Population Reference No. 3

Dorsal Root Ganglion Neurostimulation for Refractory Chronic Trunk or Limb Pain

Clinical Context and Therapy Purpose

The purpose of dorsal root ganglion neurostimulation in individuals who have treatment-refractory chronic trunk or limb pain is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with treatment-refractory chronic pain of the trunk or limbs. Examples of treatment-refractory chronic pain include failed back surgery syndrome, CRPS (ie, reflex sympathetic dystrophy), arachnoiditis, radiculopathies, phantom limb/stump pain, peripheral neuropathy, and painful diabetic neuropathy.

Interventions

The therapy being considered is dorsal root ganglion neurostimulation. Dorsal root ganglion uses the same epidural approach technique as spinal cord stimulation but targets a different anatomical target, the dorsal root ganglion. Dorsal root ganglia consist of sensory cell bodies that transmit input from the peripheral nervous system to the central nervous system and play a role in neuropathic pain perception. Dorsal root ganglia are located in the epidural space between spinal nerves and the spinal cord on the posterior root in a minimal amount of cerebrospinal fluid, amenable to epidural access.

Comparators

The following practice is currently being used to treat patients with treatment-refractory chronic pain of the trunk or limbs: standard spinal cord stimulation, medical therapy, or surgical therapy.

Outcomes

The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials group has provided recommendations for 4 core chronic pain outcome domains that should be included when selecting outcome measures for clinical trials of treatments for chronic pain: (1) pain intensity; (2) physical functioning; (3) emotional functioning; and (4) participant ratings of overall improvement.^3, The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials has also suggested specific outcome measures to address these core domains and has proposed provisional benchmarks for identifying clinically important changes in these specific outcome measures (Table 2).^4,5,

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Dorsal Root Ganglion Implanted Device

Systematic Reviews

Several systematic reviews of dorsal root ganglion devices have been published: Vuka et al (2019)^64,, Deer et al (2020)^65,, Monan et al (2021)^66,, and D'Souza et al (2022).^67, The reviews all include one RCT (ACCURATE) and several observational studies. The RCT is described in the following section.

Randomized Controlled Trial

The ACCURATE study (NCT01923285) compared dorsal root ganglion neurostimulation with standard spinal cord stimulation.^68,69, As reported by Deer et al (2017), eligibility criteria for this multicenter, unblinded, noninferiority trial included chronic (≥6 months) intractable (failed ≥2 drugs from different classes) neuropathic pain of the lower limbs associated with a diagnosis of CRPS or causalgia and no previous neurostimulation. Patients were randomized to dorsal root ganglion stimulation with the Axium device or standard spinal cord stimulation. Patients first underwent a temporary trial of stimulation lasting 3 to 30 days, depending on the protocol at each site. Patients who had a 50% or greater reduction in lower limb pain after the temporary trial were eligible for permanent stimulation. Those who failed temporary stimulation exited the trial but were included in the analysis as treatment failures. Trial characteristics are shown in Table 6.

A total of 152 patients were randomized, and 115 (n=61 dorsal root ganglion, n=54 spinal cord stimulation) had a successful temporary trial and continued to permanent implantation. The primary outcome was a composite measure of treatment success. Success was defined as (1) a 50% or greater reduction in VAS score and (2) no stimulation-related neurologic deficits. The noninferiority margin was set at 10%. Results are shown in Table 7. No patients experienced neurologic deficits in either group. Regarding paresthesias, at 3 months and 12 months, spinal cord stimulation patients were significantly more likely to report paresthesias in nonpainful areas than dorsal root ganglion patients. At 3 months, 84.7% of dorsal root ganglion patients and 65% of spinal cord stimulation patients reported paresthesias only in their painful areas; at 12 months, these percentages were 94.5% and 61.2%, respectively. Limitations in study relevance, design, and conduct are shown in Tables 8 and 9.

