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INTRODUCTION: The International Neuromodulation Society convened a multispecialty group of physicians based on expertise and international representation to establish evidence-based guidance on the mitigation of neuromodulation complications. This Neurostimulation Appropriateness Consensus Committee (NACC)® project intends to update evidence-based guidance and offer expert opinion that will improve efficacy and safety. MATERIALS AND METHODS: Authors were chosen on the basis of their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from 2017 (when NACC last published guidelines) to October 2023. Identified studies were graded using the United States Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on the strength of evidence or consensus when evidence was scant. RESULTS: The NACC examined the published literature and established evidence- and consensus-based recommendations to guide best practices. Additional guidance will occur as new evidence is developed in future iterations of this process. CONCLUSIONS: The NACC recommends best practices regarding the mitigation of complications associated with neurostimulation to improve safety and efficacy. The evidence- and consensus-based recommendations should be used as a guide to assist decision-making when clinically appropriate.
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Consenso , Terapia por Estimulación Eléctrica , Humanos , Terapia por Estimulación Eléctrica/métodos , Terapia por Estimulación Eléctrica/efectos adversos , Terapia por Estimulación Eléctrica/normas , Terapia por Estimulación Eléctrica/instrumentación , Medicina Basada en la Evidencia/normasRESUMEN
INTRODUCTION: Spinal cord stimulation (SCS) is a well-established treatment option for chronic pain. Pain over the implantable pulse generator, or pocket pain, is an incompletely understood risk of SCS implantation which may limit the efficacy of treatment and patient quality of life. The goal of this narrative review is to analyze the literature to gain a more thorough understanding of the incidence and risk factors for the development of pocket pain to help guide treatment options and minimize its occurrence in the future. METHODS: A literature review was conducted investigating the development of pocket pain in patients with SCS for the management of a variety of pain conditions. RESULTS: In total, 305 articles were included in the original database search and 50 met the criteria for inclusion. The highest level of evidence for papers that specifically investigated pocket pain was level III. Four retrospective, observational analyses included pocket pain as a primary outcome. The remainder of the included studies listed pocket pain as an adverse event of SCS implantation. CONCLUSIONS: There is a relative dearth of primary literature that examines the incidence, characteristics, and health economic implications of pocket pain in patients with SCS. This highlights the need for large-scale, high-quality prospective or randomized controlled trials examining pocket pain. This may ultimately help prevent and reduce pocket pain leading to improved efficacy of treatment and greater patient quality of life.
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Dolor Crónico , Estimulación de la Médula Espinal , Humanos , Estudios Prospectivos , Estudios Retrospectivos , Calidad de Vida , Dolor Crónico/etiología , Dolor Crónico/terapia , Estimulación de la Médula Espinal/efectos adversos , Médula Espinal , Resultado del TratamientoRESUMEN
OBJECTIVE: The objective of this study was to evaluate the effect of outpatient celiac plexus block on acute pain reduction in patients with suspected median arcuate ligament syndrome. METHODS: This is an Institutional Review Board approved, retrospective chart review. Data were collected and analyzed from patients who received celiac plexus blocks from November 1, 2021 through April 6, 2023. The primary outcome was pain reduction, determined by the change in numerical pain rating scale (NPRS) from pre-procedure to post-procedure. Additional data collected include patient demographics, comorbidities, preoperative symptoms and duration of symptoms. RESULTS: There were 33 patients identified in this study. Thirty-one patients were included in the data analysis. The median age of the cohort was 29 years, and the median BMI was 20.4. 94% of the cohort was female. These patients were referred as part of an evaluation for symptomatic vascular compression disorders. For many patients, positive response to celiac plexus block was used as an indication to proceed with surgical MALS resection. We provide a diagnostic algorithm for MALs. All patients endorsed preoperative symptoms. Patients experienced a median pain reduction of -4 from baseline to immediately post-procedure. CONCLUSIONS: Celiac plexus blocks continue to be a tool for ruling out neurogenic median arcuate ligament syndrome in patients who have undergone extensive previous imaging and assessments for vascular compression disorders. Our data suggest that patients with suspected MALS may experience substantial immediate pain relief from temporary blocks of the celiac ganglion as guided by fluoroscopy in an outpatient setting.
