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BJA Education, 16 (8): 258–263 (2016)

doi: 10.1093/bjaed/mkv072
Advance Access Publication Date: 8 February 2016

Matrix reference 3E00

Spinal cord stimulation

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D M Moore MB MRCPI FRCA1 and C McCrory MD FCAI FIPP2, *
1
SpR 4 Anaesthesia, Department of Anaesthesia and Pain Medicine, St James Hospital, Dublin, Ireland and
2
Consultant in Pain Medicine, Department of Pain Medicine, St James Hospital, Dublin, Ireland
*To whom correspondence should be addressed. Tel: +353 1 4103952; Fax: +353 1 4284069; E-mail: cmccrory@stjames.ie

been called SCS. The early interventions were effective, but were
Key points associated with multiple complications.
The techniques have evolved to less invasive percutaneous
• Spinal cord stimulation (SCS) is a cost-effective
lead insertion with multiple electrodes in the epidural space.
treatment of some common neuropathic and is-
More advanced implantable pulse generators (IPGs) and pro-
chaemic pain syndromes.
grammable systems have led to improved effectiveness and ver-
• Failed back surgery syndrome is the most common satility. This is reflected by a steady increase in the implantation
indication for SCS. rates over the last decade in Europe and the USA.
Neuromodulation techniques are also indicated in non-pain-
• Appropriate patient selection and education is key
ful conditions. Sacral stimulation of the S3 nerve is used to man-
to successful SCS.
age urinary urge incontinence and faecal incontinence. Deep
• Different stimulation regimens (frequency, pulse brain stimulation is used for a multitude of movement and psy-
width, amplitude) are used to target the relevant chiatric disorders. Vagal nerve stimulation may have a role in re-
dorsal column fibres. fractory epilepsy. However, this article will address the role of SCS
in the management of chronic pain conditions.
• Significant technological advances in SCS (re-
chargeable batteries, accelerometer technology,
new lead design) may improve effectiveness. Anatomy
The DC of the spinal cord is a layered structure with the more dis-
tal, sacral fibres located more medially, and the more rostral fi-
bres in the lateral part of the DC.2 It transmits ascending
Chronic pain conditions that fail to improve with conventional proprioceptive and light touch sensations via the A-β fibres.
medical management (CMM) are a significant burden for the These are large myelinated fibres which include the dorsal
individual and society. While the initial cost of spinal cord roots, dorsal root entry zone, dorsal horn, and DC.3 An active elec-
stimulation (SCS) is considered high, both its clinical and cost- trode placed in the posterior epidural space preferentially depo-
effectiveness are now well established. The position of SCS in larizes these large myelinated fibres. Knowledge of the spinal
the treatment algorithm has progressed, and for specific neuro- cord anatomy explains why stimulation of more rostral lateral fi-
pathic and ischaemic pain conditions, there is moderate to strong bres (as in axial back pain) is more challenging than stimulating
evidence supporting its use. caudal medial fibres (radicular leg pain). As the electrical field
Melzack and Wall presented the Gate Control Theory of Pain moves laterally, there is an increased risk of stimulating unwant-
in 1965. They proposed that transmission of pain signals could ed areas, like the dorsal or ventral roots, leading to adverse effects
be regulated at the level of the dorsal horn by inhibitory inter- ( painful sensations or muscle contractions). The target level for
neurones activated by A-fibres. In 1967, Shealy and colleagues1 stimulation in failed back surgery syndrome (FBSS) after ad-
proposed that electrical stimulation of these A-fibres in the dor- equate lumbar surgery is generally the lower thoracic spine
sal columns (DCs) could activate the inhibitory interneurones in (T8–9). This is because the low lumbar nerve fibres enter the
the dorsal horn and influence pain transmission. A bipolar plate cord at T12 and become established in the DC at the level of T9.
was placed directly over the spinal cord in cancer patients. They In the case of post-cervical surgery, the target is generally the
called it ‘Dorsal Column Stimulation’. In more recent years, it has mid-cervical (C4–5) level.