Mekhail et al (2019) conducted a sub-analysis on the patients receiving dorsal root ganglion neurostimulation in the ACCURATE study, to evaluate the occurrence and risk factors for paresthesia.^70, Among the 61 patients with dorsal root ganglion implants, the rates of paresthesia at 1 month, 3 months, 6 months, 9 months, and 12 months were 84%, 84%, 66%, 62%, and 62%, respectively. The patients who were paresthesia-free reported similar or better outcomes for pain and quality of life. Risk factors for paresthesia occurrence included higher stimulation amplitudes and frequencies, number of implanted leads, and younger age.

Table 6. RCT Characteristics of DRG Implanted Devices

ACCURATE: A Prospective, Randomized, Multi-Center, Controlled Clinical Trial to Assess the Safety and Efficacy of the Spinal Modulation™ AXIUM™ Neurostimulator System in the Treatment of Chronic Pain; CRPS: complex regional pain syndrome; DRG: dorsal root ganglion; RCT: randomized controlled trial; SCS: spinal cord stimulation. 

Table 7. RCT Results of DRG Implanted Devices

BPI: Brief Pain Inventory; CI: confidence interval; DRG: dorsal root ganglion; MCS: Mental Component Summary; NR: not reported; POMS: Profile of Mood States; PCS: Physical Component Summary; RCT: randomized controlled trial; SAE: serious adverse event; SCS: spinal cord stimulation; SF-36: 36-Item Short-Form Health Survey; TE: treatment effect; VAS: visual analog scale.

Table 8. Study Relevance Limitations for RCTs of DRG Implanted Devices

DRG: dorsal root ganglion; RCT: randomized controlled trial.

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use; 5. Enrolled study populations do not reflect relevant diversityb Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest.c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 9. Study Design and Conduct Limitations for RCTs of DRG Implanted Devices

DRG: dorsal root ganglion; RCT: randomized controlled trial; SCS: spinal cord stimulation.

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Observational Studies

Because RCT data are available for dorsal root ganglion neurostimulation, observational studies are discussed if they add information not available from the RCTs (eg, longer follow-up including adverse events, data on an important subgroup, etc). Deer et al (2019) compared the safety and complaint records from the manufacturers of dorsal root ganglion neurostimulation (n=500+) and spinal cord stimulation (n=2000+) devices, from April 2016 through March 2018.^71, The overall safety event rate for the study timeframe was 3.2% for dorsal root ganglion systems and 3.1% for spinal cord stimulation systems. Persistent pain was reported at a rate of 0.2% by patients with dorsal root ganglion implants and 0.6% by patients with spinal cord stimulation implants. Infection rates were 1.1% in both groups of patients. Cerebrospinal leaks were reported in 0.5% of patients with dorsal root ganglion implants and in 0.3% of patients with spinal cord stimulation implants.

A retrospective analysis of the FDA's Manufacturer and User Facility Device Experience (MAUDE) database provided information on complications related to the use of dorsal root ganglion stimulation.^72, The MAUDE database was queried for dorsal root ganglion stimulation reports through 2017, identifying 979 episodes. Complications were predominantly device-related (47%; lead migration and lead damage), with the remaining comprised of procedural complications (28%; infection, new neurologic symptoms, and dural puncture), patient complaints (12%; site pain and unwanted stimulation), serious adverse events (2.4%), and "other" complications (4.6%). The prevalence of complications cannot be estimated using the MAUDE database; while facilities are mandated to report events, patients and health care providers may report events, but are not mandated to do so.

Dorsal Root Ganglion Wireless Injectable Device

Case Series

A case series, which included 11 patients, was published by Weiner et al (2016).^73, This study included patients with failed back surgery syndrome who had chronic intractable neuropathic pain of the trunk and/or lower limbs. Five patients participated in phase 1 of the study (device not anchored), and 6 additional patients participated in phase 2 (device anchored). During phase 1, the device migrated more than was recommended and thus it was anchored in the remaining patients. Baseline VAS scores were 5 or higher in all patients. Seven (63%) of the 11 patients reported good to excellent overall pain relief (VAS score reduction, ≥50%), 2 patients reported fair overall intensity pain relief (25% to 50% reduction), and 2 patients reported poor or no overall pain relief (0% to 25%). No adverse events were reported.

