Pregabalin and gabapentin for chronic low back pain without radiculopathy: a systematic review.

BACKGROUND: Chronic low back pain (CLBP) is a global health problem, and gabapentin and pregabalin are often used in the treatment of patients without associated radiculopathy or neuropathy. Therefore, determining their efficacy and safety is of enormous value. OBJECTIVE: To examine the efficacy and safety of using gabapentin and pregabalin for CLBP without radiculopathy or neuropathy. METHODS: We performed a search on the CENTRAL, MEDLINE, EMBASE, LILACS, and Web of Science data bases for clinical trials, cohorts, and case-control studies that evaluated patients with CLBP without radiculopathy or neuropathy for at least eight weeks. The data were extracted and inserted into a previously-prepared Microsoft Excel spreadsheet; the outcomes were evaluated using the Cochrane RoB 2 tool, and the quality of evidence, using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. RESULTS: Of the 2,230 articles identified, only 5 were included, totaling 242 participants. In them, pregabalin was slightly less efficacious than amitriptyline, the combination of tramadol/acetaminophen, and celecoxib, and pregabalin added to celecoxib showed no benefit when compared to celecoxib alone (very low evidence for all). On the other hand, although one study with gabapentin did not support its use in a general sample of patients with low back pain, another found a reduction in the pain scale and improved mobility (moderate evidence). No serious adverse events were observed in any of the studies. CONCLUSION: Quality information to support the use of pregabalin or gabapentin in the treatment of CLBP without radiculopathy or neuropathy is lacking, although results may suggest gabapentin as a viable option. More data is needed to fill this current gap in knowledge.

ANTECEDENTES: Dor lombar crônica (DLC) é um problema de saúde global, e a gabapentina e a pregabalina são frequentemente utilizadas no tratamento de pacientes sem radiculopatia ou neuropatia associada. Por isso, determinar sua eficácia e segurança é de enorme valor. OBJETIVO: Examinar a eficácia e segurança do uso de gabapentina e pregabalina no tratamento da DLC sem radiculopatia ou neuropatia. MéTODOS: Realizamos uma pesquisa nas bases de dados CENTRAL, MEDLINE, EMBASE, LILACS e Web of Science por ensaios clínicos, coortes e estudos de caso e controle que avaliassem pacientes com DLC sem radiculopatia ou neuropatia por pelo menos oito semanas. Os dados foram extraídos e inseridos em uma planilha previamente elaborada no programa Microsoft Excel; os desfechos foram avaliados com a ferramenta RoB 2 tool da Cochrane, e a qualidade das evidências, pelo sistema Grading of Recommendations Assessment, Development and Evaluation (GRADE). RESULTADOS: Dos 2.230 artigos identificados, apenas 5 foram incluídos, com um total de 242 participantes. Neles, a pregabalina foi ligeiramente menos eficaz do que a amitriptilina, a combinação de tramadol/acetaminofeno, e o celecoxibe, assim como a pregabalina adicionada ao celecoxibe não mostrou benefício em comparação ao uso isolado de celecoxibe (evidência muito baixa para todos). Quanto à gabapentina, embora um estudo não respalde seu uso para uma amostra geral de pacientes com lombalgia, outro encontrou redução na escala de dor e melhora da mobilidade (evidência moderada). Nenhum evento adverso grave foi observado nos estudos. CONCLUSãO: Há carência de informações de qualidade que sustentem o uso de pregabalina ou gabapentina no tratamento da DLC sem radiculopatia ou neuropatia, embora resultados possam sugerir que a gabapentina é uma opção viável. Mais dados são necessários para preencher essa atual lacuna no conhecimento.

Pregabalin and gabapentin for chronic low back pain without radiculopathy: a systematic review / Pregabalina e gabapentina para dor lombar crônica sem radiculopatia: uma revisão sistemática