© The Author 2016. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved.
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258
Spinal cord stimulation

Mechanism of action multiple clinicians, tried a variety of pharmacological and inter-


ventional therapies with limited success, and are struggling with
An SCS consists of a power source (IPG) connected to a lead with a
psychological, occupational, and social stressors. The indications
cathode (negative electrode) and an anode ( positive electrode).
for SCS are as follows.
The cathode and anode create an electrical field within the bio-
logical tissue that can depolarize the target nerves. Stimulation
of the DC fibres effectively reduces pain in many neuropathic Failed back surgery syndrome
and ischaemic pain syndromes. The following mechanisms of
The majority of SCSs are implanted for FBSS. This is a syndrome
action are proposed:
that is often characterized by disabling back and/or radicular
(i) Inhibition of action of wide dynamic range (WDR) neurones: limb pain after adequate spinal surgery, with nociceptive and
WDR neurones are important ‘gate-keepers’ in the dorsal neuropathic components, which often responds poorly to anal-
horn during pain transmission. They may be switched off gesic agents or reoperation. Two randomized control trials
when stimulated by A-fibres in the DC.4 (RCTs) compared conventional SCS with either CMM or reopera-

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(ii) Activation of GABAergic inhibitory interneurones in the dor- tion in FBSS. The primary outcome in both studies was significant
sal horn. pain relief defined as more than 50% reduction in reported pain
(iii) Activation of supraspinal mechanisms: Descending seroto- scores.
nergic neurones and locus coeruleus neurones. The PROCESS study randomized 100 FBSS patients to either
(iv) Suppression of the neuroimmune response: Markers of glial SCS+CMM or CMM alone.6 The patients were followed up at 6,
and immune cell activity, up-regulated in neuropathic pain 12, and 24 months. The SCS group reported improved pain relief,
states, are down-regulated in SCS patients.5 quality of life, and functional outcomes when compared with the
(v) Suppression of efferent sympathetic fibres. CMM group. North and colleagues7 randomized 50 FBSS patients
(vi) Stimulates peripheral release of vasodilatory proteins. to either reoperation or SCS and followed them over an average of
3 yr. The patients could cross-over to the other treatment if the
initial intervention failed to adequately relieve their pain. SCS
Stimulation patterns was more effective than reoperation regarding pain relief, patient
The stimulation parameters are adjusted to achieve the best re- satisfaction, and opiate requirements. Patients in the reoperation
sults. The standard variables in SCS are the frequency, pulse group were more likely to cross-over to the SCS group. SCS may be
width, and amplitude. The pulse width is generally between an alternative to reoperation or opioid therapy in FBSS patients. It
100 and 500 μs. The amplitude is usually 2–8 V. The frequency is deemed to be a cost-effective treatment option when com-
can vary depending on the stimulation regimen. The stimulation pared with CMM (£10 480 per QALY gained) or reoperation
patterns vary between the different diagnostic groups with FBSS (£9219 per QALY gained).8
requiring higher voltages generally in the 3.0–8.0 V range while The above trials focused on patients with predominantly ra-
