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1.
Int J Neurosci ; 129(10): 1013-1023, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31092102

RESUMO

The effective treatment of many diseases requires the use of multiple treatment strategies among which neuromodulation is playing an increasingly important role. Neuromodulation devices that act to normalize or modulate nerve activity through the targeted delivery of electrical stimuli will be the focus of this review. These devices encompass deep brain stimulators, vagus nerve stimulators, spinal cord simulators and sacral nerve stimulators. Already neuromodulation has proven successful in the treatment of a broad range of conditions from Parkinson's disease to chronic pain and urinary incontinence. Many of these approaches seek to exploit the activities of the autonomic nervous system, which influences organ function through the release of neurotransmitters and associated signalling cascades. This review will outline existing and emerging applications for each of these neuromodulation devices, proposed mechanisms of action and clinical studies evaluating both their safety and therapeutic efficacy.


Assuntos
Terapia por Estimulação Elétrica/métodos , Terapia por Estimulação Elétrica/tendências , Estimulação Elétrica Nervosa Transcutânea/métodos , Estimulação Elétrica Nervosa Transcutânea/tendências , Ensaios Clínicos como Assunto/métodos , Estimulação Encefálica Profunda/métodos , Estimulação Encefálica Profunda/tendências , Epilepsia/fisiopatologia , Epilepsia/terapia , Humanos , Doença de Parkinson/fisiopatologia , Doença de Parkinson/terapia , Estimulação da Medula Espinal/métodos , Estimulação da Medula Espinal/tendências , Acidente Vascular Cerebral/fisiopatologia , Acidente Vascular Cerebral/terapia , Resultado do Tratamento , Estimulação do Nervo Vago/métodos , Estimulação do Nervo Vago/tendências
2.
Curr Pain Headache Rep ; 23(6): 39, 2019 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-31044337

RESUMO

PURPOSE OF REVIEW: Spinal cord stimulation (SCS), based on the gate theory of nociception, has been shown to be effective in the management of chronic pain conditions. While early-generation technology offered many patients improvement in their pain and symptoms, limitations including paresthesia, dependence on mapping, decreased chronological efficacy, and inadequate coverage left many patients with persistent pain and overt therapeutic failure. RECENT FINDINGS: New advances in neuromodulation technology circumvent many of these previous limitations and offer patients improved pain relief and quality of life. In this review, an update on recent technological developments in the field of SCS and peripheral neuromodulation is presented with discussion on differentiating characteristics which may help guide applicability to individual patient needs.


Assuntos
Dor Crônica/terapia , Manejo da Dor/métodos , Medição da Dor/métodos , Estimulação da Medula Espinal/métodos , Dor Crônica/diagnóstico , Gânglios Espinais/patologia , Humanos , Manejo da Dor/tendências , Medição da Dor/tendências , Estimulação da Medula Espinal/tendências , Tecnologia sem Fio/tendências
3.
Stereotact Funct Neurosurg ; 97(1): 55-65, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30995653

RESUMO

BACKGROUND/AIMS: Postherpetic neuralgia (PHN) can be refractory to both medical and minimally invasive treatments. Its complex pathophysiology explains the numerous neurosurgical procedures that have been implemented through the years. Our objective was to summarize all available neurosurgical strategies for the management of resistant PHN and evaluate their respective safety and efficacy outcomes. METHODS: A comprehensive systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. RESULTS: A total of 38 studies comprising 811 patients with refractory PHN were included. The safety and efficacy of the following procedures were investigated: spinal cord stimulation (SCS), dorsal root entry zone (DREZ) lesioning, intrathecal drug delivery, caudalis DREZ lesioning, dorsal root ganglion (DRG) radiofrequency lesioning, peripheral nerve stimulation, gamma knife surgery, deep brain stimulation, cordotomy, percutaneous radiofrequency rhizotomy and Gasserian ganglion stimulation. CONCLUSIONS: There are several available neurosurgical approaches for recalcitrant PHN including neuromodulatory and ablative procedures. It is suggested that patients with resistant PHN undergo minimally invasive procedures first, including SCS, peripheral nerve stimulation or DRG radiofrequency lesioning. More invasive procedures should be reserved for refractory cases. Comparative studies are needed in order to construct a PHN neurosurgical management algorithm.


Assuntos
Neuralgia Pós-Herpética/cirurgia , Neurocirurgiões/tendências , Procedimentos Neurocirúrgicos/tendências , Cordotomia/métodos , Cordotomia/tendências , Humanos , Neuralgia Pós-Herpética/diagnóstico por imagem , Procedimentos Neurocirúrgicos/métodos , Rizotomia/métodos , Rizotomia/tendências , Estimulação da Medula Espinal/métodos , Estimulação da Medula Espinal/tendências
4.
Neuromodulation ; 22(3): 244-252, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30840354

