Coverage Policy Manual - Arkansas Blue Cross and Blue Shield

Coverage Policy Manual
Policy #:	1997208
Category:	Surgery
Initiated:	January 1994
Last Review:	November 2023

Spinal Cord Neurostimulation for Treatment of Intractable Pain

Description:

Spinal cord stimulation delivers low-voltage electrical stimulation to the dorsal columns of the spinal cord to block the sensation of pain; this is achieved through a surgically implanted spinal cord stimulation device, which comes equipped with a radiofrequency receiver. The neurostimulator device is also issued with a standard power source (battery) that can be implanted or worn externally. Other neurostimulators target the dorsal root ganglion.

Spinal cord stimulation has been used in a wide variety of chronic refractory pain conditions, including pain associated with cancer, failed back pain syndromes, arachnoiditis, and complex regional pain syndrome (CPRS; i.e., chronic reflex sympathetic dystrophy). There has also been interest in spinal cord stimulation as a treatment of critical limb ischemia, primarily in patients who are poor candidates for revascularization and in patients with refractory chest pain.

Spinal cord stimulation (also called dorsal column stimulation) involves the use of low-level epidural electrical stimulation of the spinal cord dorsal columns. The neurophysiology of pain relief after spinal cord stimulation is uncertain but may be related to either activation of an inhibitory system or blockage of facilitative circuits.

Spinal cord stimulation (SCS) devices consist of several components: 1) the lead that delivers the 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 that generates the electrical stimulation. The lead may incorporate from 4 to 8 electrodes, with 8 electrodes more commonly used for complex pain patterns, such as bilateral pain or pain extending from the limbs to the trunk. There are two basic types of power source: In one type, the power source (battery) can be surgically implanted or worn externally with an antenna over the received; The other, a radiofrequency receiver is implanted. Totally implantable systems are most commonly used.

The patient’s pain distribution pattern dictates at what level in the spinal cord the stimulation lead is placed. The pain pattern may influence the type of device used; for example, a lead with 8 electrodes may be selected for those with complex pain patterns or bilateral pain. Implantation of the spinal cord stimulator is typically a 2-step process. Initially, the electrode is temporarily implanted in the epidural space, allowing a trial period of stimulation. Once treatment effectiveness is confirmed (defined as at least 50% reduction in pain), the electrodes and radio-receiver/transducer are permanently implanted. Successful spinal cord stimulation may require extensive programming of the neurostimulators to identify the optimal electrode combinations and stimulation channels.

Traditional spinal cord stimulation devices use electrical stimulation with a frequency of 100 to 1000 Hz. In 2016, the U.S. Food and Drug Administration (FDA) approved a clinician programmer application that allows a spinal cord stimulation device to provide stimulation in bursts rather than at a constant rate. Burst stimulation is proposed to relieve pain with fewer paresthesias. The burst stimulation device works in conjunction with standard spinal cord stimulation devices. With the newly approved app, stimulation is provided in five, 500-Hz burst spikes at a rate of 40 Hz, with a pulse width of 1 ms. Other neurostimulators target the dorsal root ganglion.

Regulatory Status

A large number of neurostimulator devices, some used for spinal cord stimulation (SCS), have been approved by the FDA through the premarket approval process under FDA product code: LGW (stimulator, spinal-cord, totally implanted for pain relief), PMP (Dorsal Root Ganglion Stimulator for Pain Relief, and GZB (Stimulator, Spinal-Cord, Implanted [Pain Relief]). In October 2016, the FDA approved BurstDR™ stimulation (St. Jude Medical), a clinician programmer application that provides intermittent "burst" stimulation for patients with certain St. Jude spinal cord stimulation devices.

The following is a list of premarket approval information for Spinal Cord and Dorsal Root Ganglion Stimulator Devices:

Algovita Spinal Cord Stimulation System, manufactured by Nuvectra Corporation, was originally approved in November of 2015 (P130028) for chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain, and leg pain. (Product code LGW)
Axium (1st generation) and Proclaim DRG (2nd generation) Neurostimulator System, manufactured by Abbott Medical, was originally approved in February of 2016 (P150004) for moderate to severe chronic intractable pain of the lower limbs in adult patients with Types I and II CRPS. (Product code PMP)
Cordis Programmable Neural Stimulator Models 900a, manufactured by Cordis Corporation, received original approval in April of 1981 (P800040) for Stimulator, Spinal-Cord, Totally Implanted for Pain Relief. (Product code LGW)
Freedom SCS, manufactured by Stimwave Technologies, received original approval in August of 2016 (K180981) for Chronic, intractable pain of the trunk and/or lower limbs, including unilateral or bilateral pain. (Product code GZB)
Genesis And Eon Family Neurostimulation (Ipg) System; Eterna Spinal Cord Stimulation (SCS) System; Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems, manufactured by St. Jude Medical /Abbott Medical, received original approval in November of 2001 (P010032) for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain, and diabetic peripheral neuropathy of the lower extremities. (Product code LGW; QRB)
Restore, Itrel, Synergy, Intellis, and Vanta Spinal Cord Stimulation Systems, manufactured by Medtronic Neuromodulation, received original approval in November of 1984 (P840001) for chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: Failed Back Syndrome (FBS) or low back syndrome or failed back; Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk; Postlaminectomy pain; Multiple back operations; Unsuccessful disk surgery; Refractory Degenerative Disk Disease (DDD)/herniated disk pain; Peripheral causalgia; Epidural fibrosis; Arachnoiditis or lumbar adhesive arachnoiditis; Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia; Diabetic peripheral neuropathy of the lower extremities. (Product code LGW)
Precision SCS Systems, manufactured by Boston Scientific Corporation, received original approval in April of 2004 (P030017) for chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, Types 1 and 2 CRPS, intractable low back pain and leg pain. (Product code LGW)
Evoke SCS System, manufactured by Saluda Medical Pty Ltd, received original approval in February of 2022 (P19000) for chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain. (Product code LGW)
Senza SCS Systems, manufactured by Nevro Corporation, received original approval in May of 2015 (P130022) for chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain, and leg pain. When programmed to include a frequency of 10 kHz: Chronic intractable pain of the lower limbs, including unilateral or bilateral pain, associated with diabetic neuropathy; non-surgical refractory back pain (intractable back pain without prior surgery and not a candidate for back surgery). (Product code LGW)

