Spinal cord stimulation for treatment of chronic neuropathic pain in adolescent patients: a single-institution series, systematic review, and individual participant data meta-analysis

Salma M. BakrFaculty of Medicine, Ain Shams University, Cairo, Egypt;

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James A. Knight IIDepartment of Radiation Oncology, University of Kentucky, Lexington, Kentucky;

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Nathan A. ShlobinDivision of Pediatric Neurosurgery, Ann and Robert H. Lurie Children’s Hospital, Chicago;
Department of Neurosurgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois;

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Hailey BudnickSection of Pediatric Neurosurgery, Riley Hospital for Children, Indiana University School of Medicine Department of Neurological Surgery, Indianapolis, Indiana;

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Virendra DesaiDepartment of Neurosurgery, University of Oklahoma School of Medicine, Oklahoma City, Oklahoma;

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Haley HillSection of Neurodiagnostics, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis;

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Sarah K. JohnsonSection of Physical Therapy, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis;

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Amy E. WilliamsDepartment of Psychiatry, Riley Child and Adolescent Psychiatry Clinic, Indiana University School of Medicine, Indiana University Health, Indianapolis; and

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James A. TolleySection of Pediatric Anesthesia, Department of Pediatrics, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, Indiana

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Jeffrey S. RaskinDivision of Pediatric Neurosurgery, Ann and Robert H. Lurie Children’s Hospital, Chicago;
Department of Neurosurgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois;

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OBJECTIVE

Neuropathic pain is undertreated in children. Neurosurgical treatments of pediatric chronic pain are limited by the absence of both US Food and Drug Administration approval and pediatric-specific hardware, as well as weak referral patterns due to a lack of physician education. This study presents a single-institution retrospective case series of spinal cord stimulation (SCS) in children ≤ 19 years of age and a systematic review of SCS in children. The authors’ findings may further validate the role of SCS as an effective treatment modality for varied neuropathic pain syndromes found in pediatric patients.

METHODS

The study was a single-center, single-surgeon, retrospective case series of individuals treated between July 2017 and May 2022. The outcomes for pediatric patients with chronic neuropathic pain syndromes indicated by the multidisciplinary pain clinic for evaluation for SCS were cataloged. A systematic review and individual participant data (IPD) meta-analysis was performed for cases treated until May 2022, using PubMed, EMBASE, and Scopus to characterize outcomes of children with neuropathic pain treated with SCS.

RESULTS

Twelve patients were evaluated and 9 were indicated for percutaneous or buried lead trials. Seven female and 2 male patients between the ages of 13 and 19 years were implanted with trial leads. Eight of 9 (89%) patients went on to receive permanent systems. The average trial length was 6 days, and the length of stay for both trial and implant was less than 1 day. Complication rates due to CSF leaks were 22% and 0% for trial and implant, respectively. Visual analog scale pain scores decreased from 9.2 to 2.9 (p = 0.0002) and the number of medications decreased from 4.9 to 2.1 (p = 0.0005). Functional status also improved for each patient. A systematic review identified 13 studies describing pediatric patients with SCS, including 12 providing IPD on 30 patients. In the IPD meta-analysis, pain was reduced in 16/16 (100%) of patients following surgery and in 25/26 (96.2%) at last follow-up. Medication use was decreased in 16/21 (76.2%), and functional outcomes were improved in 29/29 (100%). The complication rate was 5/30 (16.7%).

CONCLUSIONS

SCS effectively decreases pain and medication use for pediatric neuropathic pain syndromes. Patients also report improved functional status, including improved matriculation, gainful employment, and physical activity. There is minimal high-quality literature describing neuromodulation for pain in children. Neuromodulation should be considered earlier as a viable alternative to escalating use of multiple drugs and as a potential mechanism to address tolerance, dependence, and addiction in pediatric patients.

ABBREVIATIONS

AIS = American Spinal Injury Association (ASIA) Impairment Scale; CRPS = complex regional pain syndrome; DTM = differential target multiplexed; IPD = individual participant data; LOS = length of hospital stay; SCI = spinal cord injury; SCS = spinal cord stimulation; SSEP = somatosensory evoked potential; TCR = tethered cord release; TCS = tethered cord syndrome; VAS = visual analog scale.

OBJECTIVE

Neuropathic pain is undertreated in children. Neurosurgical treatments of pediatric chronic pain are limited by the absence of both US Food and Drug Administration approval and pediatric-specific hardware, as well as weak referral patterns due to a lack of physician education. This study presents a single-institution retrospective case series of spinal cord stimulation (SCS) in children ≤ 19 years of age and a systematic review of SCS in children. The authors’ findings may further validate the role of SCS as an effective treatment modality for varied neuropathic pain syndromes found in pediatric patients.

METHODS

The study was a single-center, single-surgeon, retrospective case series of individuals treated between July 2017 and May 2022. The outcomes for pediatric patients with chronic neuropathic pain syndromes indicated by the multidisciplinary pain clinic for evaluation for SCS were cataloged. A systematic review and individual participant data (IPD) meta-analysis was performed for cases treated until May 2022, using PubMed, EMBASE, and Scopus to characterize outcomes of children with neuropathic pain treated with SCS.

