Current Pain and Headache Reports
(2025) 29:44
https://doi.org/10.1007/s11916-024-01349-w
CHRONIC PAIN MEDICINE (O VISWANATH, SECTION EDITOR)
Consenting for Spinal Cord Stimulation – the Pitfalls and Solution
Vivek Mehta1 · Rajesh Munglani2 · Giles Eyre3 · Gaurav Bajaj1 · Alaa Abd‑Elsayed4 · Kavita Poply1,5
Accepted: 30 July 2024
© Crown 2025
Abstract
Purpose of Review To discuss the importance of the consenting process for patients undergoing spinal cord stimulation
(SCS) therapy and understanding related complications and effects.
Recent Findings Litigation for SCS/DRG related complications can be very costly, with the mean average settlement in cases
relating to SCS being $303,173 dollars in the USA. According to the US Anaesthesia Closed Claims Project database, 10,546
claims related to pain medicine were made between 1990 and 2013; 43 of which were associated with SCS complications.
This article will further explore consenting and complications within the context of SCS.
Summary Consenting for SCS is a crucial and very important step which potentially reflect on patients’ expectations and
outcomes.
Keywords Consent · Spinal cord stimulation · Claims · Complications · Pitfalls · Solutions · Chronic pain
Introduction
Spinal cord stimulation (SCS) is a treatment, commonly used
for management of several refractory chronic pain conditions,
in particular; failed back surgery syndrome (now persistent spinal pain syndrome (PSPS type-2) [1, 2], complex regional pain
syndrome (CRPS) [3], refractory angina (RA) [4, 5], chronic
pains of trunk and limbs and critical limb ischemia [5, 6].
* Kavita Poply
k.poply@qmul.ac.uk
Vivek Mehta
Vivek.mehta@nhs.net
Rajesh Munglani
rajeshmunglani@gmail.com
Giles Eyre
geyre@dekachambers.com
Gaurav Bajaj
Gaurav.bajaj2@nhs.net
Alaa Abd‑Elsayed
alaaawny@hotmail.com
1
Barts Health NHS Trust, Pain Research Centre, London, UK
2
St Thomas Hospital, London, UK
3
Chambers of Jacob Levy KC, London, UK
4
University of Wisconsin-Madison, Madison, WI, USA
5
Queen Mary University, London, UK
Other indications described for SCS include HIV and diabetic neuropathy [7], post-herpetic neuralgia, pain caused
by central nervous demyelination such as multiple sclerosis
etc [8].
Both NICE and the FDA have approved the use of SCS
primarily for pain of neuropathic origin due to its reported
effectiveness in a proportion of patients carefully selected
using a multidisciplinary approach. However, the published
literature is inconsistent, and the response rate is highly
variable. Similarly, Dorsal root stimulation (DRG), another
modality of neuromodulation has demonstrated a significant
and clinically relevant effect on neuropathic painful conditions related to the trunk and limbs as well in cases of
CRPS [9–11]. One trial has shown its superiority over SCS
in the treatment of CRPS [12]. However, use of DRG is not
without complications. Although some studies report fewer
device related complications [13, 14], one RCT has reported
higher complication rates compared to SCS [12].
Published evidence in a recent multi-centre setting demonstrates up to 81.4% responder rate when SCS was used
to treat chronic lower back pain [15]. In a separate literature review carried out by Cameron et al. (2004), varied
treatment success was attributed to phenotypic variability
of painful conditions. Successful treatment rates included a
57% response rate in spinal cord injury, 62% in PSPS type-2
and phantom limb pain, 67% in peripheral neuropathy, 77%
in ischaemic limb pain, 82% in post-herpetic neuralgia and
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83% in CRPS I/II [16]. Similarly, a varied but consistent
efficacy (42–82% pain relief) has been demonstrated for the
DRG treatment across long term follow up [13, 14, 17].
