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1.
Artigo em Inglês | MEDLINE | ID: mdl-33958537

RESUMO

STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVE: To compare the magnitude and duration of pain relief with vertebral augmentation to any other therapy for the treatment of cancer-related vertebral compression fractures through meta-analysis of randomized controlled trials. SUMMARY OF BACKGROUND DATA: Derived from search on PubMed, EMBASE, CINAHL, Scopus, Central, Scopus and Web of Science databases in May 2020. Studies selected were limited to randomized controlled trials comparing vertebral augmentation, either Balloon Kyphoplasty (BKP) or Percutaneous Vertebroplasty (PVP) with or without additional therapy to any other intervention or placebo/sham. METHODS: The methodological quality of each included study was assessed according to the Cochrane Collaboration's domain-based framework. Random-effects model. Heterogeneity assessed using the Q test and I2 statistic. RESULTS: Of 180 records identified, 7 were considered relevant, and included 476 participants. The risk of bias was considered "Low" in all studies. In five of the studies, vertebral augmentation alone (either PVP or BKP) comprised one group, while comparative treatments included non-surgical management, Kiva implantation, PVP and radiofrequency therapy, PVP and chemotherapy, PVP and intra-somatic injection of steroid, and PVP with 125I seeds. Two studies compared PVP with an additional therapy against the standard of care. With regard to changes in pain severity, the effect sizes varied from 0.0 (95% -1.7 to 1.7) to -5.1 (95% -5.3 to -4.9). Most studies demonstrated a positive and statistically significant effect associated with PVP. Four of the 7 studies demonstrated a clinically significant effect as well. Other than cement leakage, with an event rate of 0.24 (95% CI 0.11 to 0.44) or 24% (95% CI 11% to 44%), there were no major adverse events consistently observed across multiple studies. CONCLUSIONS: The included randomized controlled trials demonstrated an overall positive and statistically significant effect of vertebral augmentation surgeries, such as vertebroplasty and kyphoplasty, for the treatment of cancer-related vertebral compression fractures, especially when compared to non-surgical management, radiofrequency ablation or chemotherapy alone.Level of Evidence: 1.

2.
Pain Physician ; 24(S1): S27-S208, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33492918

RESUMO

BACKGROUND: Chronic spinal pain is the most prevalent chronic disease with employment of multiple modes of interventional techniques including epidural interventions. Multiple randomized controlled trials (RCTs), observational studies, systematic reviews, and guidelines have been published. The recent review of the utilization patterns and expenditures show that there has been a decline in utilization of epidural injections with decrease in inflation adjusted costs from 2009 to 2018. The American Society of Interventional Pain Physicians (ASIPP) published guidelines for interventional techniques in 2013, and guidelines for facet joint interventions in 2020. Consequently, these guidelines have been prepared to update previously existing guidelines. OBJECTIVE: To provide evidence-based guidance in performing therapeutic epidural procedures, including caudal, interlaminar in lumbar, cervical, and thoracic spinal regions, transforaminal in lumbar spine, and percutaneous adhesiolysis in the lumbar spine. METHODS: The methodology utilized included the development of objective and key questions with utilization of trustworthy standards. The literature pertaining to all aspects of epidural interventions was viewed with best evidence synthesis of available literature and  recommendations were provided. RESULTS: In preparation of the guidelines, extensive literature review was performed. In addition to review of multiple manuscripts in reference to utilization, expenditures, anatomical and pathophysiological considerations, pharmacological and harmful effects of drugs and procedures, for evidence synthesis we have included 47 systematic reviews and 43 RCTs covering all epidural interventions to meet the objectives.The evidence recommendations are as follows: Disc herniation: Based on relevant, high-quality fluoroscopically guided epidural injections, with or without steroids, and results of previous systematic reviews, the evidence is Level I for caudal epidural injections, lumbar interlaminar epidural injections, lumbar transforaminal epidural injections, and cervical interlaminar epidural injections with strong recommendation for long-term effectiveness.The evidence for percutaneous adhesiolysis in managing disc herniation based on one high-quality, placebo-controlled RCT is Level II with moderate to strong recommendation for long-term improvement in patients nonresponsive to conservative management and fluoroscopically guided epidural injections. For thoracic disc herniation, based on one relevant, high-quality RCT of thoracic epidural with fluoroscopic guidance, with or without steroids, the evidence is Level II with moderate to strong recommendation for long-term effectiveness.Spinal stenosis: The evidence based on one high-quality RCT in each category the evidence is Level III to II for fluoroscopically guided caudal epidural injections with moderate to strong recommendation and Level II for fluoroscopically guided lumbar and cervical interlaminar epidural injections with moderate to strong recommendation for long-term effectiveness.The evidence for lumbar transforaminal epidural injections is Level IV to III with moderate recommendation with fluoroscopically guided lumbar transforaminal epidural injections for long-term improvement. The evidence for percutaneous adhesiolysis in lumbar stenosis based on relevant, moderate to high quality RCTs, observational studies, and systematic reviews is Level II with moderate to strong recommendation for long-term improvement after failure of conservative management and fluoroscopically guided epidural injections. Axial discogenic pain: The evidence for axial discogenic pain without facet joint pain or sacroiliac joint pain in the lumbar and cervical spine with fluoroscopically guided caudal, lumbar and cervical interlaminar epidural injections, based on one relevant high quality RCT in each category is Level II with moderate to strong recommendation for long-term improvement, with or without steroids. Post-surgery syndrome: The evidence for lumbar and cervical post-surgery syndrome based on one relevant, high-quality RCT with fluoroscopic guidance for caudal and cervical interlaminar epidural injections, with or without steroids, is Level II with moderate to strong recommendation for long-term improvement. For percutaneous adhesiolysis, based on multiple moderate to high-quality RCTs and systematic reviews, the evidence is Level I with strong recommendation for long-term improvement after failure of conservative management and fluoroscopically guided epidural injections. LIMITATIONS: The limitations of these guidelines include a continued paucity of high-quality studies for some techniques and various conditions including spinal stenosis, post-surgery syndrome, and discogenic pain. CONCLUSIONS: These epidural intervention guidelines including percutaneous adhesiolysis were prepared with a comprehensive review of the literature with methodologic quality assessment and determination of level of evidence with strength of recommendations.