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INTRODUCTION: Radiofrequency ablation (RFA) has been used for nearly 100 years, treating an array of medical conditions including chronic pain. Radiofrequency (RF) energy depolarizes and repolarizes tissues adjacent to a probe producing heat and causing direct thermal injury. When positioned adjacent to neural structures, it leads to neural tissue injury and cell death interrupting pain signaling with the ultimate goal of providing lasting pain relief. Today, RFA is commonly used to treat cervical, thoracic, and lumbar zygapophyseal joints, sacroiliac joint, and more recently large peripheral joint-mediated pain. There are several applications of RFA systems, including bipolar, conventional thermal, cooled, protruding, and pulsed. As yet, no study has determined the best technical practice for bipolar RFA. OBJECTIVE: This ex vivo study examines RFA lesion midpoint (LMP) area and lesion confluence comparing three different commonly used gauge (g) probes (18-g, 20-g, and 22-g) with 10-mm active tips at various interprobe distances (IPD) to guide best technical practices for its clinical application. METHODS: Bipolar RFA lesions were generated in preservative-free chicken breast specimens using three different gauge probes (18-g, 20-g, and 22-g) with 10-mm active tips at various IPD (6, 8, 10, 12, 14, 16, and 18 mm). RF was applied for 105 s (15-s ramp time) at 80°C for each lesion at both room and human physiological temperature. The specimen tissues were dissected through the lesion to obtain a length, width, and depth, which were used to calculate the LMP area (mm2 ). The LMP areas of each thermal ablation were investigated using visualization and descriptive analysis. The Kruskal-Wallis test was performed to compare LMP areas between the two temperature groups and the three different gauge probe subgroups at the various IPDs. RESULTS: Of the 36 RF lesions (14: 18-g, 12: 20-g, and 10: 22-g) performed, 24 demonstrated lesion confluence. The average time to reach 80°C was 16-17 s; therefore, the average time of RF-energy delivery (at goal temperature) was 88-89 s despite varying needle size or IPD. Comparing the 25 and 37°C groups, 18-g probes produced mean LMP areas of 73.7 and 79.2 mm2 , respectively; 20-g probes produced mean LMP areas of 66 and 66.8 mm2 , respectively; 22-g probes produced mean LMP areas of 56.6 and 59.7 mm2 , respectively. There was no statistical evidence to state a difference regarding LMP area between temperature groups; however, the 18-g probes produced consistently larger LMP areas in the 37°C compared to 25°C specimen groups at each IPD. Lesion confluence was lost for 18-g, 20-g, and 22-g probes at IPD of 14, 12, and 10 mm, respectively, in both 25 and 37°C groups. LMP area was similar between 6 and 8 mm IPD in all of the three-gauge groups; however, there was a significant drop in LMP area from 8 mm IPD to 10 mm and greater. The 18-g, 20-g, and 22-g probes all demonstrated a sharp decline in LMP area when increasing the IPD from 8 to 10 mm. CONCLUSION: This ex vivo technical study evaluated bipolar RFA LMP areas and lesion confluence, and determined the recommended IPD of 18-g, 20-g, and 22-g probes to be less than 12, 10, and 8 mm, respectively, for best clinical practice. Placing bipolar probes at an IPD greater than 14, 12, and 10 mm, respectively, risks the loss of lesion confluence and failure to produce a clinically significant treatment response due to lack of nerve capture. In clinical practice, the use of injectate may produce larger lesions than demonstrated in this study. Additionally, in vivo factors may impact ablation zone size and ablation patterns. As there are a paucity of studies comparing various RFA applications and conventional RFA needles are least expensive, it is possible that bipolar conventional RFA is more cost-effective than other techniques.