RESUMO

BACKGROUND: Traumatic spinal cord injury (SCI) disrupts signaling pathways between the brain and spinal networks below the level of injury. In cases of severe SCI, permanent loss of sensorimotor and autonomic function can occur. The standard of care for severe SCI uses compensation strategies to maximize independence during activities of daily living while living with chronic SCI-related dysfunctions. Over the past several years, the research field of spinal neuromodulation has generated promising results that hold potential to enable recovery of functions via epidural electrical stimulation (EES). METHODS: This review provides a historical account of the translational research efforts that led to the emergence of EES of the spinal cord to enable intentional control of motor functions that were lost after SCI. We also highlight the major limitations associated with EES after SCI and propose future directions of spinal neuromodulation research. RESULTS: Multiple, independent studies have demonstrated return of motor function via EES in individuals with chronic SCI. These enabled motor functions include intentional, controlled movement of previously paralyzed extremities, independent standing and stepping, and increased grip strength. In addition, improvements in cardiovascular health, respiratory function, body composition, and urologic function have been reported. CONCLUSIONS: EES holds promise to enable functions thought to be permanently lost due to SCI. However, EES is currently restricted to scientific investigation in humans with SCI and requires further validation of factors such as safety and efficacy before clinical translation.


Assuntos
Espaço Epidural/fisiologia , Rede Nervosa/fisiologia , Desempenho Psicomotor/fisiologia , Recuperação de Função Fisiológica/fisiologia , Traumatismos da Medula Espinal/terapia , Estimulação da Medula Espinal/tendências , Humanos , Córtex Sensório-Motor/fisiologia , Medula Espinal/fisiologia , Traumatismos da Medula Espinal/fisiopatologia , Estimulação da Medula Espinal/métodos
5.
Neuromodulation ; 22(3): 302-310, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30865341

RESUMO

OBJECTIVES: Surgical site infections (SSIs) result in significant negative clinical and economic outcomes. The objective of this study is to estimate annual health expenditures associated with spinal cord stimulation (SCS)-related infections. MATERIALS AND METHODS: Data from the Truven MarketScan® databases were used to identify patients with an SCS implant (2009-2014) and a continuous health plan enrollment for at least 12-months before and after implant (index date). Annual expenditures were estimated for patients with a device-related infection vs. those without infection since index date. A generalized linear model estimated annual expenditures attributable to device-related infection. Multivariable expenditure models were conducted separately for patients in initial and replacement groups, controlling for demographics, comorbidities, and clinical characteristics. RESULTS: The study included 6615 patients. Multivariable expenditure models revealed that patients with infection have higher annual expenditures than patients without infection. Estimated incremental annual healthcare expenditures for patients with an infection were $59,716 (95% CI: $48,965-$69,480) for initial implanted patients and $64,833 (95% CI: $37,377-$86,519) for replacement patients. Only 26% of patients who were explanted for infection underwent a reimplant. CONCLUSIONS: These results show the substantial expenditure burden associated with an SCS-related infection. Management of SCS-related infection is important from both clinical and economic standpoints. The economic and clinical data presented here reinforce the need for additional research and strategies for healthcare providers to minimize SCS infections. Future economic research is needed to further define the specific economic cost drivers associated with the extensive expenditure burden.


Assuntos
Bases de Dados Factuais/tendências , Gastos em Saúde/tendências , Reembolso de Seguro de Saúde/tendências , Estimulação da Medula Espinal/tendências , Infecção da Ferida Cirúrgica/epidemiologia , Adulto , Idoso , Bases de Dados Factuais/economia , Feminino , Seguimentos , Humanos , Reembolso de Seguro de Saúde/economia , Masculino , Pessoa de Meia-Idade , Estimulação da Medula Espinal/efeitos adversos , Estimulação da Medula Espinal/economia , Infecção da Ferida Cirúrgica/diagnóstico , Infecção da Ferida Cirúrgica/economia , Estados Unidos/epidemiologia
6.
Neuromodulation ; 22(3): 262-268, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30620420

RESUMO

OBJECTIVES: The impact of spinal cord stimulation (SCS) on serum levels of metalloproteinase-2 (MMP-2) and metalloproteinase-9 (MMP-9) was assessed in a group of patients with failed back surgery syndrome (FBSS). The study was to give new insights into the SCS mechanism of action and the role of MMP-2 and MMP-9 in the development of NP. MATERIAL AND METHODS: Clinical assessments were performed and biochemical markers were determined in two groups of patients: the control group (24 individuals) and the FBSS group (24 patients). Seventeen patients with the FBSS had SCS implanted and were examined before surgical procedure, one month after (17 patients), and three months after operation (12 patients). Clinical status was assessed with the use numeric rating scale, pain rating index of McGill pain questionnaire, Oswestry disability index and Beck depression inventory. MMP-2 and MMP-9 serum levels were determined using gelatin zymography. Immunoenzymatic method was employed to determine plasma concentrations of tissue inhibitors of metalloproteinases (TIMPs). RESULTS: Levels of MMP-2 and TIMP-2 were higher in the FBSS group compared to the control group. The difference was statistically significant (p < 0.001 and p = 0.004, respectively). The concentration of MMP-2 was significantly increased (p = 0.0135) one-month post-SCS and remained elevated but stable up to three months after implantation. TIMP-2, MMP-2/TIMP-2, MMP-9, TIMP-1, and MMP-9/TIMP-1 serum levels did not change significantly. CONCLUSIONS: MMPs may play a role in the development of FBSS. SCS increases the already elevated MMP-2 serum levels which are associated with neuroinflammatory processes in FBSS patients.