In September 2020, the FDA released a letter to healthcare providers reminding them to conduct a trial stimulation period before implanting a spinal cord stimulator as the agency continues to receive reports of serious adverse effects associated with these devices (FDA, 2020). Between July 27, 2016 and July 27, 2020, the FDA received 107,728 medical device reports related to spinal cord simulators intended for pain including 497 associated with patient death, 77,937 with patient injury, and 29,924 with device malfunction. The most frequently reported patient problem codes were inadequate pain relief (28.1%), pain (15.2%), unexpected therapeutic effects (10.9%), infection (7.5%), and discomfort (5.9%). Additionally, the most frequently reported device problem codes were charging problems (11.2%), impedance (10.6%), migration (7.2%), battery problem (6.4%), and premature discharge of battery (4.2%). The FDA made the following recommendations for clinicians to consider:

⦁ Conduct a trial stimulation as described in the device labeling to identify and confirm satisfactory pain relief before permanent implantation.

⦁ Permanent spinal cord stimulation should only be implanted in patients who have undergone and passed a stimulation trial.

⦁ Providers typically perform a stimulation trial on a patient for 3 to 7 days, and success is usually defined by a 50% reduction in pain symptoms. Inform patients about the risks of serious side effects and what to expect during the trial stimulation.

⦁ Before implantation of any spinal cord stimulation, discuss the benefits and risks of the different types of implants and other treatment options, including magnetic resonance imaging (MRI) compatibility of the devices.

⦁ Before implantation, provide patients with the manufacturer's patient labeling and any other education materials for the device that will be implanted.

⦁ Develop an individualized programming, treatment, and follow-up plan for spinal cord stimulation therapy delivery with each patient.

⦁ Provide each patient with the name of the device manufacturer, model, and the unique device identifier of the implant received.

Coding

If the patient has placement of the temporary electrode, but the trial period indicates the patient will not benefit from the placement of the permanent electrode, the physician should bill CPT 63650 for the percutaneous implantation of neurostimulator electrodes, epidural, only.

If the patient has placement of the percutaneous implantation of the neurostimulator electrodes, epidural, for the trial period, and the treatment is effective, then the physician should bill CPT 63650 for the placement of that electrode, and CPT 63685 for the incision and subcutaneous placement of the spinal neurostimulator pulse generator or receiver.

If the placement of the electrode is done by laminectomy, then CPT 63655 is billed for the placement and CPT 63685 for the incision and subcutaneous placement of the spinal neurostimulator pulse generator or receiver.

Policy/
Coverage:

Effective October 2023

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Implantation of spinal neurostimulators meets primary coverage criteria for effectiveness when used in treating the following conditions and performed in accordance with the labeled indications from the FDA for specific devices:

Failed back surgery syndrome with moderate-severe low back and/or radicular pain, OR
Failed standard treatment of moderate-severe pain associated with limb diabetic neuropathy, OR
Refractory Complex regional pain syndrome (CRPS) associated with refractory moderate-severe pain, AND

when all of the following criteria is met:

The implantation of the stimulator is used only as a last resort for patients with one of the above specified conditions; and
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; and
Patients have undergone careful screening, evaluation and diagnosis by a multidisciplinary team prior to implantation. (Such screening must include psychological evaluation dated within 12 months and physical evaluation. Psychological screening is necessary for coverage of trial stimulation and must not be performed by the provider implanting the neurostimulation.); and
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 the requirement above), must be available; and
Demonstration of at least 50% pain relief with a temporarily implanted electrode (screening trial lasting 3-8 days) precedes permanent implantation.

Implantation of spinal neurostimulators for patients with documented metastatic malignant disease, who have a life expectancy of at least six months, meets member benefit certificate primary coverage criteria when above criteria are met, with the exception of psychological testing which would not be required.

Implantation of spinal neurostimulators meets member benefit certificate primary coverage criteria for patients with severe angina when the risks of surgery are deemed too high and standard medical therapy options have been exhausted and above criteria are met, with the exception of psychological testing which would not be required.

Dorsal root ganglion stimulation for treatment of moderate to severe chronic intractable pain of the lower limbs in persons with complex regional pain syndrome (CRPS) types I and II meets member benefit certificate primary coverage criteria when the above coverage criteria are met.

Psychological testing that demonstrates that the patient is not a suitable candidate for the procedure will exclude coverage for that patient.

If the patient has had the neurostimulator in place, and the patient is experiencing satisfactory reduction in pain, and the patient requires revision or removal of the spinal neurostimulator electrodes and/or revision or removal of the implanted spinal neurostimulator pulse generator or receiver, the patient does not have to undergo a trial period or any further psychological testing.

