Spinal Geometry and Paresthesia Coverage in Spinal Cord Stimulation

Objective . To test the following hypotheses, based on computer modeling studies of spinal cord stimulation, by the analysis of data from chronic pain patients: I. the probability-of-paresthesia in a dermatome is highest when the cathode is placed at the corresponding segmental level; II. variation of the rostrocaudal position of the cathode in the lower cervical/high thoracic region results in less variation of the probability-of-paresthesia in a dermatome than stimulation in more caudal regions; III. when stimulating in the midthoracic region, the probability-of-paresthesia in a dermatome is low in comparison to other regions when the cathode is not at the corresponding segmental level. Method . The probability-of-paresthesia in 16 body segments as a function of the rostrocaudal position of the cathode was analyzed from the paresthesia coverage with 3,897 bipolar and unipolar combinations from 106 chronic pain patients. Results . The distributions of the probability-of-paresthesia in the upper and lower limb are in accordance with the hypotheses, but different distributions were found in all trunk areas. Conclusion . The success to be expected from spinal cord stimulation in chronic pain management is inversely related to the thickness of the dorsal cerebrospinal fluid layer at the cathode level. Therefore, preoperative measurement from transverse images can be helpful as a predictor for success.     

Quantitative Sensory Testing of Spinal Cord and Dorsal Root Ganglion Stimulation in Chronic Pain Patients

Background/Objectives: The physiological mechanisms underlying the pain-modulatory effects of clinical neurostimulation therapies, such as spinal cord stimulation (SCS) and dorsal root ganglion stimulation (DRGS), are only partially understood. In this pilot prospective study, we used patient-reported outcomes (PROs) and quantitative sensory testing (QST) to investigate the physiological effects and possible mechanisms of action of SCS and DRGS therapies.Materials and Methods: We tested 16 chronic pain patients selected for SCS and DRGS therapy, before and after treatment. PROs included pain intensity, pain-related symptoms (e.g., pain interference, pain coping, sleep interference) and disability, and general health status. QST included assessments of vibration detection theshold (VDT), pressure pain threshold (PPT) and tolerance (PPToL), temporal summation (TS), and conditioned pain modulation (CPM), at the most painful site.Results: Following treatment, all participants reported significant improvements in PROs (e.g., reduced pain intensity [p < 0.001], pain-related functional impairment [or pain interference] and disability [p = 0.001 for both]; better pain coping [p = 0.03], sleep [p = 0.002]), and overall health [p = 0.005]). QST showed a significant treatment-induced increase in PPT (p = 0.002) and PPToL (p = 0.011), and a significant reduction in TS (p = 0.033) at the most painful site, but showed no effects on VDT and CPM. We detected possible associations between a few QST measures and a few PROs. Notably, higher TS was associated with increased pain interference scores at pre-treatment (r = 0.772, p = 0.009), and a reduction in TS was associated with the reduction in pain interference (r = 0.669, p = 0.034) and pain disability (r = 0.690, p = 0.027) scores with treatment.Conclusions: Our preliminary findings suggest significant clinical and therapeutic benefits associated with SCS and DRGS therapies, and the possible ability of these therapies to modulate pain processing within the central nervous system. Replication of our pilot findings in future, larger studies is necessary to characterize the physiological mechanisms of SCS and DRGS therapies.     

Dorsal Root Ganglion Stimulation for the Treatment of Non-Complex Regional Pain Syndrome Related Chronic Pain Syndromes: A Systematic Review