RESULTS

Twelve patients were evaluated and 9 were indicated for percutaneous or buried lead trials. Seven female and 2 male patients between the ages of 13 and 19 years were implanted with trial leads. Eight of 9 (89%) patients went on to receive permanent systems. The average trial length was 6 days, and the length of stay for both trial and implant was less than 1 day. Complication rates due to CSF leaks were 22% and 0% for trial and implant, respectively. Visual analog scale pain scores decreased from 9.2 to 2.9 (p = 0.0002) and the number of medications decreased from 4.9 to 2.1 (p = 0.0005). Functional status also improved for each patient. A systematic review identified 13 studies describing pediatric patients with SCS, including 12 providing IPD on 30 patients. In the IPD meta-analysis, pain was reduced in 16/16 (100%) of patients following surgery and in 25/26 (96.2%) at last follow-up. Medication use was decreased in 16/21 (76.2%), and functional outcomes were improved in 29/29 (100%). The complication rate was 5/30 (16.7%).

CONCLUSIONS

SCS effectively decreases pain and medication use for pediatric neuropathic pain syndromes. Patients also report improved functional status, including improved matriculation, gainful employment, and physical activity. There is minimal high-quality literature describing neuromodulation for pain in children. Neuromodulation should be considered earlier as a viable alternative to escalating use of multiple drugs and as a potential mechanism to address tolerance, dependence, and addiction in pediatric patients.

Spinal cord stimulation (SCS) was first reported as a treatment for pain in 1967.1 Over the succeeding 50 years, SCS has become an important tool for treating chronic pain, with increasing utilization in certain populations over time.2 Although the mechanism of SCS remains unclear, activation of precortical myelinated large-diameter A-β fibers traditionally has been thought to inhibit transmission of nociceptive information.3 The dorsal horn islet cells have been recently proposed as the crucial site of action based on clinical and preclinical studies.4 SCS may activate islet cell dendrites given that the SCS electrodes span the rostrocaudal orientation of the islet cells, increasing γ-aminobutyric acid release and reducing glutamate release in the dorsal horn.4

SCS is well described for adult pain syndromes. Randomized controlled trials have established its efficacy for chronic neuropathic pain generally in addition to chronic intractable angina pectoris, painful diabetic neuropathy, and complex regional pain syndromes (CRPSs).510 The recent randomized controlled trial of the Senza device validated the efficacy of 10-kHz high-frequency stimulation compared to traditional low-frequency stimulation.11 SCS is often favored in selected patients with chronic pain due to its propensity to reduce pain scores, length of hospital stay (LOS), complication rates, and opioid consumption.1215 In patients treated for back pain, SCS is more effective compared with spine surgery reoperation.16 Additionally, SCS often leads to decreased healthcare costs compared to other treatment options, serving as a cost-effective treatment for complex, high-utilization conditions.12

The evidence for SCS in children is less robust. A review demonstrated that SCS use in pediatrics is limited to CRPS, where it is noted to improve function and decrease pain.17,18 Case reports have demonstrated pain reductions for pediatric patients undergoing SCS for recurrent tethered cord syndrome (TCS), lower-limb and pelvic pain due to widespread lymphangioma, and chronic visceral pain due to abdominal adhesions and mesenteric ischemia.1921 Other rare pediatric pain conditions for which SCS has been used include erythromelalgia, neuropathic pain with concomitant structural diseases such as macrodactyly, vascular malformations, and Klippel-Trenaunay-Weber syndrome with sciatic neuroma formation.2226 To the best of our knowledge, SCS use in the pediatric population has not been described in other pain syndromes. We present a single-institution case series of medically refractory patients with pediatric pain syndromes to emphasize the role of SCS in the treatment of these conditions, and we perform a systematic review and individual participant data (IPD) meta-analysis of the literature.

Methods

Institutional Experience and Data Collection

The Indiana University Institutional Review Board approved this single-institution, single-surgeon, retrospective review for all patients receiving a procedure for SCS. Patient consent was obtained, and the electronic medical record was used to review patient information. Demographic and surgical data for consecutive patients with chronic pain who underwent SCS implantation between July 2017 and May 2022 were collected. Relevant data included age, sex, diagnosis, lead trial type, LOS, and complications. Follow-up times ranged from 15 to 49 months after implantation of a permanent stimulator. Measures presented for individual patients vary, as available in the medical record for each of the following data types: pre- and postoperative pain scores, number of pain medicines, and functional ability.

Surgical Management

All patients had either a percutaneous or buried lead trial prior to permanent device implantation. All patients had trial and implant of a device from the same company. Indications were made following referral from the comprehensive pain clinic staffed by an anesthesiologist, a physical therapist, and a psychologist, and a successful trial proceeding to implant was defined as approximately 50% pain reduction. All patients received a formal psychological evaluation.