Abstract Background Chronic low back pain (CLBP) is a global health problem, and gabapentin and pregabalin are often used in the treatment of patients without associated radiculopathy or neuropathy. Therefore, determining their efficacy and safety is of enormous value. Objective To examine the efficacy and safety of using gabapentin and pregabalin for CLBP without radiculopathy or neuropathy. Methods We performed a search on the CENTRAL, MEDLINE, EMBASE, LILACS, and Web of Science data bases for clinical trials, cohorts, and case-control studies that evaluated patients with CLBP without radiculopathy or neuropathy for at least eight weeks. The data were extracted and inserted into a previously-prepared Microsoft Excel spreadsheet; the outcomes were evaluated using the Cochrane RoB 2 tool, and the quality of evidence, using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Results Of the 2,230 articles identified, only 5 were included, totaling 242 participants. In them, pregabalin was slightly less efficacious than amitriptyline, the combination of tramadol/acetaminophen, and celecoxib, and pregabalin added to celecoxib showed no benefit when compared to celecoxib alone (very low evidence for all). On the other hand, although one study with gabapentin did not support its use in a general sample of patients with low back pain, another found a reduction in the pain scale and improved mobility (moderate evidence). No serious adverse events were observed in any of the studies. Conclusion Quality information to support the use of pregabalin or gabapentin in the treatment of CLBP without radiculopathy or neuropathy is lacking, although results may suggest gabapentin as a viable option. More data is needed to fill this current gap in knowledge.

Resumo Antecedentes Dor lombar crônica (DLC) é um problema de saúde global, e a gabapentina e a pregabalina são frequentemente utilizadas no tratamento de pacientes sem radiculopatia ou neuropatia associada. Por isso, determinar sua eficácia e segurança é de enorme valor. Objetivo Examinar a eficácia e segurança do uso de gabapentina e pregabalina no tratamento da DLC sem radiculopatia ou neuropatia. Métodos Realizamos uma pesquisa nas bases de dados CENTRAL, MEDLINE, EMBASE, LILACS e Web of Science por ensaios clínicos, coortes e estudos de caso e controle que avaliassem pacientes com DLC sem radiculopatia ou neuropatia por pelo menos oito semanas. Os dados foram extraídos e inseridos em uma planilha previamente elaborada no programa Microsoft Excel; os desfechos foram avaliados com a ferramenta RoB 2 tool da Cochrane, e a qualidade das evidências, pelo sistema Grading of Recommendations Assessment, Development and Evaluation (GRADE). Resultados Dos 2.230 artigos identificados, apenas 5 foram incluídos, com um total de 242 participantes. Neles, a pregabalina foi ligeiramente menos eficaz do que a amitriptilina, a combinação de tramadol/acetaminofeno, e o celecoxibe, assim como a pregabalina adicionada ao celecoxibe não mostrou benefício em comparação ao uso isolado de celecoxibe (evidência muito baixa para todos). Quanto à gabapentina, embora um estudo não respalde seu uso para uma amostra geral de pacientes com lombalgia, outro encontrou redução na escala de dor e melhora da mobilidade (evidência moderada). Nenhum evento adverso grave foi observado nos estudos. Conclusão Há carência de informações de qualidade que sustentem o uso de pregabalina ou gabapentina no tratamento da DLC sem radiculopatia ou neuropatia, embora resultados possam sugerir que a gabapentina é uma opção viável. Mais dados são necessários para preencher essa atual lacuna no conhecimento.

Minimally invasive swine spine surgery training: technical aspects, benefits, and anatomical limitations.

OBJECTIVE: To describe the technical specificities and feasibility of simulation of minimally invasive spine surgery in live pigs, as well as similarities and differences in comparison to surgery in humans. METHODS: A total of 22 Large White class swine models, weighing between 60 and 80kg, were submitted to surgical simulations, performed during theoretical-practical courses for training surgical techniques (microsurgical and endoscopic lumbar decompression; percutaneous pedicular instrumentation; lateral access to the thoracic spine, and anterior and retroperitoneal to the lumbar spine, and management of complications) by 86 spine surgeons. For each surgical technique, porcine anatomy (similarities and differences in relation to human anatomy), access route, and dimensions of the instruments and implants used were evaluated. Thus, the authors describe the feasibility of each operative simulation, as well as suggestions to optimize training. Study results are descriptive, with figures and drawings. RESULTS: Neural decompression surgeries (microsurgeries and endoscopic) and pedicular instrumentation presented higher similarities to surgery on humans. On the other hand, intradiscal procedures had limitations due to the narrow disc space in swines. We were able to simulate situations of surgical trauma in surgical complication scenarios, such as cerebrospinal fluid fistulas and excessive bleeding, with comparable realism to surgery on humans. CONCLUSION: A porcine model for simulation of minimally invasive spinal surgical techniques had similarities with surgery on humans, and is therefore feasible for surgeon training.

