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Background: The use of sedation during interventional procedures has continued to rise resulting in increased costs, complications and reduced validity during diagnostic injections, prompting a search for alternatives. Virtual reality (VR) has been shown to reduce pain and anxiety during painful procedures, but no studies have compared it to a control and active comparator for a pain-alleviating procedure. The main objective of this study was to determine whether VR reduces procedure-related pain and other outcomes for epidural steroid injections (ESI). Methods: A randomized controlled trial was conducted in 146 patients undergoing an ESI at 6 hospitals in Thailand and the United States. Patients were allocated to receive immersive VR with local anesthetic, sedation with midazolam and fentanyl plus local anesthetic, or local anesthetic alone. The primary outcome was procedure-related pain recorded on a 0-10 scale. Other immediate-term outcome measures were pain from a standardized subcutaneous skin wheal, procedure-related anxiety, ability to communicate, satisfaction, and time to discharge. Intermediate-term outcome measures at 4 weeks included back and leg pain scores, function, and success defined as a ≥2-point decrease in average leg pain coupled with a score ≥5/7 on a Patient Global Impression of Change scale. Findings: Procedure-related pain scores with both VR (mean 3.7 (SD 2.5)) and sedation (mean 3.2 (SD 3.0)) were lower compared to control (mean 5.2 (SD 3.1); mean differences -1.5 (-2.7, -0.4) and -2.1 (-3.3, -0.9), respectively), but VR and sedation scores did not significantly differ (mean difference 0.5 (-0.6, 1.7)). Among secondary outcomes, communication was decreased in the sedation group (mean 3.7 (SD 0.9)) compared to the VR group (mean 4.1 (SD 0.5); mean difference 0.4 (0.1, 0.6)), but neither VR nor sedation was different than control. The trends favoring sedation and VR over control for procedure-related anxiety and satisfaction were not statistically significant. Post-procedural recovery time was longer for the sedation group compared to both VR and control groups. There were no meaningful intermediate-term differences between groups except that medication reduction was lowest in the control group. Interpretation: VR provides comparable benefit to sedation for procedure-related pain, anxiety and satisfaction, but with fewer side effects, superior communication and a shorter recovery period. Funding: Funded in part by grants from MIRROR, Uniformed Services University of the Health Sciences, U.S. Dept. of Defense, grant # HU00011920011. Equipment was provided by Harvard MedTech, Las Vegas, NV.
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Sustained widespread deployment of clinically and cost-effective models of integrated pain care could be bolstered by optimally aligning shared stakeholder values.
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OBJECTIVE: The objective was to qualitatively synthesize all reported cases of complications, adverse effects, side effects, or harms arising from the use of scrambler therapy (ST). METHODS AND DESIGN: A systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. The PubMed, Embase, Scopus, Web of Science, United States National Library of Medicine clinical trials registry, and Cochrane Central Register of Controlled Trials databases were searched from database inception to December 10, 2021. Case reports/series, abstracts, retrospective studies, and prospective studies (e.g., open-label trials, randomized controlled trials) pertaining to ST and any description of a complication, adverse effect, side effect, or harm were screened. The search protocol was developed a priori and registered via the International Prospective Register of Systematic Reviews (PROSPERO ID: CRD42021291838). RESULTS: A total of six RCTs, 19 prospective open-label trials, and 11 case series / case reports met the inclusion criteria, comprising 1,152 total patients. Two patients experienced contact dermatitis, and one patient reported minor ecchymosis that resolved without intervention. This yielded a composite complication rate of 0.26% (3/1,152). There were zero reported serious adverse events. CONCLUSIONS: When used in accordance with the treatment protocols described by the United States Food and Drug Administration and device manual, ST is associated with a reported composite complication rate that is orders of magnitude lower than those of invasive neuromodulation devices. ST neuromodulation is a safe alternative for patients who cannot undergo invasive neuromodulation device implantation because of either risk or preference.
