Quantitative Aspects of the Clinical Performance of Transverse Tripolar Spinal Cord Stimulation

A multicenter study was initiated to evaluate the performance of the transverse tripolar system for spinal cord stimulation. Computer modeling had predicted steering of paresthesia with a dual channel stimulator to be the main benefit of the system. The quantitative analysis presented here includes the results of 484 tests in 30 patients. For each test, paresthesia coverage as a function of voltage levels was stored in a computerized database, including a body map which enabled calculation of the degree of paresthesia coverage of separate body areas, as well as the overlap with the painful areas. The results show that with the transverse tripolar system steering of the paresthesia is possible, although optimal steering requires proper placement of the electrode with respect to the spinal cord. Therefore, with this steering ability as well as a larger therapeutic stimulation window as compared to conventional systems, we expect an increase of the long-term efficacy of spinal cord stimulation. Moreover, in view of the stimulation-induced paresthesia patterns, the system allows selective stimulation of the medial dorsal columns.     

Spinal Cord Stimulation vs. Conventional Medical Management: A Prospective,Randomized, Controlled,Multicenter Study of Patients with Failed Back Surgery Syndrome (PROCESS Study)

Introduction. Since its first application in 1967, numerous case series indicate that spinal cord stimulation (SCS) is an effective treatment for the management of failed back surgery syndrome (FBSS). However, only one randomized controlled trial has demonstrated that SCS provides more effective pain relief than re‐operation and conventional medical management. The PROCESS randomized, controlled, multicenter trial aims to assess the clinical effectiveness and cost‐effectiveness of SCS when added to conventional medical management compared to conventional medical management alone in patients with FBSS. Methods/Design. A total of 100 FBSS patients with predominantly neuropathic leg pain will be recruited from 12 centers and randomized to receive either conventional medical management alone or in combination with SCS for a period of 24 months. Patients will be evaluated at 1, 3, 6, 9, 12, 18, and 24 months. At the 6‐month visit, patients will be classified as successful (≥  50% pain relief in the legs) or unsuccessful (< 50% pain relief in the legs). If the results of the randomized treatment are unsuccessful, patients can cross over to the alternative treatment arm. Discussion. This paper highlights the rationale, design, methods, and challenges of an ongoing prospective, randomized, controlled, multicenter clinical trial that has been undertaken to obtain conclusive evidence of the clinical efficacy and cost‐effectiveness of an SCS system in patients with FBSS.     

Comparison of Paresthesia Mapping With Anatomic Placement in Burst Spinal Cord Stimulation: Long-Term Results of the Prospective,Multicenter, Randomized,Double-Blind,Crossover CRISP Study

ObjectivesSpinal cord stimulation (SCS) is an effective therapy for chronic intractable pain. Conventional SCS involves electrode placement based on intraoperative paresthesia mapping; however, newer paradigms like burst may allow for anatomic placement of leads. Here, for the first time, we report the one-year safety and efficacy of burst SCS delivered using a lead placed with conventional, paresthesia mapping, or anatomic placement approach in subjects with chronic low back pain (CLBP).Materials and MethodsSubjects with CLBP were implanted with two leads. The first lead was placed to cross the T8/T9 disc and active contacts for this lead were chosen through paresthesia mapping. The second lead was placed at the T9/T10 spinal anatomic landmark. Subjects initially underwent a four-week, double-blinded, crossover trial with a two-week testing period with burst SCS delivered through each lead in a random order. At the end of trial period, subjects expressed their preference for one of the two leads. Subsequently, subjects received burst SCS with the preferred lead and were followed up at 3, 6, and 12 months. Pain intensity (visual analog scale), quality-of-life (EuroQol-5D instrument), and disability (Oswestry Disability Index) were evaluated at baseline and follow-up.ResultsForty-three subjects successfully completed the trial. Twenty-one preferred the paresthesia mapping lead and 21 preferred the anatomic placement lead. Anatomic placement lead was activated in one subject who had no preference. The pain scores (for back and leg) significantly improved from baseline for both lead placement groups at all follow-up time points, with no significant between-group differences.ConclusionsThis study demonstrated that equivalent clinical benefits could be achieved with burst SCS using either paresthesia mapping or anatomic landmark-based approaches for lead placement. Nonparesthesia-based approaches, such as anatomic landmark-based lead placement investigated here, have the potential to simplify implantation of SCS and improve current surgical practice.     