Assuntos
Síndrome Pós-Laminectomia/sangue , Síndrome Pós-Laminectomia/terapia , Metaloproteinase 2 da Matriz/sangue , Metaloproteinase 9 da Matriz/sangue , Estimulação da Medula Espinal/tendências , Adulto , Idoso , Biomarcadores/sangue , Eletrodos Implantados , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor/métodos , Estudos Prospectivos , Estimulação da Medula Espinal/métodos
7.
Reg Anesth Pain Med ; 44(1): 107-110, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30640661

RESUMO

BACKGROUND AND OBJECTIVE: We investigated whether an effective long-term pain relief could be achieved using subthreshold 1-1.2 kHz spinal cord stimulation (SCS) among patients who were initially implanted with traditional paresthesia-based SCS but who failed to maintain an adequate pain relief. METHODS: Retrospective chart review was conducted of patients' electronic records who underwent a trial of subthreshold 1-1.2 kHz SCS. One hundred and nine patients implanted and programmed at traditional paresthesia-based frequencies 40-90 Hz (low-frequency SCS) with unsatisfactory pain relief or unpleasant paresthesias were identified. Patients' settings were switched to 1-1.2 kHz and 60-210 µs, and variable amplitude adjusted to subthreshold. Pain scores and medication usage were collected. Complete data are presented on 95 patients. RESULTS: Data were collected from 36 men and 59 women who were converted from above-threshold 40-90 Hz SCS to 1-1.2 kHz SCS, with a minimum follow-up of 12 months. Nearly a third (63/95 or 66.3%) of the subjects deemed 1-1.2 kHz SCS ineffective and returned to low-frequency SCS within 1 week after switch, and one-sixth (16/95 or 16.8%) of the subjects returned to low-frequency SCS within 1 month. Only 13 (13.7%) subjects continued using 1-1.2 kHz subthreshold SCS for 3 months or longer and 2.1% (2/95) of subjects continued using it at 12 months. A comparison of their pain scores and opioid use before and during the time we used 1-1.2 kHz SCS revealed no significant difference. CONCLUSION: The results from our single center failed to show additional long-term clinical benefit of 1-1.2 kHz subthreshold SCS in patients with chronic pain failing traditional low-frequency SCS.


Assuntos
Manejo da Dor/métodos , Medição da Dor/métodos , Parestesia/terapia , Estimulação da Medula Espinal/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Dor/diagnóstico , Manejo da Dor/tendências , Medição da Dor/tendências , Parestesia/diagnóstico , Estudos Retrospectivos , Estimulação da Medula Espinal/tendências , Fatores de Tempo , Falha de Tratamento , Resultado do Tratamento
8.
Neuromodulation ; 22(3): 253-261, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30117650

RESUMO

BACKGROUND: Chronic pain has a substantial negative impact on work-related outcomes, which underscores the importance of interventions to reduce the burden. Spinal cord stimulation (SCS) efficiently causes pain relief in specific chronic pain syndromes. The aim of this review was to identify and summarize evidence on returning to work in patients with chronic pain treated with SCS. MATERIALS AND METHODS: A systematic literature review was performed including studies from PubMed, EMBASE, SCOPUS, and Web of Science (up till October 2017). Risk of bias was assessed using a modified version of the Downs & Black checklist. Where possible, we pooled data using random effects meta-analysis. The study protocol was registered prior to initiation of the review process (PROSPERO CRD42017077803). RESULTS: Fifteen full-text articles (total articles screened: 2835) were included. Risk of bias for these articles was scored low. Seven trials provided sufficient data and were judged similar enough to be pooled for meta-analysis on binary outcomes. SCS intervention results in a higher prevalence of patients at work compared with before treatment (odds ratio [OR] 2.15; 95% confidence interval [CI], 1.44-3.21; I2 = 42%; p < 0.001). SCS treatment also results in high odds to return to work (OR 29.06; 95% CI, 9.73-86.75; I2 = 0%; p < 0.001). CONCLUSIONS: Based on available literature, SCS proved to be an effective approach to stimulate return to work in patients with specific chronic pain syndromes.


Assuntos
Dor Crônica/terapia , Manejo da Dor/tendências , Retorno ao Trabalho/tendências , Estimulação da Medula Espinal/tendências , Dor Crônica/diagnóstico , Humanos , Manejo da Dor/métodos , Medição da Dor/métodos , Medição da Dor/tendências , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Estudos Retrospectivos , Estimulação da Medula Espinal/métodos
9.
Neuromodulation ; 22(3): 311-316, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30255537