“Burst” neurostimulation is an alternate programming of a standard SCS device. A clinician programmer application is used to configure a standard SCS device to provide stimulation in “bursts” rather than at a constant (‘tonic”) rate.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Implantation of spinal cord neurostimulators for the treatment of chronic intractable back pain without prior spine surgery and/or intractable pain in any circumstance other than those conditions listed above or those conditions not meeting the specified clinical criteria above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.

For members with contracts without primary coverage criteria, implantation of spinal cord neurostimulators for the treatment of chronic intractable back pain without prior spine surgery and/or intractable pain in any circumstance other than those conditions listed above or those conditions not meeting the specified clinical criteria above is considered not medically necessary. Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.

Implantation of spinal cord neurostimulators for the treatment of critical limb ischemia as a technique to forestall amputation does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

For members with contracts without primary coverage criteria, implantation of spinal cord neurostimulators for the treatment of critical limb ischemia as a technique to forestall amputation is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Dorsal root ganglion neurostimulation for any indication not described above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.

For members with contracts without primary coverage criteria dorsal root ganglion for any indication not described above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Psychological testing that demonstrates that the patient is not a suitable candidate for the procedure will exclude coverage for that patient.

The use of spinal cord neurostimulators and/or dorsal root ganglion neurostimulation for any other condition or circumstance other than those described above is not covered.

Effective November 2020 through September 2023

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Implantation of spinal neurostimulators meets primary coverage criteria for effectiveness for control of severe and chronic pain of the trunk or limbs that is refractory to all other pain therapies, when all of the following criteria is met:

The implantation of the stimulator is used only as a last resort for patients with chronic intractable pain; and
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; and
Patients have undergone careful screening, evaluation and diagnosis by a multidisciplinary team prior to implantation. (Such screening must include psychological evaluation dated within 12 months and physical evaluation. Psychological screening is necessary for coverage of trial stimulation and must not be performed by the provider implanting the neurostimulation.); and
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 the requirement above), must be available; and
Demonstration of at least 50% pain relief with a temporarily implanted electrode (screening trial lasting 3-8 days) precedes permanent implantation.

Psychological testing that demonstrates that the patient is not a suitable candidate for the procedure will exclude coverage for that patient.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Implantation of spinal cord neurostimulators for the treatment of intractable pain in any circumstance not noted above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.

For members with contracts without primary coverage criteria, implantation of spinal cord neurostimulators for the treatment of intractable pain in any circumstance not noted above is considered not medically necessary. Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.

Psychological testing that demonstrates that the patient is not a suitable candidate for the procedure will exclude coverage for that patient.

Effective Prior to November 2020

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

The implantation of the stimulator is used only as a last resort for patients with chronic intractable pain;
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 evaluation dated within 12 months and physical evaluation. Psychological screening is necessary for coverage of trial stimulation and must not be performed by the provider implanting the neurostimulation.);
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 the requirement above), must be available; and
Demonstration of at least 50% pain relief with a temporarily implanted electrode (screening trial lasting 3-8 days) precedes permanent implantation;

Psychological testing that demonstrates that the patient is not a suitable candidate for the procedure will exclude coverage for that patient.

Implantation of spinal neurostimulators for patients with documented metastatic malignant disease, who have a life expectancy of at least six months, meets member benefit certificate primary coverage criteria when above criteria are met, with the exception of psychological testing which would not be required.

Implantation of spinal neurostimulators meets member benefit certificate primary coverage criteria for patients with severe angina when the risks of surgery are deemed too high and standard medical therapy options have been exhausted and above criteria are met, with the exception of psychological testing which would not be required.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Psychological testing that demonstrates that the patient is not a suitable candidate for the procedure will exclude coverage for that patient.

Dorsal root ganglion neurostimulation does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.

For members with contracts without primary coverage criteria Wireless injectable dorsal root ganglion is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Effective Prior to September 2020

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

The implantation of the stimulator is used only as a last resort for patients with chronic intractable pain;
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. Psychological screening is necessary for coverage of trial stimulation and must not be performed by the provider implanting the neurostimulation.);
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 the requirement above), must be available; and
Demonstration of at least 50% pain relief with a temporarily implanted electrode (screening trial lasting 3-8 days) precedes permanent implantation;

Psychological testing that demonstrates that the patient is not a suitable candidate for the procedure will exclude coverage for that patient.

Implantation of spinal neurostimulators for patients with documented metastatic malignant disease, who have a life expectancy of at least six months, meets member benefit certificate primary coverage criteria when above criteria are met, with the exception of psychological testing which would not be required.

Implantation of spinal neurostimulators meets member benefit certificate primary coverage criteria for patients with severe angina when the risks of surgery are deemed too high and standard medical therapy options have been exhausted and above criteria are met, with the exception of psychological testing which would not be required.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Psychological testing that demonstrates that the patient is not a suitable candidate for the procedure will exclude coverage for that patient.

Dorsal root ganglion neurostimulation does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.

Due to the length of the policy, criteria for dates of service prior to June 2019, is not online. If you would like a hardcopy print, please email: codespecificinquiry@arkbluecross.com

Rationale:

This policy was originally created in 1994 and has been updated regularly with searches of the MEDLINE and PubMed database. The most recent literature search was through February 13, 2023. Following is a summary of the key literature to date:

Standard Spinal Cord Stimulation for Refractory Chronic Trunk or Limb Pain

Standard Spinal Cord Stimulation

Systematic Reviews

Numerous systematic reviews have been conducted assessing the effectiveness of spinal cord stimulation for a variety of chronic pain conditions, including CRPS (Visnjevac, 2017; O’Connell, 2013), spinal pain (Grider, 2016), failed back surgery syndrome (Head, 2019), painful diabetic neuropathy (Duarte, 2021; Henson, 2021; Raghu, 2021; Strand, 2022; Hoelzer, 2022), ,and mixed chronic pain conditions (O’Connell, 2021). However, these reviews only included 1 to 3 RCTs each of standard spinal cord stimulation; evidence from the relevant individual RCTs is discussed in the next section.

