Spinal Cord Stimulation With Hybrid Lead Relieves Pain in Low Back and Legs

Objective: The failed back surgery syndrome (FBSS) is the most common chronic pain syndrome. Whereas it is relatively easy to achieve pain relief in the lower limbs of FBSS patients with spinal cord stimulation (SCS), it is difficult to manage low back pain with SCS. The performance of a paddle‐shaped SCS lead that can be inserted surgically as well as percutaneously (a hybrid lead) was evaluated in a prospective study on the relief of low back pain and leg pain in patients with FBSS. Materials and Methods: Patients with FBSS being eligible for SCS were enrolled in the study, and a hybrid lead was placed surgically. Outcome measures included pain scores for low back and leg pain assessed by visual analog scale (VAS), pain medication, and patient satisfaction. These scores were assessed before and at regular intervals after implantation. Results: It was shown that a single hybrid lead, generally positioned over the physiological midline of the spinal cord, is capable of alleviating both low back and leg pain in patients with FBSS. Forty‐five subjects were eligible for SCS and received trial stimulation. Forty‐two of them had a successful trial period and were converted to a permanent system. Their average VAS score at baseline was 8.0 for lower limb pain and 7.5 for low back pain. After six months of SCS, these average VAS scores were reduced to 3.2 and 3.5, respectively, and also pain medication was reduced significantly. Conclusion: SCS with a hybrid lead in subjects with FBSS is safe, and causes significant pain relief in both the low back and the lower limbs.     

Long-Term Outcomes of Spinal Cord Stimulation With Paddle Leads in the Treatment of Complex Regional Pain Syndrome and Failed Back Surgery Syndrome

Introduction: Spinal cord stimulation (SCS) is frequently used to treat chronic, intractable back, and leg pain. Implantation can be accomplished with percutaneous leads or paddle leads. Although there is an extensive literature on SCS, the long‐term efficacy, particularly with paddle leads, remains poorly defined. Outcome measure choice is important when defining therapeutic efficacy for chronic pain. Numerical rating scales such as the NRS‐11 remain the most common outcome measure in the literature, although they may not accurately correlate with quality of life improvements and overall satisfaction. Methods: We reviewed the medical records of patients with failed back surgery syndrome (FBSS) or complex regional pain syndrome (CRPS) implanted with SCS systems using paddle leads between 1997 and 2008 at the Cleveland Clinic with a minimum six‐month follow‐up. Patients were contacted to fill out a questionnaire evaluating outcomes with the NRS‐11 as well as overall satisfaction. Results: A total of 35 eligible patients chose to participate. More than 50% of the patients with CRPS reported greater than 50% pain relief at a mean follow‐up of 4.4 years. Approximately 30% of the FBSS patients reported a 50% or greater improvement at a mean follow‐up of 3.8 years. However, 77.8% of patients with CRPS and 70.6% of patients with FBSS indicated that they would undergo SCS surgery again for the same outcome. Conclusion: Patients with CRPS and FBSS have a high degree of satisfaction, indexed as willingness to undergo the same procedure again for the same outcome at a mean follow‐up of approximately four years. The percentage of satisfaction with the SCS system is disproportionally greater than the percentage of patients reporting 50% pain relief, particularly among patients with FBSS. This suggests that the visual analog scale may not be the optimal measure to evaluate long‐term outcomes in this patient population.     

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.     

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.     