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Ablación por Catéter , Ablación por Radiofrecuencia , Humanos , Ablación por Catéter/métodos , Frío , Calor , DolorRESUMEN
OBJECTIVES: Spinal cord stimulation (SCS) is an established therapy option in interventional pain medicine. Recent advances in technology have allowed for greater compliance with treatment and improved efficacy in pain control. This article was proposed to fill the gap in the literature addressing this specific patient population and to facilitate further research. Even though there is a lack of consensus among societies and experts on exact parameters of physical therapy (PT) considerations and postoperative limitations in patients with SCS, we propose rehabilitative care for this population should be standardized. As the number of patients with SCS implants grow, it is vital to understand how to appropriately approach patients with implantable devices when additional treatments such as PT are prescribed. MATERIALS AND METHODS: A literature search was performed on the use of PT following SCS implantation. Presently, there is no literature to date which addresses the use of PT in this patient population. The lack of data is the largest hurdle in the creation of formal SCS therapy guidelines. The authors therefore proposed recommendations for rehabilitation based upon a detailed understanding of SCS hardware alongside well-studied physiotherapy concepts. RESULTS: Considerations when initiating PT in the SCS patient population should include: 1) biomechanics and quality of SCS output; 2) therapeutic exercise and spinal manipulation in association with risk for lead migration and fracture; 3) the application of therapeutic modalities and risk for injury to the patient and/or damage to the SCS componentry; and 4) integration of a biopsychosocial, person-centered approach. CONCLUSIONS: PT treatment protocol in patients with a recently implanted SCS device should be person-centered addressing individual needs, values, and goals. Further research is needed to fully appreciate the impact of an interprofessional approach to management of SCS patients, particularly following stimulator implantation.
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Modalidades de Fisioterapia , Estimulación de la Médula Espinal , Humanos , Estimulación de la Médula Espinal/métodos , Procedimientos Neuroquirúrgicos , Dolor/etiología , Médula EspinalRESUMEN
OBJECTIVES: The aim of this article is to discuss the possible mechanisms of action (MOAs) and results of a pilot study of a novel, anatomically placed, and paresthesia-independent, neurostimulation waveform for the management of chronic intractable pain. MATERIALS AND METHODS: A novel, multilayered pulsed stimulation pattern (PSP) that comprises three temporal layers, a Pulse Pattern layer, Train layer, and Dosage layer, was developed for the treatment of chronic intractable pain. During preliminary development, the utility was evaluated of anatomical PSP (aPSP) in human subjects with chronic intractable pain of the leg(s) and/or low back, compared with that of traditional spinal cord stimulation (T-SCS) and physiological PSP. The scientific theory and testing presented in this article provide the preliminary justification for the potential MOAs by which PSP may operate. RESULTS: During the pilot study, aPSP (n = 31) yielded a greater decrease in both back and leg pain than did T-SCS (back: -60% vs -46%; legs: -63% vs -43%). In addition, aPSP yielded higher responder rates for both back and leg pain than did T-SCS (61% vs 48% and 78% vs 50%, respectively). DISCUSSION: The novel, multilayered approach of PSP may provide multimechanistic therapeutic relief through preferential fiber activation in the dorsal column, optimization of the neural onset response, and use of both the medial and lateral pathway through the thalamic nuclei. The results of the pilot study presented here suggest a robust responder rate, with several subjects (five subjects with back pain and three subjects with leg pain) achieving complete relief from PSP during the acute follow-up period. These clinical findings suggest PSP may provide a multimechanistic, anatomical, and clinically effective management for intractable chronic pain. Because of the limited sample size of clinical data, further testing and long-term clinical assessments are warranted to confirm these preliminary findings.
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Dolor Crónico , Dolor Intratable , Estimulación de la Médula Espinal , Humanos , Pierna , Estimulación de la Médula Espinal/métodos , Proyectos Piloto , Dolor de Espalda/terapia , Dolor Crónico/terapia , Resultado del Tratamiento , Médula EspinalRESUMEN
BACKGROUND AND AIMS: Cluneal neuropathy is encompassed by three distinct clinical entities. Superior, middle, and inferior cluneal neuralgia make up the constellation of symptoms associated with cluneal neuropathy. Each has its own variable anatomy. MATERIALS AND METHODS: We compiled a narrative review including a review of available literature. We conducted searches on PubMed/MEDLINE, Embase and Google Scholar on the topics of cluneal neuropathy and treatment therein. RESULTS: We collected source articles regarding original descriptions of the disease entities in addition to articles focused on treatment. DISCUSSION: Adjusted incidence rates of superior cluneal neuropathy are 1.6%-11.7%. Accurate diagnosis remains challenging due to the lack of standardized criteria and the aforementioned variability. Treatment may include therapeutic nerve blocks, ablative techniques, neuromodulation, and surgical decompression. Gaps including those related to true incidence and work up exist. Outcomes from interventional studies are limited and mixed due to significant population heterogeneity and non-standardized treatment approaches coupled with very small sample sizes.