RESUMO

BACKGROUND: To date, clinical pain research has typically used subjective questionnaires to assess effectiveness of treatment. However, in the near future, new technologies may provide us objective outcome measures as an alternative to self-report. The goal of this study is to compare subjective and objective sleep assessments in a population of failed back surgery syndrome (FBSS) patients, treated with spinal cord stimulation (SCS). METHODS: Twenty-two patients diagnosed with FBSS received SCS. Sleep data was collected at three time point: prior to SCS implantation (B), one month after SCS (T1), and two months after SCS (T2). Sleep data measured by actigraphy provided objective sleep data and were compared to Pittsburgh sleep quality index (PSQI) scores. Agreement between sleep parameters, total sleep time (TST), sleep efficiency (SE), and sleep onset latency (SOL), was examined. RESULTS: Nineteen out of 22 patients completed the study. We identified significant differences between objective and subjective measurements for TST and SE at baseline and after two months of SCS, with patients underestimating both parameters on the PSQI in comparison to objective measurements. For SOL no significant differences were found, although patients subjectively overestimated SOL at B. CONCLUSION: The results about sleep measurements shown in this population of chronic pain patients, suggest that the subjective ratings scored worse than the objective measurements. Second, short-term SCS mainly seems to affect subjectively measured sleep parameters, especially SOL. This study shows the discrepancies between objective and subjective assessments in chronic pain research. Objective tools are indispensable for a correct assessment and treatment of sleep parameters. They are also playing a role as a biofeedback tool and are supporting the rehabilitation process.


Assuntos
Actigrafia/tendências , Síndrome Pós-Laminectomia/terapia , Autorrelato , Sono/fisiologia , Estimulação da Medula Espinal/tendências , Actigrafia/métodos , Actigrafia/normas , Adulto , Idoso , Síndrome Pós-Laminectomia/diagnóstico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor/métodos , Medição da Dor/tendências , Autorrelato/normas , Estimulação da Medula Espinal/métodos , Inquéritos e Questionários
10.
J Am Acad Orthop Surg ; 27(9): e401-e407, 2019 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-30358637

RESUMO

Chronic pain causes a tremendous burden on the society in terms of economic factors and social costs. Rates of spinal surgery, especially spinal fusion, have increased exponentially over the past decade. The opioid epidemic in the United States has been one response to the management of pain, but it has been fraught with numerous catastrophic-related adverse effects. Clinically, spinal cord stimulation (SCS)/neuromodulation has been used in the management of chronic pain (especially spine-related pain) for more than two decades. More recent advances in this field have led to new theories and approaches in which SCS can be used in the management of chronic spine-related pain with precision and efficacy while minimizing adverse effects commonly seen with other forms of chronic pain treatment (eg, narcotics, injections, ablations). Narcotic medications have adverse effects of habituation, nausea, constipation, and the like. Injections sometimes lack efficacy and can have only limited duration of efficacy. Also, they can have adverse effects of cerebrospinal fluid leak, infection, and so on. Ablations can be associated with burning discomfort, lack of efficacy, recurrent symptoms, and infection. High-frequency stimulation, burst stimulation, tonic stimulation with broader paddles, and new stimulation targets such as the dorsal root ganglion hold promise for improved pain management via neuromodulation moving forward. Although a significant rate of complications with SCS technology are well described, this can be a useful tool in the management of chronic spine-related pain.


Assuntos
Dor Crônica/terapia , Manejo da Dor/métodos , Estimulação da Medula Espinal/métodos , Estimulação Elétrica Nervosa Transcutânea/métodos , Análise Custo-Benefício , Humanos , Entorpecentes/efeitos adversos , Manejo da Dor/tendências , Estimulação da Medula Espinal/efeitos adversos , Estimulação da Medula Espinal/tendências , Estimulação Elétrica Nervosa Transcutânea/efeitos adversos , Estimulação Elétrica Nervosa Transcutânea/tendências
11.
Neuromodulation ; 22(3): 280-289, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30536545

RESUMO

OBJECTIVES: Previous studies demonstrated significant improvement in mean pain scores and quality of life (QOL) scales in patients with chronic pain who underwent spinal cord stimulation (SCS). However, the number of individuals who experience relevant improvements in QOL, termed the meaningful clinical improvement (MCI), is not known. The present study investigated changes in pain measurements based on MCI after SCS. MATERIALS AND METHODS: Thirty-four patients with chronic intractable pain completed scales of pain (visual analogue scale [VAS]), QOL (SF-36), and psychological dimensions during a 22-month follow-up period (mean). Patient-centered MCI of the VAS and SF-36 domain scores were determined based on the MacNab criteria of surgical global effectiveness. Independent presurgical predictors for MCI in the VAS and SF-36 domains were analyzed using multiple binary logistic regression. RESULTS: There was significant improvement of pain and QOL after the SCS (p < 0.00001). Twenty-three patients (67.6%) reached an MCI of pain, and 16 (47.7%)-23 (67.7%) reported an MCI of QOL. Predictors of MCI included ≥80% paresthesia coverage of the painful area, lower levels of anxiety and catastrophizing symptoms, shorter pain duration, female gender and no use of opioids before surgery. MCI of pain and QOL was observed in 50%-70% of patients with chronic pain after SCS. CONCLUSIONS: The identification of determinants for MCI is a challenge to improve the accuracy of prognostic models in SCS for patients with chronic pain. Our results, if confirmed in other populations with a larger sample size, have implications for patients with chronic pain who are candidates for SCS treatment.