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Estados Unidos , Humanos , Estudios Prospectivos , Estudios RetrospectivosRESUMEN
OBJECTIVES: Many payers and health care providers are either currently using or considering use of prior authorization schemes to redirect patient care away from hospital outpatient departments toward free-standing ambulatory surgical centers owing to the payment differential between these facilities. In this work we work with a medium size payer to develop and lay out a process for analysis of claims data that allows payers to conservatively estimate potential savings from such policies based on their specific case mix and provider network. STUDY DESIGN: We analyzed payment information for a medium-sized managed care organization to identify movable cases that can reduce costs, estimate potential savings, and recommend implementation policy alternatives. METHODS: We analyze payment data, including all professional and institutional fees over a 15-month period. A rules-based algorithm was developed to identify episodes of care with at least one alternate site for each episode, and potential savings from a site-of-service policy. RESULTS: Data on 64,884 episodes of care were identified as possible instances that could be subject to the policy. Of those, 7,679 were found to be attractive candidates for movement. Total projected savings was approximately $8.2 million, or over $1,000 per case. CONCLUSIONS: Instituting a site-of-service policy can produce meaningful savings for small and medium payers. Tailoring the policy to the specific patient and provider population can increase the efficacy of such policies in comparison to policies previously established by other payers.
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Instituciones de Atención Ambulatoria , Autorización Previa , Costos y Análisis de Costo , Personal de Salud , Humanos , Derivación y Consulta , Estados UnidosRESUMEN
The clinical manifestations of Marfan syndrome frequently cause pain. This study aimed to characterize pain in a cohort of adults with Marfan syndrome and investigate demographic, physical, and psychological factors associated with pain and pain-related disability. Two hundred and forty-five participants (73% female, 89% non-Hispanic white, 90% North American) completed an online questionnaire assessing clinical features of Marfan syndrome, pain severity, pain-related disability, physical and mental health, depressive symptoms, pain catastrophizing, and insomnia. Eighty-nine percent of respondents reported having pain with 28% of individuals reporting pain as a presenting symptom of Marfan syndrome. Almost half of individuals reported that pain has spread from its initial site. Participants in our study reported poor physical and mental health functioning, moderate pain-related disability, and mild levels of depressive symptoms, sleep disturbances, and pain catastrophizing. Those who identified pain as an initial symptom of Marfan syndrome and those who reported that pain had spread from its initial site reported greater psychological burden compared with those without pain as an initial symptom or pain spreading. Physical health is the largest predictor of pain severity and pain-related disability. While pain catastrophizing and worse mental health functioning are significant correlates of pain severity and pain-related disability, respectively. Pain is a significant and persistent problem in Marfan syndrome and is associated with profound disability and psychological burden. Further studies are indicated to better characterize the directionality of pain, pain-related disability, and psychological burden in Marfan syndrome. © 2016 Wiley Periodicals, Inc.
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Personas con Discapacidad , Síndrome de Marfan/diagnóstico , Síndrome de Marfan/psicología , Dolor/diagnóstico , Fenotipo , Adolescente , Adulto , Anciano , Femenino , Humanos , Masculino , Síndrome de Marfan/epidemiología , Síndrome de Marfan/genética , Persona de Mediana Edad , Pruebas Neuropsicológicas , Dimensión del Dolor , Vigilancia de la Población , Sistema de Registros , Autoinforme , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios , Adulto JovenRESUMEN
OBJECTIVES: We examine interactions among 3 factors that affect patient waits and use of overtime in outpatient clinics: clinic congestion, patient punctuality and physician processing rates. We hypothesise that the first 2 factors affect physician processing rates, and this adaptive physician behaviour serves to reduce waiting times and the use of overtime. SETTING: 2 urban academic clinics and an affiliated suburban clinic in metropolitan Baltimore, Maryland, USA. PARTICIPANTS: Appointment times, patient arrival times, start of service and physician processing times were collected for 105 visits at a low-volume suburban clinic 1, 264 visits at a medium-volume academic clinic 2 and 22â 266 visits at a high-volume academic clinic 3 over 3 distinct spans of time. INTERVENTION: Data from the first clinic were previously used to document an intervention to influence patient punctuality. This included a policy that tardy patients were rescheduled. PRIMARY AND SECONDARY OUTCOME MEASURES: Clinicians' processing times were gathered, conditioned on whether the patient or clinician was tardy to test the first hypothesis. Probability distributions of patient unpunctuality were developed preintervention and postintervention for the clinic in which the intervention took place and these data were used to seed a discrete-event simulation. RESULTS: Average physician processing times differ conditioned on tardiness at clinic 1 with p=0.03, at clinic 2 with p=10-5 and at clinic 3 with p=10-7. Within the simulation, the adaptive physician behaviour degrades system performance by increasing waiting times, probability of overtime and the average amount of overtime used. Each of these changes is significant at the p<0.01 level. CONCLUSIONS: Processing times differed for patients in different states in all 3 settings studied. When present, this can be verified using data commonly collected. Ignoring these behaviours leads to faulty conclusions about the efficacy of efforts to improve clinic flow.