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Bloqueo Nervioso , Síndromes de Compresión Nerviosa , Neuralgia , Humanos , Síndromes de Compresión Nerviosa/complicaciones , Neuralgia/cirugía , Nalgas/inervación , Nalgas/cirugía , Bloqueo Nervioso/métodos , Descompresión QuirúrgicaRESUMEN
BACKGROUND: Effective symptom control in painful knee osteoarthritis (OA) may improve patient quality of life. In a randomised crossover trial (NCT03381248), COOLIEF* cooled radiofrequency ablation (CRFA) reduced pain and stiffness and improved physical function and quality of life compared with intra-articular hyaluronan (HA) injections. The present study aimed to establish the cost effectiveness of CRFA versus intra-articular HA injections for treating moderate-to-severe OA knee pain from a US Medicare perspective. METHODS: We conducted a cost-effectiveness analysis using utility data (EQ-5D) from the randomised crossover trial of CRFA versus intra-articular HA injections, which had follow-ups at 1, 3, 6, and 12 months. Patients in the HA group with unsatisfactory outcomes (e.g., continued pain) at 6 months could cross over to CRFA. Economic analysis outcomes included quality-adjusted life-years (QALYs), costs, and cost effectiveness (cost per QALY gained). Base-case analyses were modelled on a 6-month time horizon (to trial crossover). Due to limited trial data in the HA arm beyond 6 months, scenarios explored potential outcomes to 12 months if: 1) Utility with HA persisted for a further 6 months; 2) A second HA injection was received at 6 months and achieved the same utility change for the second 6 months. In both scenarios, the CRFA arm used trial data for patients who received CRFA from baseline to 12 months. Alternative costing scenarios were also explored. RESULTS: CRFA resulted in an incremental QALY gain of 0.020 at an incremental cost of US$1707, equating to an incremental cost-effectiveness ratio (ICER) of US$84,392 per QALY over 6 months, versus intra-articular HA injections. Extending the analysis to 12 months and assuming persistence in utility in the HA arm resulted in a larger utility gain for CRFA (0.056 QALYs) and a lower ICER of US$30,275 per QALY. If patients received a second HA injection, the incremental benefit of CRFA out to 12 months was reduced (QALY gain 0.043) but was offset by the costs of the second HA injection (incremental cost US$832). This resulted in an ICER of US$19,316 per QALY. CONCLUSIONS: CRFA is a cost-effective treatment option for patients with OA-related knee pain considering the typical US threshold of US$100,000/QALY.
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Dolor Crónico , Osteoartritis de la Rodilla , Ablación por Radiofrecuencia , Anciano , Dolor Crónico/diagnóstico , Dolor Crónico/tratamiento farmacológico , Dolor Crónico/etiología , Análisis Costo-Beneficio , Humanos , Ácido Hialurónico , Medicare , Osteoartritis de la Rodilla/complicaciones , Osteoartritis de la Rodilla/terapia , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida , Ablación por Radiofrecuencia/métodos , Estados UnidosRESUMEN
OBJECTIVE: Lumbar radiofrequency ablation is a commonly used intervention for chronic back pain. However, the pain typically returns, and though retreatment may be successful, the procedure involves destruction of the medial branch nerves, which denervates the multifidus. Repeated procedures typically have diminishing returns, which can lead to opioid use, surgery, or implantation of permanent neuromodulation systems. The objective of this report is to demonstrate the potential use of percutaneous peripheral nerve stimulation (PNS) as a minimally invasive, nondestructive, motor-sparing alternative to repeat radiofrequency ablation and more invasive surgical procedures. DESIGN: Prospective, multicenter trial. METHODS: Individuals with a return of chronic axial pain after radiofrequency ablation underwent implantation of percutaneous PNS leads targeting the medial branch nerves. Stimulation was delivered for up to 60 days, after which the leads were removed. Participants were followed up to 5 months after the start of PNS. Outcomes included pain intensity, disability, and pain interference. RESULTS: Highly clinically significant (≥50%) reductions in average pain intensity were reported by a majority of participants (67%, n = 10/15) after 2 months with PNS, and a majority experienced clinically significant improvements in functional outcomes, as measured by disability (87%, n = 13/15) and pain interference (80%, n = 12/15). Five months after PNS, 93% (n = 14/15) reported clinically meaningful improvement in one or more outcome measures, and a majority experienced clinically meaningful improvements in all three outcomes (i.e., pain intensity, disability, and pain interference). CONCLUSIONS: Percutaneous PNS has the potential to shift the pain management paradigm by providing an effective, nondestructive, motor-sparing neuromodulation treatment.