Assuntos
Dor Crônica/terapia , Medição da Dor/tendências , Dor Intratável/terapia , Qualidade de Vida , Estimulação da Medula Espinal/tendências , Adulto , Idoso , Dor Crônica/diagnóstico , Dor Crônica/psicologia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor/psicologia , Dor Intratável/diagnóstico , Dor Intratável/psicologia , Valor Preditivo dos Testes , Qualidade de Vida/psicologia , Estimulação da Medula Espinal/psicologia , Resultado do Tratamento
12.
Neuromodulation ; 22(3): 235-243, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30311715

RESUMO

BACKGROUND: There is increasing literature evidence both clinically and experimentally on the existence of potent, adaptive interactions between the central and peripheral aspects of the neuroimmune system in the genesis and maintenance of chronic neuropathic extremity pain and nociceptive back pain. The neuroinflammatory pathways are modulated by the interaction of pro- and anti-inflammatory cytokines and chemokines, which are released by peripheral immune system-derived cell species (macrophages and leukocytes). This review examines the possible impact of spinal and peripheral neurostimulation on the inflammatory response in the context of acute and chronic pain pathologies of different origin. STUDY DESIGN: A narrative review of preclinical and clinical studies addressed to the spinal cord and peripheral nerve stimulation and neuroinflammation. METHODS: Available literature was reviewed on neurostimulation technologies and both acute and chronic low-grade inflammation to identify primary outcome measures and to provide an overview of postulated mechanisms of action of neurostimulation on host inflammatory responses. Data sources included relevant literature identified through searches of PubMed, MEDLINE/OVID, SCOPUS, and manual searches of the bibliographies of known primary and review articles. RESULTS: A comprehensive review of the literature indicates an alternate or synergistic mechanism of action of neurostimulation, beyond modulating somatosensory pain pathways, in modifying inflammatory response associated with chronic pain, by promoting a systemic anti-inflammatory state with upregulation of anti-inflammatory mediators. CONCLUSIONS: These preliminary findings may have important implications on the potential applications of neurostimulation as an anti-inflammatory therapy and the role of molecular profiling as a preimplant screening modality and post-implant outcome validation. Thus, future targeted clinical and experimental research is highly warranted in this particular novel field of neuromodulation.


Assuntos
Dor Crônica/terapia , Manejo da Dor/tendências , Doenças do Sistema Nervoso Periférico/terapia , Estimulação da Medula Espinal/tendências , Medula Espinal/fisiologia , Estimulação Elétrica Nervosa Transcutânea/tendências , Dor Crônica/fisiopatologia , Previsões , Humanos , Inflamação/fisiopatologia , Inflamação/terapia , Neuralgia/fisiopatologia , Neuralgia/terapia , Manejo da Dor/métodos , Doenças do Sistema Nervoso Periférico/fisiopatologia , Estimulação da Medula Espinal/métodos , Estimulação Elétrica Nervosa Transcutânea/métodos
14.
Reg Anesth Pain Med ; 43(7): 768-775, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30192304

RESUMO

BACKGROUND AND OBJECTIVES: Despite the observation that select nicotine receptor agonists have analgesic effects, smokers report higher pain scores and more functional impairments than lifelong nonsmokers, attributable to exaggerated stress responses, receptor desensitization, and altered pharmacokinetics compounded by accelerated structural damage resulting from impaired bone healing, osteoporosis, and advancement of disk disease. We hypothesized that smoking diminishes the analgesic response to spinal cord stimulation (SCS) in patients with chronic spine-related pain conditions. METHODS: A retrospective cohort study was performed at Cleveland Clinic by collecting and assessing data of 213 patients who had been implanted with SCS for spine-pain indications. History of tobacco smoking was subcategorized into 3 categories: past (former smoker), present (current smoker), or those who had never previously smoked (lifelong nonsmokers), and a multivariable linear regression was run to measure the correlation, if any, between smoking status and numerical rating scale pain score. In addition, opioid consumption at baseline and 12-month follow-up, expressed in milligram oral morphine equivalents, was collected and compared. RESULTS: Adjusted for differences, at 1-year follow-up, current smokers (n = 62) reported numerical rating scale pain score of 7.0, which is 1.93 (P < 0.001) and 1.32 (P = 0.001) points higher than those of lifelong nonsmokers (n = 77) and former smokers (n = 74), respectively. Opioid intake was 2.4 times higher (P = 0.004) in smokers than in lifelong nonsmokers. CONCLUSIONS: Among our SCS-implanted sample, a positive correlation was observed between tobacco use and degree of pain reduction as early as 12 months postimplant; this was evident by the reported higher pain scores and opioid use in current smokers in comparison with former smokers and lifelong nonsmokers.