Background: While the majority of indications and approvals for dorsal root ganglion stimulation (DRGS) are for the refractory management of complex regional pain syndrome (CRPS), emerging evidence has suggested that DRGS may be favorably used for a plethora of other chronic pain phenomena. Consequently, we aimed to characterize the use and efficacy of DRGS for these non–CRPS-related chronic pain syndromes.Materials and Methods: A systematic review of clinical studies demonstrating the use of DRGS for non–CRPS-related chronic pain syndromes. The literature search was performed using PubMed, Cochrane Library, and CINAHL plus across August and September 2020.Results: A total of 28 reports comprising 354 total patients were included in the analysis. Of the chronic pain syndromes presented, axial low back pain, chronic pelvic and groin pain, other peripheral neuropathies, and studies with multiple concomitant pain syndromes, a majority demonstrated >50% mean pain reduction at the time of last follow-up following DRGS. Physical function, quality of life (QOL), and lesser pain medication usage also were repeatedly reported to be significantly improved.Conclusions: DRGS continues to lack supportive evidence from well designed, high level studies and recommendations from consensus committee experts. However, we present repeated and consistent evidence from lower level studies showing success with the use of DRGS for various non-CRPS chronic pain syndromes in reducing pain along with increasing function and QOL from one week to three years. Due to such low-level, high bias evidence, we strongly encourage the continuation of high-level studies in order to provide a stronger foundation for the use of DRGS in non-CRPS chronic pain patients. However, it may be reasonable and appropriate to evaluate patients for DRGS candidacy on a case-by-case basis particularly if they manifest focal pain syndromes refractory to noninterventional measures and may not be ideal candidates for other forms of neuromodulation.     

Dorsal Root Ganglion Stimulation for Chronic Groin Pain: A Review

IntroductionChronic neuropathic groin pain develops in a significant number of postsurgical patients; however, multiple etiologies have been identified, and this makes it a challenging condition to treat. While treatment often involves a multimodal approach, advancements in neuromodulation technology, particularly dorsal root ganglion (DRG) stimulation, have benefited patients plagued by chronic pain refractory to standard treatment modalities. Our goal was to provide a definitive source of information for interventional pain physicians regarding groin pain and the use of DRG stimulation for its treatment.Materials and MethodsIn this narrative review, we provide an overview of groin pain and discuss potential pain generators. We also outline appropriate treatment options with particular interest on DRG stimulation. Lastly, we provide a narrative review of the published literature regarding DRG stimulation for chronic groin pain from a variety of etiologies.ConclusionDRG stimulation has emerged as an alternative neuromodulatory technique for patients with chronic groin pain. While previous studies suggest substantial sustained pain relief with DRG stimulation in this patient population, prospective randomized controlled studies are necessary before formal recommendations can be made.     

Dorsal Root Ganglion Stimulation as a Salvage Therapy Following Failed Spinal Cord Stimulation

IntroductionSpinal cord stimulation (SCS) can provide long-term pain relief for various chronic pain conditions, but some patients have no relief with trial stimulation or lose efficacy over time. To “salvage” relief in patients who do not respond or have lost efficacy, alternative stimulation paradigms or anatomical targets can be considered. Dorsal root ganglion stimulation (DRG-S) has a different mechanism of action and anatomical target than SCS.ObjectivesWe assessed DRG-S salvage therapy outcomes in patients who did not respond to SCS or had lost SCS efficacy.Materials and MethodsWe retrospectively included consecutive patients from 2016 to 2020 who were salvaged with DRG-S after failed SCS trials (<50% pain reduction) or who had lost efficacy after permanent SCS. We compared numerical rating scale (NRS) pain, Oswestry disability index (ODI), health-related quality of life (EuroQol five-dimensions five-level), and oral morphine equivalent (OME) opioid requirements before DRG-S salvage and at patients’ last follow-up.ResultsA total of 60 patients who had failed SCS were salvaged with DRG-S. The mean age was 56 ± 12 years, and the most common diagnoses were complex regional pain syndrome (n = 24) and failed back surgery syndrome (n = 24). The most common failed modalities included tonic (n = 32), Burst (n = 18), and high-frequency (n = 10) SCS. The median follow-up duration of salvage DRG-S was 34 months. With DRG-S, NRS decreased (8.7 ± 1.2 to 3.8 ± 2.1), and OME declined (median 23 mg to median 15 mg), whereas EuroQol 5D scores increased (0.40 ± 0.15 to 0.71 ± 0.15), and ODI improved (64 ± 14% to 31 ± 18%) (all p < 0.05).ConclusionsDRG-S can be used in patients with chronic pain who have previously failed to receive persistent benefit from SCS.     