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 for neuropathic pain

Spinal cord stimulation (SCS) is used for more than 40 years to treat localized chronic medically refractory neuropathic pain involving limb(s) and trunk. The most frequent indications remain complex regional pain syndrome (CRPS) failed back surgery syndrome (FBSS), and peripheral neuropathy. Stimulation-induced paresthesias, perceived by the patient, prevent blinded evaluation and increase the placebo effect, decreasing the credibility of the tonic SCS efficacy. Retrospective studies reported that about 50% of the patients are improved more than 50% at short-term, but long-term improvement is less. Several comparative randomized trials (RCT) are now available. In CRPS, a RCT demonstrated the superiority of SCS plus physiotherapy compared to physiotherapy alone. In FBSS, two RCTs have shown that SCS was superior to reoperation and conventional medical treatment, (CMM) respectively. New stimulation waveforms, namely burst, high frequency (10 KHz) stimulation and close-loop SCS, have been proposed recently to avoid the perception of paresthesias and/or increase the pain relief. RCTs in FBSS have suggested that these new SCS modalities were as least as efficient than conventional tonic SCS and perhaps slightly superior. Two RCTs confirmed SCS efficacy in painful diabetic neuropathy in comparison with CMM. Complications are frequent (hardware dysfunction or migration, superficial infection) but exceptionally serious. Consequently, the risk/benefit ratio is favorable to SCS, considering that chronic pain patients undergoing this procedure are usually resistant to all the other therapies.     

Results of neuromodulation for the management of chronic pain

Background and purpose : Neuromodulative treatment of chronic pain syndromes is a modern mode of treatment of neuropathic and ischaemic pain. Its effectiveness is well documented in the literature. The objective of this work is to present the results of treatment of chronic pain syndromes on the basis of eight-year experience in our department. Material and methods : Since 2002, we have conducted 9 operations of motor cortex stimulation (MCS), 2 of deep brain stimulation (DBS), 45 of spinal cord stimulation (SCS) and 5 of sacral root stimulation (SRS) in the treatment of chronic pain. Results : We obtained good long-term results of neuromodulation in the form of clinical improvement (> 50%) in 4 of 9 patients with MCS (44%), in 13 diagnosed with failed back surgery syndrome (FBSS), 8 with other neuropathic pain, and 11 with angina pectoris from a group of 45 treated with SCS. Sacral root stimulation has been successful in 3 of 5 patients with perianal pain. The best treatment results in SCS, although not statistically significant, were observed in patients treated due to FBSS (13 out of 15) and angina pectoris (11 out of 15) (p = 0.12). In patients with neuropathic pain, peripheral and central, improvement was obtained in 8 out of 15 patients. Conclusions : A good indication for spinal cord stimulation is FBSS and angina pectoris. Motor cortex stimulation is helpful in the treatment of chronic central neuropathic pain. Further observations and a larger group of patients are necessary for a reliable assessment of the effectiveness of neuromodulative treatment of chronic pain in our clinic.     

Using the SAFE Principles When Evaluating Electrical Stimulation Therapies for the Pain of Failed Back Surgery Syndrome

Objective: In this paper we review the literature on failed back surgery syndrome (FBSS) and use principles of Safety, Appropriateness, Fiscal Neutrality, and Effectiveness (SAFE) to determine the appropriate place for spinal cord stimulation (SCS) for the treatment of FBSS. Methods and Results: We analyzed the most recent literature regarding treatments of pain due to FBSS and used the SAFE principles to reprioritize pain treatments, particularly electrical stimulation therapies, for FBSS in a more appropriate, relevant, and up to date continuum of care. Conclusions: Based on this review and analysis of the safety, appropriateness, cost‐effectiveness, and efficacy of treatments for the pain of FBSS, relegating SCS to a last resort therapy is no longer justifiable. SCS should be considered before submitting a patient to either long‐term systemic opioid therapy or repeat spinal surgery for chronic pain resulting from FBSS.     

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.     