Section Summary: Dorsal Root Ganglion Neurostimulators for Refractory Chronic Trunk or Limb Pain

Systematic reviews, 1 unblinded RCT, and case series have evaluated dorsal root ganglion neurostimulators in patients with chronic trunk and/or limb pain. The RCT (N=152) found that patients receiving dorsal root ganglion neurostimulation had significantly higher rates of treatment success (physical functioning score and quality of life measures) at 3 and 12 months compared with those receiving standard spinal cord stimulation devices. In addition, dorsal root ganglion neurostimulation was found to be noninferior to spinal cord stimulation in the percentage achieving >50% pain reduction, emotional functioning score, and 36-Item Short-Form Health Survey scores. Both groups experienced paresthesias but patients in the dorsal root ganglion group reported less postural variation in paresthesia and reduced extraneous stimulation in nonpainful areas. Patients in the dorsal root ganglion group also reported more improvement in interference with physical functioning and mood states. Rates of serious adverse events were similar.

Summary of Evidence

Treatment-Refractory Chronic Pain

For individuals who have treatment-refractory chronic pain of the trunk or limbs who receive dorsal root ganglion neurostimulation, the evidence includes a systematic reviews, a RCT, and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. The unblinded RCT found that patients receiving dorsal root ganglion neurostimulation had significantly higher rates of treatment success (physical functioning score and quality of life measures), at 3 and 12 months compared with those receiving standard spinal cord stimulation devices. Dorsal root ganglion neurostimulation was found to be noninferior to spinal cord stimulation in the percentage achieving >50% pain reduction, emotional functioning score, and 36-Item Short-Form Health Survey scores. Both groups experienced paresthesias but patients in the dorsal root ganglion group reported less postural variation in paresthesia and reduced extraneous stimulation in nonpainful areas. Rates of serious adverse events were similar between the 2 study arms. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 4

Spinal Cord Stimulation for Critical Limb Ischemia

Clinical Context and Therapy Purpose

The purpose of spinal cord stimulation in individuals who have critical limb ischemia is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with critical limb ischemia. Critical limb ischemia is described as pain at rest or the presence of ischemic limb lesions.

Interventions

The therapy being considered is spinal cord stimulation. Spinal cord stimulation uses low-level epidural electrical stimulation of the spinal cord dorsal columns. Its mechanism of action is uncertain but may be related to either activation of an inhibitory system or blockage of facilitative circuits. Spinal cord stimulation devices consist of several components: (1) the lead delivering electrical stimulation to the spinal cord; (2) an extension wire that conducts the electrical stimulation from the power source to the lead; and (3) a power source. The lead may incorporate 4 to 8 electrodes, depending on the complexity of the pain pattern. A trial period in which the electrode is temporarily implanted in the epidural space is recommended, prior to the permanent implantation. Most spinal cord stimulation devices operate under a frequency of 100 to 1000 Hz.

If patients are not suitable candidates for limb revascularization (typically due to insufficient distal runoff), amputation may be required. Spinal cord stimulation has been investigated in this subset of patients as a technique to relieve pain and decrease the incidence of amputation.

Comparators

The following practice is currently being used to treat patients with critical limb ischemia: medical therapy or surgical therapy (revascularization surgery or amputation).

Outcomes

The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials group has provided recommendations for 4 core chronic pain outcome domains that should be included when selecting outcome measures for clinical trials of treatments for chronic pain: (1) pain intensity; (2) physical functioning; (3) emotional functioning; and (4) participant ratings of overall improvement.^3, The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials has also suggested specific outcome measures to address these core domains and has proposed provisional benchmarks for identifying clinically important changes in these specific outcome measures (Table 2).^4,5,