D'Souza et al conducted a systematic review of literature for treatment options for painful diabetic neuropathy (D’Souza, 2022). In addition to intensive glycemic control with insulin and pharmacologic therapy, the authors noted that there is level 1 evidence for dorsal column SCS for treating painful diabetic neuropathy.

In 2022, D'Souza et al conducted a systematic review of neuromodulation treatment for painful diabetic neuropathy unresponsive to conventional medical management (D’Souza, 2022). They found level 1 evidence supporting the use of 10-kHz and tonic dorsal column SCS. Other neuromodulation modalities, such as burst SCS, DRG, and peripheral nerve stimulation, are still limited with evidence levels of II-3, III, and II-3, respectively. Individuals undergoing 10-kHz SCS for treating painful diabetic neuropathy had improvements in neurological physical examination, sensory testing, and/or reflex testing (level of evidence: I)

Randomized Controlled Trials

Six RCTs (in 10 publications) (N=528 patients; range, 36 to 218 patients) have evaluated standard spinal cord stimulation for various chronic pain conditions (North, 2005; Kumar, 2007; Kumar, 2008; Kemler, 2000; Kemler, 2004; Kemler, 2008; Slangen, 2014; de Vos, 2014; Duarte, 2016; Rigoard, 2019). Patient populations had failed back surgery syndrome, diabetic neuropathy, and CRPS. The comparators were primarily conventional medical management, although 1 RCT compared spinal cord stimulation with reoperation for failed back surgery syndrome, and another compared spinal cord stimulation with physical therapy. All RCTs reported results at 6 months. The most common primary outcome reported was a responder outcome of 50% reduction in pain; Kemler et al reported the absolute change in visual analog scale (VAS) pain score (Kemler, 2000). Consistent with clinical practice, RCTs included a trial period of spinal cord stimulation, usually a few days to a week. Patients not reporting improvement in pain during the trial period did not continue receiving spinal cord stimulation during the remainder of follow-up. In most RCTs, these patients were included in the intention-to-treat analyses either as failures to respond or using imputation techniques. All RCTs with the responder primary outcomes reported clinically and statistically significant differences in the primary outcomes at 6 months, favoring spinal cord stimulation (spinal cord stimulation range, 39% to 63% vs. comparator range, 5% to 12%). Outcomes measuring the reduction in analgesic use were consistently numerically larger for spinal cord stimulation, but not statistically significant in all studies. Four of the 5 studies did not report differences in functional, quality of life, or utility outcomes. Device-related complications ranged from 17% to 32%, with the most common being infection and discomfort or pain due to positioning or migration of electrodes or leads. However, 2 studies reported dural puncture headaches and Slangen et al (2014) reported a dural puncture headache ending in death (Slangen, 2014). Two studies reported longer-term results for both treatment groups. In each, results continued to favor spinal cord stimulation at 2 years, but for 1 with 5 years of follow-up, results were not statistically significant at 5 years.

Uncontrolled studies

Because RCT data are available for spinal cord stimulation, uncontrolled studies are discussed if they add information not available from the RCTs (e.g., longer follow-up including adverse events, data on an important subgroup, etc). Rauck et al reported an analysis of long-term (>2 years) complications and explantation rates from the RELIEF registry (Rauck, 2023). RELIEF is a global, multicenter, prospective registry including individuals with chronic pain who are eligible to receive neurostimulation therapy to treat pain. Adults who enrolled between January 2013 and November 2021 and were permanently implanted with a commercially available spinal cord stimulation (SCS) system were included in analysis (N=1289). The mean (standard deviation) age at enrollment was 58 (14) years and 57% were women. Participants reported duration of chronic pain of 12 (11) years. Study follow-up visits occurred at 6, 12, 24 and 36 months. Ninety-eight participants (8%) required an explant (annualized explant rate of 3.5%); 32 of the explants were due to inadequate pain relief. High lead impedance (5%) and lead migration/movement (5%) were the most common complications. Thirty-two serious adverse events (SAEs) related to device and 51 SAEs related to procedure were reported; device-related implant site infection (11 events) and procedure-related implant site infection (17 events) were the most common SAEs. There were 5 SAEs related to implant site pain, 3 device- or procedure-related neurological deficits, and 2 life-threatening local infections (implant site infection, meningitis). No deaths were reported.

Mekhail et al retrospectively reviewed 707 patients treated with SCS between 2000 and 2005 (Mekhail, 2011). Patients' diagnoses included CRPS (n=345 [49%]), failed back surgery syndrome (n=235 [33%]), peripheral vascular disease (n=20 [3%]), visceral pain in the chest, abdomen, or pelvis (n=37 [5%]), and peripheral neuropathy (n=70 [10%]). Mean follow-up across studies was 3 years (range, 3 months to 7 years). A total of 527 (36%) of the 707 patients eventually underwent permanent implantation of an SCS device. Hardware-related complications included lead migration in 119 (23%) of 527 patients, lead connection failure in 50 (9.5%) patients, and lead break in 33 (6%) patients. Revisions or replacements corrected the hardware problems. The authors noted that rates of hardware failure have decreased due to advances in SCS technology. Documented infection occurred in 32 (6%) of 527 patients with implants; there were 22 cases of deep infection, and 18 patients had abscesses. There was no significant difference in the infection rate by diagnosis. All cases of infection were managed by device removal.