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Ablación por Radiofrecuencia , Estimulación Eléctrica Transcutánea del Nervio , Dolor de Espalda , Humanos , Nervios Periféricos , Estudios Prospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: The objective of this prospective, multicenter study is to characterize responses to percutaneous medial branch peripheral nerve stimulation (PNS) to determine if results from earlier, smaller single-center studies and reports were generalizable when performed at a larger number and wider variety of centers in patients recalcitrant to nonsurgical treatments. MATERIALS & METHODS: Participants with chronic axial low back pain (LBP) were implanted with percutaneous PNS leads targeting the lumbar medial branch nerves for up to 60 days, after which the leads were removed. Participants were followed long-term for 12 months after the 2-month PNS treatment. Data collection is complete for visits through end of treatment with PNS (primary end point) and 6 months after lead removal (8 months after start of treatment), with some participant follow-up visits thereafter in progress. RESULTS: Clinically and statistically significant reductions in pain intensity, disability, and pain interference were reported by a majority of participants. Seventy-three percent of participants were successes for the primary end point, reporting clinically significant (≥30%) reductions in back pain intensity after the 2-month percutaneous PNS treatment (n = 54/74). Whereas prospective follow-up is ongoing, among those who had already completed the long-term follow-up visits (n = 51), reductions in pain intensity, disability, and pain interference were sustained in a majority of participants through 14 months after the start of treatment. CONCLUSION: Given the minimally invasive, nondestructive nature of percutaneous PNS and the significant benefits experienced by participants who were recalcitrant to nonsurgical treatments, percutaneous PNS may provide a promising first-line neurostimulation treatment option for patients with chronic axial back pain.
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Dolor de la Región Lumbar , Estimulación Eléctrica Transcutánea del Nervio , Dolor de Espalda/tratamiento farmacológico , Humanos , Dolor de la Región Lumbar/terapia , Estudios Prospectivos , Resultado del TratamientoRESUMEN
OBJECTIVE: The objective of this study was to determine the effect of axillary peripheral nerve stimulation (PNS) on pain reduction in patients with chronic shoulder pain. Chronic shoulder pain was defined as pain greater than six months originating from any of the following and not the result of a stroke: subacromial impingement syndrome/rotator cuff pathology, glenohumeral joint arthritis, acromioclavicular joint arthritis, adhesive capsulitis, or biceps tendinopathy. MATERIALS AND METHODS: Eight adult patients with chronic shoulder pain, as defined above, who either did not respond to surgical intervention or who were deemed not ideal surgical candidates underwent permanent axillary PNS therapy. Follow-up ranged from 44 to 733 days (avg 445 days). The primary outcome was percent pain reduction, determined by the change in average numerical pain rating scale (NPRS). Additionally, secondary outcome measures were the change in opioid requirements and satisfaction rate. RESULTS: Based on the ≥50% pain reduction for treatment success, 88% (7/8) were "responders." Overall average pain reduction was 67% and 70% among responders; 62.5% (5/8) of patients reported that they used opioids prior to axillary PNS therapy for pain relief. Among these patients, 100% reported decreased opioid use after axillary PNS implant, with an average reduction of 88% (based on self-reported reductions). Additionally, 100% (8/8) of patients reported that they would recommend this therapy to other patients suffering from chronic pain. CONCLUSIONS: This retrospective case series provides level IV evidence supporting the use of axillary PNS therapy for the management of chronic shoulder pain. Additional, higher-level studies are required to further support its use.