3.
Tech Vasc Interv Radiol ; 23(4): 100701, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33308580

RESUMO

Vertebral compression fractures (VCFs) result from either trauma or a pathologic process that weakens the bone by conditions such as osteoporosis or tumor. The incidence of VCFs has been rising over the last few decades in accordance with the aging population. These fractures can result in severe pain, physical limitation and disability, as well as increased morbidity and mortality. Patients with VCFs are optimally treated by accurate and early diagnosis and treatment. An effective method to treat these fractures is percutaneous vertebral augmentation, which is a set of minimally invasive procedures that stabilizes osseous fractures, provides immediate pain relief, and improves quality of life. Vertebral augmentation procedures include vertebroplasty, kyphoplasty, and vertebral augmentation with implants. Each of these techniques is described in general terms in this article. The ideal candidate for vertebral augmentation is a patient with a symptomatic fracture seen on cross-sectional imaging in which nonsurgical management has failed and has positive signs on physical examination with no absolute contraindication. This procedure should be done with the appropriate equipment and personnel in a facility designed for this purpose. After the procedure, the patient should undergo the appropriate follow-up to ensure optimal recovery. Additionally, it is essential that the patient receives appropriate therapy for the underlying disorder that predisposed them to the vertebral fracture.


Assuntos
Fraturas por Compressão/cirurgia , Cifoplastia , Radiografia Intervencionista , Fraturas da Coluna Vertebral/cirurgia , Vertebroplastia , Tomada de Decisão Clínica , Protocolos Clínicos , Fraturas por Compressão/diagnóstico por imagem , Fraturas por Compressão/fisiopatologia , Humanos , Cifoplastia/efeitos adversos , Radiografia Intervencionista/efeitos adversos , Fatores de Risco , Fraturas da Coluna Vertebral/diagnóstico por imagem , Fraturas da Coluna Vertebral/fisiopatologia , Vertebroplastia/efeitos adversos
5.
J Bone Joint Surg Am ; 102(17): 1501-1510, 2020 Sep 02.
Artigo em Inglês | MEDLINE | ID: mdl-32898379

RESUMO

BACKGROUND: Knee osteoarthritis is a painful and sometimes debilitating disease that often affects patients for years. Current treatments include short-lasting and often repetitive nonsurgical options, followed by surgical intervention for appropriate candidates. Cooled radiofrequency ablation (CRFA) is a minimally invasive procedure for the treatment of pain related to knee osteoarthritis. This trial compared the efficacy and safety of CRFA with those of a single hyaluronic acid (HA) injection. METHODS: Two hundred and sixty subjects with knee osteoarthritis pain that was inadequately responsive to prior nonoperative modalities were screened for enrollment in this multicenter, randomized trial. One hundred and eighty-two subjects who met the inclusion criteria underwent diagnostic block injections and those with a minimum of 50% pain relief were randomized to receive either CRFA on 4 genicular nerves or a single HA injection. One hundred and seventy-five subjects were treated (88 with CRFA and 87 with HA). Evaluations for pain (Numeric Rating Scale [NRS]), function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]), quality of life (Global Perceived Effect [GPE] score and EuroQol-5 Dimensions-5 Level [EQ-5D-5L] questionnaire), and safety were performed at 1, 3, and 6 months after treatment. RESULTS: Demographic characteristics did not differ significantly between the 2 study groups. A total of 158 subjects (76 in the CRFA group and 82 in the HA group) completed the 6-month post-treatment follow-up. In the CRFA group, 71% of the subjects had ≥50% reduction in the NRS pain score (primary end point) compared with 38% in the HA group (p < 0.0001). At 6 months, the mean NRS score reduction was 4.1 ± 2.2 for the CRFA group compared with 2.5 ± 2.5 for the HA group (p < 0.0001). The mean WOMAC score improvement at 6 months from baseline was 48.2% in the CRFA group and 22.6% in the HA group (p < 0.0001). At 6 months, 72% of the subjects in the CRFA group reported improvement in the GPE score compared with 40% in the HA group (p < 0.0001). CONCLUSIONS: CRFA-treated subjects demonstrated a significant improvement in pain relief and overall function compared with subjects treated with a single injection of HA. No serious adverse events related to either procedure were noted, and the overall adverse-event profiles were similar. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

6.
Neuroradiology ; 62(12): 1607-1615, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32803337

RESUMO

This article is to review the different types of vertebral augmentation implants recently becoming available for the treatment of benign and malignant spinal compression fractures. After a detailed description of the augmentation implants, we review the available clinical data. We will conclude with a summary of the advantages and disadvantages of vertebral implants and how they can affect the future treatment options of compression fractures.