Standard Spinal Cord Stimulation With Burst

Systematic Reviews

Hou et al published a systematic review of burst spinal cord stimulation for the treatment of chronic back and limb pain (Hou, 2016). Reviewers identified 5 studies of burst spinal cord stimulation in patients with intractable chronic pain of more than 3 months in duration who had failed conservative treatment. Three studies, with sample sizes of 12, 15, and 20, respectively, used randomized crossover designs to compare burst stimulation with tonic stimulation; 2 studies also included a placebo stimulation intervention. Also, there were 2 case series with sample sizes of 22 and 48 patients, respectively. Data were collected after 1 to 2 weeks of treatment. Study findings were not pooled. Using the American Academy of Neurology criteria, reviewers originally rated 4 studies as class III and 1 study as class IV. However, given the small sample sizes and short duration of follow-up of the 4 studies, all were downgraded to class IV. Overall, the level of confidence in the evidence on burst spinal cord stimulation for treating chronic pain without paresthesia was rated as "very low."

Randomized Controlled Trials

Six crossover RCTs with a total of 199 patients (range, 12 to 100 patients) were identified, 5 of which were conducted in Europe and the other in the United States. The trials by De Ridder et al enrolled patients with neuropathic pain, the trial by Schu et al enrolled patients with failed back surgery syndrome, Kriek et al enrolled patients with CRPS, Deer et al (2018) enrolled patients with chronic intractable pain of the trunk and/or limbs, and Eldabe et al enrolled patients with chronic back and leg pain (De Ridder, 2010; De Ridder, 2013; Schu, 2014; Kriek, 2017; Deer, 2018; Eldabe, 2020; Eldabe, 2021). All trials compared burst stimulation with spinal cord stimulation. Schu et al, De Ridder et al, Kriek et al, and Eldabe et al also compared burst with a sham stimulation group. Schu et al and Eldabe et al included patients receiving standard spinal cord stimulation while De Ridder et al and Deer et al included patients not previously treated with spinal cord stimulation. It was not clear in Kriek et al whether patients had previously received spinal cord stimulation. Results were reported for 1 week of stimulation in Schu et al and De Ridder et al, after 2, 1-hour sessions of spinal cord stimulation or burst in De Ridder et al, after 2 weeks of stimulation in Kriek et al and Eldabe et al, and after 12 weeks of stimulation in Deer et al. All trials reported reductions in absolute pain scores (numeric rating scale or VAS). Schu et al and De Ridder et al did not account for their crossover designs in data analyses, so analyses and p values are incorrect. De Ridder et al did not provide between-group comparisons. Kriek et al reported only per-protocol analyses. Four trials reported numerically larger reductions in pain scores with burst than with spinal cord stimulation; Kriek et al did not report less pain for spinal cord stimulation at any frequency compared with burst. In Kriek et al, 48% of patients preferred the 40-Hz spinal cord stimulation compared with 21%, 14%, 14%, and 3% that preferred 500-Hz spinal cord stimulation, 1200-Hz spinal cord stimulation, and burst and sham, respectively. In Eldabe et al, the mean reduction in pain with 500-Hz spinal cord stimulation was significantly greater than that seen with sham (25%; 95% confidence interval [CI], 8% to 38%; p=.008) or burst (28%; 95% CI, 13% to 41%; p=.002), with no significant differences in pain visual analog score for burst versus sham (p=.59). The interpretation of 5 of the trials was limited by small sample sizes, short follow-up, and incorrect, inadequate, or missing statistical analyses.

The largest trial of burst stimulation is the Success Using Neuromodulation with BURST (SUNBURST) trial reported by Deer et al (Deer, 2018). SUNBURST was a 12-week, multicenter, randomized, unblinded, crossover, noninferiority trial evaluating traditional spinal cord stimulation or burst stimulation in 100 patients with chronic pain of the trunk and/or limbs enrolled between January 2014 and May 2015. Patients were spinal cord stimulation naive and completed a trial stimulation period. Forty-five patients were randomized to spinal cord stimulation then burst, and the remaining 55 were randomized to burst then spinal cord stimulation. At the end of the second crossover period, patients were allowed to choose the stimulation mode they preferred and were followed for 1 year. Patients' mean age was 59 years, 60% of patients were women, and 42% of patients had failed back surgery syndrome while 37% had radiculopathies. The primary outcome was the difference in mean VAS score, with a noninferiority margin of 7.5 mm. Analyses were intention-to-treat with missing values imputed using the hot deck method. Also, outcomes were imputed for patients who underwent invasive procedures for pain or had medication increases. The estimated difference in the overall VAS score between burst and spinal cord stimulation was -5.1 mm (95% upper CI, -1.14 mm), demonstrating noninferiority (p<.001) and superiority (p<.017). The proportion of patients with a decrease in VAS score of 30% or more was 60% (60/100) during burst stimulation and 51% (51/100) during spinal cord stimulation. The proportion of patients whose global impression was minimally improved, moderately improved, or very much improved was approximately 74% in both groups. There were no significant differences in Beck Depression Inventory scores (p=.230). Patients were asked to rate their satisfaction levels for both periods: 78% were satisfied with both spinal cord stimulation and burst, 4% were dissatisfied with both spinal cord stimulation and burst, 7% were satisfied with spinal cord stimulation but not burst, and 10% were satisfied with burst but not spinal cord stimulation. However, more patients (70.8%) reported preferring burst stimulation over spinal cord stimulation after the 24-week crossover period. After 1 year of follow-up, 60 (68%) of the 88 patients completing follow-up reported preferring burst stimulation. The authors reported that the programming parameters were not standardized at the beginning of the study but a more standardized approach with lower amplitudes was implemented as the trial was ongoing. Trial limitations included the crossover design, which limits comparison of pain over longer periods of time, lack of blinding, and variable burst programming parameters.