Percutaneous Lead Trial

Percutaneous lead trials were performed in awake, prone patients with the aid of fluoroscopy. After antibiotic administration and a surgical pause, proprietary introducing needles were placed into the epidural space at midlumbar starting points over the pedicle of the level below epidural access, using the loss-of-resistance technique under anterior-posterior fluoroscopy. When in position, 1–2 octrode electrodes were navigated to the intended thoracic or cervical anatomical area. The electrodes were connected to the trial stimulator, and electrical current was titrated in collaboration with the device manufacturer’s representative. Upon adequate coverage of the pain segments, the electrodes were secured at the exit points with 2-0 nylon stitches and the trial stimulator was taped to the patient’s flank opposite the side where a permanent device might reside in the future. The child was sent for recovery in the postanesthesia care unit and then discharged home (Fig. 1 left). Following a successful trial, the patient returned to the operating room for explantation if it had not already been performed in clinic, and underwent permanent implantation of percutaneous leads placed with the aid of fluoroscopy under general anesthesia.

FIG. 1.
FIG. 1.

Left: Anteroposterior radiograph demonstrating dual octrode electrodes in situ spanning T9–10, slightly offset to the right for the patient in case 1, who had right lower-extremity CRPS I. Right: Anteroposterior radiograph demonstrating paddle electrode midline within the posterior instrumented fusion with connection to left flank generator.

Buried Lead Trial

Patients with previous posterior instrumented fusion and heterotopic bone formation were not candidates for percutaneous placement of epidural electrodes, and instead underwent a buried lead procedure. The buried lead trial was performed with patients prone, under general anesthesia, and receiving intraoperative neuromonitoring and somatosensory evoked potential (SSEP) collision testing. Following antibiotic administration and a surgical pause, a fluoroscopy-guided incision was opened sharply and a bilateral paraspinal muscle dissection was performed. Heterotopic osteotomy was performed 1–2 segments below the final intended location of the paddle electrode until the spinal dura mater became obvious. Dissection continued until the paddle fit into the epidural space. Collision testing was performed by stimulating both the SSEPs and epidural electrodes until we identified signal dampening above the pain segments (Fig. 2). The electrodes were then tunneled to a separate midline incision, where extension electrodes were connected and tunneled opposite to the flank where a final implant would reside. Exiting electrodes were secured with 2-0 nylon stitches and the trial stimulator was taped to the patient’s flank. The child was sent for recovery in the postanesthesia care unit and admitted overnight to the hospital (Fig. 1 right). Following a successful trial, the child returned to the operating room for removal of extension leads and implant of a contralateral generator.

FIG. 2.
FIG. 2.

SCS collision testing. Lower SSEPs were present in two cortical channels bilaterally (red = baseline, blue = all trials) prior to the placement of the implant. Once the epidural electrode array was in place, stimulus was delivered, and collision successfully occurred bilaterally in both channels. This confirmed proper placement of the stimulator to achieve bilateral coverage from the implant.

Stimulation Parameters

Traditional tonic stimulation is defined as lower-frequency stimulation producing perceived paresthesia and tingling over a target area of pain.27 Newer stimulation parameters include high-dose stimulation, which is defined as stimulation > 10,000-Hz frequency with no perceivable paresthesia;11 and differential target multiplexed (DTM) programming, which is proprietary and uses electrical pulses that vary in amplitudes, frequencies, and pulse widths.28 All patients were started on classic tonic, paresthesia-inducing settings. Once the patient identified that the paresthesias correlated to the painful body areas, we iterated electrical dosing. The eventual therapeutic programming was selected by the patient based on tolerance of paresthesias and extent of pain reduction.

Statistical Analyses

All data were stored in Excel 2018 (Microsoft, Inc.). Prism 8 (GraphPad, Inc.) was used for statistical analyses. The visual analog scale (VAS) pain score and the number of medications pre- and postimplantation were considered continuous variables. The Shapiro-Wilk test was used to test for normality in these outcomes pre- and postimplantation. Given that these outcomes did not meet the conditions of normality, the Mann-Whitney U-test was used to analyze nonparametric continuous data. A p value < 0.05 was deemed statistically significant.

Systematic Review

A systematic review and IPD meta-analysis was conducted according to the PRISMA 2020 and PRISMA-IPD guidelines.29,30 In May 2022, we searched PubMed (National Library of Medicine), EMBASE (Elsevier), and Scopus (Elsevier) with terms detailed in Supplementary Table 1. No restrictions on date, article type, or language were used. No protocol was prepared or registered.

Search results were aggregated in EndNote X9 (Clarivate Analytics), in which the automated deduplication feature removed duplicates. Two reviewers independently screened the remaining articles by title/abstract for relevance and then via full text based on prespecified inclusion/exclusion criteria. Disagreements were resolved by consensus at both stages. The inclusion criteria were pediatric patients ≤ 18 years of age, condition of neuropathic pain, intervention of SCS, and with outcomes of interest pre- and postimplantation. Outcomes of interest were pain, functionality, and medication usage. The exclusion criteria were nonhuman studies, conference abstracts, existing reviews/meta-analyses.