7.
Pain Physician ; 23(4): E343-E352, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32709180

RESUMO

BACKGROUND: The BenchMarket Medical (BMM) Vertebral Compression Fracture (VCF) Registry, now known as Talosix, is a collaborative effort between Talosix (the authorized registry vendor), Noridian Healthcare Solutions, and clinicians to gather outcomes evidence for cement augmentation treatments in patients with acute painful osteoporotic VCFs. The VCF Registry was designed to provide outcomes evidence to inform the Medicare payer's "coverage with evidence development" decision to authorize reimbursement for cement augmentation treatments. OBJECTIVES: The purpose of this article was to present a pathway for appropriate use of vertebral augmentation based on the findings of the VCF Registry. STUDY DESIGN: Prospective observational data, including patient characteristics, diagnosis, process of care, and patient-reported outcomes (PROs) for pain and function, were collected from patients undergoing cement augmentation treatment. The PROs were collected at baseline, 1, 3, and 6 months following the procedure. SETTING: The VCF Registry is a national ongoing registry with no specified end time or designated sample size. METHODS: Primary outcomes were pain improvement measured using the Numeric Rating Scale and function improvement, measured using the Roland Morris Disability Questionnaire (RMDQ). Secondary outcomes included cement leakage, new neurologic deficits, adverse events, readmissions, and death. RESULTS: The VCF Registry delivered outcomes data to support Noridian's "coverage with evidence development" decision. A total of 732 patients were included in this study. Registry outcomes confirmed postmarket evidence of highly significant pain relief with mean pain score improvement of 6.5/10 points at 6 months. Function also improved significantly with mean RMDQ score change of 11.4/24 points 6 months after surgery. Results also showed the safety and reliability of cement augmentation. LIMITATIONS: The nature of the registry data is that it contains nonrandomized, nonplacebo controlled data and should not be perceived as such. The real-world setting and the large number of patients within the dataset should increase the external validity of the findings. CONCLUSIONS: Cement augmentation treatments of patients with acute painful VCFs reliably results in highly significant benefits of pain decrease and functional improvement for this Medicare population. KEY WORDS: Vertebral compression fractures, osteoporosis, kyphoplasty, back pain, registry.


Assuntos
Cimentos para Ossos , Fraturas por Compressão/cirurgia , Cifoplastia/normas , Sistema de Registros , Fraturas da Coluna Vertebral/cirurgia , Vertebroplastia/normas , Idoso , Idoso de 80 Anos ou mais , Cimentos para Ossos/uso terapêutico , Gerenciamento Clínico , Feminino , Fraturas por Compressão/diagnóstico , Fraturas por Compressão/epidemiologia , Humanos , Cifoplastia/métodos , Masculino , Pessoa de Meia-Idade , Osteoporose/diagnóstico , Osteoporose/epidemiologia , Osteoporose/cirurgia , Manejo da Dor/métodos , Manejo da Dor/normas , Medição da Dor/métodos , Medição da Dor/normas , Estudos Prospectivos , Reprodutibilidade dos Testes , Fraturas da Coluna Vertebral/diagnóstico , Fraturas da Coluna Vertebral/epidemiologia , Resultado do Tratamento , Estados Unidos/epidemiologia , Vertebroplastia/métodos
8.
BMC Musculoskelet Disord ; 21(1): 363, 2020 Jun 09.
Artigo em Inglês | MEDLINE | ID: mdl-32517739

RESUMO

BACKGROUND: Safe and effective non-surgical treatments are an important part of the knee osteoarthritis (OA) treatment algorithm. Cooled radiofrequency ablation (CRFA) and hyaluronic acid (HA) injections are two commonly used modalities to manage symptoms associated with knee OA. METHODS: A prospective 1:1 randomized study was conducted in 177 patients comparing CRFA to HA injection with follow-ups at 1, 3, 6 and 12 months. HA subjects with unsatisfactory outcomes at 6-months were allowed to crossover and receive CRFA. Knee pain (numeric rating scale = NRS), WOMAC Index (pain, stiffness and physical function), overall quality of life (global perceived effect = GPE, EQ-5D-5 L), and adverse events were measured. RESULTS: At 12-months, 65.2% of subjects in the CRFA cohort reported ≥50% pain relief from baseline. Mean NRS pain score was 2.8 ± 2.4 at 12 months (baseline 6.9 ± 0.8). Subjects in the CRFA cohort saw a 46.2% improvement in total WOMAC score at the 12-month timepoint. 64.5% of subjects in the crossover cohort reported ≥50% pain relief from baseline, with a mean NRS pain score of 3.0 ± 2.4 at 12 months (baseline 7.0 ± 1.0). After receiving CRFA, subjects in the crossover cohort had a 27.5% improvement in total WOMAC score. All subjects receiving CRFA reported significant improvement in quality of life. There were no serious adverse events related to either procedure and overall adverse event profiles were similar. CONCLUSION: A majority of subjects treated with CRFA demonstrated sustained knee pain relief for at least 12-months. Additionally, CRFA provided significant pain relief for HA subjects who crossed over 6 months after treatment. TRIAL REGISTRATION: This trial was registered on ClinicalTrials.gov, NCT03381248. Registered 27 December 2017.