other groups would require lower amplitudes, generally in the dicular lower limb pain. Patients with axial back pain are a
2.5–4.0 V range. The same applies to pulse width and frequency more difficult group of patients to treat with conventional SCS.
selection with FBSS requiring larger pulse width settings. The Recent data suggest that high-frequency SCS, burst stimulation,
stimulation patterns are individualized. or combined SCS+peripheral nerve field stimulation (PNfS) may
Power output or amplitude from the IPG may be in the form of a increase the efficacy of neurostimulation in this challenging
constant current (CC) or constant voltage (CV). With CC, the voltage group.9–13
is automatically adjusted with changes in the resistance (imped- HF-SCS may be particularly effective for the management of
ance) to maintain a CC. The amplitude is given in volts (V). With patients who have failed conventional SCS or patients with
CV, the voltage remains constant and as the impedance varies, axial back pain.9 However, the findings of Al-Kaisy and colleagues
the current will change. The amplitude is given in milliamps (mA). contrast with the first double-blind placebo-controlled RCT in
Shorter pulse widths preferentially recruit dorsal roots, and SCS. Perruchoud and colleagues10 compared HF-SCS with sham
target specific dermatomes. As the pulse width increases, the in a group of patients established on conventional SCS. HF-SCS
medial DC fibres are recruited preferentially, and a greater area at a frequency of 5 kHz was not significantly better than sham
of the DC is stimulated. stimulation in terms of difference to conventional stimulation,
The frequency can vary depending on the stimulation pain control, and quality of life. While these results are equivocal,
regimen. preliminary reports from the SENZA-RCT US Pivotal Study (un-
published data at present) would suggest that HF-SCS has a role
(i) Conventional or tonic stimulation: Uses frequencies of 60– in the management of back and leg pain in FBSS.
100 Hz. This produces paraesthesia in the target area. This Burst stimulation may be more effective than tonic stimula-
is the most common mode of stimulation, but in the last tion in some chronic radicular pain syndromes.11 Schu and col-
few years, two more modes have gained in popularity. leagues12 randomized patients already receiving conventional
(ii) Burst stimulation: Involves five pulses in a burst (500 Hz SCS to tonic 500 Hz stimulation, burst stimulation, or a sham
pulse frequency in each burst) with a burst frequency of treatment. Burst stimulation does not produce paraesthesia,
40 Hz. Burst stimulation produces little or no paraesthesia. and this fact facilitates a double-blind, placebo-controlled study
(iii) High-frequency stimulation: Uses frequencies of 5–10 kHz. design. Burst stimulation was significantly better than the
This pattern does not generate paraesthesia, but may pro- other two treatment arms. RCTs comparing conventional and
duce effective pain relief. burst stimulation directly in FBSS, and in various neuropathic
pain syndromes, are required.
PNfS is achieved with a subcutaneous lead placed directly into
Indications for SCS the painful area. The logic behind this is to target the traditionally
The management of chronic neuropathic and ischaemic pain difficult to treat areas such as the lumbar spine which often re-
conditions is challenging. Often, these patients have attended spond poorly to SCS or other simulation regimens. PNfS systems