High-Frequency Spinal Cord Stimulation for Refractory Chronic Trunk or Limb Pain

Systematic Reviews

Bicket et al published a systematic review of controlled trials on high-frequency spinal cord stimulation (Bicket, 2016). Reviewers searched for RCTs and controlled nonrandomized studies of adults with pain for at least 3 months who were treated with high-frequency spinal cord stimulation (i.e., ≥1000 Hz) and prospectively assessed pain outcomes. Eight studies met these inclusion criteria: 2 RCTs (detailed below) and 6 controlled nonrandomized studies. Both RCTs and 5 of 6 controlled studies addressed low back pain; the remaining controlled study addressed migraine. Reviewers used the Cochrane criteria to rate bias in the RCTs. One trial (Perruchoud et al,) was not rated as having a high-risk of bias in any domain, and the other (Kapural et al,) was rated as having a high-risk of bias in the domain of performance and detection bias because it was unblinded (Perruchoud, 2013; Kapural, 2015). Studies were reviewed qualitatively (i.e., study findings were not pooled).

Randomized Controlled Trials

Six RCTs identified addressed high-frequency spinal cord stimulation: Perruchoud et al compared high-frequency spinal cord stimulation (5000 Hz) with sham-control in a crossover design (N=40), Petersen et al compared high-frequency spinal cord stimulation plus medical management with medical management alone, while Kapural et al (N=198), Bolash et al N=99), and De Andres et al (N=60) compared high-frequency spinal cord stimulation (10000 Hz) with standard spinal cord stimulation (Perruchoud, 2013; Petersen, 2021; Kapural, 2015; Bolash, 2019; De Andres, 2017).

Petersen et al randomized 216 participants with painful diabetic neuropathy (baseline lower limb VAS ≥5 cm on a 10 cm scale) refractory to prior pharmacological treatment to high-frequency spinal cord stimulation plus conventional medical management (n=113) versus conventional medical management alone (n=103) (Petersen, 2021). All participants were randomized to high-frequency spinal cord stimulation and underwent a trial stimulation period. Participants were eligible for permanent implantation of the stimulation device if at least 50% pain relief was achieved during the trial period. Participants remained in their randomized groups for 6 months, after which time they were eligible to crossover to the other group in the event of inadequate pain relief. The addition of high-frequency spinal cord stimulation to conventional medical management was associated with significantly improved pain scores at 6-month follow-up. Results from 12-month follow-up were consistent in finding a significant pain benefit for high-frequency spinal cord stimulation plus medical management versus medical management alone (Petersen, 2022). Limitations of the study include a lack of blinding for participants and investigators.

Kapural et al included 198 patients with chronic leg and back pain who had received conventional medical management but not spinal cord stimulation (Kapural, 2015; Kapural, 2016). Kapural et al included an active, but unblinded, comparator (standard spinal cord stimulation) and included a trial spinal cord stimulation period up to 2 weeks post-randomization after which only responders continued with stimulation. Outcomes were reported after 3, 12, and 24 months of treatment. The response in the standard spinal cord stimulation group was similar to previous trials of spinal cord stimulation, between 45% and 50% for back pain and 50% to 55% for leg pain at 3, 12, and 24 months. The response was clinically and statistically significantly higher with high-frequency spinal cord stimulation than with spinal cord stimulation for both back (range, »75% to 85%) and leg pain (range, »70% to 85%) at all time points. A limitation of the Kapural et al trial was that nonresponders during the stimulation trial period were excluded from statistical analysis. Instead, assuming patients who were not implanted were nonresponders corresponds to response rates at 3 months of about 75% in high-frequency spinal cord stimulation and 37% in spinal cord stimulation for back pain and 74% and 46% for leg pain (calculated, data not shown).

Retrospective Review

A multi-center, retrospective review was conducted on 89 individuals 18 years of age and older with diabetic neuropathy who had a high-frequency (10 kHz) spinal cord stimulation (SCS) device implanted (Chen, 2022). 79.5% of patients achieved at least 50% pain relief compared to baseline. Successful response to 10 kHz SCS was defined as at least 50% patient-reported pain relief.

Case Series

Because RCT data are available for HFSCS, case series are discussed if they add information not available from the RCTs (e.g., longer follow-up, data on an important subgroup). Al-Kaisy et al reported 36-month results for 20 patients with chronic low back pain without previous spinal surgery who were treated with 10-kHz HFSCS (Al-Kaisy, 2018). Seventeen patients completed the 36-month follow-up; 1 patient died (unrelated to study treatment), 1 patient was explanted due to lack of efficacy, and 1 patient had new leg pain. Among patients analyzed, the mean VAS score for pain intensity decreased from 79 to 10 mm (p<.001) and the mean Oswestry Disability Index score decreased from 53 to 20 (p<.001). At baseline, 90% of the patients were using opioids compared with 12% at 36 months.

Dorsal Root Ganglion Neurostimulation for Refractory Chronic Trunk or Limb Pain

Dorsal Root Ganglion Implanted Device

Systematic Reviews

Several systematic reviews of dorsal root ganglion devices have been published: Vuka et al, Deer et al, Moman et al, and D'Souza et al (Vuka, 2019; Deer, 2020; Moman, 2022; D’Souza, 2022). 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 (FDA, 2016; Deer, 2017). As reported by Deer et al, 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.