Litigation for SCS/DRG related complications can be
very costly, with the mean average settlement in cases relating to SCS being $303,173 dollars in the USA – almost double the average settlement for other claims associated with
pain medicine [18]. According to the US Anaesthesia Closed
Claims Project database, 10,546 claims related to pain medicine were made between 1990 and 2013; 43 of which were
associated with SCS complications. During this period the
use of implanted devices for pain management increased;
alongside the proportion of pain medicine claims attributed
to implantable devices, which increased from 3–16% [19].
As the use of SCS for chronic pain management increases,
so does the importance of fully disclosing potential complications to patients; both from a clinical perspective and
a medicolegal perspective. This article will further explore
consenting and complications within the context of SCS.
Shared Decision Making and Consent
The principle of shared decision making and consent to
treatment is an important part of medical ethics, and fundamental to good medical practice. Patient consent is at the
heart of good medical practice and patients have both a right
to be involved in decisions regarding their treatment care and
to be fully informed.
In order to facilitate informed decision making, patient
concerns and expectations must be acknowledged, and they
must be provided with clear and accurate information with
adequate time for understanding and assimilation of said
information. Clear exchange of information and communication between patients and doctors is important; as it helps
manage expectations [20].
Before providing treatment or care for a patient, doctors
must be satisfied that the patient has the capacity to consent.
This entails being able to understand and retain information
regarding treatment, using the information provided to settle
on a decision and then finally communicating their decision.
In all cases i.e. not just those involving issues of capacity;
patients should be provided with ample time to ensure they
understand the procedure and the risks involved, in order
for them to be able to provide informed consent. If significant time has passed since the initial consent was given, it
is the duty of the doctor to respond to any new or repeated
concerns or questions of the patient before proceeding with
the treatment [20].
Prior to treatment, doctors have a duty to make patients
aware of any material risks involved in any recommended
treatment, and of any reasonable alternative or variant
treatments. A risk is material if a reasonable person in the
Current Pain and Headache Reports
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patient’s position would be likely to attach significance to
the risk. Therefore, doctors have a duty to inform patients
of all potential significant adverse events that may occur as
a result of said treatment; serious adverse events that have
a low but well-established risk are likely to be regarded as
significant by a patient. Awareness of these risks can have a
large impact on a patient’s treatment preference, as they may
choose not to undergo such treatment once they are made
aware of such risks or choose to undergo a less risky and
less efficacious treatment [20].
Clinical Negligence, SCS/DRG
and the Consenting Process
Clinical negligence can be defined as “an act of omission
or commission in planning or execution that contributes or
could contribute to an unintended result” [21].
This could involve giving substandard treatment or misdiagnosing a patient, causing injury to a patient or making an
existing condition worse, giving incorrect or inappropriate
treatment or making mistakes during surgery.
In the case of SCS/DRG this can manifest in a number of
ways, for example by inappropriately offering SCS/DRG to
patients for their presenting indications, by failing to obtain
informed consent from patients by omitting reference to certain possible complications or by not explaining the chances
of success and/or medical errors appropriately during device
implantation management [18].
These instances of negligence can result in litigation by
patients against the medical professionals involved in their
SCS/DRG treatment. These claims often come with great
financial and emotional cost for the doctor, but they also
bear the non-monetary cost of patients losing confidence in
the physicians responsible for their treatment.
Screening and Complications Associated
with SCS and DRG
SCS is not without risk of complications however there are
many precautions that can be taken to reduce this risk, one of
the most important being careful pre-implantation screening
of the patients, as this often determines the success rate of
the SCS/DRG therapy (Table 1).
