнем тревоги и депрессии.Материалы и методы. Обследованы 100 стационарных пациентов с болями в нижней части спины, разделенных на 3 группы: консервативного лечения, ранней и поздней послеоперационной реабилитации. Выполнена комплексная характеристика болевого синдрома по шкалам ВАШ, DN4, PainDetect, Мак-Гилловскому опроснику, а также установлен уровень тревоги и депрессии с помощью шкал Спилбергера – Ханина и Бека.Результаты. Установлено уменьшение интенсивности болевого синдрома в спине в процессе реабилитации после оперативного вмешательства на позвоночнике. Тем не менее доля пациентов с умеренным и выраженным болевым синдромом в раннем и позднем восстановительном периоде после операции оставалась значительной (более 80%). При этом в позднем восстановительном периоде наблюдалось нарастание эмоционального компонента в формировании болевого синдрома при увеличении его длительности, что также подтверждалось высокими значениями реактивной и личностной тревожности данной группы пациентов. Доля лиц с нейропатическим болевым синдромом оставалась одинаковой как среди пациентов, пролеченных консервативно, так и среди пациентов в реабилитационном периоде после оперативного вмешательства на позвоночнике и составляла около 30%, что свидетельствует о значительном отличии механизмов его формирования и необходимости поиска иных путей его лечения.Заключение. Несмотря на снижение интенсивности болевого синдрома у пациентов после операции на позвоночнике, доля лиц с умеренным и выраженным болевым синдромом оставалась высокой. У них нарастали эмоциональный компонент болевого синдрома с высокими показателями тревоги и депрессии. Нейропатический компонент боли не изменялся, что свидетельствует о необходимости его отдельной коррекции. Purpose. To assess the severity and characteristics of pain syndrome in patients without and after surgical treatment of pain in the lower spine, as well as its relationship with the level of anxiety and depression.Materials and methods. 100 inpatient patients with lower back pain were examined and divided into 3 groups: preventive treatment, early and late postoperative rehabilitation. A comprehensive description of the pain syndrome was performed using the VAS, DN4, PainDetect scales, and the McGill questionnaire; the level of anxiety and depression was determined using the Spielberger – Hanin and Beck scales.Results. A decrease of the intensity of back pain during rehabilitation after spinal surgery was found. However, the proportion of patients with moderate and severe pain in the early and late recovery period after surgery remained significant (more than 80%). At the same time, in the late recovery period, there was an increase in the emotional component in the formation of pain syndrome with an increase of its duration, which was also confirmed by high values of reactive and personal anxiety in this group of patients. The proportion of people with neuropathic pain syndrome remained the same both in patients treated conservatively and in the rehabilitation period after spinal surgery, and was about 30%, which indicates a significant difference in the mechanisms of its formation and the need to find other ways to treat it.Conclusion. Despite the decrease of the intensity of pain in patients after spinal surgery, the proportion of people with moderate and severe pain remained high. They developed an emotional component of pain syndrome with high rates of anxiety and depression. The neuropathic component of pain did not change, which indicates the need for its separate correction.