Minimally invasive swine spine surgery training: technical aspects, benefits, and anatomical limitations

ABSTRACT Objective To describe the technical specificities and feasibility of simulation of minimally invasive spine surgery in live pigs, as well as similarities and differences in comparison to surgery in humans. Methods A total of 22 Large White class swine models, weighing between 60 and 80kg, were submitted to surgical simulations, performed during theoretical-practical courses for training surgical techniques (microsurgical and endoscopic lumbar decompression; percutaneous pedicular instrumentation; lateral access to the thoracic spine, and anterior and retroperitoneal to the lumbar spine, and management of complications) by 86 spine surgeons. For each surgical technique, porcine anatomy (similarities and differences in relation to human anatomy), access route, and dimensions of the instruments and implants used were evaluated. Thus, the authors describe the feasibility of each operative simulation, as well as suggestions to optimize training. Study results are descriptive, with figures and drawings. Results Neural decompression surgeries (microsurgeries and endoscopic) and pedicular instrumentation presented higher similarities to surgery on humans. On the other hand, intradiscal procedures had limitations due to the narrow disc space in swines. We were able to simulate situations of surgical trauma in surgical complication scenarios, such as cerebrospinal fluid fistulas and excessive bleeding, with comparable realism to surgery on humans. Conclusion A porcine model for simulation of minimally invasive spinal surgical techniques had similarities with surgery on humans, and is therefore feasible for surgeon training.

Prognostic factors in low back pain individuals undergoing steroid and anaesthetic intra-articular facet joint infiltration: a protocol for a prospective, longitudinal, cohort study.

INTRODUCTION: Lumbar pain of facet origin is a common problem worldwide. For those patients not responding to traditional treatment, one approach may be intra-articular infiltration of corticoid and anaesthetic. However, despite the increasing demand for this procedure, no consensus exists regarding its therapeutic value. The selection of eligible participants may be a determining factor since only those with an inflammatory process will benefit from the use of corticosteroids. This study aims to identify differences in disability, pain and quality of life scores in individuals with and without facet joint inflammation who were diagnosed using MRI. METHOD AND ANALYSIS: This prospective cohort will include individuals older than 18 years with a clinical diagnosis of facet syndrome who underwent intra-articular infiltration. Changes in scores of pain, disability and quality of life questionnaires at 1, 3, 6 and 12 months of follow-up compared with baseline will be analysed. An MRI examination performed before infiltration will help to distinguish between exposed (with inflammation) and non-exposed (non-inflammation) groups with facet syndrome. The primary outcome will be the disability questionnaire (Roland Morris), and the secondary outcomes will be the score questionnaires for pain (Visual Analogue Scale), quality of life (EuroQol Quality of Life Questionnaire) and disability (Oswestry). ETHICS AND DISSEMINATION: The Internal Review Board approved this study, which started only after the approval number (5291417.0.0000.0071) was received. All recruited participants will receive a verbal explanation about the purpose of the study, and their decision to participate will be free and voluntary. All participants enrolled in the study will provide a signed informed consent form including confidentiality terms. The results obtained in this study will be presented at national and international conferences and published in peer-reviewed scientific journals to disseminate the knowledge. TRIALS REGISTRATION NUMBER: NCT03304730; Pre-results.

Interspinous process devices for treatment of degenerative lumbar spine stenosis: A systematic review and meta-analysis.

BACKGROUND: Degenerative lumbar spinal stenosis is a condition related to aging in which structural changes cause narrowing of the central canal and intervertebral foramen. It is currently the leading cause for spinal surgery in patients over 65 years. Interspinous process devices (IPDs) were introduced as a less invasive surgical alternative, but questions regarding safety, efficacy, and cost-effectiveness are still unanswered. OBJECTIVES: The aim of this study was to provide complete and reliable information regarding benefits and harms of IPDs when compared to conservative treatment or decompression surgery and suggest directions for forthcoming RCTs. METHODS: We searched MEDLINE, EMBASE, Cochrane Library, Scopus, and LILACS for randomized and quasi-randomized trials, without language or period restrictions, comparing IPDs to conservative treatment or decompressive surgery in adults with symptomatic degenerative lumbar spine stenosis. Data extraction and analysis were conducted following the Cochrane Handbook. Primary outcomes were pain assessment, functional impairment, Zurich Claudication Questionnaire, and reoperation rates. Secondary outcomes were quality of life, complications, and cost-effectiveness. This systematic review was registered at Prospero (International prospective register of systematic reviews) under number 42015023604. RESULTS: The search strategy resulted in 17 potentially eligible reports. At the end, nine reports were included and eight were excluded. Overall quality of evidence was low. One trial compared IPDs to conservative treatment: IPDs presented better pain, functional status, quality of life outcomes, and higher complication risk. Five trials compared IPDs to decompressive surgery: pain, functional status, and quality of life had similar outcomes. IPD implant presented a significantly higher risk of reoperation. We found low-quality evidence that IPDs resulted in similar outcomes when compared to standard decompression surgery. Primary and secondary outcomes were not measured in all studies and were often published in incomplete form. Subgroup analysis was not feasible. Difficulty in contacting authors may have prevented us of including data in quantitative analysis. CONCLUSIONS: Patients submitted to IPD implants had significantly higher rates of reoperation, with lower cost-effectiveness. Future trials should improve in design quality and data reporting, with longer follow-up periods.