An Analysis of the Components of Pain,Function, and Health‐Related Quality of Life in Patients with Failed Back Surgery Syndrome Treated with Spinal Cord Stimulation or Conventional Medical Management

Objectives: Failed back surgery syndrome (FBSS) patients experience pain, functional disability, and reduced health‐related quality of life (HRQoL) despite anatomically successful surgery. Examining sub‐dimensions of health outcomes measures provides insight into patient well‐being. Materials and Methods: The international multicenter PROCESS trial collected detailed HRQoL (EuroQol‐5D; Short‐Form 36) and function (Oswestry Disability Index) information on 100 FBSS patients. Results: At baseline, patients reported moderate‐to‐severe leg and back pain adversely affecting all dimensions of function and HRQoL. Compared with conventional medical management alone, patients also receiving spinal cord stimulation (SCS) reported superior pain relief, function, and HRQoL at six months on overall and most sub‐component scores. The majority of these improvements with SCS were sustained at 24 months. Nonetheless, 36–40% of patients experienced ongoing marked disability (standing, lifting) and HRQoL problems (pain/discomfort). Conclusions: Longer‐term patient management and research must focus on these refractory FBSS patients with persisting poor function and HRQoL outcomes.     

Effects of spinal cord stimulation on voxel-based brain morphometry in patients with failed back surgery syndrome

ObjectiveDespite the clinical effectiveness of Spinal Cord Stimulation (SCS), potential structural brain modifications have not been explored. Our aim was to identify structural volumetric changes during subsensory SCS, in patients with Failed Back Surgery Syndrome (FBSS).MethodsIn this cohort study, twenty-two FBSS patients underwent a magnetic resonance imaging protocol before SCS and 3 months after SCS. Clinical parameters were correlated with volumetric changes, calculated with voxel-based morphometry.ResultsAfter 3 months, a significant volume decrease was found in the inferior frontal gyrus, precuneus, cerebellar posterior lobe and middle temporal gyrus. Significant increases were found in the inferior temporal gyrus, precentral gyrus and the middle frontal gyrus after SCS. Additionally, significant increases in volume of superior frontal and parietal white matter and a significant decrease in volume of white matter underlying the premotor/middle frontal gyrus were revealed after SCS. A significant correlation was highlighted between white matter volume underlying premotor/middle frontal gyrus and leg pain relief.ConclusionsThis study revealed for the first time that SCS is able to induce volumetric changes in gray and white matter, suggesting the reversibility of brain alterations after chronic pain treatment.SignificanceVolumetric brain alterations are observable after 3 months of subsensory SCS in FBSS patients.     

Experiences From the Patient Perspective on Spinal Cord Stimulation for Failed Back Surgery Syndrome: A Qualitatively Driven Mixed Method Analysis

IntroductionWhen neither pharmacological therapies nor alternative interventions provide sufficient pain relief, spinal cord stimulation (SCS) can be used to treat Failed Back Surgery Syndrome (FBSS). Although it seems reasonable that quality of life (QoL)- and psychosocial-related factors contribute to the outcome of SCS since pain is a multidimensional experience, few qualitative studies have explored the expectations of SCS and experiences on SCS to treat FBSS from the patient perspective.ObjectivesThe aim of this study was to qualitatively and quantitatively map the FBSS patients’ experiences with SCS and the effects of SCS on low back pain caused by FBSS.Materials and MethodsA qualitative study with in-depth semi-structured interviews, assisted by the Brief Pain Inventory (BPI)-questionnaire.ResultsSeven themes regarding patients’ experiences, subdivided into 15 categories, were identified, including an understudied theme within this field of research, Spiritual Well-Being. “Acceptance” and “coping” emerged as pre-eminent motifs throughout these themes. Moreover, the realization of patients’ expectations were variable throughout the presented themes. According to the BPI Questionnaire, four out of 13 patients (31%) had significant pain relief (≥50%). Seven out of 13 (54%) reported a ≥50% increase regarding enjoyment of life.ConclusionMultiple QoL- and psychosocial-related themes are related to SCS-outcomes. In order to improve SCS-outcomes for both short- and long-term, these themes should be implemented as a multidimensional approach, both prior to implantation as during follow-up.     