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Nervios Periféricos , Dolor de Hombro , Estimulación Eléctrica Transcutánea del Nervio , Adulto , Humanos , Estudios Retrospectivos , Articulación del Hombro , Dolor de Hombro/terapia , Resultado del TratamientoRESUMEN
INTRODUCTION: In the PROMISE study, a multinational randomized controlled trial (RCT) of the effectiveness of spinal cord stimulation (SCS) with multicolumn surgical leads as a treatment of low back pain, clinicians followed their usual practice. An early, unplanned safety analysis revealed that the infection rate in Belgium (5/23), where trial duration was a median 21.5 days, was significantly higher than the 1/64 rate observed in the other study countries (median 5.8 days, p < 0.01). This report reviews infections observed in the PROMISE study after study completion. MATERIALS AND METHODS: For all infections related to SCS, we used descriptive statistics and tests of independent variables to analyze potentially contributing factors (age, sex, coexisting medical conditions, tobacco use, lead type, and trial duration) between subjects with infections versus those without. Cumulative incidence curves were created using the Kaplan-Meier method and compared between the two strata using a log-rank test. RESULTS: Among nine (5.2%) infections in 174 subjects trialed, the only significant contributing factor to infection was trial duration: median 21 days (range 3-56) for those with infection vs. six days (1-41) for those without (p = 0.001; Wilcoxon rank-sum test). The cumulative incidence of infection for subjects trialed >10 days was 24.1% vs. 1.4% for subjects trialed ≤10 days (p < 0.001). After the protocol was amended to limit trial duration to 10 days, 14 infection-free trials were performed in Belgium. CONCLUSIONS: Although not part of the preplanned analysis, our observation supports the hypothesis of a cause-effect relationship between trial duration and the risk of infection and the conclusion that prolonged SCS trials should be avoided.
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Síndrome de Fracaso de la Cirugía Espinal Lumbar , Dolor de la Región Lumbar , Complicaciones Posoperatorias , Estimulación de la Médula Espinal , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dimensión del Dolor , Médula Espinal , Estimulación de la Médula Espinal/efectos adversosRESUMEN
INTRODUCTION: Regenerative injection-based therapy has established itself as a therapeutic option for the management of a variety of painful musculoskeletal conditions. The aim of this work was to review the current literature regarding regenerative injection therapy for axial/radicular spine pain. METHODS: A comprehensive literature review was conducted on the use of regenerative medicine for axial/radicular spine pain. Eligible articles analyzed the therapeutic injection effects of platelet-rich plasma (PRP), prolotherapy, or mesenchymal signaling cells (MSCs) via intradiscal, facet joint, epidural, or sacroiliac joint delivery. RESULTS: Regarding intradiscal PRP, there are level I/IV studies supporting its use. Regarding intradiscal prolotherapy, there are level III to IV studies supporting its use. Regarding intradiscal MSCs, there are level I/IV studies supporting its use with the exception of one level IV study that found no significant improvement at 12 months. Regarding facet joint injections with PRP, there are level I/IV studies supporting its use. Regarding facet joint injections with prolotherapy, there are level IV studies supporting its use, though the one level I study did not demonstrate any statistical significance supporting its use. Regarding epidural injections with PRP, there are level I/IV studies supporting its use. Regarding epidural injections with prolotherapy, there are level IV studies supporting its use, though the one level I study did not demonstrate statistical significance beyond 48 hours. Regarding sacroiliac joint injections with PRP, there are level I/IV studies supporting its use. Regarding sacroiliac joint injections with prolotherapy, there are level I/III studies supporting its use. CONCLUSIONS: Currently, there are level I studies to support the use of PRP and MSC injections for discogenic pain; facet joint injections with PRP; epidural injections of autologous conditioned serum and epidural prolotherapy; and PRP and prolotherapy for sacroiliac joint pain. One level I study showed that facet joint prolotherapy has no significant benefit. Notably, no intervention has multiple published level I studies.
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Dolor de Espalda/terapia , Trasplante de Células Madre Mesenquimatosas/métodos , Manejo del Dolor/métodos , Plasma Rico en Plaquetas , Proloterapia/métodos , Humanos , Inyecciones Epidurales , Inyecciones Intraarticulares , Medicina Regenerativa/métodosRESUMEN
BACKGROUND: Low back pain (LBP) is a ubiquitous, heterogeneous disorder that affects most people at some point in their lives. The efficient management of LBP remains elusive, with direct and indirect costs attributed to LBP surpassing many other common conditions. An emphasis on a structural basis of LBP often fails to recognize movement, specifically patterns of movement that may provide biomechanical signatures of painful conditions. The primary objective of this registry is to understand the differences in movement patterns among those with LBP and those without pain in a U.S. population sample. METHODS: This ongoing, non-randomized, prospective post-market registry will consist of two groups: patients with LBP, and age and sex-matched controls without LBP. We will seek to recruit 132 subjects in each group. Data collection will take place in two phases: (1) baseline assessment of LBP patients and matched controls; (2) assessment of LBP patients at 6 and 12-months follow up. The primary outcome measure will be differences in movement patterns between those with LBP and those without LBP. Secondary outcomes will include differences in patient reported outcomes including pain, disability and quality of life. DISCUSSION: The findings will help determine if there are meaningful differences in movement patterns between those with and those without LBP. Further, an initial understanding of movement signatures specific to certain subtypes of patients with LBP may be achieved. TRIAL REGISTRATION: The study was registered on the clinicaltrials.gov portal: NCT03001037 . Trial retrospectively registered 12/22/2016.