9.
Pain Physician ; 23(3S): S1-S127, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32503359

RESUMO

BACKGROUND: Chronic axial spinal pain is one of the major causes of significant disability and health care costs, with facet joints as one of the proven causes of pain. OBJECTIVE: To provide evidence-based guidance in performing diagnostic and therapeutic facet joint interventions. METHODS: The methodology utilized included the development of objectives and key questions with utilization of trustworthy standards. The literature pertaining to all aspects of facet joint interventions, was reviewed, with a best evidence synthesis of available literature and utilizing grading for recommendations.Summary of Evidence and Recommendations:Non-interventional diagnosis: • The level of evidence is II in selecting patients for facet joint nerve blocks at least 3 months after onset and failure of conservative management, with strong strength of recommendation for physical examination and clinical assessment. • The level of evidence is IV for accurate diagnosis of facet joint pain with physical examination based on symptoms and signs, with weak strength of recommendation. Imaging: • The level of evidence is I with strong strength of recommendation, for mandatory fluoroscopic or computed tomography (CT) guidance for all facet joint interventions. • The level of evidence is III with weak strength of recommendation for single photon emission computed tomography (SPECT) . • The level of evidence is V with weak strength of recommendation for scintography, magnetic resonance imaging (MRI), and computed tomography (CT) .Interventional Diagnosis:Lumbar Spine: • The level of evidence is I to II with moderate to strong strength of recommendation for lumbar diagnostic facet joint nerve blocks. • Ten relevant diagnostic accuracy studies with 4 of 10 studies utilizing controlled comparative local anesthetics with concordant pain relief criterion standard of ≥80% were included. • The prevalence rates ranged from 27% to 40% with false-positive rates of 27% to 47%, with ≥80% pain relief.Cervical Spine: • The level of evidence is II with moderate strength of recommendation. • Ten relevant diagnostic accuracy studies, 9 of the 10 studies with either controlled comparative local anesthetic blocks or placebo controls with concordant pain relief with a criterion standard of ≥80% were included. • The prevalence and false-positive rates ranged from 29% to 60% and of 27% to 63%, with high variability. Thoracic Spine: • The level of evidence is II with moderate strength of recommendation. • Three relevant diagnostic accuracy studies, with controlled comparative local anesthetic blocks, with concordant pain relief, with a criterion standard of ≥80% were included. • The prevalence varied from 34% to 48%, whereas false-positive rates varied from 42% to 58%.Therapeutic Facet Joint Interventions: Lumbar Spine: • The level of evidence is II with moderate strength of recommendation for lumbar radiofrequency ablation with inclusion of 11 relevant randomized controlled trials (RCTs) with 2 negative studies and 4 studies with long-term improvement. • The level of evidence is II with moderate strength of recommendation for therapeutic lumbar facet joint nerve blocks with inclusion of 3 relevant randomized controlled trials, with long-term improvement. • The level of evidence is IV with weak strength of recommendation for lumbar facet joint intraarticular injections with inclusion of 9 relevant randomized controlled trials, with majority of them showing lack of effectiveness without the use of local anesthetic. Cervical Spine: • The level of evidence is II with moderate strength of recommendation for cervical radiofrequency ablation with inclusion of one randomized controlled trial with positive results and 2 observational studies with long-term improvement. • The level of evidence is II with moderate strength of recommendation for therapeutic cervical facet joint nerve blocks with inclusion of one relevant randomized controlled trial and 3 observational studies, with long-term improvement. • The level of evidence is V with weak strength of recommendation for cervical intraarticular facet joint injections with inclusion of 3 relevant randomized controlled trials, with 2 observational studies, the majority showing lack of effectiveness, whereas one study with 6-month follow-up, showed lack of long-term improvement. Thoracic Spine: • The level of evidence is III with weak to moderate strength of recommendation with emerging evidence for thoracic radiofrequency ablation with inclusion of one relevant randomized controlled trial and 3 observational studies. • The level of evidence is II with moderate strength of recommendation for thoracic therapeutic facet joint nerve blocks with inclusion of 2 randomized controlled trials and one observational study with long-term improvement. • The level of evidence is III with weak to moderate strength of recommendation for thoracic intraarticular facet joint injections with inclusion of one randomized controlled trial with 6 month follow-up, with emerging evidence. Antithrombotic Therapy: • Facet joint interventions are considered as moderate to low risk procedures; consequently, antithrombotic therapy may be continued based on overall general status. Sedation: • The level of evidence is II with moderate strength of recommendation to avoid opioid analgesics during the diagnosis with interventional techniques. • The level of evidence is II with moderate strength of recommendation that moderate sedation may be utilized for patient comfort and to control anxiety for therapeutic facet joint interventions. LIMITATIONS: The limitations of these guidelines include a paucity of high-quality studies in the majority of aspects of diagnosis and therapy. CONCLUSIONS: These facet joint intervention guidelines were prepared with a comprehensive review of the literature with methodologic quality assessment with determination of level of evidence and strength of recommendations. KEY WORDS: Chronic spinal pain, interventional techniques, diagnostic blocks, therapeutic interventions, facet joint nerve blocks, intraarticular injections, radiofrequency neurolysis.