Neurostimulation in patients with chronic neuropathic pain in the so-called failed back surgery syndrome (world and the author's experience)

The failed back surgery syndrome (FBSS) is defined as protracted or recurrent pain, mainly in the lower back and/or legs, even after previous anatomically successful spinal surgery. Treatment of such patients commonly involves difficulties since neither medical therapy nor repeated back surgery does not result in adequate pain relief. Spinal cord stimulation (SCS) is a minimally invasive procedure that allows physicians and patients to define the effect of therapy just before permanent implantation. Both trial stimulation and permanent implantation are fully reversible. Early treatment with SCS has been shown to be very effective in correctly selected FBSS patients and therefore this procedure should be preferred over back resurgery. Clinical studies have demonstrated that CSC provides a sustained, long-term, 50% or more pain relief in over 60% of the patients and makes it possible to reduce the use of analgesics and to improve quality of life and functional status, thus permit many patients to resume work. Many patients told about fair therapeutic effects and the occurrence of mild side effects. Thus, SCS is an accessible alternative to traditional therapy. It is the treatment of choice in drug-resistant FBSS patients where recurrent neuropathic pin persists after surgery and analgesics are no longer effective.     

Treatment of Multifocal Pain with Spinal Cord Stimulation

Introduction: We report a retrospective case study of combined treatment of cancer‐related pain and chronic low back and lower extremity pain related to postlaminectomy syndrome (PLS) with one spinal cord stimulation (SCS) system. Methods: The patient underwent an uneventful SCS trial with percutaneous placement of two temporary eight‐electrode leads (Medtronic Inc., Minneapolis, MN) placed at the level of T8‐T9‐T10 and T5‐T6‐T7. Results: After successful trial, he was implanted with permanent leads and generator, reporting sustained pain relief at 12‐month follow‐up visit. Discussion: SCS is a trialable, reversible, and interactive therapy permitting patients to control the level of stimulation they feel based on their degree of pain. Conclusion: SCS provides an effective, alternative treatment for select patients with cancer‐related chest wall pain and pain related to PLS who have failed conservative treatment.     

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.     

The Link Between Spinal Cord Stimulation and the Parasympathetic Nervous System in Patients With Failed Back Surgery Syndrome

ObjectivesIn patients with chronic pain, a relative lower parasympathetic activity is suggested based on heart rate variability measurements. It is hypothesized that spinal cord stimulation (SCS) is able to influence the autonomic nervous system. The aim of this study is to further explore the influence of SCS on the autonomic nervous system by evaluating whether SCS is able to influence skin conductance, blood volume pulse, heart rate, and respiration rate.Materials and MethodsTwenty-eight patients with Failed Back Surgery Syndrome (FBSS), who are being treated with SCS, took part in this multicenter study. Skin conductance and cardiorespiratory parameters (blood volume pulse, heart rate, and respiration rate) were measured during on and off states of SCS. Paired statistics were performed on a 5-min recording segment for all parameters.ResultsSCS significantly decreased back and leg pain intensity scores in patients with FBSS. Skin conductance level and blood volume pulse were not altered between on and off states of SCS. Heart rate and respiration rate significantly decreased when SCS was activated.ConclusionsParameters that are regulated by the sympathetic nervous system were not significantly different between SCS on and off states, leading to the hypothesis that SCS is capable of restoring the dysregulation of the autonomic nervous system by primarily increasing the activity of the parasympathetic system in patients with FBSS.     

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.     

Treatment of Chronic Chest Wall Pain in a Patient With Loeys-Dietz Syndrome Using Spinal Cord Stimulation

Objective: Spinal cord stimulation (SCS) has been used with increased frequency for the treatment of intractable pain including chronic chest pain. Methods: The patient with a history of Loeys‐Dietz syndrome who underwent repair of pectus excavatum with subsequent chronic chest wall pain underwent an uneventful SCS trial with percutaneous epidural placement of two temporary eight‐electrode leads placed at the level of T3‐T4‐T5. Results: After experiencing excellent pain relief over the next two days, the patient was implanted with permanent leads and rechargeable generator four weeks later and reported sustained pain relief at 12‐month follow‐up visit. Conclusion: SCS provides an effective, alternative treatment option for select patients with Loeys‐Dietz syndrome who underwent repair of pectus excavatum with subsequent chronic chest wall pain who have failed conservative treatment. SCS may provide pain relief with advantages over conservative treatments and more invasive techniques.     