Spinal Cord Stimulation for Failed Back Surgery Syndrome

Objective. The purpose of this study is to evaluate the effectiveness of modern spinal cord stimulation (SCS) for the treatment of failed back surgery syndrome (FBSS). Materials and Methods. Thirty patients were treated with SCS between December 1992 and January 1998 for low back and radicular pain after multiple failed back surgeries. Permanent systems were implanted if trial stimulation led to > 50% pain reduction. Median long‐term follow‐up was 34 months (range, 6–66 months). Severity of pain was determined postoperatively by a disinterested third party. Results. Overall, 12 of the 16 patients (75%) who received permanent implants continued to report at least 50% relief of pain at follow‐up. All six patients who underwent placement of laminectomy‐styled electrode for SCS in the thoracic region had > 50% pain relief at long‐term follow‐up. Visual analog scores decreased an average of 3.2 (from 8.6 preoperatively to 5.4 postoperatively). Patients undergoing SCS placement via laminectomy in the thoracic region experienced an average decrease of 4.9 in VAS, whereas those who underwent percutaneous placement of thoracic leads had an average decrease of 2.5. Conclusions. SCS is an effective treatment for chronic low back and lower extremity pain which is refractory to conservative therapy and which is not amenable to corrective anatomic surgery. Though our patient population is small, our results imply that the laminectomy‐style electrodes in the thoracic region achieve better long‐term effectiveness than percutaneous leads.     

Hardware Failures in Spinal Cord Stimulation for Failed Back Surgery Syndrome

Spinal cord stimulation (SCS) is an efficient means for treatment of the postsurgical lumbar spine condition known as failed back surgery syndrome (FBSS). Although the devices and the implantation techniques are well established and the technology is sophisticated, there are some complications caused by hardware failures. This study was aimed at identifying the most frequent types of hardware failures and their causes in FBSS patients treated with SCS. In a retrospective analysis, a group of 42 FBSS patients using single lead SCS for 6–74 months was evaluated. Only hardware failures were considered in the analysis, and parameters such as occurrence of failure after primary implantation of the device, frequency and site of failure, stimulation time to failure (TF), and overall time of SCS usage were recorded. In the patient group studied, 12 surgical corrections of the hardware were carried out in 10 patients. In eight patients there was a single corrective procedure, in two additional cases there were two surgically corrected hardware failures each. The most often encountered type of hardware failure was lead breakage or disruption of insulation (percutaneously placed Quad leads only) leading to short circuiting and dysfunction (n= 8). Second in frequency were receiver (model 3470) failures due to insulation leakage at the plug connection site (n= 2). In one case, extension cable breakage caused dysfunction of the system, and another dysfunction was caused by distal extension cable disconnection. In conclusion, SCS is a low‐complication procedure for treatment of benign low‐back pain, but seems to be prone to lead and insulation failures.     