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Systematic Reviews

An updated Cochrane review by Ubbink and Vermeulen (2013) assessed the use of spinal cord stimulation in peripheral vascular diseases.^74, Reviewers included RCTs and non-RCTs evaluating the efficacy of spinal cord stimulation in adults with non-reconstructable, chronic critical leg ischemia. Six trials were identified; all were conducted in Europe and 5 were single-country studies. Spinal cord stimulation was compared with other nonsurgical interventions. One study was not randomized, and none were blinded. In a pooled analysis of data from all 6 studies, there was a significantly higher rate of limb survival in the spinal cord stimulation group than in the control group at 12 months (relative risk [RR], 0.75; 95% CI, 0.57 to 0.95;absolute risk difference, -0.11; 95% CI, -0.20 to -0.02). The 11% difference in the rate of limb salvage means that 9 patients would need to be treated to prevent 1 additional amputation (95% CI, 5 to 50 patients). However, when the nonrandomized study was excluded, the difference in the rate of amputation no longer differed significantly between groups (RR, 0.78; 95% CI, 0.58 to 1.04; absolute risk difference, -0.09; 95% CI, -0.19 to 0.01). The spinal cord stimulation patients required significantly fewer analgesics, and more patients reached Fontaine stage II (intermittent claudication) than in the control group. There was no difference in ulcer healing (but only 2 studies were included in this analysis). In the 6 trials, 31 (15%) of 210 patients had a change in stimulation requiring intervention, 8 (4%) experienced the end of battery life, and 6 (3%) infections required device removal.

Previously, Klomp et al (2009) published a meta-analysis of RCTs that used spinal cord stimulation to treat patients with critical limb ischemia.^75, The same 5 RCTs identified in the Cochrane review were included. Reviewers did not find a statistically significant difference in the rate of amputation in the treatment or control groups. The RR of amputation was 0.79 (95% CI, 0.59 to 1.06), with a risk difference of -0.07 ( 95% CI, -0.17 to 0.03). Reviewers also conducted additional analyses of data from their 1999 RCT to identify factors associated with better or worse prognoses.^76, They found that patients with ischemic skin lesions had a higher risk of amputation than patients with other risk factors. There were no significant interactions between this and any other prognostic factor. The analyses did not identify subgroups of patients who might benefit from spinal cord stimulation.

A systematic review of non-revascularization-based treatments by Abu Dabrh et al (2015) for patients with critical limb ischemia included spinal cord stimulation as 1 of the treatments. The review identified 5 RCTs for inclusion.^77, In the pooled analysis, reviewers found that spinal cord stimulation was associated with reduced risk of amputation (odds ratio [OR], 0.53; 95% CI, 0.36 to 0.79); risk difference was not reported.

Section Summary: Critical Limb Ischemia

Five relatively small RCTs comparing spinal cord stimulation with usual care have assessed patients with critical limb ischemia. In pooled analyses from 3 systematic reviews, spinal cord stimulation was associated with a lower risk of amputation versus control, but results were not consistently statistically significant due to differences in methodologies. This evidence is not sufficient to determine whether spinal cord stimulation would improve outcomes for patients with critical limb ischemia.

Summary of Evidence

For individuals who have critical limb ischemia who receive spinal cord stimulation, the evidence includes systematic reviews of several small RCTs. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment-related morbidity. In some pooled analyses of these RCTs, spinal cord stimulation did not result in a significantly lower rate of amputation, although 1 meta-analysis that included a nonrandomized study reported a significant difference. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 5

Spinal Cord Stimulation for Selected Other Medical Conditions

Clinical Context and Therapy Purpose

The purpose of spinal cord stimulation in individuals who have other medical conditions (eg, angina pectoris, heart failure, or cancer-related pain) is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review.

Populations

The relevant populations of interest are individuals with treatment-refractory angina pectoris, heart failure, or cancer-related pain.

Interventions

The therapy being considered is spinal cord stimulation. Spinal cord stimulation uses low-level epidural electrical stimulation of the spinal cord dorsal columns. Its mechanism of action is uncertain but may be related to either activation of an inhibitory system or blockage of facilitative circuits. Spinal cord stimulation devices consist of several components: (1) the lead delivering electrical stimulation to the spinal cord; (2) an extension wire that conducts the electrical stimulation from the power source to the lead; and (3) a power source. The lead may incorporate 4 to 8 electrodes, depending on the complexity of the pain pattern. A trial period in which the electrode is temporarily implanted in the epidural space is recommended, prior to the permanent implantation. Most spinal cord stimulation devices operate under a frequency of 100 to 1000 Hz.