Article
Background: Recent evidence suggests that IL-33, a novel member of the IL-1β family, is involved in organ fibrosis. However, the roles of IL-33 and its receptor ST2 in epidural fibrosis post spine operation remain elusive. Methods: A mouse model of epidural fibrosis was established after laminectomy. IL-33 in the wound tissues post laminectomy was measured with Western blotting, ELISA and immunoflurosence imaging. The fibroblast cell line NIH-3T3 and primary fibroblasts were treated with IL-33 and the mechanisms of maturation of fibroblasts into myofibroblasts were analyzed. To explore roles of IL-33 and its receptor ST2 in vivo, IL-33 knockout (KO) and ST2 KO mice were employed to construct the model of laminectomy. The epidural fibrosis was evaluated using H&E and Masson staining, western-blotting, ELISA and immunohistochemistry. Results: As demonstrated in western blotting and ELISA, IL-33 was increased in epidural wound tissues post laminectomy. The immunoflurosence imaging revealed that endothelial cells (CD31+) and fibroblasts (α-SAM+) were major producers of IL-33 in the epidural wound tissues. In vitro, IL-33 promoted fibroblast maturation, which was blocked by ST2 neutralization antibody, suggesting that IL-33-promoted-fibroblasts maturation was ST2 dependent. Further, IL-33/ST2 activated MAPK p38 and TGF-β pathways. Either p38 inhibitor or TGF-β inhibitor decreased fibronectin and α-SAM production from IL-33-treated fibroblasts, suggesting that p38 and TGF-β were involved with IL-33/ST2 signal pathways in the fibroblasts maturation. In vivo, IL-33 KO or ST2 KO decreased fibronectin, α-SMA and collagen deposition in the wound tissues of mice that underwent spine surgery. In addition, TGF-β1 was decreased in IL-33 KO or ST2 KO epidural wound tissues. Conclusion: In summary, IL-33/ST2 promoted fibroblast differentiation into myofibroblasts via MAPK p38 and TGF-β in a mouse model of epidural fibrosis after laminectomy.
Article
Background. Epidural fibrosis (EF) is one of the reasons of the failed back surgery syndrome manifesting in back pain and pain in extremities as well as other signs of the compression or irritation of the nerve structures. The numerous approaches to prevent EF have been elaborated. Nowadays, many years of experience in the usage of different barrier materials in microdiscectomy such as polyacrylamide hydrogel (PAH) have been accumulated. Nevertheless, the results of such treatment are rather controversial. The aim of the study was to assess the radiological data on the state of the backbone according to MRI findings and the clinical symptoms of the patients following the surgery as well as to determine the long-term strength of the interaction between the factors under study after the repeated lumbar microdiscectomies performed with intraoperative epidural PAH administration. Materials and methods. The results of the clinical and radiological assessment of 96 patients (mean age 45.7 years; 95 % CI [43.5; 47.9]; 59 males and 37 females) enrolled into the single-center prospective cohort study performed at the State Institution «Romodanov Neurosurgery Institute National Academy of Medical Sciences of Ukraine» have been presented. The patients were divided into two groups. The main group (MG) consisted of 35 (36.5 %) patients with recurrent intervertebtral disc (IVD) herniation to whom PAH was administered epidurally at the final step of the surgery comprising disc removal and decompression of the nervous structures with the aim of preventing cicatrical adhesive EF. In control group (61 patients, 63.5 %), barrier materials were not used. The primary end-points of the study were the long-term outcomes of the repeated lumbar microdiscectomies: EF rate at the postoperative site; the rate of the displacement of spinal root at the postoperative site; the rate of the repeated recurrent IVD herniation and de novo IVD herniation; the rate of the cases with the residual radicular pain localized in the area of the surgical intervention and the extent of the worsening of life quality in the treated patients. The secondary end-points of the study were the following: the analysis of the associations with delineation of the strength of such factorsaffecting the residual radicular pain as EF, the displacement of spinal root at the postoperative site, the repeated recurrent IVD herniation the repeated recurrent IVD herniation and de novo IVD herniation. Results. In 12 months following the surgical treatment, EF frequency was significantly lower in MG as compared with CG where PAH was not used (p = 0.02936). Nevertheless, the difference between groups was not significant when MRI findings of the displacement of spinal root at the postoperative site (р = 0.46759), the frequency of the repeated recurrent IVD herniation (p = 0.90904) and de novo IVD herniation (p = 0.60385) were compared. In study group, there were no association between MRI signs of postoperative EF, the displacement of spinal root or new recurrent IVD herniation on the one hand and the frequency of the radicular pain localized at the area of the surgical intervention on the other hand (p = 0.66482; p = 0.09515; p = 0.22857, respectively). In CG, the significant association between the displacement of spinal root at the postoperative site and the clinical symptoms above was revealed (p = 0.00222) with association coefficient φ = 0.41 indicating the moderate strength of this association. Conclusions. The data obtained generally suggest the reasonability of applying PAH manufactured in Ukraine as a barrier material at least for the treatment of the patients with recurrent IVD herniation representing the challenging category of spinal patients.