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Spinal cord stimulation

are sometimes combined with a conventional SCS to create hy- syndromes. However, these indications currently lack evidence
brid systems. Observational studies of hybrid systems indicate and implantation should only be considered on a case-by-case
an additional benefit with PNfS+SCS, in particular in patients basis after a successful trial period.
with nociceptive axial back pain refractory to SCS alone.13 We
did not identify an RCT to support the routine use of hybrid sys- Insertion of an SCS
tems in FBSS.
Patient selection
Complex regional pain syndrome type 1
The success of SCS is heavily dependent on appropriate patient
One RCT investigated the use of SCS in combination with physic- selection. To date, RCTs in SCS involved patients with persistent
al therapy (SCS+PT) (n=36) vs physical therapy only (PT) (n=18) for pain (neuropathic or ischaemic) resistant to CMM for more than 6
the management of complex regional pain syndrome (CRPS).14 Of months. They should have a definite diagnosis or an identifiable
the 36 patients, trial stimulation was successful in 24. After 6 pain generator, and a positive trial of stimulation. Patients with

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months, there was a significant decrease in pain in the SCS+PT major psychiatric disorders, psychological distress, or unreason-
group. The pain relief was sustained at 2 yr. A 5 yr follow-up sug- able expectations are not suitable. For these reasons, a preopera-
gested that there was no sustained benefit at this point. However, tive psychological assessment is advised. The patient must have
this may be due to methodological problems in the follow-up the cognitive capacity to give informed consent, demonstrate an
study, and a long-term retrospective analysis supports the effect- ability to understand and use the device properly, and commit to
iveness of SCS for CRPS type 1 over a 5 yr period.15 weaning off inappropriate and/or ineffective medication.
Taylor and colleagues16 performed a systematic review of SCS
in CRPS in 2006. They identified level A evidence for SCS in CRPS Pre-implantation considerations
type 1, and level D evidence in type 2 CRPS. A 12 yr prospective
cohort study supported SCS as an effective pain treatment in (i) Stimulation trial: Before inserting the full system, the im-
63% of CRPS type 1 patients implanted with an SCS.17 A predictor planter can site a temporary percutaneous lead under
of long-term success in this study was a reduction of more than local anaesthetic and connect it to an external pulse gener-
50% in the pain score after a 1 week stimulation trial. ator. The patient may report where they feel paraesthesia,
SCS is also a cost-effective option in CRPS. When compared and whether it is covering the painful area. This allows the
with CMM, SCS cost £16 596 per QALY gained. implanter to position the electrodes over the appropriate
area. The temporary lead may be left in situ for a few
Chronic leg ischaemia days. This allows the patient to experience SCS. There is
no consensus on the adequate length of stimulation trial
Pain associated with chronic leg ischaemia (CLI) is difficult to to accurately predict success of implantation. There is sig-
manage. Surgical restoration of adequate blood flow to the leg nificant inter-institutional variation. There may also be
is desirable, but it is often impossible to achieve. These patients complications during the trial phase such as disconnection
are referred to as non-reconstructable chronic critical leg ischae- and infection which can distort the patient’s experience.
mia, and their pain is often inadequately controlled with oral After a successful trial, the temporary lead is removed
analgesics. Lower limb amputation is sometimes indicated. and a permanent lead placed. Occasionally, the coverage
In 2013, Ubbink and Vermeulen18 reviewed six controlled may not be as good with the permanent lead resulting in
trials comparing the use of SCS+CMM with CMM. The primary disappointment. The accuracy of the trial in predicting suc-
outcome in most of the studies was limb salvage. The review de- cessful implantation has never been fully established. Re-
monstrated a significantly higher limb salvage rate in the SCS cently, there has been a trend towards on-table trial with
group. Also, patients managed with SCS had a significant reduc- implantation on the same visit to theatre in selected pa-
tion in pain score, analgesic use, and Fontaine stage (III to II). The tients with strong indications for SCS such as FBSS and
cost associated with SCS at 2 yr in one study was higher than the CRPS.21 A failed trial is declared if it is not possible to stimu-
conservative management group (€36 500 vs €28 600). The mech- late the painful area, or the patient finds the paraesthesia is
anism of action of SCS in CLI may be modulation of nitric oxide or ineffective or unpleasant. If this occurs, the trial lead is re-
prostaglandin production, or modulation of the sympathetic ner- moved and an alternative management plan is discussed
vous system.19 with the patient.
(ii) IPG type: Determine if a rechargeable device (RIPG) or a pri-
Chronic angina refractory to treatment mary cell (IPG) is most appropriate. If the patient has a busy
Several small RCTs have investigated the role of SCS in chronic life with limited time for recharging and uses basic pro-
angina refractory to treatment (CART). It compares favourably grams with low energy requirements, then a primary cell
with coronary artery bypass grafting (CABG). A systematic review is probably more appropriate. Conversely, a patient with
of these studies suggested that SCS was an effective and safe less time constraints who uses complex programs (i.e.
treatment option for CART.20 It produced similar symptom con- high-energy requirements) should consider a rechargeable
trol when compared with CABG, but in some cases, SCS was asso- system. RIPGs are growing in popularity.
ciated with lower morbidity and mortality. Implantation of an (iii) Site of the IPG: It is important for the comfort of the patient
SCS is also a more cost-effective therapy than revascularization to determine the best location for the IPG. Avoid placing
in CART. under the belt line, or in areas of allodynia. The most com-
mon sites for IPG implantation are the gluteal region or an-
terior abdominal wall.
Other indications (iv) Lead type: Two main types of lead exist. A cylindrical lead
Multiple case reports and small case series exist describing the can be placed percutaneously via an epidural needle sys-
use of SCS in other neuropathic conditions including diabetic tem. Alternatively, a paddle lead can be placed in the epi-
neuropathy, post-herpetic neuralgia, and post-amputation pain dural space via a laminectomy and sutured to the dura.