Comparators

The following practice is currently being used to treat patients with

• refractory angina pectoris: medical therapy or coronary revascularization.

• heart failure: medical therapy or coronary revascularization.

• cancer-related pain: medical therapy.

Outcomes

The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials group has provided recommendations for 4 core chronic pain outcome domains that should be included when selecting outcome measures for clinical trials of treatments for chronic pain: (1) pain intensity; (2) physical functioning; (3) emotional functioning; and (4) participant ratings of overall improvement.^3, The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials has also suggested specific outcome measures to address these core domains and has proposed provisional benchmarks for identifying clinically important changes in these specific outcome measures (Table 2).^4,5,

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Refractory Angina Pectoris

Systematic Reviews

Pan et al (2017) identified 12 RCTs that evaluated spinal cord stimulation versus control in patients with refractory angina pectoris.^78, Most studies had small sample sizes (i.e., <50 patients; N=476). Follow-up ranged widely from 2 weeks to 12 months, and control interventions were not well described in the systematic review. The included studies were generally assessed to have low risk of bias.. Pooled analyses favored the spinal cord stimulation group for most outcomes (e.g., for exercise time after the intervention, pain level [VAS score], angina frequency), but there were no significant differences between intervention and control groups for physical limitation or angina stability.

Another systematic review was published by Tsigaridas et al (2015).^79, It included 9 RCTs evaluating spinal cord stimulation for refractory angina: 7 compared spinal cord stimulation with low or no stimulation and 2 compared spinal cord stimulation with alternative medical or surgical therapy for angina. Reviewers found that most RCTs were small and variable in quality based on modified Jadad criteria. Reviewers reported: "2 of the RCTs were of high quality (Jadad score 4); 2 were of low quality (Jadad score 1), and the remaining ones were of intermediate quality (Jadad score 2 to 3)." Most trials comparing spinal cord stimulation with low or no stimulation found improvements in outcomes with spinal cord stimulation; however, given limitations in the evidence base, reviewers concluded that larger multicenter RCTs would be needed to assess the efficacy of spinal cord stimulation for angina.

Randomized Controlled Trials

Two of the largest RCTs included in the systematic reviews were Zipes et al (2012)^80, and Lanza et al (2011).^81,

Zipes et al (2012) published an industry-sponsored, single-blind, multicenter trial with sites in the United States and Canada.^80, This trial was terminated early because interim analysis by the data and safety monitoring board found the treatment futile. A total of 118 patients with severe angina, despite maximal medical treatment, were enrolled. Of the 118 patients, 71 (60%) underwent spinal cord stimulation implantation with the Intrel III neurostimulator (Medtronic). The remaining 47 patients did not meet eligibility criteria post-enrollment or had other issues (eg, withdrew consent). The investigators had originally been planning to randomize up to 310 patients but enrollment was slow. Implantation was successful in 68 patients; this group was randomized to high-stimulation (n=32) or a low-stimulation control (n=36). The low-stimulation control was designed so that patients would feel paresthesia but the effect of stimulation would be subtherapeutic. The primary outcome was a composite of major adverse cardiac events, which included death from any cause, acute myocardial infarction, or revascularization through 6 months. Fifty-eight (85%) of 68 patients contributed data to the 6-month analysis; analysis was by intention-to-treat. The proportion of patients experiencing major adverse cardiac events at 6 months did not differ significantly between groups (12.6% in the high-stimulation group vs. 14.6% in the low-stimulation group; p=.81). The trial sample size was small, and it might have been underpowered for clinically meaningful differences.