Assuntos
Dor nas Costas/terapia , Dor Crônica/terapia , Manejo da Dor/métodos , Articulação Zigapofisária , Humanos , Estados Unidos
10.
Int J Spine Surg ; 14(2): 239-253, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32355632

RESUMO

Background: The function of the intervertebral disc is structural. Loss of tissue alters biomechanics, leads to subsequent disc degeneration, and is attributable to discogenic pain. A viable structural allograft was delivered into degenerate discs to determine whether intervention could safely stabilize anatomy, reduce pain, and improve function. Methods: Following institutional review board approval and patient consent, subjects were randomized to receive allograft or saline at either 1 or 2 levels or continue nonsurgical management (NSM). Data were collected at baseline, 3, 6, and 12 months. Back pain with a visual analog scale (VAS) and disability by the Oswestry Disability Index (ODI) were assessed, as were adverse events. This trial is registered on http://www.clinicaltrials.gov (NCT03709901). Results: At 6 and 12 months, the VAS improved from 54.81, 55.25, and 62.255 in the allograft, saline, and NSM subjects, respectively, to 16.0 and 41.0 in the allograft and saline groups at 6 months, and 12.27 and 19.67, respectively, at 12 months. All subjects in the NSM cohort crossed over to allograft treatment. At 6 and 12 months, ODI improved from 53.73, 49.25, and 55.75 in the allograft, saline, and NSM subjects, respectively, to 18.47 and 28.75 in the allograft and saline groups 1 and 2 at 6 months, and 15.67 and 9.33, respectively, at 12 months. At 3 months the ODI of the NSM group was 62.75 and subjects reached 19.0 and 11.0 at 6 and 12 months, respectively. Adverse events were transient and resolved in all cohorts. Conclusions: This study is supported by data demonstrating that improved pain and function at 12 months can be attained with a supplemental viable disc matrix. Subjects receiving the VIA Disc Matrix achieved improvements that were durable at 12 months. Level of Evidence: 1. Clinical Relevance: Initial assessments indicate that a 1-level or 2-level treatment offers a reliable intervention that is safe and beneficial.

11.
Pain physician ; 23(3S): S1-S127, May 2020.
Artigo em Inglês | BIGG - guias GRADE | ID: biblio-1129928

RESUMO

Chronic axial spinal pain is one of the major causes of significant disability and health care costs, with facet joints as one of the proven causes of pain. To provide evidence-based guidance in performing diagnostic and therapeutic facet joint interventions. The methodology utilized included the development of objectives and key questions with utilization of trustworthy standards. The literature pertaining to all aspects of facet joint interventions, was reviewed, with a best evidence synthesis of available literature and utilizing grading for recommendations.


Assuntos
Humanos , Masculino , Feminino , Bloqueio Nervoso Autônomo , Dor nas Costas/terapia , Denervação/métodos , Dor Crônica/terapia , Manejo da Dor/métodos , Terapia por Radiofrequência , Avaliação de Resultado de Intervenções Terapêuticas , Injeções Intra-Articulares
12.
Int J Spine Surg ; 14(1): 18-25, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32128298

RESUMO

This International Society for the Advancement of Spine Surgery guideline is generated to respond to growing requests for background, supporting literature and evidence, and proper coding for intraosseous ablation of the basivertebral nerve for chronic low back pain.