Article
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Zafeer Baber, Michael A Erdek Division of Pain Medicine, Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA Abstract: The treatment of failed back surgery syndrome (FBSS) can be equally challenging to surgeons, pain specialists, and primary care providers alike. The onset of FBSS occurs when surgery fails to treat the patient’s lumbar spinal pain. Minimizing the likelihood of FBSS is dependent on determining a clear etiology of the patient’s pain, recognizing those who are at high risk, and exhausting conservative measures before deciding to go into a revision surgery. The workup of FBSS includes a thorough history and physical examination, diagnostic imaging, and procedures. After determining the cause of FBSS, a multidisciplinary approach is preferred. This includes pharmacologic management of pain, physical therapy, and behavioral modification and may include therapeutic procedures such as injections, radiofrequency ablation, lysis of adhesions, spinal cord stimulation, and even reoperations. Keywords: back pain, back pain with radiation, back pain without radiation, low back pain, spinal cord stimulation, review, pain disorder
Article
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Background: Our aim was to determine whether patients derived benefit from removal of pedicle screw instrumentation for axial pain without other cause using our surgical technique and patient selection. A secondary aim was to investigate factors that were associated with poorer outcomes for this procedure as well as complication rate in this cohort. Methods: Theater records from a single spinal surgeon's practice were reviewed to identify patients that had undergone lumbar fusion for discogenic back pain with subsequent pedicle screw instrumentation removal (Expedium, DePuy Synthes) in the preceding 3 years with a minimum of 18 months follow-up. Inclusion criteria were persisting midline axial back pain with computed tomography (CT)-confirmed solid fusion with non-radicular symptoms and nil other potential causes found, e.g., infection. Case note review along with pre- and post-operative Oswestry disability index (ODI) questionnaires and visual analog scores (VAS) were assessed for all patients. Surgical technique included re-use of previous midline posterior incision and the Wiltse approach with removal of implants, confirmation of a solid fusion mass, washout and bone grafting of removal sites. Results: From 50 consecutive patients who underwent removal of posterolateral instrumentation for an index elective lumbar fusion for discogenic back pain, 34 patients were identified that met the criteria with a mean follow-up of 25 months (range, 18-36 months). The VAS and ODI improved in 22/34 (65%) of participants. The mean cohort VAS score was 6.6 pre-surgery and 4.3 post-surgery (P=0.04). Preoperative and postoperative mean Oswestry disability scores were 64 and 41, respectively (P=0.05). There was a statistically significant difference in the proportion of patients with poorer compared to satisfactory outcomes with regards to compensable status, preoperative grade II opioid use and shorter time between fusion and removal procedure. Complications were one postoperative hematoma and one superficial wound infection, both of which settled without re-operation. Conclusions: Approximately two thirds of patients were satisfied with removal of instrumentation for treatment of residual low back pain (LBP) following elective lumbar fusion and recorded reduced VAS and grade II opioid use. A subset of patients remained that did not derive benefit and were associated with compensable status, preoperative grade II opioid use and a shorter time between fusion and removal procedure. A prospective cohort study with preoperative diagnostic injections and standardized imaging and microscopic techniques would strengthen future studies. However, this study suggests that removal of instrumentation is safe and provides modest benefit as a palliative procedure for a subset of patients with significant disability from chronic LBP without an underlying cause following lumbar fusion.