1.2 kHz High-Frequency Stimulation as a Rescue Therapy in Patients With Chronic Pain Refractory to Conventional Spinal Cord Stimulation

ObjectivesWe aimed to investigate the efficacy of new subperception stimulation paradigms including 1.2 kHz-high-frequency stimulation (HFS) and advanced-HFS field-shaping algorithm (dorsal horn HFS [DHHFS]) in refractory cases which initially benefited from conventional spinal cord stimulation (SCS) and lost the effect throughout time.Materials and MethodsIn the context of a rescue-therapy, patients underwent externalization of the implanted SCS-leads and were tested with multiple combinations of new SCS paradigms. Pain intensity was analyzed using the numeric rating scale (NRS), and data were collected preoperatively and at multiple postoperative follow-ups.ResultsThirty-seven patients underwent externalization of the leads. Mean preoperative NRS-score was 8.1/10 points (SD ± 0.9) for the ON-stimulation period. Patients received a combination of either tonic, burst and 1.2 kHz-HFS, or burst and 1.2 kHz-HFS, DHHFS, or 1.2 kHz-HFS and DHHFS, or 1.2 kHz-HFS alone. The mean postoperative NRS-score after the testing-phase was 3.8/10 points (SD ± 2.5), showing a 48.0% mean reduction (p < 0.001). In total, 29 patients reported a significant reduction above 50% in NRS-scores and therefore were reimplanted with new generators that could deliver the new paradigms. Eight patients underwent full SCS-system explantation. The patients who continued with the new paradigms (n = 29) reported mean NRS-scores of 3.5/10 points (SD ± 1.7) 12 months postoperatively, still showing a significant reduction of 43.3% when compared to preoperative scores (p < 0.001).ConclusionRescue-therapy with combination of multiple waveforms, including tonic, burst, 1.2 kHz-HFS, and DHHFS, was associated with a significant pain relief in patients with failed conventional SCS. This approach is a safe and efficient and should be considered before explantation of the SCS-system.     

Subcutaneous Stimulation as an Additional Therapy to Spinal Cord Stimulation for the Treatment of Lower Limb Pain and/or Back Pain: A Feasibility Study

Objective: The objective of this study was to demonstrate the efficacy of subcutaneous stimulation (SubQ) as an additional therapy in patients with failed back surgery syndrome (FBSS) with chronic refractory pain, for whom spinal cord stimulation (SCS) was unsuccessful in treating low back pain. Study Design: Case series. Materials and Methods: FBSS patients with chronic limb and/or low back pain whose conventional therapies had failed received a combination of SCS (8‐contact Octad lead) and/or SubQ (4‐contact Quad Plus lead(s)). Initially leads were placed in the epidural space for SCS for a trial stimulation to assess response to suppression of limb and low back pain. Where SCS alone was insufficient in treating lower back pain, leads were placed superficially in the subcutaneous tissue of the lower back, directly in the middle of the pain area. A pulse generator was implanted if patients reported more than 50% pain relief during the trial period. Pain intensity for limb and lower back pain was scored separately, using visual analog scale (VAS). Pain and Quebec Back Pain Disability Scale (QBPDS) after 12‐month treatment were compared with pain and QBPDS at baseline. Results: Eleven FBSS patients, five male and six female (age: 51 ± 8 years; mean ± SD), in whom SCS alone was insufficient in treating lower back pain, were included. In nine cases, SubQ was used in combination with SCS to treat chronic lower back and lower extremity pain. In two cases only SubQ was used to treat lower back pain. SCS significantly reduced limb pain after 12 months (VAS_bl: 62 ± 14 vs. VAS_12m: 20 ± 11; p= 0.001, N= 8). SubQ stimulation significantly reduced low back pain after 12 months (VAS_bl: 62 ± 13.0 vs. VAS_12m: 32 ± 16; p= 0.0002, N= 10). Overall pain medication was reduced by more than 70%. QBPDS improved from 61 ± 15 to 49 ± 12 (p= 0.046, N= 10). Furthermore, we observed that two patients returned to work. Conclusion: SubQ may be an effective additional treatment for chronic low back pain in patients with FBSS for whom SCS alone is insufficient in alleviating their pain symptoms.     