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Instituciones de Atención Ambulatoria , Citas y Horarios , Cooperación del Paciente/estadística & datos numéricos , Satisfacción del Paciente/estadística & datos numéricos , Médicos/psicología , Derivación y Consulta/estadística & datos numéricos , Instituciones de Atención Ambulatoria/estadística & datos numéricos , Femenino , Relaciones Paciente-Hospital , Humanos , Masculino , Maryland , Mejoramiento de la Calidad , Estudios Retrospectivos , Factores de Tiempo , Administración del TiempoRESUMEN
OBJECTIVE: Spinal cord stimulation (SCS) has become a widely used treatment option for a variety of pain conditions. Substantial variability exists in the degree of benefit obtained from SCS and patient selection is a topic of expanding interest and importance. However, few studies have examined the potential benefits of dynamic quantitative sensory testing (QST) to develop objective measures of SCS outcomes or as a predictive tool to help patient selection. Psychological characteristics have been shown to play an important role in shaping individual differences in the pain experience and may aid in predicting responses to SCS. Static laboratory pain-induction measures have also been examined in their capacity for predicting SCS outcomes. METHODS: The current study evaluated clinical, psychological and laboratory pain measures at baseline, during trial SCS lead placement, as well as 1 month and 3 months following permanent SCS implantation in chronic pain patients who received SCS treatment. Several QST measures were conducted, with specific focus on examination of dynamic models (central sensitization and conditioned pain modulation [CPM]) and their association with pain outcomes 3 months post SCS implantation. RESULTS: Results suggest few changes in QST over time. However, central sensitization and CPM at baseline were significantly associated with clinical pain at 3 months following SCS implantation, controlling for psycho/behavioral factors and pain at baseline. Specifically, enhanced central sensitization and reduced CPM were associated with less self-reported pain 3 months following SCS implantation. CONCLUSIONS: These findings suggest a potentially important role for dynamic pain assessment in individuals undergoing SCS, and hint at potential mechanisms through which SCS may impart its benefit.
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Dolor Crónico/psicología , Manejo del Dolor/métodos , Manejo del Dolor/psicología , Dimensión del Dolor/métodos , Estimulación de la Médula Espinal/métodos , Estimulación de la Médula Espinal/psicología , Adulto , Emociones , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Pruebas Neuropsicológicas , Dimensión del Dolor/psicología , Percepción del Dolor , Selección de Paciente , Fenotipo , Proyectos Piloto , Resultado del TratamientoRESUMEN
OBJECTIVES: This study investigated the effect on patient waiting times, patient/doctor contact times, flow times, and session completion times of having medical trainees and attending physicians review cases before the clinic session. The major hypothesis was that review of cases prior to clinic hours would reduce waiting times, flow times, and use of overtime, without reducing patient/doctor contact time. DESIGN: Prospective quality improvement. SETTING: Specialty pain clinic within Johns Hopkins Outpatient Center, Baltimore, MD, United States. PARTICIPANTS: Two attending physicians participated in the intervention. Processing times for 504 patient visits are involved over a total of 4 months. INTERVENTION: Trainees were assigned to cases the day before the patient visit. Trainees reviewed each case and discussed it with attending physicians before each clinic session. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary measures were activity times before and after the intervention. These were compared and also used as inputs to a discrete event simulation to eliminate differences in the arrival process as a confounding factor. RESULTS: The average time that attending physicians spent teaching trainees while the patient waited was reduced, but patient/doctor contact time was not significantly affected. These changes reduced patient waiting times, flow times, and clinic session times. CONCLUSIONS: Moving some educational activities ahead of clinic time improves patient flows through the clinic and decreases congestion without reducing the times that trainees or patients interact with physicians.