A controlled trial from Italy by Lanza et al (2011) randomized 25 patients to 1 of 3 treatment groups: spinal cord stimulation with standard stimulation (n=10), spinal cord stimulation with low-level stimulation (75% to 80% of the sensory threshold) (n=7), or very low-intensity spinal cord stimulation (n=8).^81, Thus, patients in groups 2 and 3 were unable to feel sensation during stimulation. After a protocol adjustment at 1 month, patients in the very low-intensity group were re-randomized to 1 of the other groups of which there were 13 patients in the standard stimulation group and 12 patients in the low-level stimulation group. At the 3-month follow-up (2 months after re-randomization), there were statistically significant between-group differences in 1 of 12 outcome variables. There was a median of 22 angina episodes in the standard stimulation group and 10 in the low-level stimulation group (p=.002). Nonsignificant variables included the use of nitroglycerin, quality of life, VAS score, Canadian Cardiovascular Society angina class, exercise-induced angina, and scores on 5 subscales of the Seattle Angina Questionnaire.

Uncontrolled studies

Because RCT data are available for spinal cord stimulation, uncontrolled studies are discussed if they add information not available from the RCTs (eg, longer follow-up including adverse events, data on an important subgroup, etc). Lanza et al (2012) reviewed observational studies on spinal cord stimulation in patients with refractory angina pectoris.^82, They identified 16 studies (N=1204 patients) but noted that patients might have been included in more than 1 report. The most frequently reported complications were lead issues (ie, electrode dislodgement or fracture requiring repositioning) or internal programmable generator failure during substitution. Lead issues were reported by 10 studies (N=450 patients). In these studies, 55 cases of lead or internal programmable generator failure were reported. No fatalities related to spinal cord stimulation treatment were reported.

Section Summary: Refractory Angina Pectoris

Numerous small RCTs have evaluated spinal cord stimulation as a treatment for refractory angina. While some studies have reported benefits, most have not. In 2 more recent RCTs, there were no significant benefits for the primary outcomes. Overall, this evidence is mixed and insufficient to permit conclusions on whether health outcomes are improved.

Summary of Evidence

For individuals who have treatment-refractory angina pectoris who receive spinal cord stimulation, the evidence includes systematic reviews and RCTs. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment-related morbidity. Numerous small RCTs have evaluated spinal cord stimulation as a treatment for refractory angina. While some have reported benefits, most have not. In 2 recent RCTs, there was no significant benefit in the primary outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 6

Heart Failure

Randomized Controlled Trials

Findings of a small pilot crossover RCT evaluating spinal cord stimulation for heart failure were published by Torre-Amione et al (2014).^83, Eligibility included symptomatic heart failure despite optimal medical therapy, left ventricular ejection fraction less than 30%, hospitalization or need for intravenous inotropic support in the past year, and inability to walk more than 450 meters on a 6-minute walk test. All patients had an implanted heart device. Nine patients underwent spinal cord stimulation implantation and received 3 months of active and 3 months of inactive (off position) treatment, in random order. There was a 1-month washout period between treatments. The primary outcome was a composite of death, hospitalization for worsening heart failure, and symptomatic bradyarrhythmia or tachyarrhythmia requiring high-voltage therapy. Four patients experienced at least 1 of the events in the composite endpoint. The events occurred in 2 patients while the device was turned on and in 2 while it was turned off. One patient died about 2 months after implantation with the device turned off. The spinal cord stimulation devices did not interfere with the functioning of implantable cardioverter defibrillators.

Zipes et al (2016) reported on the results of Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure (DEFEAT-HF) study, a prospective, multicenter, single-blind RCT comparing spinal cord stimulation using active stimulation with sham-control in patients who had New York Heart Association functional class III heart failure and a left ventricular ejection fraction of 35% or less.^84, Sixty-six patients were implanted with a spinal cord stimulation and randomized 3:2 to spinal cord stimulation on (n=42) or spinal cord stimulation off (sham; n=24). For the trial's primary endpoint (change in left ventricular end-systolic volume index from baseline to 6 months), there was no significant difference between groups (p=.30). Other endpoints related to heart failure hospitalization and heart failure-related quality of life scores and symptoms did not differ significantly between groups. After completion of the 6-month randomization period, all subjects received active spinal cord stimulation. From baseline to 12-month follow-up, there were no significant treatment effects in the overall patient population for echocardiographic parameters (p=.36). The trial was originally powered based on a planned enrollment of 195 implanted patients but enrollment was stopped early due to futility. The nonsignificant difference between groups might have been the result of underpowering. However, the absence of any treatment effects or between-group differences is further suggestive of a lack of efficacy of spinal cord stimulation for heart failure.