NICE (The National Institute of Health and Care Excellence) in UK has also published guidelines regarding the
use of SCS. These guidelines recommend SCS as a treatment option for adults who have been suffering from chronic
neuropathic pain for at least 6 months despite appropriate
conventional medical management [23]. Examples of neuropathic pain include failed back surgery syndrome (PSPS
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Table 1 Patient screening criteria for SCS implantation outlined by the NACC (Neuromodulation Appropriateness Consensus Committee) [22]
Screening Criteria
• Patients must have capacity to give informed consent for the procedure
• Patients must agree to:
• Adhere to institutional protocol
• Attend post-implantation follow-up appointments
• Patients should have a well-defined, non-cancer, physiological source of pain:
• If the pain is related to surgical morbidity from tumour resection or cancer treatment and the patient is in stable condition, SCS may be
considered
• The patient has undergone a 3–6-month trial of conservative medical management which has failed, additionally:
o The patient must not have undergone re-operation for back surgery
o The patient must be neurologically stable
o The patient must not be using long-acting opioid maintenance therapy
• The patient must possess sufficient cognitive ability to operate SCS/DRG equipment
• SCS/DRG should be avoided if remedial surgical procedures are not feasible, advisable or the preferred management for the patient
• The patient should undergo a well performed psychological screening in order to determine whether there are any major untreated or unstable
psychiatric disorders; patients who are found to have significant somatisation complaints should be excluded.
• Expectations of the therapy should be set and discussed with the patient.
• The use of inappropriate drugs should be stopped prior to device implantation
• The patient must have a life expectancy greater than 12 months
• A preoperative MRI or CT myelogram of the spine should be carried out (< 12 months prior to the procedure) to rule out pathology that might
confound diagnosis and/or compromise outcomes of SCS/DRG.
• The patient must not have any unresolved issues of secondary gain or litigation that could be central to the propagation of the pain complaint.
type-2) [1, 2] and complex regional pain syndrome (CRPS)
[3].
NICE does not recommend SCS as a routine treatment
option for adults with chronic pain of ischaemic origin,
except in the context of research as part of a clinical trial
[23]. Examples of such conditions include refractory angina
(RA) [4], chronic pains of trunk and limbs and critical limb
ischemia [5, 6]. The aim of this research should be to generate robust evidence about the benefits of SCS in comparison
to the standard care being offered for these conditions. However, if a patient is currently using SCS to treat chronic pain
of ischaemic origin, they should have the option to continue
treatment until they and their clinicians consider it appropriate to stop [23].
Furthermore, SCS/DRG should only be offered after
an assessment by a multidisciplinary team (MDT) experienced in the assessment and management of chronic pain in
patients who have been treated with SCS devices. A trial of
SCS should be carried out as a part of this assessment; with
the continuation of the treatment being dependent on its success. It is also important that this MDT contains individuals
with experience in the provision of ongoing monitoring and
support for patients receiving SCS treatment. When assessing the severity of pain and the trial of stimulation, the MDT
should be aware of the need to ensure equality of access to
SCS treatment. Tests to assess a patient’s pain and response
to spinal cord stimulation should take into account any disabilities (e.g. physical or sensory disabilities), or linguistic
or other communication difficulties, and should be adapted
accordingly [23].
Following a recent multicentre RCT by Eldabe et al.
(2020), a move towards direct to implant is prevailing based
on nil significant advantage of trial versus direct to implant.
Moreover, the study demonstrated cost-effectiveness and
lower infection rate with single stage direct to implant procedures [24].
Spinal cord stimulation has been shown to be safe and
reversible while also being effective in providing pain relief
and improving functioning and quality of life in patients
[25]. As is the case with many surgical interventions, spinal
cord stimulation is associated with certain risks and complications. Approximately 30–40% of spinal cord stimulation patients may experience a range of complications that
may necessitate some sort of intervention. The majority of
these complications are minor and therefore reversible via
minor interventions , meaning that they don’t usually impact
patient morbidity or mortality in a significant way [22].
Complications of SCS/DRG can be grouped into hardware-related, biological and miscellaneous (Table 2). The
most common hardware-related complications are lead
related complications such as lead migration and fracture;
these are correctable by lead replacement or repositioning.