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The majority of SCS leads are placed percutaneously. There If no complications are identified after operation, they may be
is also a hybrid percutaneous paddle lead now available. discharged home. Any signs of neurological deterioration post-
(v) Psychological evaluation by a mental health professional: implant should prompt an urgent CT scan to rule out epidural
Significant psychiatric disorders or psychological distress haematomas or spinal cord injury from the SCS lead. Other com-
are contraindications to implantation. A mental health plications occur over the medium to long term. Lead migration
professional should screen all potential SCS recipients, and fracture have been significant problems in the past. However,
identify and treat any mental health issues, and make a the incidence of these complications is falling with the introduc-
recommendation to the pain physician on the suitability tion of new anchoring techniques and more resilient leads.
of implantation. Table 2 lists the more common SCS complications.
(vi) Optimization of co-morbidities: Diabetes mellitus, system-
ic infection, coagulopathies, or low platelets (<100 000
mm−3).
Special considerations
(vii) Screen for methicillin-resistant Staphylococcus aureus: If

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positive, the patient should undergo eradication therapy (i) MRI compatibility: The use of MRI in patients with a SCS in
(follow local policy guidelines). situ is controversial. It may lead to unintended stimulation,
lead heating which could cause tissue damage, movement
Factors that are contraindications to implantation or raise con- of the system with loss of pain relief, and/or damage to the
cern for the implanter are listed in Table 1. Most factors are rela- system. If imaging is required in these patients, the medical
tive contraindications, and the ultimate decision to proceed team should consider another modality (CT scan). If MRI is
should be made by an informed patient and their consultant. indicated, it may be possible to keep the leads out of the mag-
netic field. Newer SCS systems are MRI compatible with lead
shielding that resists significant heating and tissue damage.
SCS implantation
(ii) Diathermy: This should be avoided in patients with an SCS. If
The procedure should be undertaken in a standard operating the- necessary, bipolar diathermy should be used. If unipolar dia-
atre environment with appropriate monitoring, X-ray screening, thermy is warranted, the reference plate should be posi-
and trained personnel. The patient should receive prophylactic tioned as far away from the SCS system as possible.
antibiotics within the hour pre-procedure, and staff should pay (iii) Cardiac pacemakers and defibrillators: Pacemakers may per-
meticulous attention to sterility. The procedure may be per- ceive SCS signals as cardiac activity and may not pace in de-
formed under local, spinal, or general anaesthesia (GA). If GA is mand mode. The implanter should communicate with the
used, somatosensory-evoked potentials may be required to con- patients’ cardiology team if a pacemaker is in situ. The pace-
firm that the correct level of paraesthesia is achieved. Alterna- maker may be re-programmed to reduce its sensitivity to
tively, the implanter can use X-ray images to match the trial extra-cardiac electrical activity.
leads position. Figure 1 shows two eight-electrode percutaneous (iv) Pregnancy: A growing number of females of child-bearing
leads in the posterior epidural space. age are having spinal surgery with resulting FBSS in this
age group. The safety profile and management of SCS in
pregnancy is a relatively new clinical concern, and several
IPG programming case reports and case series detailing the management of
After implantation, a number of programs can be uploaded to the these women have been published.23 We are not aware of
IPG. The frequency, amplitude, and pulse width can be varied to data to suggest any adverse obstetric outcomes in women
optimize the SCS efficacy. The patient can then use a hand-held with an active SCS. Conversely, there are no prospective
telemetry programmer at home to switch the IPG on and off, and data at present to support safety in the obstetric population.
to switch between programs. (v) Neuraxial analgesia/anaesthesia: There is a risk of damage
or infection of the SCS leads when performing a neuraxial
technique. It is possible to perform a neuraxial technique,
Postoperative management after discussion with the pain team, under strict sterile con-
The patient is assessed to ensure that appropriate paraesthesia ditions and with radiological guidance. However, other an-
or pain relief is achieved and they can use the system effectively. aesthetic and analgesic options should be considered first.