Section Summary: Heart Failure

Two RCTs have evaluated spinal cord stimulation as a treatment for heart failure. One was a small pilot crossover trial (N=9) that reported at least 1 adverse event in 2 patients with the device turned on and in 2 patients with the device turned off. The other RCT (N=66) was sham-controlled; it did not find significant differences between groups but might have been underpowered.

Summary of Evidence

For individuals who have heart failure who receive spinal cord stimulation, the evidence includes RCTs. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment (n=66) did not find significant differences between groups but might have been underpowered to do so. The evidence is insufficient to determine the effects of the technology on health outcomes.

Population Reference No. 7

Cancer-Related Pain

Systematic Reviews

A Cochrane review by Lihua et al (2013) assessed spinal cord stimulation for the treatment of cancer-related pain in adults.^85, Reviewers did not identify any RCTs evaluating the efficacy of spinal cord stimulation in this population. Four case series using a before-after design (N=92 patients) were identified. Peng et al (2015) updated this review, finding no new studies meeting inclusion criteria identified.^86, They concluded: "Current evidence is insufficient to establish the role of spinal cord stimulation in treating refractory cancer-related pain."

Section Summary: Cancer-Related Pain

A Cochrane review did not identify any RCTs evaluating spinal cord stimulation for the treatment of cancer-related pain.

Summary of Evidence

For individuals who have cancer-related pain who receive spinal cord stimulation, the evidence includes case series. Relevant outcomes are symptoms, functional outcomes, medication use, and treatment-related morbidity. No RCTs evaluating spinal cord stimulation in this population were identified. The evidence is insufficient to determine the effects of the technology on health outcomes.

Supplemental Information

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

practice guidelines and position statements

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information’ if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Association of Clinical Endocrinology

In 2022, the American Association of Clinical Endocrinology published evidence-based recommendations for the care of individuals with diabetes mellitus.^87,. The guidelines state that 'Neuromodulatory techniques such as high-frequency spinal cord stimulation and combining pharmacological with nonpharmacological approaches should be considered in those with refractory painful DPN [diabetic peripheral neuropathy]'. The evidence for the statement was rated as Grade B [Strong]; BEL[best evidence level] 1 [Randomized controlled trial; Meta-analysis of only randomized controlled trials].

American Society of Interventional Pain Physicians

In 2013, the American Society of Interventional Pain Physicians updated its evidence-based guidelines on interventional techniques for the management of chronic spinal pain.^88, The guidelines included a statement that there is fair evidence for the following recommendation for spinal cord stimulation: "spinal cord stimulation is indicated in chronic low back pain with lower extremity pain secondary to failed back surgery syndrome, after exhausting multiple conservative and interventional modalities".

American Society of Pain and Neuroscience

The American Society of Pain and Neuroscience issued a comprehensive guideline in 2021 on the management of cancer-related pain.^89, The guideline found that spinal cord stimulation may be considered for 1) treatment of refractory cancer pain (level II-3-C evidence: multiple series compared over time, with or without intervention, and surprising results in noncontrolled experience; treatment is neither recommendable nor inadvisable), and 2) on a case-by-case basis for "pain that is related to cancer treatment such as chemotherapy-induced peripheral neuropathy" (level III-C evidence: clinical experiences-based opinions, descriptive studies, clinical observations, or reports of expert committee; treatment is neither recommendable nor inadvisable).

The American Society of Pain and Neuroscience published consensus guidelines on interventional therapies for knee pain in 2022.^90, The guidelines state that "Chronic pain that is refractory to acute treatment is managed by progressing to spinal cord stimulator, dorsal root ganglion stimulator, or botulinum toxin (Botox) injection." They also include the statement that "DRG [Dorsal Root Ganglion Stimulation] is a safe and effective treatment option for chronic post-surgical and focal neuropathic pain of the knee (ie, complex regional pain syndrome [CRPS]); Level I, Grade A, Consensus Strong."