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Educación de Postgrado en Medicina/métodos , Internado y Residencia , Clínicas de Dolor , Evaluación de Procesos, Atención de Salud , Flujo de Trabajo , Centros Médicos Académicos , Humanos , Clínicas de Dolor/organización & administración , Médicos , Proyectos Piloto , Estudiantes de Medicina , Factores de TiempoRESUMEN
OBJECTIVES: The aim of this study was to examine the effects of an intervention to alter patient unpunctuality. The major hypothesis was that the intervention will change the distribution of patient unpunctuality by decreasing patient tardiness and increasing patient earliness. DESIGN: Prospective Quality Improvement. SETTING: Specialty Pain Clinic in suburban Baltimore, Maryland, USA. PARTICIPANTS: The patient population ranged in age from 18 to 93â years. All patients presenting to the clinic during the study period were included in the study. The average monthly volume was 86.2 (SD=13) patients. A total of 1500 patient visits were included in this study. INTERVENTIONS: We tracked appointment times and patient arrival times at an ambulatory pain clinic. An intervention was made in which patients were informed that tardy patients would not be seen and would be rescheduled. This policy was enforced over a 12-month period. PRIMARY AND SECONDARY OUTCOME MEASURES: The distribution of patient unpunctuality was developed preintervention and at 12â months after implementation. Distribution parameters were used as inputs to a discrete event simulation to determine effects of the change in patient unpunctuality on clinic delay. RESULTS: Data regarding patient unpunctuality were gathered by direct observation before and after implementation of the intervention. The mean unpunctuality changed from -20.5â min (110 observations, SD=1.7) preintervention to -23.2 (169, 1.2) at 1â month after the intervention, -23.8â min (69, 1.8) at 6â months and -25.0â min (71, 1.2) after 1â year. The unpunctuality 12â months after initiation of the intervention was significantly different from that prior to the intervention (p<0.05). CONCLUSIONS: Physicians and staff are able to alter patient arrival patterns to reduce patient unpunctuality. Reducing tardiness improves some measures of clinic performance, but may not always improve waiting times. Accommodating early arriving patients does serve to improve clinic performance.
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Citas y Horarios , Clínicas de Dolor , Cooperación del Paciente/estadística & datos numéricos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Humanos , Persona de Mediana Edad , Práctica Privada , Estudios Prospectivos , Mejoramiento de la Calidad , Factores de Tiempo , Adulto JovenRESUMEN
The purpose of this study was to determine if well-understood, positive reinforcement performance improvement models can successfully improve compliance by resident physicians with medication reconciliation in an outpatient clinical setting. During the preintervention phase, 36 anesthesiology residents who rotate in an outpatient pain clinic were instructed in the medication reconciliation process. During the postintervention phase, instruction was given, and then improvement was recognized publicly. Data on physician compliance were collected monthly. The authors performed a secondary analysis of the audit database, which contained 1733 patient charts. The data were divided into preintervention and postintervention phases for comparison. A 4-fold increase in compliance was found. When logistic regression was used to adjust for adaptation of resident physicians over time and year, the odds of reconciling were 82% higher postintervention. By the consistent application of this effective tool, the authors have demonstrated that sustained performance of a tedious but important task can be achieved.
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Instituciones de Atención Ambulatoria/organización & administración , Internado y Residencia/métodos , Conciliación de Medicamentos/métodos , Instituciones de Atención Ambulatoria/normas , Adhesión a Directriz/organización & administración , Adhesión a Directriz/normas , Adhesión a Directriz/estadística & datos numéricos , Humanos , Internado y Residencia/normas , Conciliación de Medicamentos/normas , Mejoramiento de la Calidad/organización & administración , Mejoramiento de la Calidad/normas , Refuerzo en PsicologíaRESUMEN
In this study, the relationship between patients' perceptions of pain control during hospitalization and their overall satisfaction with care was examined. Satisfaction data were collected from the federally mandated Hospital Consumer Assessment of Healthcare Providers and Systems survey for 4349 adult patients admitted to any surgical unit over an 18-month period. Patients' perceptions of pain control and staff's efforts to control pain were associated with their overall satisfaction scores. These perceptions varied widely among services and nursing units. Interestingly, patient satisfaction was more strongly correlated with the perception that caregivers did everything they could to control pain than with pain actually being well controlled. The odds of a patient being satisfied were 4.86 times greater if pain was controlled and 9.92 times greater if the staff performance was appropriate. Hospitals may improve their patients' satisfaction by focusing on improving the culture of pain management.