13.
Pain Physician ; 23(2): E85-E131, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32214287

RESUMO

BACKGROUND: The use of bone marrow concentrate (BMC) for treatment of musculoskeletal disorders has become increasingly popular over the last several years, as technology has improved along with the need for better solutions for these pathologies. The use of cellular tissue raises a number of issues regarding the US Food and Drug Administration's (FDA) regulation in classifying these treatments as a drug versus just autologous tissue transplantation. In the case of BMC in musculoskeletal and spine care, this determination will likely hinge on whether BMC is homologous to the musculoskeletal system and spine. OBJECTIVES: The aim of this review is to describe the current regulatory guidelines set in place by the FDA, specifically the terminology around "minimal manipulation" and "homologous use" within Regulation 21 CFR Part 1271, and specifically how this applies to the use of BMC in interventional musculoskeletal medicine. METHODS: The methodology utilized here is similar to the methodology utilized in preparation of multiple guidelines employing the experience of a panel of experts from various medical specialties and subspecialties from differing regions of the world. The collaborators who developed these position statements have submitted their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these position statements. The literature pertaining to BMC, its effectiveness, adverse consequences, FDA regulations, criteria for meeting the standards of minimal manipulation, and homologous use were comprehensively reviewed using a best evidence synthesis of the available and relevant literature. RESULTS/Summary of Evidence: In conjunction with evidence-based medicine principles, the following position statements were developed: Statement 1: Based on a review of the literature in discussing the preparation of BMC using accepted methodologies, there is strong evidence of minimal manipulation in its preparation, and moderate evidence for homologous utility for various musculoskeletal and spinal conditions qualifies for the same surgical exemption. Statement 2: Assessment of clinical effectiveness based on extensive literature shows emerging evidence for multiple musculoskeletal and spinal conditions. • The evidence is highest for knee osteoarthritis with level II evidence based on relevant systematic reviews, randomized controlled trials and nonrandomized studies. There is level III evidence for knee cartilage conditions. • Based on the relevant systematic reviews, randomized trials, and nonrandomized studies, the evidence for disc injections is level III. • Based on the available literature without appropriate systematic reviews or randomized controlled trials, the evidence for all other conditions is level IV or limited for BMC injections. Statement 3: Based on an extensive review of the literature, there is strong evidence for the safety of BMC when performed by trained physicians with the appropriate precautions under image guidance utilizing a sterile technique. Statement 4: Musculoskeletal disorders and spinal disorders with related disability for economic and human toll, despite advancements with a wide array of treatment modalities. Statement 5: The 21st Century Cures Act was enacted in December 2016 with provisions to accelerate the development and translation of promising new therapies into clinical evaluation and use. Statement 6: Development of cell-based therapies is rapidly proliferating in a number of disease areas, including musculoskeletal disorders and spine. With mixed results, these therapies are greatly outpacing the evidence. The reckless publicity with unsubstantiated claims of beneficial outcomes having putative potential, and has led the FDA Federal Trade Commission (FTC) to issue multiple warnings. Thus the US FDA is considering the appropriateness of using various therapies, including BMC, for homologous use. Statement 7: Since the 1980's and the description of mesenchymal stem cells by Caplan et al, (now called medicinal signaling cells), the use of BMC in musculoskeletal and spinal disorders has been increasing in the management of pain and promoting tissue healing. Statement 8: The Public Health Service Act (PHSA) of the FDA requires minimal manipulation under same surgical procedure exemption. Homologous use of BMC in musculoskeletal and spinal disorders is provided by preclinical and clinical evidence. Statement 9: If the FDA does not accept BMC as homologous, then it will require an Investigational New Drug (IND) classification with FDA (351) cellular drug approval for use. Statement 10: This literature review and these position statements establish compliance with the FDA's intent and corroborates its present description of BMC as homologous with same surgical exemption, and exempt from IND, for use of BMC for treatment of musculoskeletal tissues, such as cartilage, bones, ligaments, muscles, tendons, and spinal discs. CONCLUSIONS: Based on the review of all available and pertinent literature, multiple position statements have been developed showing that BMC in musculoskeletal disorders meets the criteria of minimal manipulation and homologous use. KEY WORDS: Cell-based therapies, bone marrow concentrate, mesenchymal stem cells, medicinal signaling cells, Food and Drug Administration, human cells, tissues, and cellular tissue-based products, Public Health Service Act (PHSA), minimal manipulation, homologous use, same surgical procedure exemption.


Assuntos
Transplante de Medula Óssea/normas , Medicina Baseada em Evidências/normas , Doenças Musculoesqueléticas/terapia , Manejo da Dor/normas , Médicos/normas , Sociedades Médicas/normas , Medula Óssea/fisiologia , Transplante de Medula Óssea/métodos , Medicina Baseada em Evidências/métodos , Humanos , Doenças Musculoesqueléticas/diagnóstico , Doenças Musculoesqueléticas/epidemiologia , Dor/diagnóstico , Dor/epidemiologia , Manejo da Dor/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Resultado do Tratamento , Estados Unidos , United States Food and Drug Administration/normas
14.
Spine J ; 19(10): 1620-1632, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31229663