Four Year Follow‐up of Dual Electrode Spinal Cord Stimulation for Chronic Pain

This paper reports on 80 patients using dual electrode, spinal cord stimulation (SCS) over a four‐year period Implant status, stimulation mode, anode‐cathode configuration (array), cathode position, paresthesia overlap, explantation rates, complications, Visual Analog Scores (VAS), and overall satisfaction were examined in patients implanted with dual 8 contact, staggered, percutaneous electrodes. All patients had undergone implantation for chronic axial and extremity pain [e.g., Failed Back Surgery Syndrome (FBSS), Complex Regional Pain Syndrome (CRPS)]. Outcomes were evaluated in view of our previous reports in this same group at 24 and 30 months 1 , 2 . Data was collected by a disinterested third party. At 48 months, 18 of the original 80 patients were lost to follow‐up. Of the 62 patients contacted, 33 remained implanted and 29 (47%) had been explanted. After an average evaluation of 85 arrays (PainDoc, Advanced Neuromodulation Systems, Plano, Texas), 88% of patients reported using one or two “best” arrays (bipolar or guarded tripolar) to maintain favorable paresthesia overlap (89%), VAS reduction (8.1 to 4.9), and overall patient satisfaction (63%). These arrays were most commonly positioned about the physiologic midline of the COL3–4 vertebral segments for upper extremity pain, and the T9–10 vertebral segments for low back and lower extremity pain. In contrast to our initial reports where essentially all patients preferred more than two arrays to maintain “best” paresthesia overlap and outcome, only 12% of these same patients maintained this trend in this long‐term follow‐up study. The arrays most commonly selected long‐term as the “best” ones (88% of all electrodes) were narrow (adjacent contact) bipoles and guarded cathode tripoles (< 8 contacts). Thirty‐five percent of patients with thoracic implants achieved paresthesia in the low back at 48 months. Explantation rates and overall patient satisfaction were significantly affected by painful radio frequency (RF) antenna coupling. This data supports the efficacy of dual electrodes in optimizing long‐term SCS paresthesia overlap and complex pain outcomes.     

Men and Women Respond Equally Well to Spinal Cord and Dorsal Root Ganglion Stimulation

ObjectivesThe influence of gender on outcomes in individuals undergoing treatment for chronic pain is unclear. This retrospective, single-site study explored the impact of gender on pain, quality of life (QoL), revisions, and explants in patients with failed back surgery syndrome or visceral pain, who received a fully implanted 10 kHz spinal cord stimulation (SCS), burst SCS, or dorsal root ganglion (DRG) stimulation system.Materials and MethodsThe following data were collected from paper and electronic records: gender, age, chronic pain diagnosis, system, baseline and follow-up scores (average pain [visual analog scale, VAS], worst pain [VAS], QoL [EQ-5D-3L]), revisions, and explants. Data were statistically analyzed by one-way ANCOVAs controlling for age, chi-square tests of independence, and logistic regression.ResultsThe final sample comprised 387 patients (176 males and 211 females). Males were significantly older compared to females (mean difference: 2.33 years, p = 0.044). Controlling for age, baseline average pain was significantly lower in males than females (mean difference: ?0.32, p = 0.049). Males and females responded equally well to 10 kHz SCS and burst SCS as well as DRG stimulation. A greater percentage of males (5%) than females (1%) had revisions due to lead fractures. Additionally, more females (13%) than males (6%) had an explant due to insufficient pain relief. Female gender and older age were associated with greater likelihood of having an explant compared to male gender and younger age.ConclusionGender may play an influential role in pain severity at baseline but have little effect at follow-up. To help identify which patients may undergo a revision or explant, gender and age could be important factors and should be further scrutinized. Even though men and women responded equally well to SCS and DRG stimulation, more men had a revision due to lead fractures, and more women were explanted due to insufficient pain relief.     