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Manejo del Dolor/estadística & datos numéricos , Percepción del Dolor , Satisfacción del Paciente/estadística & datos numéricos , Servicio de Cirugía en Hospital/estadística & datos numéricos , Adulto , Anciano , Baltimore , Recolección de Datos , Femenino , Hospitales de Enseñanza , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Dimensión del Dolor , Centros de Atención TerciariaRESUMEN
BACKGROUND: The medical, social, and economic effects of the teaching mission on delivery of care at an academic medical center (AMC) are not fully understood. When a free-standing private practice ambulatory clinic with no teaching mission was merged into an AMC, a natural experiment was created. The authors compared process measures across the two settings to observe the differences in system performance introduced by the added steps and resources of the AMC's teaching mission. METHODS: After creating process maps based on activity times realized in both settings, the authors developed discrete-event simulations of the two environments. The two settings were comparable in the levels of key resources, but the AMC process flow included three residents/fellows. Simulation enabled the authors to consider an identical schedule across the two settings. RESULTS: Under identical schedules, the average accumulated processing time per patient was higher in the AMC. However, the use of residents allowed simultaneous processing of multiple patients. Consequently, the AMC had higher throughput (3.5 vs. 2.7 patients per hour), higher room utilization (82.2% vs. 75.5%), reduced utilization of the attending physician (79.0% vs. 93.4%), and a shorter average waiting time (30.0 vs. 83.9 min). In addition, the average completion time for the final patient scheduled was 97.9 min less, and the average number of patients treated before incurring overtime was 37.9% greater. CONCLUSIONS: Although the teaching mission of the AMC adds processing steps and costs, the use of trainees within the process serves to increase throughput while decreasing waiting times and the use of overtime.
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Centros Médicos Académicos/métodos , Atención a la Salud/métodos , Educación Médica/métodos , Manejo del Dolor/métodos , Evaluación de Procesos, Atención de Salud/métodos , Centros Médicos Académicos/normas , Atención a la Salud/normas , Educación Médica/normas , Humanos , Manejo del Dolor/normas , Evaluación de Procesos, Atención de Salud/normasRESUMEN
Lead migration (LM) is the most common complication after spinal cord stimulation (SCS). Although multiple reports of caudad LM have been described, cephalad LM has not been reported. Here we describe a case in which a stimulator lead migrates in the cephalad direction. A 60-year-old male with failed back surgery syndrome underwent SCS lead implantation via a dual lead approach to the top of vertebral body (VB) T9. A standard strain relief loop was used for each lead in the paramedian pocket. Postoperative testing revealed 100% paresthesia coverage of the painful areas. For the first 4 days, the patient continued to have excellent coverage; however, by the seventh day, the paresthesias ascended to above the nipple line. At the 2-week follow-up, cephalad migration of the left lead to the top of VB T1 was confirmed on fluoroscopy. The patient underwent successful lead revision in which a single paramedian incision technique was used to place extra sutures and a "figure-of-eight" strain relief loop. We provide the first case report of significant cephalad LM following SCS lead implantation. This migration can occur despite the use of current standard anchoring techniques. Additional investigation into the mechanism of such LM and lead-securing techniques is warranted.
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Terapia por Estimulación Eléctrica/métodos , Migración de Cuerpo Extraño , Neuroestimuladores Implantables/efectos adversos , Complicaciones Posoperatorias , Médula Espinal/cirugía , Electrodos , Humanos , Dolor de la Región Lumbar/cirugía , Masculino , Persona de Mediana EdadRESUMEN
SUMMARY Spinal cord stimulation has been in clinical use for the treatment of chronic pain for over four decades. Since the initial use by Norman Shealy, the indications for its use have increased steadily over the decades to include neuropathic pain owing to failed back surgery syndrome, complex regional pain syndrome and painful diabetic peripheral neuropathies. To date, the precise mechanism of action of spinal cord stimulation remains unclear, yet it is still one of the most expensive interventional treatment modalities available in pain medicine with increasing application across the world. Given the worldwide focus on cost-effective care, there is an opportunity to focus on process analysis as a mechanism for optimizing the operations within and between all specialties engaged in the provision of care in pain medicine. Here, we propose a process analysis approach to model, measure and improve the delivery of disease-based care to enhance effective treatment with a costly modality. Systems-based process analysis is not widely utilized in pain medicine, and there is a limited body of evidence for its application. The purpose of this article is to generate interest in the discipline of process analysis in pain medicine, as it has found value in other healthcare settings and industries. We mention the applicability across countries and specialties that we hope will increase the awareness of this concept and possibly generate interest in further examination by investigators that will lead to the development of highly efficient and effective healthcare delivery processes and systems across the globe.