For all included studies, data regarding demographics, clinical variables, and outcomes were extracted. The Risk of Bias in Nonrandomized Studies—of Interventions (ROBINS-I) tool was used to determine the risk of bias of the included studies. The overall risk of bias for the systematic review was determined by aggregating the risk of bias of all included studies.31 The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework was used to determine the quality of all included studies.32 In addition to study-level data, IPD were acquired from studies providing demographic, clinical, and outcome data of pediatric patients with neuropathic pain who underwent SCS. Given a presumed heterogeneity in outcome reporting, pain, medication usage, and functional status were characterized as "reduced/improved," "no change," or "increased/worsened."

Results

Institutional Series

Twelve patients ages 13–19 years were referred by the comprehensive pain clinic for evaluation of dorsal column stimulation. Seven female and 2 male patients were indicated for SCS trial electrode placement, and all went on to receive a percutaneous or buried lead trial. The trials lasted on average 6 days, whereas the LOS for both trial and implant was less than 1 day each. Etiologies were heterogeneous and included CRPS I (n = 3), CRPS II (n = 1), deafferentation pain secondary to American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A spinal cord injury (SCI) (n = 1), chronic visceral hyperpathia secondary to chronic pancreatitis (n = 1), urogenic neuropathic pain secondary to tethered cord release (TCR) (n = 1), chronic low-back pain (n = 1), and inguinal neuralgia secondary to pelvic reconstruction for midline duplication disorder (n = 1) (Table 1).

TABLE 1.

Demographic data and outcomes in 9 pediatric patients who received SCS

Case No.Age (yrs), SexDiagnosisPretrialTrialPostimplantation
Pain Duration (yrs)VAS Score (avg)Pain Meds (no.)Pain Meds ListedFunctional StatusVAS Score (avg)Successful6-Mo VAS Score12-Mo VAS ScorePain Meds (no.)Pain Meds ListedFunctional Status
117, FCRPS I of rt LE secondary to crush injury6105Ketamine, methadone, oxycodone/acetaminophen, duloxetine, clonidineNonambulatory5Yes450NoneRuns 10-min mile, attends school, works
215, FDeafferentation pain secondary to AIS grade A SCI4103Gabepentin, ibuprofen, TylenolWheelchair0Yes002Gabapentin, TylenolWheelchair, school
319, FChronic visceral hyperpathia secondary to chronic pancreatitis6105Fentanyl patches, morphine, gabapentin, Percocet, Norco, & AtivanTruancy0Yes332Fentanyl patches, PercocetActive, college, works
417, MUrogenic neuropathic pain secondary to TCR275Acetaminophen, citalopram, Lyrica, meloxicam, tizanidineImpaired bladder/sexual function, wheelchair1Yes102Tizandine, LyricawAsymp, improved urodynamics, full activity, school, works
518, FCRPS I of rt LE secondary to tractor crush injury587Amitriptyline, clonidine, duloxetine, gabapentin, oxcarbazepine, lorazepam, morphine, lidocaine patchesDifficulty sleeping, decreased socialization, truancy5Yes355Amitriptyline, clonidine, duloxetine, gabapentin, oxcarbazepineSleeps well, no truancy, more social
617, FLumbago1107Duloxetine, clonidine, Emgality, hydroxyzine, Percocet, ketamine infusion, prochlorperazinPT, ambulates10NoNANANANAPT, ambulates
713, MCRPS II of rt forearm secondary to traumatic ulnar sensorineuropathy5104Lyrica, amitriptyline, duloxetine, & clonidineUnable to write w/ dominant rt hand3Yes332Amitriptyline, duloxetineAble to write 2–3 pages w/ rt hand, active
817, FCRPS I of bilat LEs secondary to unknown trauma283Meloxicam, gabapentin, tizanidineGained 30 lbs, nonambulatory4Yes200NoneAttending college
917, FRt inguinal neuralgia secondary to pelvic reconstruction for midline duplication disorder2105Amitriptyline, duloxetine, gabapentin, hydrocodone, meloxicamFunctionally normal, pain-limited5Yes774Duloxetine, gabapentin, hydrocodone, meloxicamFunctionally normal, pain-limited but less so

Asymp = asymptomatic; avg = average; LE = lower extremity; meds = medications; NA = not available; PT = physical therapy.

Eight of 9 trials (89%) proceeded to implantation of a permanent device following a successful trial—defined as approximately 50% pain reduction. Demographic data are found in Table 1. The average preoperative pain duration was 3.7 years. Pain scores on the VAS were reduced from an average of 9.2 preimplantation to an average of 3.7 during the trial. Pain reduction was maintained at an average of 2.9 at both the 6- (p = 0.0005) and 12-month follow-up visits (p = 0.0005). Patients who responded to the trial and received implants experienced a decrease in the number of pain medications used—from an average of 4.6 to 2.1 (p = 0.0065)—with 2 patients ceasing all pain medications (cases 1 and 8), and 2 patients ceasing all or some of their opioids (cases 3 and 5). Functional outcomes are listed in Table 1. Surgical data are present in Table 2. Three patients underwent paddle implantation, whereas the remaining 5 implants were percutaneous (the patient in case 6 received no implant). Three patients were programmed using low-dose tonic stimulation (cases 1–3); 3 others (cases 4, 8, and 9) were programmed using DTM proprietary programming; and high-dose subperception stimulation was used for the remaining 2 patients (cases 5 and 7). Complications occurred during the trial phase, with transient intraoperative CSF leaks not requiring further intervention occurring in 2 patients (22%), whereas no complications occurred during implantation. The single trial nonresponder had a course complicated by a CSF leak and noncompliance with bedrest therapy.