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%. 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.

Mekhail et al 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 (Mekhail, 2019). 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.

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 (e.g., longer follow-up including adverse events, data on an important subgroup, etc). Deer et al 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 (Deer, 2020). 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 (Sivanesan, 2019). 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 (Weiner, 2016). 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.

Spinal Cord Stimulation for Critical Limb Ischemia

An updated Cochrane review by Ubbink and Vermeulen assessed the use of spinal cord stimulation in peripheral vascular diseases (Ubbink, 2013). 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 published a meta-analysis of RCTs that used spinal cord stimulation to treat patients with critical limb ischemia (Klomp, 2009). 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 (Klomp, 1999). 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 for patients with critical limb ischemia included spinal cord stimulation as 1 of the treatments. The review identified 5 RCTs for inclusion (Abu Dabrh, 2015). 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.

Spinal Cord Stimulation for Selected Other Medical Conditions

Refractory Angina Pectoris

Systematic Reviews

Pan et al identified 12 RCTs that evaluated spinal cord stimulation versus control in patients with refractory angina pectoris (Pan, 2017). 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 (Tsigaridas, 2015). 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 and Lanza et al (Zipes, 2012; Lanza, 2011).

Zipes et al published an industry-sponsored, single-blind, multicenter trial with sites in the United States and Canada (Zipes, 2012). 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 (e.g., 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 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) (Lanza, 2011). 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

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 (Torre-Amione, 2014). 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 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 (Zipes, 2016). 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.

Cancer-Related Pain

Systematic Reviews

A Cochrane review by Lihua et al assessed spinal cord stimulation for the treatment of cancer-related pain in adults (Lihua, 2013). 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 updated this review, finding no new studies meeting inclusion criteria identified (Peng, 2015). They concluded: "Current evidence is insufficient to establish the role of spinal cord stimulation in treating refractory cancer-related pain."

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 (Blonde, 2022). 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 (Manchikanti, 2013). 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 (Aman, 2021). 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 (Hunter, 2022). 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 (i.e., 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 (Sayed, 2022). The guidelines make the following recommendations for spinal cord stimulation:

American Society of Pain and Neuroscience Recommendations for Spinal Cord Stimulation for Back Pain:

Recommendation – Following lumbar surgery

Grade A
Level of Evidence I-A
Level of Certainty of Net Benefit - Strong

Recommendation – Treatment of Non-Surgical Low Back Pain

Grade B
Level of Evidence I-C
Level of Certainty of Net Benefit - Moderate

Recommendation – Treatment of Lumbar Spinal Stenosis

Grade C
Level of Evidence I-C
Level of Certainty of Net Benefit - Moderate

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 (Dworkin, 2013). 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. 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.

International Association for the Study of Pain Recommendations for Spinal Cord Stimulation:

Complex Regional Pain Syndrome 1 - Long-term benefits demonstrated though benefits may diminish over time (in RCT, the reoperation rate was 42%). May be considered for patients not responding to non-invasive treatments and sympathetic nerve blocks or for whom nerve blocks would be inappropriate. Quality of Evidence: Moderate; Strength of Recommendation: Weak
Complex Regional Pain Syndrome 2 – Limited Evidence. Quality of Evidence: Low; Strength of Recommendation: Inconclusive
Failed Back Surgery Syndrome with Radiculopathy - Based on 2 RCTs, appears to be better than reoperation and conventional medical management, However, response rates were relatively low and complication rates were relatively high. Quality of Evidence: Moderate; Strength of Recommendation: Weak

International Neuromodulation Society

The International Neuromodulation Society 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 (Deer, 2019). 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. Below is a summary of 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.

NACC Consensus Recommendations for the Use of DRG Stimulation:

DRG stimulation should be considered primarily for patients with focal neuropathic pain syndromes with identified pathology - Level I; Grade A ; Consensus: Strong
DRG stimulation is recommended for CRPS type I or type II of the lower extremity - Level I; Grade A; Consensus: Strong
DRG stimulation for CRPS type I or type II of the upper extremity requires more study - Level II-2; Grade A; Consensus: Strong
DRG stimulation for DPN may be effective based on limited data. Since there is good evidence for SCS, the use of DRG must be justified. - Level III; Grade C; Consensus: Strong
Evidence for DRG stimulation for non-diabetic peripheral neuropathy is limited; use should be determined on a case-by-case basis. - Level III; Grade B; Consensus: Moderate
Evidence for DRG stimulation for chronic postoperative surgical pain is limited; use should be determined on a case-by-case basis. - Level III; Grade C; Consensus: Moderate
DRG stimulation for pelvic pain should be used under strict criteria depending on mechanism of injury and visceral/somatic designation. Psychologic comorbidity is a contraindication. - Level III; Grade I; Consensus: Moderate
DRG stimulation for groin pain is recommended. - Level II-2; Grade B; Consensus: Strong
DRG stimulation is superior to standard SCS for unilateral focal pain from CRPS type I or type II of the lower extremity - Level I; Grade A; Consensus: Strong
No evidence for DRG stimulation over SCS for other indications

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 (NICE, 2008). 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.

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 (CMS, 1995):

"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."