Assuntos
Dor nas Costas/terapia , Dor Crônica/terapia , Fumar Cigarros/tendências , Medição da Dor/tendências , Estimulação da Medula Espinal/tendências , Adulto , Idoso , Dor nas Costas/diagnóstico , Dor nas Costas/epidemiologia , Dor Crônica/diagnóstico , Dor Crônica/epidemiologia , Fumar Cigarros/efeitos adversos , Fumar Cigarros/epidemiologia , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor/métodos , Estudos Retrospectivos , Estimulação da Medula Espinal/métodos , Resultado do Tratamento
15.
Reg Anesth Pain Med ; 43(4): 391-406, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29481371

RESUMO

To assess the efficacy of spinal cord stimulation (SCS) for each indication, one must critically assess each specific clinical outcome to identify outcomes that benefit from SCS therapy. To date, a comprehensive review of clinically relevant outcome-specific evidence regarding SCS has not been published. We aimed to assess all randomized controlled trials from the world literature for the purpose of evaluating the clinical outcome-specific efficacy of SCS for the following outcomes: perceived pain relief or change pain score, quality of life, functional status, psychological impact, analgesic medication utilization, patient satisfaction, and health care cost and utilization. Interventions were SCS, without limitation to the type of controls or the type of SCS in the active arms. For each study analyzed, a quality assessment was performed using a validated scale that assesses reporting, external validity, bias, confounding, and power. Each outcome was assessed specific to its indication, and the primary measure of each abovementioned outcome was a summary of the level of evidence. Twenty-one randomized controlled trials were analyzed (7 for trunk and limb pain, inclusive of failed back surgery syndrome; 8 for refractory angina pectoris; 1 for cardiac X syndrome; 3 for critical limb ischemia; 2 for complex regional pain syndrome; and 2 for painful diabetic neuropathy). Evidence assessments for each outcome for each indication were depicted in tabular format. Outcome-specific evidence scores were established for each of the abovementioned indications, providing both physicians and patients with a summary of evidence to assist in choosing the optimal evidence-based intervention. The evidence presented herein has broad applicability as it encompasses a breadth of patient populations, variations of SCS therapy, and comparable controls that, together, reflect comprehensive clinical decision making.


Assuntos
Manejo da Dor/tendências , Medição da Dor/tendências , Ensaios Clínicos Controlados Aleatórios como Assunto , Estimulação da Medula Espinal/tendências , Humanos , Dor/diagnóstico , Dor/epidemiologia , Manejo da Dor/métodos , Medição da Dor/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Estimulação da Medula Espinal/métodos , Fatores de Tempo , Resultado do Tratamento
16.
Pain Physician ; 20(6): E797-E805, 2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28934786

RESUMO

BACKGROUND: Failed back surgery syndrome (FBSS) is a cause of significant morbidity for up to 40% of patients following spine surgery, and is estimated to cost almost $20 billion. Treatment options for these patients currently include conventional medical management (CMM), repeat operation, or spinal cord stimulation (SCS). Much of the published data regarding cost effectiveness of SCS comprise smaller scale randomized controlled trials (RCTs) rather than large databases capturing practices throughout the US. SCS has been shown to have superior outcomes to CMM or repeat spinal operation in several landmark studies, yet there are few large studies examining its long-term economic impact. OBJECTIVES: This study compares health care utilization for SCS compared to other management in patients with FBSS. STUDY DESIGN: Retrospective. SETTING: Inpatient and outpatient sample. METHODS: Patients with a history of FBSS from 2000 to 2012 were selected. We compared those who received SCS to those who underwent conventional management. A longitudinal analysis was used to model the value of log(cost) in each one year interval using a generalized estimating equations (GEE) model to account for the correlation of the same patient's cost in multiple years. Similarly, a Poisson GEE model with the log link was applied to correlated count outcomes. RESULTS: We identified 122,827 FBSS patients. Of these, 5,328 underwent SCS implantation (4.34%) and 117,499 underwent conventional management. Total annual costs decreased over time following implantation of the SCS system, with follow-up analysis at 1, 3, 6, and 9 years. The longitudinal GEE model demonstrated that placement of an SCS system was associated with an initial increase in total costs at the time of implantation (cost ratio [CR]: 1.74; 95% confidence interval [CI]: 1.41, 2.15, P < 0.001), however there was a significant and sustained 68% decrease in cost in the year following SCS placement (CR: 0.32; 95% CI: 0.24, 0.42, P < 0.001) compared to CMM. There was also an aggregate time trend that for each additional year after SCS, cost decreased on average 40% percent annually (CR: 0.60; 95% CI: 0.55, 0.65, P < 0.001), with follow-up up to 1, 3, 6, and 9 years post-procedure. LIMITATIONS: Costs are not correlated with patient outcomes, patients are not stratified in terms of complexity of prior back surgery, as well as inherent limitations of a retrospective analysis. CONCLUSIONS: We found that from 2000 to 2012, only 4.3% of patients across the United States with FBSS were treated with SCS. Long-term total annual costs for these patients were significantly reduced compared to patients with conventional management. Although implantation of an SCS system results in a short-term increase in costs at one year, the subsequent annual cumulative costs were significantly decreased long-term in the following 9 years after implantation. This study combines the largest group of FBSS patients studied to date along with the longest follow-up interval ever analyzed. Since SCS has repeatedly been shown to have superior efficacy to CMM in randomized clinical trials, the current study demonstrating improved long-term health economics at 1, 3, 6, and 9 years supports the long-term cost utility of SCS in the treatment of FBSS patients. Key words: Failed back surgery syndrome, spinal cord stimulation, back pain, leg pain, neuromodulation, FBSS, SCS.