Continuous Versus Intermittent Spinal Cord Stimulation: An Analysis of Factors Influencing Clinical Efficacy

Objectives: Spinal cord stimulation (SCS) has, for decades, been shown to be successful in a variety of chronic neuropathic pain syndromes. However, there is a paucity of reports in the literature comparing different stimulation patterns. The impact of different stimulation patterns upon outcome remains to be determined, as well as how the latter is influenced by the duration of the post‐SCS pain‐free interval. Materials and Methods: Data from 61 patients (of 71 eligible patients) were collected by means of a telephone interview. These data included the pattern of stimulation (intermittent or continuous), the intensity of stimulation with regard to threshold, the mean, maximal, and minimal pain strength on a numerical rating scale with and without stimulation, the average duration and number of daily stimulation intervals, the average duration of the pain‐relieving effect after switching off the impulse generator, the pain medication intake, the extent of paresthesia coverage, unpleasant side effects, and patient satisfaction. Results: The average improvement in pain score following SCS was 3.10 (50.61%). Twenty‐four patients (39.3%) performed continuous stimulation, and 37 patients (60.7%) performed intermittent stimulation. Patients who performed continuous stimulation had significantly shorter pain‐free intervals following the cessation of stimulation. These patients also showed a tendency toward higher pain scores with and without stimulation, which was not statistically significant. There were no significant differences in pain scores, duration of pain relief, and usage of the stimulation system between patients with different diagnoses and lead locations. Conclusion: Our data showed an equal effectiveness of SCS in the intermittent and in the continuous stimulation mode. The duration of the post‐SCS pain‐free interval may be predictive for the choice of the most effective individual stimulation pattern and deserves further investigation.     

Spinal Cord Stimulation in Failed Back Surgery Syndrome: An Integrative Review of Quantitative and Qualitative Studies

BackgroundSpinal cord stimulation (SCS) is an established therapy of failed back surgery syndrome (FBSS), although the effects on daily functioning, quality of life (QoL), and patients’ expectations, experiences, and satisfaction remain elusive. The current integrative review aimed to summarize the overall effects of SCS in patients with FBSS on pain relief, health-related QoL, and daily activities.Materials and MethodsPubMed, CINAHL, Embase, ClinicalTrials.gov, gray literature, and reference lists of relevant articles were searched for additional papers. All included studies were assessed for risk of bias using the Mixed Methods Appraisal Tool. Following the methods of Whittemore and Knafl, an integrative review and a meta-analysis were performed.ResultsIn total, 16 articles were included; 11 articles presented quantitative outcomes, and five articles presented qualitative data. Lower back pain, leg pain, overall pain, Oswestry Disability Index, EuroQol Five Dimensions Health Questionnaire three-level/five-level, and the physical component score of Short Form Health Survey (SF-36) significantly improved during all follow-up moments. Only the mental component score of the SF-36 did not significantly improve, compared with baseline. Heterogeneity was diversely present among the studies. Patients’ expectations and goals were disparate, although patients seemed to desire a return to their pre-FBSS state. Experiences with regard to the outcomes showed that patients largely recuperated after SCS, although limitations were still present. Patients also expressed inconvenience with regard to the trial period, implantation location, and recharging of the implantable pulse generator.ConclusionsSCS showed beneficial effects on different domains of life in patients with FBSS. The quantitative analyses suggest an overall improvement in most domains, although patients’ experiences show that limitations in daily life and living with the SCS system persist. Multiple extensive preoperative counseling sessions and discussions with patients are deemed necessary to improve patient satisfaction and meet their expectations. Shared decision-making and provision of complete information are key factors for success.