Article
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Background: High frequency spinal cord stimulation at 10 kHz (HF10 therapy) represents a prominent advance in spinal cord stimulation (SCS) therapy, having demonstrated enhanced efficacy in patients with back and leg pain and pain relief without paresthesia that is sustained at 24 months post implant. Objective: To report on the effectiveness HF10 SCS therapy for a wide range of intractable pain conditions in clinical practice. Study design: Retrospective investigation of 256 patients who trialed HF10 SCS for chronic intractable pain of various etiologies. Setting: Three Australian pain clinics. Methods: Two hundred fifty-six patients trialed HF10 SCS with view of a permanent implant if successful. Pain distributions included back + leg, back only, head ± neck, and neck ± arm/shoulder. About 30% of patients had previously failed traditional low-frequency paresthesia-based stimulation, while the remaining cohort were either highly refractory to treatment or not recommended by the pain physician for traditional SCS. Pain scores (numerical pain rating scale - NPRS) and functional outcome measures (Oswestry Disability Index - ODI; and activity tolerance times) were assessed at baseline, post-trial, and at 3 and 6 months post-implant as available in the medical records. Results: Of the 256 patients, 189 (73%) reported a positive trial and were implanted. Patients with back + leg pain demonstrated the highest trial success rate (81%). A mean reduction in pain, among those for whom data were available, of 50% was sustained up to 6 months post-implant across the entire patient population. Sixty-eight percent of patients who failed traditional SCS reported a positive trial and mean pain relief at 6 months was 49% (P < 0.001). An 8.6 point reduction in ODI (21%) at 6 months and improved sitting, standing, and walking tolerances were also reported. Limitations: As data was collected retrospectively, missing data points were unavoidable; this was primarily due to inconsistent data collection and patients being lost to follow-up. Patient populations were diverse and a control group was not appropriate in this setting. Conclusions: These retrospective results demonstrate a significant advancement for patients suffering with chronic intractable pain and are consistent with recently published clinical results for HF10 SCS. HF10 SCS appears to be a viable, paresthesia-free alternative to traditional SCS, with high trial success rates, demonstrated effectiveness in a range of pain distributions including those typically difficult to treat with traditional SCS, and the possibility to restore pain control in patients who have previously failed traditional SCS. Key words: Spinal cord stimulation, high frequency stimulation, HF10, paresthesia-free stimulation, back pain, leg pain, cervical pain, neuromodulation.
Article
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Objective Pregabalin group (PGB) is an antiepileptic used to treat neuropathic pain. We evaluated analgesic efficacy and safety for postoperative/chronic pain, disability, and sleep quality in patients who underwent spine surgery administered with PGB, or not, during the presurgical and postsurgical periods.DesignRetrospective cohort study of 60 patients (two groups with 30 patients) with full information on 50 (29 with PGB and 21 without PGB). Ten patients were dismissed as information was lacking. The PGB group (P) (29 patients) received 75 mg/12 hours before surgery, 150 mg 10 hours after surgery, and 150 mg/12 hours 3 days after surgery. The control group (C; 21 patients) took no PGB.Methods Neuropathic pain was assessed before surgery, and 2 and 6 months later using visual analog scales (VAS), DN4, disability (Oswestry), and sleep quality. No serious adverse events occurred with PGB.ResultsThe median VAS pain score at rest was lower in the PGB group at 2 months postsurgery (1 vs 2, P = 0.032), as was the median DN4 score (0 vs 3, P = 0.032) and the median Oswestry disability index (ODI: 12 vs 18, P = 0.001). At 6 months postsurgery, pain scores were also lower in the PGB group for VAS (0 vs 4, P = 0.001), DN4 score (0 vs 4, P = 0.001) and the ODI (10 vs 24, P = 0.001). Improvement in the functionality and sleep quality of the PGB group was noteworthy (P = 0.018).ConclusionsPGB has analgesic/antihyperalgesic effects on postoperative neuropathic pain after surgery for lumbar disc hernia. Our findings show that this benefit increases with time.