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A substantial body of literature is available on the natural history of diabetes, but much less is understood of the natural history of painful diabetic peripheral neuropathy (PDPN), a pervasive and costly complication of diabetes mellitus. Multiple mechanisms have been proposed, including polyol pathway activation, advanced glycosylation end-product formation, and vasculopathic changes. Nevertheless, specific treatment modalities addressing these basic issues are still lacking. The mainstay of treatment includes pharmacological management with antidepressants, anticonvulsants, and opioids, but these drugs are often limited by unfavorable side-effect profiles. For over 30 years, spinal cord stimulation (SCS) has been used extensively for the management of various chronic neuropathic pain states. In the past decade, interest in the use of SCS for treatment of PDPN has increased. This article reviews pathophysiological mechanisms of PDPN, proposed mechanisms of SCS, and the role of SCS for the treatment of PDPN.
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Analgésicos Opioides/uso terapéutico , Antidepresivos Tricíclicos/uso terapéutico , Neuropatías Diabéticas/terapia , Terapia por Estimulación Eléctrica , Médula Espinal , Análisis Costo-Beneficio , Neuropatías Diabéticas/economía , Neuropatías Diabéticas/fisiopatología , Terapia por Estimulación Eléctrica/economía , Terapia por Estimulación Eléctrica/métodos , Humanos , Dimensión del Dolor , Médula Espinal/fisiopatologíaRESUMEN
BACKGROUND: In addition to its conventional use as a treatment for refractory neuropathic extremity pain, spinal cord stimulation (SCS) has recently emerged as a possible treatment for visceral and arthritic pain. But concurrent with the expansion of possible conditions amenable to SCS, other studies have questioned the long-term efficacy of SCS for traditional indications. These disparate findings argue strongly for the refinement of selection criteria. The purpose of this study is to identify correlates of outcome for SCS. METHODS: Data were retrospectively collected on 244 patients who underwent a SCS trial at two academic medical centers. Success was predefined as ≥50% pain relief sustained for ≥6 months. Variables analyzed for their association with outcome included demographics, location of pain, diagnosis, presence of coexisting diseases, pain descriptors, opioid and adjuvant medication use, duration and pain relief during trial, and complications. RESULTS: The presence of allodynia and/or hyperalgesia correlated with both a positive SCS trial (P = 0.01) and long-term implantation outcome (P = 0.05). History of substance abuse was associated with a negative permanent SCS outcome (P = 0.05) but bore no relationship to trial results. The variable most strongly associated with an SCS outcome was experiencing <50% pain relief during the trial, which strongly presaged a negative result (P < 0.001). CONCLUSIONS: Although weak associations with outcome were noted for several clinical variables, none was strongly associated with trial and permanent implantation results. The strongest predictor of a negative SCS outcome was obtaining <50% pain relief during the trial period.
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Dolor Crónico/terapia , Terapia por Estimulación Eléctrica/métodos , Médula Espinal/fisiología , Adulto , Electrodos Implantados , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
Confirming the absence of the placebo response has been the bane of researchers throughout the ages. Thus, the gold standard of research methodology is the evidence for a treatment modality provided by a prospective randomized controlled trial. The "control" arm of a trial is the arm in which the placebo has been administered. Increasing evidence from basic science and clinical research is pointing to the fact that the placebo response may have some biological basis that can translate into enduring therapeutic benefit. Have our placebo-controlled trials simply compared one treatment effect to the treatment effect of the "placebo"? Thus, the "δ" is relative treatment effect; perhaps this may provide some insight as to why some treatment response is low compared to a relatively strong placebo response. How can we use this knowledge to create more robust clinical designs that help establish true treatment effect? This article aims to provide an overview of the contemporary insight into the placebo response.