Superficial infection and pain over the implant side are the
most common biological complications. Hardware related
complications are more common than biological complications [22]. However, the technologies for SCS leads, IPGs,
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Current Pain and Headache Reports
Table 2 A summary of complications associated with SCS and their
rates of occurrence adapted from complications of spinal cord stimulation and peripheral nerve stimulation techniques: a review of the literature, Eldabe et al. [27]
Type of Complication Complication
Rate of Occurrence
(%)
Hardware/technology
2.1 – 27% [28, 29]
0 – 10.2% 33 [30, 31]
2.9% [16]
Biological
Other
Lead Migration
Lead Breakage
Hardware Malfunction
Battery/IPG Failure
Loose Connection
Infection
CSF Leak
Epidural haematoma
IPG Seroma
Spinal Cord Injury
Undesirable Stimulation
Pain over implant
Skin erosion
Allergic reaction
Other
1.6% [16]
0.4% [26]
2.5 – 10% [31, 32]
0–0.3% [27, 33]
0.3% [33]
2.5% [22]
0.03–2.35% [32]
2.4% [16]
0.9 – 12% [16, 28]
0.2% [16]
0.1% [16]
1.4% [16]
and programmers are rapidly evolving, resulting in fewer
device-related events [26].
Historically, DRG has been associated with more common device related complications (lead fracture and displacement). Nevertheless, a recent safety analysis report
published by Tim Deer et al. (2019) concluded DRG therapy
event rates are similar to previously reported adverse event
and complaint rates in the literature. Similarly, safety event
rates were lower or similar to previously reported rates for
SCS [34].
Lead Migration
Lead migration remains the most prevalent hardware malfunction in SCS as well as DRG and tends to present as a
change in the stimulation pattern for a patient. The angle of
lead entry, battery placement as well as suturing techniques
can all impact lead migration. Mechanical locking anchors
have been shown to secure the leads with a higher tensile
strength, adhesives have also been reported to improve
anchor clinical performance, both of which decrease the
likelihood of lead migration. Strain-relief loops near the
anchor and IPG, and placement of the tip of the anchor
into the supraspinous ligament can all contribute towards
reducing lead migration. Ensuring the IPG is placed near
the permanent leads can also reduce lead migration. A postoperative precaution that can be used to reduce lead migration is the limitation of a patient’s movements (especially
(2025) 29:44
those of twisting, bending etc.) during the post-operative
period. This helps to scar the lead in the epidural space and
decrease the amount it can migrate.
Lead migration can usually be visualised radiographically
and should be compared to radiographs taken at the time of
implantation. In order to remedy the migration, leads may
have to be replaced or a paddle lead may have to be considered in certain cases, as they are less prone to movement
than cylindrical percutaneous leads [22].
Lead Disconnection/Fractures
Lead disconnection/fractures also present as a change in the
stimulation pattern for the patient. The likelihood of lead
fractures can be decreased by using stress loops and appropriate anchoring techniques, minimising distance between
the IPG and permanent leads and also avoiding mobile
structures such as joints. Macrofractures and lead disconnection from the IPG tend to be visible on x-ray whereas
microfractures of a lead tend not to be visualised on x-rays.
If there is any suspicion of micro- or macrofractures of the
leads, impedance testing should be conducted in order to
confirm it [22].
Should patients experience a change in stimulation
pattern as mentioned above, re-programming should be
attempted. If this fails then x-rays should be taken and
compared to those done at time of implantation. There is a
chance that these changes may be related to lead migration/
fracture or potentially due to pre-existing or new neurological abnormalities in the patient. The solutions to changes in
stimulation pattern are replacement or removal of the device
and lead revision [22].
IPG Failure
Batteries in IPGs can end up failing to hold charge or work
properly. It is crucial that manufacturer instructions are followed carefully and that device connections are tested during
implantation, as both can reduce the chances of battery/IPG
failure. In order to rule out battery failure, the patient should
be questioned about direct trauma to the battery site and
x-rays should be carried out so that they can be compared
to those taken at the time of implantation. In most cases
battery failure will require replacement of the device, but
prior to replacement it should be double checked with the
manufacturer that this is not a known issue with the device
in question [22].
Infection
In cases of infection, patients may complain of any combination of nausea, vomiting, fevers, chills and malaise. Physical
examination may reveal redness, warmth, swelling, pain and
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purulent drainage from the IPG site or any other incisions
made during implantation. In cases of advanced infection,
patients may also exhibit neurological changes.