Very Low Frequencies Maintain Pain Relief From Dorsal Root Ganglion Stimulation: An Evaluation of Dorsal Root Ganglion Neurostimulation Frequency Tapering

BackgroundDorsal root ganglion neurostimulation (DRG-S) is effective in treating various refractory chronic pain syndromes. In preclinical studies, DRG-S at very low frequencies (<5 Hz) reduces excitatory output in the superficial dorsal horn. Clinically, we have also observed the effectiveness of DRG-S at low frequencies. We conducted a case series to describe the effect of very low-frequency DRG-S stimulation on clinical outcomes.Materials and MethodsDRG-S for refractory low back pain was initiated at parameters consistent with published values. Thereafter, the stimulation frequency of DRG-S was reduced in a stepwise fashion to the lowest frequency that maintained pain relief. Pain intensity, disability, and general health status data were collected at baseline, prior to initiation of tapering, and at four weeks after each patient’s lowest effective stimulation frequency was reached.ResultsAfter device activation (N = 20), DRG-S frequency was tapered from 16 to 4 Hz over a 4- to 17-week period, reducing charge-per-second by nearly two-thirds. Even so, pain relief was maintained at more than 75%, with consistent findings in the other measures.ConclusionDRG-S may have utility in treating chronic pain at lower stimulation frequencies than previously recognized. We have previously theorized that the mechanism of action may involve preferential recruitment of low-threshold mechanoreceptor fibers via the endogenous opioid system. Of clinical relevance, lower frequency stimulation maintains DRG-S efficacy regarding improvements in pain, disability, and quality of life. It can extend battery life and may potentially lead to the development of smaller implantable pulse generators.     

Patient Satisfaction With Spinal Cord Stimulation and Dorsal Root Ganglion Stimulation for Chronic Intractable Pain: A Systematic Review and Meta-Analysis

ObjectivesIn the spinal cord stimulation (SCS) and dorsal root ganglion stimulation (DRG-S) literature, the typical primary outcome measure includes pain relief, whether numeric rating scale changes or percentage pain relief, and functional outcomes and patient satisfaction are included as secondary outcomes. This systematic review and meta-analysis aims to determine the rate of patient satisfaction with the use of SCS and DRG-S in the treatment of chronic intractable pain.Materials and MethodsThe study protocol was registered in the PROSPERO International prospective register of systematic reviews. We queried articles from multiple electronic data bases, including MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials data bases, and hand-searched reference lists of identified publications. All periods were included. Inclusion criteria encompassed randomized controlled trials (RCTs) and prospective observational studies that reported patient satisfaction in patients who underwent SCS or DRG-S. Bias evaluation for the included studies involved appropriate guidelines for each study design (Cochrane risk of bias tool for RCTs and Newcastle-Ottawa scale for observational studies).ResultsOur search strategy identified 242 unique citations, of which nine RCTs and 23 observational studies were included for analysis. Overall, 25 studies comprising 1355 participants were pooled in our quantitative analysis. The pooled proportion of patients who reported satisfaction from all studies was 82.2% (95% CI, 77.8%–86.2%). This finding had high statistical heterogeneity (I² = 74.0%). Subgroup analysis did not reveal differences in satisfaction when studies were stratified based on study design (RCT or observational study) or follow-up period (six, 12, 24, and 36 months).ConclusionsOur results show high levels of patient satisfaction across the SCS and DRG-S literature when these treatment modalities are used for chronic intractable pain, regardless of SCS programming algorithm. However, there is a scarcity of unbiased and/or non–industry-funded prospective studies in the neuromodulation field, and future efforts to expand this area of the SCS and DRG-S literature are greatly needed.