Ongoing and Unpublished Trials

Some currently ongoing and unpublished trials that might influence this review are listed below:

Ongoing

NCT03312010 A European, Prospective, Multi-Center, Double-Blind, Randomized, Controlled, Clinical Trial Investigating the Effects of High-Frequency Wireless Spinal Cord Stimulation (SCS) Over Exiting Nerve Roots in the Treatment of Chronic Back Pain has a planned enrollment of 38 and a planned completion date of December 2022
NCT03957395 Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes: a Double-blind, Randomised, Cross-over, Placebo-Controlled Trial has a planned enrollment of 50 and a planned completion date of December 2022
NCT03681262 Comparing Long-Term Effectiveness of High Frequency and Burst Spinal Cord Stimulation has a planned enrollment of 160 and a planned completion date of Dec 2026

Unpublished

NCT02514590a Multi-center, Prospective, Clinical Trial of Wireless Spinal Cord Stimulation in the Treatment of Chronic Pain has a planned enrollment of 49 and a planned completion date of July 2019
NCT03318172 High-Density Spinal Cord Stimulation for the Treatment of Chronic Intractable Pain Patients: A Prospective Multicenter Randomized Controlled, Double-blind, Crossover Exploratory Study With 6-m Open Follow-up has a planned enrollment of 100 and a planned completion date of July 2019
NCT02093793a mA Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Precision Spinal Cord Stimulator System Adapted for High-Rate Spinal Cord Stimulation has a planned enrollment of 383 and a planned completion date of August 2019
NCT02902796 Comparison of 1000 Hertz (Hz), Burst, and Standard Spinal Cord Stimulation in Chronic Pain Relief has a planned enrollment of 20 and a planned completion date of December 2019

NCT03014583 Prospective, Randomized Study Comparing Conventional, Burst and High Frequency (HF) Spinal Cord Stimulation (SCS) in Refractory Failed Back Surgery Syndrome (FBSS) Patients After a 32-contact Surgical Lead Implantation has a planned enrollment of 28 and a planned completion date of September 2021.

2023 Update

Annual policy review completed with a literature search using the MEDLINE database through October 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.

The study by Zuidema aimed to evaluate the long-term effects of spinal cord stimulation (SCS) in patients with painful diabetic polyneuropathy(PDPN) (Zuidema, 2022). This prospective cohort study was the eight-to-ten-year follow-up of a previously performed pilot and randomized controlled trial on the effects of SCS in PDPN, initiated by the multidisciplinary pain center of Maastricht University Medical Center. The study population consisted of a subgroup of patients who still used SCS treatment eight years or more after implantation (n = 19). for more than 50% of the patients there was a reduction in VAS pain score in the daytime. There was no improvement in health utility or quality of life vs baseline.

The study by Bolash evaluated the high-frequency spinal cord stimulation (10,000 Hz) with standard spinal cord stimulation for the treatment of failed back surgery syndrome (FBSS) (Bolash, 2019). Ninety-nine subjects were evaluated. Seventy-two subjects completed the six-month follow-up after an initial 30-day trial period. Results include 50% or more reduction VAS for back pain (Int 92%, Ctrl 82%, p Noninferiority <.001) and remission VAS for back pain of 25 mm or less (Int 84%, Ctrl 47%).

Kapural et al enrolled 159 individuals with nonsurgical refractory back pain, defined as patients with chronic back pain refractory to conventional medical management (CMM) who have no history of spine surgery and are not acceptable candidates for spine surgery, who were randomized in a 1:1 ratio to CMM with and without high-frequency (10-kHz) SCS (HFSCS) from September 2018 to January 2020 (Kapural, 2022). Conventional medical management was generally consistent with clinical guidelines. Participants randomized to HFSCS received trial stimulation of up to 14 days. Follow-up visits were completed at 1, 3, 6, 9, and 12 months. The median age was between 53 and 58 years and median time from diagnosis was 8 years. Eighty-one percent of CMM + HFSCS participants versus 1% of CMM participants were responders (primary outcome, ≥ 50% pain relief) at 3 months (p<.001) and 80% versus 3% were responders at 6 months (p<.001). The study was not blinded and nonresponders during the stimulation period were excluded from further analysis.

CPT/HCPCS:

0784T	Insertion or replacement of percutaneous electrode array, spinal, with integrated neurostimulator, including imaging guidance, when performed
0785T	Revision or removal of neurostimulator electrode array, spinal, with integrated neurostimulator
0789T	Electronic analysis with complex programming of implanted integrated neurostimulation system (eg, electrode array and receiver), including contact group(s), amplitude, pulse width, frequency (Hz), on/off cycling, burst, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters, when performed by physician or other qualified health care professional, spinal cord or sacral nerve, 4 or more parameters
63650	Percutaneous implantation of neurostimulator electrode array, epidural
63655	Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural
63685	Insertion or replacement of spinal neurostimulator pulse generator or receiver, direct or inductive coupling
63688	Revision or removal of implanted spinal neurostimulator pulse generator or receiver
95970	Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with brain, cranial nerve, spinal cord, peripheral nerve, or sacral nerve, neurostimulator pulse generator/transmitter, without programming
95971	Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with simple spinal cord or peripheral nerve (eg, sacral nerve) neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional
95972	Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with complex spinal cord or peripheral nerve (eg, sacral nerve) neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional
L8678	Electrical stimulator supplies (external) for use with implantable neurostimulator, per month
L8679	Implantable neurostimulator, pulse generator, any type
L8680	Implantable neurostimulator electrode, each
L8682	Implantable neurostimulator radiofrequency receiver
L8685	Implantable neurostimulator pulse generator, single array, rechargeable, includes extension
L8686	Implantable neurostimulator pulse generator, single array, non rechargeable, includes extension
L8687	Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
L8688	Implantable neurostimulator pulse generator, dual array, non rechargeable, includes extension
L8695	External recharging system for battery (external) for use with implantable neurostimulator, replacement only

References:

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