Spinal Cord Stimulation: A 20‐Year Retrospective Analysis in 260 Patients

Introduction. Spinal cord stimulation (SCS) is used clinically by many pain physicians and neurosurgeons alike without regard to their own outcome data. Methods. We reviewed our 20‐year experience retrospectively of patients receiving SCS implants and analyzed our data by pain type and group. Results. We present 260 patients, 140 men and 120 women. The most frequent type of pain in our series was neuropathic pain in 44.25% and the most frequent diagnosis was peripheral vascular disease (PVD) with 98 cases. The second was failed back surgery syndrome (FBSS) with 65 cases and the third was complex regional pain syndrome type I (CRPS I), with 40 cases. In CRPS group, the mean visual analog scale (VAS) of this group was 77.89 ± 13.38. In total, 5% had no pain relief, 40% had poor pain relief, 47.5% had good pain relief, and 7.5% had excellent pain relief. In FBSS group, the mean VAS was 79.62 ± 11.69 mm. A total of 13.80% had no pain relief at all, 35.39% had poor pain relief, 50.76% had good pain relief, and there were no patients in this group who had complete pain relief. A total of 98 patients, 78 men and 20 women, were diagnosed with PVD. The mean VAS of this group was 69.75 ± 14.36 mm. A total of 11.22% had poor pain relief, 87.75% had good pain relief. One patient had complete pain relief and all patients in this group perceived at least some improvement in their symptoms. The rate of complications was close to 28% in our overall sample. Conclusions. In conclusion, we demonstrated the utility over time of this type of treatment is comparable with other series of efficacy of SCS. The analgesic efficacy was close to 65% in the overall group. The therapy was not free of complications. The preponderance of our patients was patients with the diagnosis of PVD and our results in this group of patients were excellent. These excellent results of more than 90% improvement suggest to us that SCS be considered as a first‐line approach to the clinical management of patients with pain and ulcer of PVD.     

Neuropathic Limb Pain and Spinal Cord Stimulation: Results of the Dutch Prospective Study

Baseline and 12‐month follow‐up data from a prospective controlled study on patients treated with SCS for neuropathic limb pain (NLP) are analyzed critically. The outcome on pain, use of medication, and quality of life are reported and compared with the literature. Patients enrolled from April 1999 to December 2001 were part of a quality system study by the Dutch Working Group on Neuromodulation. In two years, more than 400 patients were admitted for several indications of chronic neuropathic pain. Failed back surgery syndrome (FBSS) and complex regional pain syndrome (CRPS) were the largest cohorts. FBSS was defined as persistent limb pain with/or without concomitant minor back pain after prior surgery for a slipped lumbar disc or spinal instability. SCS was a last resort therapy. Two criteria were used for eligibility: a SCL‐90 score below 225 and a mean visual analog score (VAS) of four days according to Jensen of ≥ 5. One hundred sixty nine patients were registered for FBSS. Thirty four did not fulfill the eligibility criteria, and 135 received several questionnaires for baseline evaluation. Thirty patients did not have successful trial stimulation (< 50% pain relief), leaving 105 patients for implantation. The mean scores of the baseline evaluation were: SCL 137 (SD 28.3) and VAS 7.3 (SD 1.2), McGill pain questionnaire (MPQ) total PRI: 22.4 (9.4), Sickness Impact Profile (SIP) total score: 19.4 (SD10.1), ROLAND disability (RD) 16.9 (SD 3.5) and EUROQOL (EQ‐5D) 55.2 (SD 14.5) (simple linear index). Medication quantification scale at intake was 11.5 (SD 7.9). 56.2% of the patients used one or more narcotic drugs at intake. 82% of the patients did not have a paid job at the time of inclusion. 61% of the patients lost their job due to their medical problems. Scores at 12‐m follow‐up were VAS 3.0 (SD 2.4), MPQ 10.8 (SD 8), SIP 11.7 (SD 9.4), EQ‐5D 38.2 (SD 19.2) and RD 12.4 (SD 4.8). The difference between baseline and 12‐m follow‐up is statistically significant for all measures. We conclude that the outcome measures indicate that SCS significantly reduces pain and enhances quality of life in patients having NLP not responding to other adjuvant therapy. Recommendations are proposed to make studies more comparable.     