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Dolor de la Región Lumbar/fisiopatología , Actividad Motora/fisiología , Sistema de Registros , Adolescente , Adulto , Anciano , Fenómenos Biomecánicos/fisiología , Estudios de Casos y Controles , Femenino , Humanos , Dolor de la Región Lumbar/diagnóstico , Dolor de la Región Lumbar/epidemiología , Masculino , Persona de Mediana Edad , Estudios Observacionales como Asunto , Estudios Prospectivos , Adulto JovenRESUMEN
Objective: This report conveys 12-month outcomes of subjects treated with intradiscal biacuplasty (IDB) and conservative medical management (CMM) for chronic low back pain of discogenic origin, and results for subjects who elected to receive IDB + CMM 6 months after CMM-alone. Methods: Sixty-three subjects were originally randomized to the IDB + CMM group (N = 29) or CMM-alone (N = 34). Six months following continuous CMM-alone treatment, participants in this study group were permitted to "cross-over" to IDB + CMM (N = 25), and followed for an additional 6 months. The original IDB + CMM study subjects were followed for a total of 12 months (N = 22). Results: Pain reduction at 12 months was statistically significant and clinically meaningful in the original IDB + CMM group compared to baseline. Functional and disability outcomes were also improved statistically and clinically. Fifty-five percent of the IDB + CMM patients responded to treatment with a mean VAS reduction of 2.2 points at 12 months. Furthermore, 50% and 64% of subjects reported clinically significant improvements in SF36-PF and in ODI, respectively. There was a 1.7-point reduction (improvement) on a 7-point PGIC scale, and a 0.13-point increase (improvement) in the EQ-5D Health Index. Fifty-percent of cross-over subjects responded to IDB + CMM intervention. Mean outcome scores for cross-over subjects were similar to those of the originally-treated subjects, and functional and disability endpoints were improved statistically and clinically compared to respective baseline values. Conclusions: The study demonstrated long-term clinical effectiveness of IDB + CMM for treating chronic lumbar discogenic pain. Furthermore, the cross-over study subjects experienced similar improvements in pain, function, disability, and satisfaction.
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Ablación por Catéter/métodos , Dolor Crónico/prevención & control , Hipertermia Inducida/métodos , Degeneración del Disco Intervertebral/terapia , Dolor de la Región Lumbar/prevención & control , Adolescente , Adulto , Anciano , Dolor Crónico/diagnóstico , Dolor Crónico/etiología , Terapia Combinada , Femenino , Estudios de Seguimiento , Humanos , Degeneración del Disco Intervertebral/complicaciones , Degeneración del Disco Intervertebral/diagnóstico , Estudios Longitudinales , Dolor de la Región Lumbar/diagnóstico , Dolor de la Región Lumbar/etiología , Masculino , Persona de Mediana Edad , Dimensión del Dolor , Recuperación de la Función , Resultado del Tratamiento , Estados Unidos , Adulto JovenAsunto(s)
Osteoartritis , Manejo del Dolor , Nervios Periféricos , Articulación del Hombro , Estimulación Eléctrica Transcutánea del Nervio , Humanos , Osteoartritis/complicaciones , Osteoartritis/diagnóstico por imagen , Osteoartritis/terapia , Dolor , Hombro , Articulación del Hombro/fisiopatologíaRESUMEN
BACKGROUND AND PURPOSE: Sacroiliac joint pain and dysfunction affect 15-25% of patients reporting low back pain, including reports of spontaneous, idiopathic, traumatic, and non-traumatic onsets. The poor reliability and validity associated with diagnostic clinical and imaging techniques leads to challenges in diagnosing and managing sacroiliac joint dysfunction. CASE DESCRIPTION: A 35-year-old nulliparous female with a 14-year history of right sacroiliac joint dysfunction was managed using a multimodal and multidisciplinary approach when symptoms failed to resolve after 2 months of physical therapy. The plan of care included four prolotherapy injections, sacroiliac joint manipulation into nutation, pelvic girdle belting, and specific stabilization exercises. OUTCOMES: The patient completed 20 physical therapy sessions over a 12-month period. At 6 months, the patient's Oswestry Disability Questionnaire score was reduced from 34% to 14%. At 1-year follow-up, her score was 0%. The patient's rating of pain on a numeric rating scale decreased to an average of 4/10 at 6 months and 0/10 at 1-year follow-up. DISCUSSION: A multidisciplinary and multimodal approach for the management of chronic sacroiliac joint dysfunction appeared successful in a single-case design at 1-year follow-up.