Assuntos
Análise Custo-Benefício/tendências , Síndrome Pós-Laminectomia/economia , Síndrome Pós-Laminectomia/terapia , Estimulação da Medula Espinal/economia , Estimulação da Medula Espinal/tendências , Idoso , Feminino , Seguimentos , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Procedimentos Neurocirúrgicos/efeitos adversos , Procedimentos Neurocirúrgicos/economia , Procedimentos Neurocirúrgicos/tendências , Aceitação pelo Paciente de Cuidados de Saúde , Reoperação/economia , Reoperação/tendências , Estudos Retrospectivos , Estimulação da Medula Espinal/métodos , Fatores de Tempo
17.
Neuromodulation ; 20(6): 600-605, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28699685

RESUMO

OBJECTIVES: Pain encountered at the site of the implantable pulse generator (IPG) after invasive neuromodulation is a well-known and important complication. The reported incidence of implant site pain is variable, ranging between 0.4 and 35%. Implant site pain has never been systematically studied and no treatment guidelines are available. MATERIAL AND METHODS: We performed an observational study (study registration number mp05728) on the incidence and the determining factors of implant site pain, the subjective rating of intensity by sending questionnaires (n = 554) to our cohort of neuromodulation patients with IPGs. The number of revision surgeries and explants due to implant site pain were also analyzed. RESULTS: Total response rate was 50% (n = 278). Pain patients suffered significantly (p < 0.05) more often from IPG site pain than other patients undergoing neuromodulation therapies. Up to 64% of patients undergoing spinal cord stimulation reported IPG site discomfort or pain. Severe pocket pain was found in up to 8% of patients. No association was found between other variables (age, BMI, duration of follow-up, gender, smoking, number of pocket surgeries) and implant site pain. CONCLUSION: Pocket pain represents an important problem after invasive neuromodulation and is more prevalent in pain patients. We believe further technological improvements with miniaturized IPGs will impact the incidence of pocket pain and could even obviate the need for an IPG pocket.


Assuntos
Eletrodos Implantados/tendências , Dor Pós-Operatória/diagnóstico , Dor Pós-Operatória/etiologia , Estimulação da Medula Espinal/tendências , Estimulação Elétrica Nervosa Transcutânea/tendências , Idoso , Estudos Transversais , Eletrodos Implantados/efeitos adversos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Dor , Reoperação/tendências , Estudos Retrospectivos , Estimulação da Medula Espinal/efeitos adversos , Inquéritos e Questionários , Estimulação Elétrica Nervosa Transcutânea/efeitos adversos
18.
Spine (Phila Pa 1976) ; 42 Suppl 14: S41-S52, 2017 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-28505029

RESUMO

STUDY DESIGN: A significant number of lumbar postsurgical patients continue to suffer persistent pain and limited function and are termed to have "Failed back surgery syndrome" (FBSS). This review evaluates clinical trial data for the treatment of FBSS patients. OBJECTIVE: Using an evidence-based approach to evaluate FBSS treatments will assist clinicians in choosing the most effective options for FBSS patients. Furthermore, reducing the utilization of less effective therapies may result in substantial financial savings for this patient population. SUMMARY OF BACKGROUND DATA: Treatments for FBSS may be generally categorized as physical therapy and exercise, medications, interventional procedures, neuromodulation, and reoperation. Careful review and classification of the level of evidence available for each category of treatment for FBSS patients will help guide clinical decision-making. METHODS: A literature review was performed for FBSS treatments. The publications were arranged hierarchically according to the North American Spine Society's guidelines as randomized controlled trials (RCTs), prospective studies, retrospective chart, and systematic reviews. Book chapters, nonsystematic reviews, and expert opinions were excluded. The review focused on studies with at least 20 FBSS patients and 6-month follow-up. RESULTS: Evidence is weak for medications and reoperation, but strong for active exercise and interventional procedures such as adhesiolysis. The strongest evidence for long-term treatment is for spinal cord stimulation (SCS), showing favorable Level I RCT results compared with conventional medical management and reoperation. In addition, high-frequency SCS at 10 kHz has demonstrated superiority over traditional, low-frequency SCS for treating low back and leg pain in a recent Level I RCT. CONCLUSION: Clinicians may increasingly utilize levels of evidence during their evaluation of each FBSS patient to render the best therapeutic plan, likely resulting in improved long-term pain control and reducing costs by avoiding less effective modalities. New directions in SCS show promising results for the treatment of FBSS. LEVEL OF EVIDENCE: 1.