RESUMO

BACKGROUND CONTEXT: Current literature suggests that degenerated or damaged vertebral endplates are a significant cause of chronic low back pain (LBP) that is not adequately addressed by standard care. Prior 2-year data from the treatment arm of a sham-controlled randomized controlled trial (RCT) showed maintenance of clinical improvements at 2 years following radiofrequency (RF) ablation of the basivertebral nerve (BVN). PURPOSE: The purpose of this RCT was to compare the effectiveness of intraosseous RF ablation of the BVN to standard care for the treatment of chronic LBP in a specific subgroup of patients suspected to have vertebrogenic related symptomatology. STUDY DESIGN/SETTING: A prospective, parallel, open label RCT was conducted at 20 U.S. sites. PATIENT SAMPLE: A total of 140 patients with chronic LBP of at least 6 months duration, with Modic Type 1 or 2 vertebral endplate changes between L3 and S1, were randomized 1:1 to undergo either RF ablation of the BVN or continue standard care. OUTCOME MEASURES: Oswestry Disability Index (ODI) was collected at baseline, 3, 6, 9, and 12-months postprocedure. Secondary outcome measures included a 10-point Visual Analog Scale (VAS) for LBP, ODI and VAS responder rates, SF-36, and EQ-5D-5L. The primary endpoint was a between-arm comparison of the mean change in ODI from baseline to 3 months post-treatment. METHODS: Patients were randomized 1:1 to receive RF ablation or to continue standard care. Self-reported patient outcomes were collected using validated questionnaires at each study visit. An interim analysis to assess for superiority was prespecified and overseen by an independent data management committee when a minimum of 60% of patients had completed their 3-month primary endpoint visit. RESULTS: The interim analysis showed clear statistical superiority (p<.001) for all primary and secondary patient-reported outcome measures in the RF ablation arm compared with the standard care arm. This resulted in a data management committee recommendation to halt enrollment in the study and offer early cross-over to the control arm. These results are comprised of the outcomes of the 104 patients included in the intent-to-treat analysis of the 3-month primary endpoint, which included 51 patients in the RF ablation arm and 53 patients in the standard care arm. Baseline ODI was 46.1, VAS was 6.67, and mean age was 50 years. The percentage of patients with LBP symptoms ≥5 years was 67.3%. Comparing the RF ablation arm to the standard care arm, the mean changes in ODI at 3 months were -25.3 points versus -4.4 points, respectively, resulting in an adjusted difference of 20.9 points (p<.001). Mean changes in VAS were -3.46 versus -1.02, respectively, an adjusted difference of 2.44 cm (p<.001). In the RF ablation arm, 74.5% of patients achieved a ≥10-point improvement in ODI, compared with 32.7% in the standard care arm (p<0.001). CONCLUSIONS: Minimally invasive RF ablation of the BVN led to significant improvement of pain and function at 3-months in patients with chronic vertebrogenic related LBP.


Assuntos
Ablação por Cateter/métodos , Dor Lombar/terapia , Complicações Pós-Operatórias/epidemiologia , Adulto , Ablação por Cateter/efeitos adversos , Feminino , Humanos , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade
15.
Int J Spine Surg ; 13(1): 1-10, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30805279

RESUMO

The ISASS Policy Statement on vertebral augmentation has the objectives to provide a background and an update with the latest clinical evidence for the international spine community. A SpineLine Panel Review (2010) appropriately recommended an exploration of "the seeming disconnect between the conclusions of … two [Level I] PRCT's and previous experience and data" regarding vertebral augmentation. ISASS responded by supporting a comprehensive meta-analysis to help frame a cogent historical analysis of vertebral augmentation. This ISASS Policy 2018 is based on a thorough literature search for relevant studies, including systematic reviews and meta-analyses, that are subjected to thorough quality appraisal for the purpose of informing public opinion and decision making. Given the abundance of high-quality information, ISASS can confidently advocate that there is strong support for vertebral augmentation in the treatment of symptomatic vertebral compression fractures.

16.
Pain Physician ; 22(1S): S1-S74, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30717500

RESUMO

BACKGROUND: Regenerative medicine is a medical subspecialty that seeks to recruit and enhance the body's own inherent healing armamentarium in the treatment of patient pathology. This therapy's intention is to assist in the repair, and to potentially replace or restore damaged tissue through the use of autologous or allogenic biologics. This field is rising like a Phoenix from the ashes of underperforming conventional therapy midst the hopes and high expectations of patients and medical personnel alike. But, because this is a relatively new area of medicine that has yet to substantiate its outcomes, care must be taken in its public presentation and promises as well as in its use. OBJECTIVE: To provide guidance for the responsible, safe, and effective use of biologic therapy in the lumbar spine. To present a template on which to build standardized therapies using biologics. To ground potential administrators of biologics in the knowledge of the current outcome statistics and to stimulate those interested in providing biologic therapy to participate in high quality research that will ultimately promote and further advance this area of medicine. METHODS: The methodology used has included the development of objectives and key questions. A panel of experts from various medical specialties and subspecialties as well as differing regions collaborated in the formation of these guidelines and submitted (if any) their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these guidelines. The literature pertaining to regenerative medicine, its effectiveness, and adverse consequences was thoroughly reviewed using a best evidence synthesis of the available literature. The grading for recommendation was provided as described by the Agency for Healthcare Research and Quality (AHRQ). SUMMARY OF EVIDENCE: Lumbar Disc Injections: Based on the available evidence regarding the use of platelet-rich plasma (PRP), including one high-quality randomized controlled trial (RCT), multiple moderate-quality observational studies, a single-arm meta-analysis and evidence from a systematic review, the qualitative evidence has been assessed as Level III (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best-evidence synthesis. Based on the available evidence regarding the use of medicinal signaling/ mesenchymal stem cell (MSCs) with a high-quality RCT, multiple moderate-quality observational studies, a single-arm meta-analysis, and 2 systematic reviews, the qualitative evidence has been assessed as Level III (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. Lumbar Epidural Injections Based on one high-quality RCT, multiple relevant moderate-quality observational studies and a single-arm meta-analysis, the qualitative evidence has been assessed as Level IV (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. Lumbar Facet Joint Injections Based on one high-quality RCT and 2 moderate-quality observational studies, the qualitative evidence for facet joint injections with PRP has been assessed as Level IV (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. Sacroiliac Joint Injection Based on one high-quality RCT, one moderate-quality observational study, and one low-quality case report, the qualitative evidence has been assessed as Level IV (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. CONCLUSION: Based on the evidence synthesis summarized above, there is Level III evidence for intradiscal injections of PRP and MSCs, whereas the evidence is considered Level IV for lumbar facet joint, lumbar epidural, and sacroiliac joint injections of PRP, (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis.Regenerative therapy should be provided to patients following diagnostic evidence of a need for biologic therapy, following a thorough discussion of the patient's needs and expectations, after properly educating the patient on the use and administration of biologics and in full light of the patient's medical history. Regenerative therapy may be provided independently or in conjunction with other modalities of treatment including a structured exercise program, physical therapy, behavioral therapy, and along with the appropriate conventional medical therapy as necessary. Appropriate precautions should be taken into consideration and followed prior to performing biologic therapy. Multiple guidelines from the Food and Drug Administration (FDA), potential limitations in the use of biologic therapy and the appropriate requirements for compliance with the FDA have been detailed in these guidelines. KEY WORDS: Regenerative medicine, platelet-rich plasma, medicinal signaling cells, mesenchymal stem cells, stromal vascular fraction, bone marrow concentrate, chronic low back pain, discogenic pain, facet joint pain, Food and Drug Administration, minimal manipulation, evidence synthesis.