Factors that increase risk of infection include immunosuppressive medications and conditions (e.g. corticosteroids, HIV, diabetes), prolonged hospital stay, undergoing
multiple surgeries, perioperative transfusions, inappropriate or inadequate antibiotic therapy, poor ventilation of the
operative suite and improper skin preparation at the surgical site. Certain comorbidities (e.g. diabetes, rheumatoid
arthritis, malnutrition, obesity) and lifestyle choices (smoking tobacco, drinking alcohol) increase the risk of infection
too [22]. Prophylactic antibiotics should be administered
intravenously 30–60 min prior to surgery, with the exception of vancomycin which should be given within 120 min
of surgery. The antibiotic dose should be calculated according to the patient’s body weight for maximum efficacy. The
NACC recommends that antibiotics be discontinued within
24 h of surgery, however post-operative antibiotics may be
considered in high-risk patients [35].
In addition to these other precautions used in high infection risk procedures should be utilised, such as limiting traffic through the operation theatre, irrigating wounds well and
thorough scrubbing of the area.
If infection is suspected then FBC, ESR, CRP, wound cultures and blood cultures should be carried out. If the results
point to a diagnosis of infection, then management usually
involves opening of the device pocket and removal of the
IPG. The IPG as well as the tissue and fluid cultures should
be sent off to microbiology and pathology to identify the
responsible pathogen and inform antibiotic choice [22].
Post‑Dural Puncture Headache (PDPH)
When performing epidural needle placement for lead positioning, an accidental dural puncture is a possibility. This
can result in a patient experiencing a post-dural puncture
headache (PDPH) as well as CSF leakage into the wound
created by the needle. Patients who develop PDPH complain of positional headaches, diplopia, tinnitus, neck pain,
photophobia. Most PDPH symptoms resolve within a week,
some patients may require further intervention to get rid
of them. Developing PDPH can complicate SCS trials for
stimulation efficacy as the PDPH pain may become the focus
of their pain rather than the indication for the SCS. Risk
factors for dural puncture include uncooperative patients,
calcification of the ligamentum flavum and previous surgery
or spinal stenosis at the site of needle entry into the epidural
space. If a patient experiences a dural puncture during their
implantation, a range of opinions on management exist,
where some surgeons may choose to abandon the procedure
intraoperatively whilst others may continue at the same level
or adjust the level of insertion. Conservative management
44
such as supine positioning, caffeine and IV fluid administration may be used post-operatively in cases of dural puncture.
Autologous epidural blood patches have also been used prophylactically and therapeutically in cases of dural puncture.
However there is controversy surrounding their use as they
may become a focus of infection later on [22].
Epidural Haematomas
Epidural haematomas are a rare complication that may
develop as a result of SCS trials or implantation. They tend
to present with new neurological changes such as a paraesthesia not due to the SCS device; other possible symptoms
include paralysis, weakness or bowel and bladder dysfunction. Other symptoms include radicular or back pain developing in a previously unaffected area or worsening of pain
that is already present. The only risk factors that increase
the chance of epidural haematoma are use of aspirin or
other anticoagulant medication. It is important to follow
the NACC recommendations on stopping these medications prior to implantation [36]. If epidural haematoma is
suspected, an emergency CT scan with contrast should be
carried out. If the findings correlate with that of an epidural
haematoma, surgical evacuation of the haematoma should
be carried out within 8 h of the initial neurological deficit.
Prompt evacuation of the haematoma is crucial to reduce
the risk of any neurological complications being permanent
[22].
IPG Seromas
IPG seromas present as redness, swelling and/or pain at the
IPG site. Risk of seroma formation can be reduced by careful haemostasis and limiting the amount of blunt dissection
and cautery done during implantation. Creating a smaller
IPG pocket and using layered closure to limit dead space
can also help to reduce seroma formation risk. Using an
abdominal binder pre-emptively for approximately 2 months
post-implantation is a technique that has been used sometimes to mitigate seroma risk. If an IPG seroma is suspected
a CT with contrast should be carried out and the same blood
tests mentioned in the previous paragraph should be conducted in order to rule out infection. Should a seroma form,
it should be treated using an abdominal binder and drainage
in a sterile environment, with wound cultures being sent off
for analysis if infection is suspected [22].