TABLE 2.

Surgery characteristics in 9 pediatric patients who received SCS

Case No.Age (yrs), SexDiagnosisTrialImplant
Percutaneous or BuriedSpinal LevelLOS (days)Implant Duration (days)ComplicationPaddle or PercutaneousLOS (days)ComplicationProgramming
117, FCRPS I of rt LE secondary to crush injuryPercutaneous octrode (2; midline & rt adjacent)T9–10110CSF leakPercutaneous1NoneTonic
215, FDeafferentation pain secondary to AIS grade A SCIBuried paddleT1107NonePaddle1NoneTonic
319, FChronic visceral hyperpathia secondary to chronic pancreatitisPercutaneous octrode (2; tandem midline)T5–1004NonePercutaneous1NoneTonic
417, MUrogenic neuropathic pain secondary to TCRPercutaneous octrode (2; tandem midline)T8–1104NonePercutaneous1NoneDTM
518, FCRPS I of rt LE secondary to tractor crush injuryPercutaneous octrode (2; tandem midline)T9–120NonePercutaneous1NoneHD
617, FLumbagoPercutaneous octrode (2; midline)T8–1014CSF leakNANANANA
713, MCRPS II of rt forearm secondary to traumatic ulnar sensorineuropathyPercutaneous octrode (2; midline)C4–517NonePaddle1NoneHD
817, FCRPS I of bilat LEs secondary to unknown traumaPercutaneous octrode (2; tandem midline)T8–1007NonePercutaneous0NoneDTM
917, FRt inguinal neuralgia secondary to pelvic reconstruction for midline duplication disorderBuried paddleT10–1218NonePaddle1NoneDTM

HD = high dose, subperception high energy, and pulse width; Tonic = stimulation parameters causing perceived tingling in distribution.

Systematic Review

Of 584 articles retrieved in the search, 13 studies with 31 pediatric patients who underwent SCS were included in the systematic review. Figure 3 presents the PRISMA flowchart for this systematic review.1823,25,26,3337 Studies focused on pediatric patients with CRPS, lymphangioma, erythromelalgia, thoracic outlet syndrome, Klippel-Trenaunay-Weber syndrome, recurrent TCS, chronic visceral pain, and unspecified chronic pain. Nine (69.2%) studies were case reports, and 4 (30.8%) were case series. Most studies reported decreased pain and improved function following SCS. The quality of most included studies was very low. The risk of bias of most studies was serious, predisposing the systematic review to a serious risk of bias overall. Table 3 presents the characteristics of all included studies.

FIG. 3.
FIG. 3.

PRISMA flowchart for the systematic review.

TABLE 3.

Studies included in systematic review of pediatric patients with SCS

Authors & YearStudy DesignQuality GradeRisk of BiasConditionNo. of Pediatric Pts w/ SCSKey Findings
Bakr et al., 202018Case reportVery lowSeriousCRPS1Normal ROM, stamina, strength after SCS; reduced pain, weaned medications, & improved functional status
Dones et al., 201620Case reportVery lowSeriousLymphangioma1Pain disappeared, affected limb shrank, & resumed ADLs
Fan et al., 202023Case reportVery lowSeriousErythromelalgia1Marked reduction in pain
Hale & Cheng, 202035Case reportVery lowSeriousThoracic outlet syndrome1Marked pain relief & functional improvement
Kapural et al., 201021Case seriesLowHighChronic visceral abdominal pain1Most pts had ≤50% pain relief
Kim & Cucchiaro, 201725Case reportVery lowSeriousKTW syndrome1Several attempts at lead placement required
Kim et al., 201826Case seriesLowHighChronic pain4Pain & function improved after implantation
Olsson et al., 200837Case seriesLowHighCRPS7Pain alleviated in 5 pts; 4 pts had diminished SCS use & removal of device; 1 pt w/ infection
Patel et al., 201522Case reportVery lowSeriousErythromelalgia1Improved pain & functioning but not sensation of burning pain
Rodriguez-Lopez et al., 201533Case seriesLowHighCRPS10Pain alleviated in 8 pts & markedly decreased in 2; reduced motor dysfunction, medication usage, & absences from school
Stanton-Hicks & Kapural, 200636Case reportVery lowSeriousCRPS1Reduced pain for 5 mos, but then burning dysesthesia returned
Tseng et al., 201434Case reportVery lowSeriousChronic pain1Minimal pain relief w/ SCS
Tyagi et al., 201619Case reportVery lowSeriousRecurrent TCS1Pain decreased postimplant

ADL = activities of daily living; KTW = Klippel-Trenaunay-Weber; pts = patients; ROM = range of motion.