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Efecto Placebo , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Artefactos , HumanosRESUMEN
BACKGROUND: Among patients presenting with axial low back pain, facet arthropathy accounts for approximately 10-15% of cases. Facet interventions are the second most frequently performed procedures in pain clinics across the United States. Currently, there are no uniformly accepted criteria regarding how best to select patients for radiofrequency denervation. METHODS: A randomized, multicenter study was performed in 151 subjects with suspected lumbar facetogenic pain comparing three treatment paradigms. Group 0 received radiofrequency denervation based solely on clinical findings; group 1 underwent denervation contingent on a positive response to a single diagnostic block; and group 2 proceeded to denervation only if they obtained a positive response to comparative blocks done with lidocaine and bupivacaine. A positive outcome was predesignated as > or =50% pain relief coupled with a positive global perceived effect persisting for 3 months. RESULTS: In group 0, 17 patients (33%) obtained a successful outcome at 3 months versus eight patients (16%) in group 1 and 11 (22%) patients in group 2. Denervation success rates in groups 0, 1, and 2 were 33, 39, and 64%, respectively. Pain scores and functional capacity were significantly lower at 3 months but not at 1 month in group 2 subjects who proceeded to denervation compared with patients in groups 0 and 1. The costs per successful treatment in groups 0, 1, and 2 were $6,286, $17,142, and $15,241, respectively. CONCLUSIONS: Using current reimbursement scales, these findings suggest that proceeding to radiofrequency denervation without a diagnostic block is the most cost-effective treatment paradigm.
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Ablación por Catéter/economía , Dolor de la Región Lumbar/diagnóstico , Dolor de la Región Lumbar/economía , Vértebras Lumbares/inervación , Bloqueo Nervioso/economía , Articulación Cigapofisaria/inervación , Adulto , Anciano , Análisis Costo-Beneficio , Desnervación/economía , Femenino , Humanos , Dolor de la Región Lumbar/terapia , Masculino , Persona de Mediana Edad , Resultado del Tratamiento , Adulto JovenRESUMEN
Approximately 70% of the United States population older than 65 yr has osteoarthritis. Chronic obstructive pulmonary disease (COPD) is also more prevalent in the elderly, and thus, the likelihood of having elderly patients with osteoarthritis and COPD in clinical settings is significant. COPD may preclude the optimum use of opioids, thus the potential to provide pain control with nonpharmacological treatment modalities becomes a valuable option. We present the case of an elderly woman with severe degenerative joint disease of the shoulder and severe COPD in whom spinal cord stimulation was used to provide pain control.
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Terapia por Estimulación Eléctrica , Osteoartritis/complicaciones , Enfermedad Pulmonar Obstructiva Crónica/complicaciones , Dolor de Hombro/etiología , Dolor de Hombro/terapia , Médula Espinal/fisiología , Estimulación Eléctrica Transcutánea del Nervio , Anciano , Electrodos Implantados , Espacio Epidural/diagnóstico por imagen , Espacio Epidural/fisiología , Femenino , Humanos , Osteoartritis/diagnóstico por imagen , Enfermedad Pulmonar Obstructiva Crónica/diagnóstico por imagen , Radiografía , Dolor de Hombro/diagnóstico por imagen , Médula Espinal/diagnóstico por imagenRESUMEN
INTRODUCTION: Complex regional pain syndrome type I (CRPS I) is a neuropathic pain disorder of unclear etiology. It commonly follows a trivial injury and is characterized by spontaneous pain manifesting regionally that is disproportionate to the inciting event. Associated signs and symptoms include allodynia, hyperalgesia, edema, sudomotor, vasomotor abnormalities, and trophic changes. Although multiple modalities exist to treat CRPS I, significant disability, diminution in quality of life, and reduction in overall health often accompany the syndrome. CASE: A case of a 57-year-old man with CRPS I who was treated with spinal cord stimulation (SCS) after failing conservative therapy is presented. One month following treatment, he experienced complete symptom resolution such that stimulation was subsequently discontinued without recurrence over the 1-year follow-up period. CONCLUSIONS: To date there is currently no reliably validated "cure" for CRPS. There has only been one recent report where SCS resulted in the complete eradication of the signs and symptoms associated with CRPS. This series involved adolescent girls aged 11-14 years of age, who tend to have a more benign and self-limited treatment course than that seen in adults. This raises the question as to whether a "neural switch" exists, and if so, where it is located. We postulate that the inter-neuronal connections between the central and peripheral nervous systems implicated by the current pathophysiological model is the most plausible site of this "neural switch," and that reorganization of this interface can account for the ability of SCS to effect a complete "cure" in CRPS.