Article
Background: Pain relief with spinal cord stimulation (SCS) has focused historically on paresthesias overlapping chronically painful areas. A higher level evidence supports the use of SCS in treating leg pain than supports back pain, as it is difficult to achieve adequate paresthesia coverage, and then pain relief, in the low back region. In comparison, 10-kHz high-frequency (HF10) SCS therapy does not rely on intraoperative paresthesia mapping and remains paresthesia-free during therapy. Objective: To compare long-term results of HF10 therapy and traditional low-frequency SCS. Methods: A pragmatic randomized, controlled, pivotal trial with 24-month follow-up was conducted across 11 comprehensive pain treatment centers. Subjects had Visual Analog Scale scores of ≥5.0/10.0 cm for both back and leg pain, and were assigned randomly (1:1) to receive HF10 therapy or low-frequency SCS. The primary end point was a responder rate, defined as ≥50% back pain reduction from baseline at 3 months with a secondary end point at 12 months (previously reported). In this article, 24-month secondary results are presented. Non-inferiority was first assessed, and if demonstrated the results were tested for superiority. Results: In the study, 198 subjects were randomized (101 HF10 therapy, 97 traditional SCS). One hundred seventy-one subjects (90 HF10 therapy, 81 traditional SCS) successfully completed a short-term trial and were implanted. Subjects averaged 54.9 ± 12.9 years old, 13.6 ± 11.3 years since diagnosis, 86.6% had back surgery, 88.3% were taking opioid analgesics. At 3 months, 84.5% of implanted HF10 therapy subjects were responders for back pain and 83.1% for leg pain, and 43.8% of traditional SCS subjects were responders for back pain and 55.5% for leg pain (P < .001 for both back and leg pain comparisons, non-inferiority and superiority). At 24 months, more subjects were responders to HF10 therapy than traditional SCS (back pain: 76.5% vs 49.3%; 27.2% difference, 95% CI, 10.1%-41.8%; P < .001 for non-inferiority and superiority; leg pain: 72.9% vs 49.3%; 23.6% difference, 95% CI, 5.9%-38.6%; P < .001 for non-inferiority and P = .003 for superiority). Also at 24 months, back pain decreased to a greater degree with HF10 therapy (66.9% ± 31.8%) than traditional SCS (41.1% ± 36.8%, P < .001 for non-inferiority and superiority). Leg pain also decreased to a greater degree with HF10 therapy (65.1% ± 36.0%) than traditional SCS (46.0% ± 40.4%, P < .001 for non-inferiority and P = .002 for superiority). Conclusion: This study demonstrates long-term superiority of HF10 therapy compared with traditional SCS in treating both back and leg pain. The advantages of HF10 therapy are anticipated to impact the management of chronic pain patients substantially. Abbreviations: HF10, 10-kHz high-frequency therapyIPG, implantable pulse generatorMCID, minimal clinically important differencePI, permanent implantODI, Oswestry Disability IndexSCS, spinal cord stimulationVAS, Visual Analog ScaleThis is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially.
Article
Background: Chronic neuropathic pain has been recognized as contributing to a significant proportion of chronic pain globally. Among these, spinal pain is of significance with failed back surgery syndrome (FBSS), generating considerable expense for the health care systems with increasing prevalence and health impact. Objective: To assess the role and effectiveness of spinal cord stimulation (SCS) in chronic spinal pain. Study design: A systematic review of randomized controlled trials (RCTs) of SCS in chronic spinal pain. Methods: The available literature on SCS was reviewed. The quality assessment criteria utilized were Cochrane review criteria to assess sources of risk of bias and Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment (IPM - QRB) criteria for randomized trials.The level of evidence was based on a best evidence synthesis with modified grading of qualitative evidence from Level I to Level V.Data sources included relevant literature published from 1966 through March 2015 that were identified through searches of PubMed and EMBASE, manual searches of the bibliographies of known primary and review articles, and all other sources. Outcome measures: RCTs of efficacy with a minimum 12-month follow-up were considered for inclusion. For trials of adaptive stimulation, high frequency stimulation, and burst stimulation, shorter follow-up periods were considered. Results: Results showed 6 RCTs with 3 efficacy trials and 3 stimulation trials. There were also 2 cost effectiveness studies available. Based on a best evidence synthesis with 3 high quality RCTs, the evidence of efficacy for SCS in lumbar FBSS is Level I to II. The evidence for high frequency stimulation based on one high quality RCT is Level II to III. Based on a lack of high quality studies demonstrating the efficacy of adaptive stimulation or burst stimulation, evidence is limited for these 2 modalities. Limitations: The limitations of this systematic review continue to require future studies illustrating effectiveness and also the superiority of high frequency stimulation and potentially burst stimulation. Conclusion: There is significant (Level I to II) evidence of the efficacy of spinal cord stimulation in lumbar FBSS; whereas, there is moderate (Level II to III) evidence for high frequency stimulation; there is limited evidence for adaptive stimulation and burst stimulation.