Assuntos
Dor Crônica/terapia , Medicina Baseada em Evidências/métodos , Síndrome Pós-Laminectomia/terapia , Manejo da Dor/métodos , Dor Intratável/terapia , Adulto , Dor Crônica/diagnóstico , Medicina Baseada em Evidências/tendências , Síndrome Pós-Laminectomia/diagnóstico , Feminino , Humanos , Masculino , Manejo da Dor/tendências , Dor Intratável/diagnóstico , Modalidades de Fisioterapia/tendências , Estudos Prospectivos , Reoperação/métodos , Reoperação/tendências , Estudos Retrospectivos , Estimulação da Medula Espinal/métodos , Estimulação da Medula Espinal/tendências , Resultado do Tratamento
19.
Neuromodulation ; 20(6): 558-562, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28493599

RESUMO

OBJECTIVES: Spinal cord stimulation is an evidence-based treatment for a number of chronic pain conditions. While this therapy offers improvement in pain and function it is not without potential complications. These complications include device failure, migration, loss of therapeutic paresthesia, and infection. This article looked to establish a modern infection rate for spinal cord stimulators, assess the impact of known risk factors for surgical site infections and to determine the impact of certain preventative measures on the rate of infection. METHODS: After institutional review board approval, a multisite, retrospective review was conducted on 2737 unique implants or revisions of SCS systems. Patient demographics, risk factors including diabetes, tobacco use, obesity, revision surgery, trial length, implant location, implant type, surgeon background, prophylactic antibiotic use, utilization of a occlusive dressing, and post-operative antibiotic use were recorded and analyzed. RESULTS: The overall infection rate was 2.45% (n = 67). Diabetes, tobacco use, and obesity did not independently increase the rate of infection. Revision surgeries had a trend toward higher infection rate; however, this did not meet statistical significance. There was no difference in the rate of infection between implants performed by physicians of different base specialties, cylinder leads vs. paddle leads, or between different prophylactic antibiotics. Implants performed at academic centers had a higher rate of infection when compared to implants performed in nonacademic settings. When patients received an occlusive dressing or post-operative antibiotics they had a lower rate of infection. CONCLUSIONS: The infection rate (2.45%) reported in this study is lower than the previously reported rates (3-6%) and are on par with other surgical specialties. This study did not show an increased rate of infection for patients that used tobacco, had diabetes or were obese. It's possible that given the low overall infection rate a larger study is needed to establish the true impact of these factors on infection. In addition, this study did not address the impact of poorly controlled diabetes mellitus (elevated hemoglobin A1c) vs. well-controlled diabetes. It can be concluded from this study that utilizing an occlusive dressing over the incision in the post-operative period decreases the rate of infection and should become the standard of care. This study also demonstrated the positive impact of post-operative antibiotics in decreasing the rate of infection. Studies in other surgical specialties have not shown this impact which would suggest that further research is needed.


Assuntos
Eletrodos Implantados/tendências , Contaminação de Equipamentos , Estimulação da Medula Espinal/tendências , Infecção da Ferida Cirúrgica/diagnóstico , Infecção da Ferida Cirúrgica/etiologia , Adulto , Idoso , Antibacterianos/uso terapêutico , Eletrodos Implantados/efeitos adversos , Eletrodos Implantados/microbiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Estimulação da Medula Espinal/efeitos adversos , Estimulação da Medula Espinal/instrumentação , Infecção da Ferida Cirúrgica/tratamento farmacológico
20.
Neuromodulation ; 20(4): 340-347, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28370989

RESUMO

OBJECTIVES: Spinal cord stimulation (SCS) has emerged as an appropriate modality of treatment for intractable chronic pain. The present study examines variations in SCS trial-to-permanent conversion rates based on provider types performing the procedure. MATERIALS AND METHODS: We designed a large, retrospective analysis using the Truven MarketScan data base analyzing adult SCS patients with provider information available, with or without IPG implantation from the years 2007-2012. Patients were categorized based on provider type performing the implantation including anesthesiologists, neurosurgeons, orthopedic surgeons, and physical medicine and rehabilitation (PM&R). Univariate and multivariate models identified factors associated with successful conversion. RESULTS: A total of 7667 unique instances of SCS implants were identified across five providers. Overall, 4842 (63.2%) of those receiving trials underwent permanent SCS system implantation. Anesthesiology performed the majority of implants (62.8%), followed by neurosurgery (22.0%), orthopedic surgery (10.2%), and PM&R (5.3%). Compared to anesthesiologists, both neurosurgeons (OR 10.99, 95% CI [9.11, 13.25]; p < 0.001) and orthopedic surgeons (OR 4.64, 95% CI [3.81, 5.65]; p < 0.001) had significantly higher conversion rates, while PM&R (OR 0.71, 95% CI [0.58, 0.87]; p = 0.001) had significantly lower. Percutaneous implants comprised 5473 (71.4%) of all implants. Neurosurgeons and orthopedic surgeons performed a significantly greater number of paddle implants among the different providers (p < 0.0001). Explant rates were similar across all cohorts analyzed (average 11.6%; p = 0.546). CONCLUSIONS: In this nationwide analysis, our results suggest that over a recent five-year period, conversion rates are highest when SCS trials are performed by neurosurgeons and orthopedic surgeons. The study has important implications for establishing uniform guidelines for training, patient selection, and education of physicians across multiple disciplines.


Assuntos
Dor Crônica/terapia , Medicina/normas , Medicina/tendências , Estimulação da Medula Espinal/normas , Estimulação da Medula Espinal/tendências , Adulto , Idoso , Dor Crônica/diagnóstico , Dor Crônica/epidemiologia , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
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