Multiple Program Spinal Cord Stimulation in the Treatment of Chronic Pain: Follow-Up of Multiple Program SCS

Objective. Follow-up of 80 patients using multiple program spinal cord stimulation (SCS). Methods. For 30 months, we followed 80 chronic pain patients who had undergone SCS implantations at our center. Thirty-six patients had Failed Back Surgery Syndrome (FBSS). Patients were evaluated in patient-controlled stimulation mode (patients can select one of several specific programs in response to their activities and pain level). We collected visual analog pain scores, patient satisfaction scores, pain maps, and paresthesia maps. Results. We previously reported our preliminary findings (Neuromodulation 1998;1 :30–45). At 24 months all patients were using more than one program. At 30 months, 62 patients (76%) were using more than two programs as their preferred stimulation mode and three patients (4%) were satisfied with only one stimulation program. At 30 months all patients chose patient-controlled stimulation as their preferred mode of stimulation. A total of 18 patients (23%) were explanted. Mean pain scores declined from 8.2 at baseline to 4.8 (p < 0.05, n= 79). Paresthesia overlap was 91% (n= 79). Of the patients with FBSS, 81% reported that they were using their SCS daily. Conclusions. In spinal cord stimulation the use of multiple electrodes and multiple stimulation programs, together with advanced programmability, increases paresthesia overlap, reduces pain scores, and may improve patient satisfaction with SCS therapy. This study indicates a significant patient preference for multiple program SCS, if patients are given the option to choose between a single program SCS system or a multiple program SCS system.     

Spinal Cord Stimulation in Conjunction With Peripheral Nerve Field Stimulation for the Treatment of Low Back and Leg Pain: A Case Series

Background. The treatment of chronic low back and leg pain remains a difficult medical challenge, particularly for patients with postlaminectomy syndrome. While spinal cord stimulation (SCS) has been a significant addition to the available options, it is often inadequate in relieving both the back and leg pain components. We hypothesized that for some patients the combination of SCS with peripheral nerve field stimulation (PNFS) would be a safe, effective alternative that would be more effective than either modality alone. Objective. Our objective was to demonstrate the efficacy of PNFS used in combination with SCS for the treatment of chronic pain syndromes involving the lower back and legs. Study Design. Case series. Methods. A total of 20 patients with chronic low back and leg pain syndromes who had failed conventional therapies underwent implantation of a combination of traditional SCS and PNFS. Leads were placed in the epidural space, as well as superficially in the subcutaneous tissues of the lower back, directly in the region of maximum pain. Patients initially underwent a trial of stimulation to assess response, and a permanent system was implanted if patients reported greater than 50% pain relief during the trial. For some patients, a combination was used at the time of the initial trial. In other cases, the decision to proceed with the combination was made later, either at the time of permanent implant, or later on, after SCS alone failed to adequately control pain. Results. In each case, PNFS was used in combination with traditional SCS for patients with chronic lower back and lower extremity pain. While not all of these patients ultimately proceeded with the combination of SCS and PNFS to control their pain, the majority of patients found the combination better in controlling their overall pain than either modality alone. In addition, using a combined approach at the time of trial provided a noninvasive and effective method of comparing the efficacy of each method, allowing patients to identify the best form of neuromodulation for their particular pain. Conclusions. Due to the availability of 16 contact capacity generators, neurostimulation with multiple leads in various combinations—including both epidural and peripheral nerve field stimulation simultaneously—can be applied safely and effectively. The availability of this combined approach for a trial of stimulation prior to implant allows patients to compare SCS to PNFS and to indicate a preference for one over the other or for the combination. We conclude that PNFS may be used in combination with SCS as a safe and effective alternative treatment for patients with chronic low back and leg pain, and further suggest that the combined approach should be considered as a treatment option for this population.