Article
Current treatments for chronic pain have limited effectiveness and commonly known side effects. Given the prevalence and burden of intractable pain, additional therapeutic approaches are desired. Spinal cord stimulation (SCS) delivered at 10 kHz (as in HF10 therapy) may provide pain relief without the paresthesias typical of traditional low-frequency SCS. The objective of this randomized, parallel-arm, noninferiority study was to compare long-term safety and efficacy of SCS therapies in patients with back and leg pain. A total of 198 subjects with both back and leg pain were randomized in a 1:1 ratio to a treatment group across 10 comprehensive pain treatment centers. Of these, 171 passed a temporary trial and were implanted with an SCS system. Responders (the primary outcome) were defined as having 50% or greater back pain reduction with no stimulation-related neurological deficit. At 3 months, 84.5% of implanted HF10 therapy subjects were responders for back pain and 83.1% for leg pain, and 43.8% of traditional SCS subjects were responders for back pain and 55.5% for leg pain (P < 0.001 for both back and leg pain comparisons). The relative ratio for responders was 1.9 (95% CI, 1.4 to 2.5) for back pain and 1.5 (95% CI, 1.2 to 1.9) for leg pain. The superiority of HF10 therapy over traditional SCS for leg and back pain was sustained through 12 months (P < 0.001). HF10 therapy subjects did not experience paresthesias. HF10 therapy promises to substantially impact the management of back and leg pain with broad applicability to patients, physicians, and payers.
Article
The Patient Safety Subcommittee requested a review of the science and policy issues regarding the rapidly emerging public health epidemic of prescription opioid-related morbidity and mortality in the United States. Over 100,000 persons have died, directly or indirectly, from prescribed opioids in the United States since policies changed in the late 1990s. In the highest-risk group (age 35-54 years), these deaths have exceeded mortality from both firearms and motor vehicle accidents. Whereas there is evidence for significant short-term pain relief, there is no substantial evidence for maintenance of pain relief or improved function over long periods of time without incurring serious risk of overdose, dependence, or addiction. The objectives of the article are to review the following: (1) the key initiating causes of the epidemic; (2) the evidence for safety and effectiveness of opioids for chronic pain; (3) federal and state policy responses; and (4) recommendations for neurologists in practice to increase use of best practices/universal precautions most likely to improve effective and safe use of opioids and to reduce the likelihood of severe adverse and overdose events.
Article
Objectives Spinal cord stimulation of the dorsal root ganglion (DRG-SCS) is a new therapy for treating chronic neuropathic pain. Previous work has demonstrated the effectiveness of DRG-SCS for pain associated with failed back surgery syndrome, complex regional pain syndrome, chronic postsurgical pain, and other etiologies through 6 months of treatment; this report describes the maintenance of pain relief, improvement in mood, and quality of life through 12 months.Materials and Methods Subjects with intractable pain in the back and/or lower limbs were implanted with an active neurostimulator device. Up to four percutaneous leads were placed epidurally near DRGs. Subjects were tracked prospectively for 12 months.ResultsOverall, pain was reduced by 56% at 12 months post-implantation, and 60% of subjects reported greater than 50% improvement in their pain. Pain localized to the back, legs, and feet was reduced by 42%, 62%, and 80%, respectively. Measures of quality of life and mood were also improved over the course of the study, and subjects reported high levels of satisfaction. Importantly, excellent pain–paresthesia overlap was reported, remaining stable through 12 months.DiscussionDespite methodological differences in the literature, DRG-SCS appears to be comparable to traditional SCS in terms of pain relief and associated benefits in mood and quality of life. Its benefits may include the ability to achieve precise pain–paresthesia concordance, including in regions that are typically difficult to target with SCS, and to consistently maintain that coverage over time.