Twelve studies included IPD on 30 patients with a mean age of 13.1 ± 2.6 years, of which 23 (76.7%) were female and 7 (23.3%) were male. Pathologies included 19 (63.3%) CRPS, 3 (10.0%) erythromelalgia, 2 (6.7%) Klippel-Trenaunay-Weber syndrome, 2 (6.7%) unspecified chronic pain, 1 (3.3%) lymphangioma, 1 (3.3%) thoracic outlet syndrome, 1 (3.3%) vascular malformation, and 1 (3.3%) recurrent TCS. Most but not all studies used the VAS to quantify pain. Pain was reduced in 16/16 (100%) of patients with reported pain following the procedure and 25/26 (96.2%) at last follow-up. Medication use was decreased in 16/21 (76.2%) of patients, whereas functional outcomes were improved in 29/29 (100%) of patients. Other noted outcomes were improvements in sleep and mood, weight loss, and reduction in size of a lymphangiomatous limb. The complication rate was 5/30 (16.7%), including 2 patients with CSF leaks (1 necessitating reoperation), 1 infection requiring SCS removal, 1 lead migration requiring revision, and 1 challenging lead placement. The mean ± SD for follow-up duration was 15.4 ± 12.6 months. Table 4 presents IPD.

TABLE 4.

IPD from systematic review of pediatric patients with SCS

Authors & YearCase No.Age (yrs), SexConditionPain ScalePain PostopPain at Last FUUse of MedsFunctionOther OutcomeComplicationsFU (mos)
Bakr et al., 202018117, FCRPSVASReducedReducedReducedImprovedNRCSF leak, spinal headache15
Dones et al., 201620114, MLymphangiomaVASReducedReducedNRImprovedLimb size reducedNone12
Fan et al., 202023112, FErythromelalgiaVASReducedReducedReducedImprovedNRNone8
Hale & Cheng, 202035117, FThoracic outlet syndromeVAS (presumed)ReducedReducedReducedImprovedImproved sleepNone36
Kim & Cucchiaro, 201725116, FKTW syndromeNRReducedReducedNRImprovedNRSeveral attempts at lead placement requiredNR
Kim et al., 201826116, MChronic painNRReducedReducedNRImprovedNR1 pt w/ lead migration requiring revision28 ± 23
216, MVascular malformationNRReducedReducedNRImprovedNR
316, FKTW syndromeNRReducedReducedNRImprovedNR
415, FErythromelalgiaNRReducedReducedNRImprovedNR
Olsson et al., 200837112, FCRPSVASReducedReducedReducedImprovedNRNone45
212, FCRPSVASReducedReducedReducedImprovedNRInfection requiring removal of trial electrode1
314, FCRPSVASReducedReducedReducedImprovedNRNone36
414, FCRPSVASReducedReducedReducedImprovedNRNone48
514, FCRPSVASReducedReducedReducedImprovedNRNone7
611, FCRPSVASReducedReducedReducedImprovedNRNone3
713, FCRPSVASReducedReducedReducedImprovedNRNone4
Patel et al., 201522115, FErythromelalgiaNRReducedReducedNRImprovedImproved sleep & moodNone24
Rodriguez-Lopez et al., 201533113, MCRPSVASNRReducedReducedImprovedNRNone12
213, FCRPSVASNRReducedNCImprovedNRNone12
310, MCRPSVASNRReducedReducedImprovedNRNone12
411, MCRPSVASNRReducedNCImprovedNRNone12
58, FCRPSVASNRReducedNCImprovedNRNone12
610, FCRPSVASNRReducedReducedImprovedNRNone12
79, MCRPSVASNRReducedReducedImprovedNRNone12
811, FCRPSVASNRReducedNCImprovedNRNone12
913, FCRPSVASNRReducedReducedImprovedNRNone12
108, FCRPSVASNRReducedNCImprovedNRNone12
Stanton-Hicks & Kapural, 200636117, FCRPSVASReducedNCNRNRNRNone3
Tseng et al., 201434115, FChronic painNRReducedReducedReducedImprovedWeight lossNone12
Tyagi et al., 201619112, FRecurrent TCSNRReducedReducedNRImprovedNo improvement in B/B functionCSF leak; reop 1 wk after surgery10

B/B = bowel or bladder; FU = follow-up; NC = no change; NR = not reported.

Follow-up for the 4 patients in Kim et al.26 was reported as the mean ± SD. The study does not specify which of the 4 patients had the complication.

Discussion

We present 8 pediatric patients whose pain was successfully managed with a permanent SCS for a heterogeneous group of neuropathic pain syndromes, including deafferentation pain secondary to AIS grade A spinal cord injury, chronic visceral hyperpathia secondary to chronic pancreatitis, urogenic neuropathic pain secondary to TCR, chronic low-back pain, inguinal neuralgia secondary to pelvic reconstruction for midline duplication disorder, CRPS I, and CRPS II. These individuals uniformly experienced a statistically significant decrease in patient-reported VAS score, pain medication use, and had improved functional ability.