The American Society of Pain and Neuroscience published consensus guidelines on interventional therapies for back pain in 2022. ^91, The guidelines recommendations for spinal cord stimulation are summarized in Table 10.

Table 10. American Society of Pain and Neuroscience Recommendations for Spinal Cord Stimulation for Back Pain

International Association for the Study of Pain

In 2013, the International Association for the Study of Pain published recommendations on the management of neuropathic pain.^92, The Association issued recommendations on spinal cord stimulation, considered weak due to the amount and consistency of the evidence. The recommendations supported the use of spinal cord stimulation for failed back surgery syndrome and CRPS (Table 11). In regards to high-frequency stimulation and dorsal root ganglion stimulation, the publication states that long-term effectiveness of these techniques needs to be determined with further studies.

Table 11. International Association for the Study of Pain Recommendations for Spinal Cord Stimulation

CRPS: complex regional pain syndrome; FBSS: failed back surgery syndrome; RCT: randomized controlled trial.

International Neuromodulation Society

The International Neuromodulation Society (2019) convened a Neuromodulation Appropriateness Consensus Committee (NACC) to develop best practices for the use of dorsal root ganglion stimulation for the treatment of chronic pain syndromes.^93, The NACC was comprised of experts in anesthesiology, neurosurgery, and pain medicine. The NACC performed a systematic literature search through June 2017 and identified 29 publications providing evidence for the consensus recommendations. The evidence was graded using the modified Pain Physician criteria and the United States Preventive Services Task Force criteria. Table 12 summarizes the consensus recommendations on the use of dorsal root ganglion stimulation. Additional recommendations on the dorsal root ganglion stimulation procedure are provided in the publication.

Table 12. NACC Consensus Recommendations for the Use of DRG Stimulation

CRPS: complex regional pain syndrome; DPN: diabetic peripheral neuropathy; DRG: dorsal root ganglion; GRADE: Grading of Recommendations Assessment, Development and Evaluation; NACC: Neuromodulation Appropriateness Consensus Committee; SCS: spinal cord stimulation.

National Institute for Health and Care Excellence

In 2008, NICE issued guidance on spinal cord stimulation for chronic pain of neuropathic or ischemic origin, which was reaffirmed in 2014.^94, The NICE recommended spinal cord stimulation as a treatment option for adults with chronic pain of neuropathic origin (measuring at least 50 mm on a 0 to 100 mm visual analog scale) that continues for at least 6 months despite appropriate conventional medical management, and who have had a successful trial of stimulation as part of an assessment by a specialist team.

In the same guidance, the NICE stated that spinal cord stimulation was not recommended for chronic pain of ischemic origin except in the context of research.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Medicare National Coverage

According to Medicare policy, the implantation of central nervous system stimulators may be covered as therapies for the relief of chronic intractable pain, subject to the following conditions:

• "The implantation of the stimulator is used only as a late resort (if not a last resort) for patients with chronic intractable pain;

• With respect to item a, other treatment modalities (pharmacological, surgical, physical, or psychological therapies) have been tried and did not prove satisfactory, or are judged to be unsuitable or contraindicated for the given patient;

• Patients have undergone careful screening, evaluation, and diagnosis by a multidisciplinary team prior to implantation. (Such screening must include psychological, as well as physical evaluation);

• All the facilities, equipment, and professional and support personnel required for the proper diagnosis, treatment training, and follow-up of the patient (including that required to satisfy item c) must be available; and

• Demonstration of pain relief with a temporarily implanted electrode precedes permanent implantation."^95,

Ongoing and Unpublished Clinical Trials

Some currently ongoing and unpublished trials that might influence this review are listed in Table 13.

Table 13. Summary of Key Trials

NCT: national clinical trial.a Denotes industry-sponsored or cosponsored trial.

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