Contact Dermatitis, Allergic Reactions
Contact dermatitis, allergic reactions and foreign body
reactions to SCS implants are known to happen in some
instances. These may present as itching, malaise and/or pain
around the implant site. If allergic reaction is suspected,
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blood tests should be carried out to rule out infection and
skin patch testing can be carried out using a kit provided
by the manufacture of the implant. It is important to bear
in mind that the allergic reaction may in fact be due to
other materials present during surgery, e.g. scrub solutions,
sutures, medications, IPG, silicone, latex etc. If there is high
pre-operative suspicion of allergic reaction to an implant,
skin patch testing should be carried out prior to implantation. Implant removal may have to be considered in some
cases, depending on the severity and cause of the allergic
reaction [22].
Pain Related to the Device Site
Patients may experience pain related to the site of device
components, e.g. pain around the IPG site (pocket pain),
lead anchor sites or lead extension junctions [22]. Incisional
pain and scar tissue formation are believed to be contributing
factors to pain over the IPG site. Pre-operative effectiveness
of the endogenous analgesia system in a pain-free state and
the intensity of acute post-operative pain are important predictors as to whether a patient will suffer from IPG pocket
pain. Other factors that may affect the risk of developing
pocket pain include pre-operative pain in the surrounding
area, psychosocial vulnerability, younger age and female
gender. Once low-grade infection and lead migration are
ruled out as causes of pain, pocket pain is treated with conservative measures such as physiotherapy and medication
for neuropathic pain. Should these conservative measures
fail, the next solution is relocation of the IPG to a new site.
Permanent removal of an IPG solely due to pocket pain is
very rare and should be balanced against the gain from the
therapy [37].
IPG Flipping
IPG flipping occurs due to a large IPG pocket or as a result
of Twiddler’s syndrome which involves patients manipulating the IPG within the pocket – it has an incidence of 0.54%
[38–40]. This can result in twisting of the leads, breakage
and inadequate IPG charging amongst other issues. The likelihood of IPG flipping can be decreased by ensuring the IPG
pocket is of an optimal size and also by anchoring the IPG
above the iliac crest subcutaneously in the lumbar region
[39, 41].
Skin Erosion
Skin erosion is a rare complication of SCS that tends to
occur due to superficial placement of leads. IPG battery
erosion or dehiscence can be avoided by placing the IPG
away from bony sites and sites with high mobility. If a deep
infection occurs to an SCS implant it should be removed
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regardless of whether the infection is systemic or not. After
removal, MRI and wound cultures should be done to determine the presence of an epidural abscess. If re-implantation
is going to be attempted precautions should be taken to avoid
the same outcome and wound dehiscence [22].
Nerve Root and Spinal Cord Injury
Some of the rare but serious complications of SCS implantation are nerve root and spinal cord injury. Spinal cord or
nerve root trauma can be caused by a puncture from the
introducer needle or it can be caused by the SCS implant
leads. The symptoms of this can vary from no obvious
injury, to sensorimotor deficits, to paralysis to neuropathic
pain. In order to avoid this complication it is important that
the surgeon implanting the device evaluates pre-operative
imaging to determine important points of anatomy such as
the location of the conus medullaris and any anatomical
abnormalities that may increase the risk of trauma to spinal
cord/nerve roots, e.g. spinal canal stenosis, spinal deformities and previous surgery at the site of needle placement
[32].
Explantation
Loss of therapeutic efficacy has been reported as the most
common cause of explant in multiple studies. Recent technological breakthroughs have led to the availability of various
waveforms and stimulation algorithms. These waveforms
and stimulation algorithms provide promising outcomes
by allowing the most suitable programs to be tailored to
the needs of individual patients. However, these new technologies have their own limitations [38, 42], which must be
weighed against the benefits they provide when consenting patients. Reliance on traditional paraesthesia based
waveforms, unwanted stimulation and tolerance may have
led to loss of efficacy in some cases. Literature suggests an
explant rate ranging from 7.6–30% [43–45]. A recent survey
from ASRA (American Society of Regional Anaesthetists)
and SIS (Spine Intervention Society) members reports loss
of efficacy as the primary reason for explantation of SCS
devices (53.72%). Although loss of efficacy comprised a
significant fraction of explants, the survey still contained
significant reports of biological (12.2%) and device complications (20.7%) that necessitated removal [46].