Chronic pain in children greatly impacts patients and caregivers and presents a significant economic burden to society.38 Adolescents with chronic pain are at increased risk for psychiatric illnesses including anxiety and depression, social withdrawal, school absenteeism, and an overall decrease in quality of life.3941 Opioid use leads to escalation and presents additional risk of early opioid dependence.

SCS is well supported in adult patients for multiple indications including failed back surgery syndrome, ischemic limb pain, CRPS, neuropathic pain, and postsurgical inguinal pain.4245 The preponderance of evidence in pediatric patients is limited to CRPS. While the observed benefits of SCS in pediatric patients with CRPS mimic those in adults, SCS is often considered very late in the pediatric therapeutic algorithm.46,47

Children with CRPS have been found to have significantly lower physical, psychological, and emotional quality of life on the pediatric quality of life 4–0 scale compared to a healthy control group.48 Our systematic review identified 19 of 30 pediatric patients treated with SCS for CRPS. Pain was reported as "reduced" at last follow-up, and medication use was either reduced or did not change. Real-world function improved in all patients, although due to the heterogeneous etiologies these improvements were diverse.18,33,36,37

To our knowledge, the use of SCS in pediatric patients with chronic back pain has not been reported in the literature. In the adult population, the efficacy of SCS in postsurgical back pain syndromes has been established,11,49,50 with less rigorous evidence regarding chronic back pain in surgery-naïve patients resembling our pediatric patients in this case series.51 Chronic back pain in pediatric patients is not likely to have the same pathophysiology as in adult patients who have suffered the consequences of degenerative disease and usually surgical management over time. Pediatric patients with back pain are also not likely to receive SCS because it is considered a last-resort therapy. Based on the dearth of literature for this demographic it is not possible to tell what the effect is of SCS in pediatric chronic back pain. In our series, the patient with low-back pain was the only individual in whom SCS trial placement failed and who did not receive an implant.

Chronic pancreatitis causes a mixed pain syndrome requiring a multimodal approach. The use of SCS in the management of adult patients with refractory chronic visceral pain secondary to chronic pancreatitis has been reported in the literature; however, there are no reports on its use in a pediatric population.5256 Epidural electrodes generally target T4–6, where the greater and lesser splanchnic nerves emerge from the spinal cord.53 Adult patients report a median pain reduction of 61% on the VAS, ranging between 50% and 100%, and reduced morphine equivalent opioid usage by a median of 69%, with a range of 25%–100%.57 The patient treated for chronic visceral hyperpathia secondary to chronic pancreatitis had a profound improvement at 1 year, with 70% reduction of pain by VAS score and 60% reduction in pain medications.

Inguinal pain is most commonly reported following herniorrhaphy, gynecological and pelvic surgeries secondary to injury or entrapment of the ilioinguinal nerve, genital branch of the genitofemoral nerve, and the iliohypogastric nerve.5860 In patients with postherniorrhaphy pain, leads are placed at levels T7–9, and are associated with a pain reduction of > 50%.61,62 Long-term adequate paresthesia coverage is somewhat limited due to the involvement of unaffected nearby areas, leading to discomfort.63,64 Hence there has been an evolution in neuromodulation and a shift toward dorsal root ganglion stimulation.6567 No pediatric patients with inguinal pain treated with SCS have been identified in our systematic review. Our patient with congenital duplication of the genitourinary structures and > 50 surgeries had a disappointing response; after a 50% pain reduction on trial she had only 30% improvement at 1 year and stopped 20% of her medications, still requiring multiple pain medications.

Chronic pelvic pain is a broad heterogeneous group of pain etiologies, anatomical distributions, and syndromes.68,69 No reports on the use of SCS in pediatric chronic neurogenic visceral pelvic pain have been reported, and the evidence in the adult literature is also scarce. Lack of consensus on the optimal lead placement in SCS could be one of the barriers to SCS use in pelvic pain, although conus stimulation at T12 has been linked with good effects.68 Our systematic review did reveal a patient treated with SCS for recurrent TCS, who experienced reduced pain but did not have any improvement in bowel or bladder function.19 In contradistinction, our patient with recurrent TCS without radiographic tethering had complete resolution of symptoms and returned to normal genitourinary and sexual function.

SCI causes chronic pain in approximately 65%–85% of cases.70 SCS has been used in patients with SCI to affect numerous outcomes including motor rehabilitation below the level of the lesion, bone and muscle health improvements, and management of spasticity and of neuropathic pain syndromes.71,72 The adult literature presents some heterogeneity regarding the results, etiologies of the SCI, pain types, stimulation parameters, follow-up periods, and pain outcome measures. Cioni et al. reported pain reduction of at least 50% in 9 of the 25 patients with SCI undergoing an SCS trial, but this lacked durability when success rates dropped to 18.2% at 3-year follow-up.73 Some studies demonstrated higher efficacy rates in those with incomplete SCI over those with complete injuries, leading to the conclusion that incomplete SCI could be a positive prognostic factor, as well as spasm or contracture pain and thoracic level of injury.74,75 To our knowledge, SCS to alleviate neuropathic pain from SCI has not been reported in children. Our patient had a 70% reduction in pain and stopped 1 of 3 medications.