Table 1 Contraindications or cautions to SCS

No definite diagnoses or pain generator


Spinal stenosis (with effacement of CSF, cord compression, or both) at the site of lead placement
Significant psychological or psychiatric disorder
Evidence of substance abuse
Pacemakers or defibrillators (consult with cardiology team)
Require frequent MRIs in the future (e.g. active malignancy)
Anticoagulation therapy or coagulopathy
Significant cognitive impairment (unable to appreciate the goals and limitations of SCS)
Concerns of secondary gain (e.g. ongoing litigation, compensation, etc.)
Driving with a conventional SCS switched on is not recommended (especially in operators of heavy goods vehicles—this should be discussed in
the pre-trial counselling)—an HF-SCS system (HF10) is approved for driving in Europe
Pregnancy (some patients continue stimulation, but it is not licensed in pregnancy)
Failed trial in conventional SCS

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Early systems supported a single four-contact lead. Now, multi-


lead systems with up to 32-contacts are available. Surgically
placed paddle-leads with up to five electrode columns are also
available. Postural changes can pose significant problems for pa-
tients with an SCS. They may report more intense stimulation
when lying supine and inadequate stimulation when mobilizing.
This is related to the mobility of the spinal cord within the cere-
brospinal fluid. Some manufacturers are incorporating acceler-
ometer technology to adapt the systems output for different
postures. New wireless devices remove the need to implant
large IPGs, and reduce the risks associated with the conventional
implantation techniques.
There is a growing interest in paraesthesia-free stimulation

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with burst and high-frequency regimens. These are more accept-
able to patients, and may provide equal, if not better, symptom
control. However, there is a need for adequately powered RCTs
to support their use.
While not strictly SCS, stimulation of the dorsal root ganglion
(DRG) is a promising new neuromodulation technique. The DRG
plays a central role in neuropathic pain syndromes, and has be-
come a target in the management of dermatomal neuropathic
pain. Early reports from observational studies are promising,
with good pain relief reported in leg and foot regions in patients
with dermatomal neuropathic pain.25 RCTs are awaited to con-
firm these results.

Conclusion
There has been an explosion in the variety of SCS devices, stimu-
lation regimens, and clinical applications. However, the evi-
dence-base is lagging behind. Further RCTs are required to
stratify the use of this technique and identify the best patient po-
Fig 1 Two percutaneous leads are positioned in the posterior thoracic epidural pulations. Currently, the evidence base supports conventional
space [anteroposterior view () and lateral view ()]. They are positioned at the SCS in patients with FBSS, CRPS, CLI, and CART. Further evidence
level of T8–12 in a patient with FBSS. is required to definitively establish the role of HF-SCS and/or
burst stimulation in FBSS patients refractory to conventional
Table 2 Common SCS complications22 stimulation. The roles of hybrid systems and DRG stimulation
remain to be established. Appropriate patient selection and edu-
Hardware-related (27–30%) cation with specialist physician training are crucial for best
Lead migration (13%) outcomes.
Lead fracture (9%)
Hardware malfunction (3%)
Biologic (3–5%) Declaration of interest
Infection (3–5%) None declared.
CSF leak (0.3%)
Symptomatic hematoma (0.3%)
Other (3–4%) MCQs
Procedural pain
Device-pocket pain The associated MCQs (to support CME/CPD activity) can be
accessed at https://access.oxfordjournals.org by subscribers to
BJA Education.
Optimizing outcomes
The Neuromodulation Appropriateness Consensus Committee References
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