Summary and Conclusion
The paternalistic role of doctors deciding what treatment
to offer a patient, which was unpinned by the decision in
Bolam v Friern Hospital Management Committee [1957] 1
WLR 582 (where the standard of care required of a doctor
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was judged by the standard to be expected of a reasonable
group of their peers) is no longer acceptable and does not
hold value in modern day clinical practice [47].
The emphasis is now on a patient’s choice made after being
informed of clinically appropriate options. The patient has the
right to choose a therapeutic option and its possible impact
on their health. The medical advice about treatment options
must consider medical factors whilst taking into account the
patient’s value judgements. The implications relate to the
clinicians necessitating to familiarise themselves with their
patients sufficiently well to understand their views and values
and thereby support them in the decision-making process.
The acceptable standard of patient / clinician interaction
in the consenting process is now much higher. The assessment of that standard now will combine factors important to
both the clinician and patient. Clinicians should ensure there
is enough space and time allowed for jargon-free, meaningful, patient-centred dialogue. A short conversation, just prior
to surgery, with an unfamiliar patient pulled from a group
waiting list is unlikely to reach that standard.
Providing patients with evidence-based information
and realistic expectations of SCS treatment outcomes would
bolster patient confidence in the clinicians delivering SCS
treatments; and allow them to be reassured that their decisions regarding treatment are based on a foundation of accurate and up-to-date information.
Although there are many clear and thorough guidelines
describing the nuances of SCS device implantation and patient
selection, no such guidelines exist on consenting patients for
SCS, leaving physicians unsupported in this process and therefore at risk of litigation. This could relate to poor patient understanding of various risks and expectations that were set during
their consenting for implantation. Moreover, in the absence of
insufficient data on the efficacy of SCS in socioeconomically
deprived populations, consenting of this subgroup could be
challenging and would require a judicious approach in order to
avoid precluding these groups when offering therapy [48]. This
article emphasises the importance and need for such guidelines
to be developed, in order to ensure that informed consent is
gained satisfactorily and that patient expectations are managed
appropriately, with the aim to ensure the highest standards of
care and to maintain the integrity of both the care provider
and the therapy being provided. A standardised consenting
paradigm can help in developing confidence among clinicians
and patients by minimising undue litigation risk significantly.
Key References
26. Kumar K et al. (2007) Avoiding complications from spinal cord
stimulation: Practical recommendations from an international
panel of experts. Neuromodulation: Technology at the Neural
Interface. 2007;10(1):24–33. https://d​ oi.o​ rg/1​ 0.1​ 111/j.1​ 525-1​ 403.​
2007.​00084.x. *complementary article outining complications.
44
34. Deer T, et al. Safety analysis of dorsal root ganglion stimulation
in the treatment of chronic pain. Neuromodulation: Technol Neural Interface. 2020;23(2):239–44. https://​doi.​org/​10.​1111/​ner.​
12941. ** recent article discussing safety of dorsal root ganglion
implants.
Author Contributions All authors participated in literature review,
article drafting and final writing.
Data Availability No datasets were generated or analysed during the
current study.
Declarations
Competing Interests Dr. Abd-Elsayed is a section editor for the journal.
Human and Animal Rights and Informed Consent This article does not
contain any studies with human or animal subjects performed by any
of the authors.
Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long
as you give appropriate credit to the original author(s) and the source,
provide a link to the Creative Commons licence, and indicate if changes
were made. The images or other third party material in this article are
included in the article’s Creative Commons licence, unless indicated
otherwise in a credit line to the material. If material is not included in
the article’s Creative Commons licence and your intended use is not
permitted by statutory regulation or exceeds the permitted use, you will
need to obtain permission directly from the copyright holder. To view a
copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
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