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Chronic pain is one of the most prevalent and costly health care problems in the United States today. Two conditions, failed back surgery syndrome (FBSS) and complex regional pain syndrome (CRPS), in particular have been difficult to manage, resulting in increased disability and poorer quality of life measures for patients as well as increased treatments cost for payers. Given the cost of chronic pain management and overall subjectivity of analog pain scores, many payers are emphasizing the importance of functional outcomes as a means of assessing efficacy of treatment. Neuromodulation devices such as spinal cord stimulators are shown to be cost effective and able to improve functional outcomes and quality of life. Specific rehabilitation therapies also demonstrate improved functional outcomes. This article aims to discuss the role of rehabilitation in the patient with a neuromodulatory device. From the available data and our clinical experience, we recommend incorporating rehabilitation after placement of a neuromodulation device in order to optimize functional outcomes.
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Dolor Crónico/rehabilitación , Síndromes de Dolor Regional Complejo/rehabilitación , Terapia por Estimulación Eléctrica , Síndrome de Fracaso de la Cirugía Espinal Lumbar/rehabilitación , Modalidades de Fisioterapia , Dolor Crónico/economía , Dolor Crónico/fisiopatología , Dolor Crónico/terapia , Terapia Combinada/economía , Síndromes de Dolor Regional Complejo/economía , Síndromes de Dolor Regional Complejo/fisiopatología , Síndromes de Dolor Regional Complejo/terapia , Análisis Costo-Beneficio , Terapia por Estimulación Eléctrica/economía , Diseño de Equipo , Síndrome de Fracaso de la Cirugía Espinal Lumbar/economía , Síndrome de Fracaso de la Cirugía Espinal Lumbar/fisiopatología , Síndrome de Fracaso de la Cirugía Espinal Lumbar/terapia , Femenino , Humanos , Masculino , Dimensión del Dolor , Satisfacción del Paciente , Modalidades de Fisioterapia/economía , Prótesis e Implantes/economía , Calidad de Vida , Resultado del TratamientoRESUMEN
INTRODUCTION: Transforaminal epidural steroid injections (TFESI) are commonly performed for the treatment of lumbar herniated nucleus pulposus and lumbosacral radiculopathy. Although rare, documented complications including spinal cord infarction, paraparesis, epidural abscess, paraplegia, and epidural hematoma have been reported. Here, we present a case of perineural hematoma affecting the L4 nerve root resulting in progressive acute-on-chronic lumbar radiculopathy following TFESI. CASE REPORT: A 72-year-old female presented with 3 months of low back and right anterior thigh pain. She subsequently underwent right L3 and L4 TFESI for physical examination findings concordant with radiographic right foraminal stenosis at L3-4 and L4-5 with L3-4 spondylolisthesis. Over the following week, the patient reported progressive right lower extremity weakness, worsening sensory loss, and ambulatory dysfunction. Examination revealed mild L3/4 myotomal weakness, sensory changes, and areflexia at the right patella. A gadolinium-enhanced MRI was ordered, which showed focal abnormal signal with involvement of the right L4-L5 neuroforamina and extending slightly far laterally, consistent with a small hematoma, affecting the L4 nerve root. Within 2 months, her strength and reflexes normalized and sensory loss diminished following medical management. DISCUSSION: Although extremely rare, perineural or foraminal hematomas may occur as a serious complication of TFESI, even in the setting of a standardized procedure. Hematoma may cause worsening of symptoms in the acute and subacute phase following TFESI. Further investigation into the etiologies of such injuries is warranted and must be added to the considerations of pain physicians performing these procedures.