Radiofrequency denervation for facet joint low back pain: a systematic review.

STUDY DESIGN: A systematic review and meta-analysis of randomized controlled trials. OBJECTIVE: To assess treatment effects (benefits and harms) of radiofrequency denervation for patients with facet joint-related chronic low back pain. SUMMARY OF BACKGROUND DATA: There is no consensus regarding the treatment efficacy of facet joint radiofrequency denervation (FJRD) and how it compares with nerve blockades and joint infiltration with anesthetics and/or corticosteroids. METHODS: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and LILACS for randomized controlled trials that compared FJRD with blockades, infiltrations, or placebo. Primary outcomes were pain, functional status, and quality of life. Secondary outcomes were cost-effectiveness and complications. RESULTS: Fifteen studies were selected and 9 were eligible. Overall quality of evidence was rated low to moderate. The evidence favored FJRD regarding pain control. There was no sufficient evidence for cost-effectiveness and complications. CONCLUSION: The available evidence reviewed in this study should be interpreted with caution. The data indicate that FJRD is more effective than placebo in pain control and functional improvement and is also possibly more effective than steroid injections in pain control. Complications and adverse effects were not sufficiently reported to allow comparisons, and there was no evidence for cost-effectiveness. High-quality randomized controlled trials addressing pain, function, quality of life, complications, and cost-effectiveness are urgently needed. LEVEL OF EVIDENCE: 1.

Para-muscular and trans-muscular approaches to the lumbar inter-vertebral foramen: an anatomical comparison.

Foraminal and extra-foraminal disc herniations comprise up to 11.7% of all lumbar disc herniations. Facetectomy, which had been the classic approach, is now recognized as cause of pain and instability after surgery. Otherwise, posterior lateral approaches through a trans-muscular or a para-muscular technique offer no significant damage to key structures for spinal stability. The surgical anatomy of these approaches has already been described, but they were not compared. In order to quantify the angle of vision towards the intervertebral foramen offered by each technique, 12 fresh cadavers were dissected and studied regarding these approaches. The angle presented by trans-muscular approach was wider in all studied lumbar levels. Surgery through the trans-muscular approach is performed with a better working angle, requiring a smaller resection of surrounding tissues. Therefore, minor surgical trauma can be expected. Our measurements support previously published data that point the trans-muscular approach as the best surgical option.

Para-muscular and trans-muscular approaches to the lumbar inter-vertebral foramen: an anatomical comparison

As hérnias de disco lombares apresentam-se como foraminais ou extra-foraminais em até 11,7% dos casos. Seu tratamento cirúrgico através de facetectomias pode causar dor e instabilidade, o que não ocorre com a utilização de acessos cirúrgicos posteriores laterais ao canal central, quer seja por via transmuscular ou paramuscular. Nosso objetivo foi comparar o ângulo de trabalho relativo ao forame intervertebral permitido por cada via e avaliar possíveis implicações cirúrgicas. Dissecções e medidas realizadas em doze cadáveres frescos demonstraram que este ângulo é maior na via transmuscular em todos os níveis lombares estudados. Dado que um ângulo mais favorável permite uma ressecção menor das estruturas envolvidas para que se estabeleça o campo de trabalho, a cirurgia por meio da via transmuscular permitirá, então, um trauma cirúrgico menor. Nossos resultados corroboram publicações prévias que apontam a via transmuscular como a melhor opção cirúrgica.