Our systematic review identified SCS implantation for several rare etiologies not yet discussed including lymphangioma, erythromelalgia, thoracic outlet syndrome, Klippel-Trenaunay-Weber syndrome, vascular malformation, and chronic pain. The generalization of SCS to these rare conditions and others will require registry-based, mechanistic studies.

Limitations

This is a retrospective, single-institution, single-surgeon case series using a single industry partner. Rigorous outcome comparisons cannot be made between patients because different types of functional data were recorded. Follow-up times were not standardized. A heterogeneous population of disease states prevents any sweeping conclusions about efficacy. Programming varies among patients, and is broadly, or in the case of proprietary stimulation, incompletely defined. Pediatric neurosurgery has benefited tremendously from multisite collaborations for myriad diagnoses: hydrocephalus (Hydrocephalus Clinical Research Network [HCRN], HCRN implementation/quality improvement arm [HCRNq]); cerebral palsy (Cerebral Palsy Research Network [CPRN]); Chiari malformation (Park-Reeves); deep brain stimulation (the Child & Youth Comprehensive Longitudinal Database of DBS [DBS-CHILD); and epilepsy (Pediatric Emergency Care Applied Research Network [PECARN], Pediatric Epilepsy Research Consortium [PERC]). A multisite registry for the treatment of pediatric pain disorders could provide a way forward to better treatment of pediatric patients with chronic pain.

Conclusions

SCS may be useful for treating a variety of chronic, medically refractory neuropathic pain syndromes in children. In this series, SCS was associated with a decrease in pain scores and medication use, and patients experienced improved individualized functional ability. A systematic review demonstrates that SCS is an uncommon therapy for neuropathic pain in children, and across multiple etiologies it remains a similarly effective treatment paradigm to use in adult patients. It may be appropriate to initiate SCS earlier in the course of treatment for neuropathic pain syndromes in children.

Disclosures

Dr. Raskin receives honoraria from Medtronic.

Author Contributions

Conception and design: Raskin, Bakr, Knight, Shlobin, Desai. Acquisition of data: Knight, Budnick, Hill, Johnson. Analysis and interpretation of data: Raskin, Bakr, Shlobin, Desai. Drafting the article: Raskin, Bakr, Knight, Shlobin, Desai. Critically revising the article: Raskin, Bakr, Shlobin, Budnick, Williams, Tolley. Reviewed submitted version of manuscript: all authors. Approved the final version of the manuscript on behalf of all authors: Raskin. Statistical analysis: Shlobin. Study supervision: Raskin, Tolley.

Supplemental Information

Videos

Video Abstract. https://vimeo.com/745509028.

Online-Only Content

Supplemental material is available online.

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Supplementary Materials

  • Collapse
  • Expand
  • View in gallery
    FIG. 1.

    Left: Anteroposterior radiograph demonstrating dual octrode electrodes in situ spanning T9–10, slightly offset to the right for the patient in case 1, who had right lower-extremity CRPS I. Right: Anteroposterior radiograph demonstrating paddle electrode midline within the posterior instrumented fusion with connection to left flank generator.

  • View in gallery
    FIG. 2.

    SCS collision testing. Lower SSEPs were present in two cortical channels bilaterally (red = baseline, blue = all trials) prior to the placement of the implant. Once the epidural electrode array was in place, stimulus was delivered, and collision successfully occurred bilaterally in both channels. This confirmed proper placement of the stimulator to achieve bilateral coverage from the implant.

  • View in gallery
    FIG. 3.

    PRISMA flowchart for the systematic review.

  • 1

    Shealy CN, Mortimer JT, Reswick JB. Electrical inhibition of pain by stimulation of the dorsal columns: preliminary clinical report. Anesth Analg. 1967;46(4):489491.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 2

    Manchikanti L, Pampati V, Vangala BP, et al. Spinal cord stimulation trends of utilization and expenditures in fee-for-service (FFS) Medicare population from 2009 to 2018. Pain Physician. 2021;24(5):293308.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 3

    Tieppo Francio V, Polston KF, Murphy MT, Hagedorn JM, Sayed D. Management of chronic and neuropathic pain with 10 kHz spinal cord stimulation technology: summary of findings from preclinical and clinical studies. Biomedicines. 2021;9(6):644.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 4

    Jensen MP, Brownstone RM. Mechanisms of spinal cord stimulation for the treatment of pain: still in the dark after 50 years. Eur J Pain. 2019;23(4):652659.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 5

    de Vos CC, Meier K, Zaalberg PB, et al. Spinal cord stimulation in patients with painful diabetic neuropathy: a multicentre randomized clinical trial. Pain. 2014;155(11):24262431.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 6

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