Assuntos
Produtos Biológicos/uso terapêutico , Dor Lombar/terapia , Manejo da Dor/métodos , Manejo da Dor/normas , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Medicina Regenerativa/métodos , Medicina Regenerativa/normas
17.
Pain Physician ; 22(1S): S75-S128, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30717501

RESUMO

BACKGROUND: Interventional pain management involves diagnosis and treatment of chronic pain. This specialty utilizes minimally invasive procedures to target therapeutics to the central nervous system and the spinal column. A subset of patients encountered in interventional pain are medicated using anticoagulant or antithrombotic drugs to mitigate thrombosis risk. Since these drugs target the clotting system, bleeding risk is a consideration accompanying interventional procedures. Importantly, discontinuation of anticoagulant or antithrombotic drugs exposes underlying thrombosis risk, which can lead to significant morbidity and mortality especially in those with coronary artery or cerebrovascular disease. This review summarizes the literature and provides guidelines based on best evidence for patients receiving anti-clotting therapy during interventional pain procedures. STUDY DESIGN: Best evidence synthesis. OBJECTIVE: To provide a current and concise appraisal of the literature regarding an assessment of the bleeding risk during interventional techniques for patients taking anticoagulant and/or antithrombotic medications. METHODS: A review of the available literature published on bleeding risk during interventional pain procedures, practice patterns and perioperative management of anticoagulant and antithrombotic therapy was conducted. Data sources included relevant literature identified through searches of EMBASE and PubMed from 1966 through August 2018 and manual searches of the bibliographies of known primary and review articles. RESULTS: 1. There is good evidence for risk stratification by categorizing multiple interventional techniques into low-risk, moderate-risk, and high-risk. Also, their risk should be upgraded based on other risk factors.2. There is good evidence for the risk of thromboembolic events in patients who interrupt antithrombotic therapy. 3. There is good evidence supporting discontinuation of low dose aspirin for high risk and moderate risk procedures for at least 3 days, and there is moderate evidence that these may be continued for low risk or some intermediate risk procedures.4. There is good evidence that discontinuation of anticoagulant therapy with warfarin, heparin, dabigatran (Pradaxa®), argatroban (Acova®), bivalirudin (Angiomax®), lepirudin (Refludan®), desirudin (Iprivask®), hirudin, apixaban (Eliquis®), rivaroxaban (Xarelto®), edoxaban (Savaysa®, Lixiana®), Betrixaban(Bevyxxa®), fondaparinux (Arixtra®) prior to interventional techniques with individual consideration of pharmacokinetics and pharmacodynamics of the drugs and individual risk factors increases safety.5. There is good evidence that diagnosis of epidural hematoma is based on severe pain at the site of the injection, rapid neurological deterioration, and MRI with surgical decompression with progressive neurological dysfunction to avoid neurological sequelae.6. There is good evidence that if thromboembolic risk is high, low molecular weight heparin bridge therapy can be instituted during cessation of the anticoagulant, and the low molecular weight heparin can be discontinued 24 hours before the pain procedure.7. There is fair evidence that the risk of thromboembolic events is higher than that of epidural hematoma formation with the interruption of antiplatelet therapy preceding interventional techniques, though both risks are significant.8. There is fair evidence that multiple variables including anatomic pathology with spinal stenosis and ankylosing spondylitis; high risk procedures and moderate risk procedures combined with anatomic risk factors; bleeding observed during the procedure, and multiple attempts during the procedures increase the risk for bleeding complications and epidural hematoma.9. There is fair evidence that discontinuation of phosphodiesterase inhibitors is optional (dipyridamole [Persantine], cilostazol [Pletal]. However, there is also fair evidence to discontinue Aggrenox [dipyridamole plus aspirin]) 3 days prior to undergoing interventional techniques of moderate and high risk. 10. There is fair evidence to make shared decision making between the patient and the treating physicians with the treating physician and to consider all the appropriate risks associated with continuation or discontinuation of antithrombotic or anticoagulant therapy.11. There is fair evidence that if thromboembolic risk is high antithrombotic therapy may be resumed 12 hours after the interventional procedure is performed.12. There is limited evidence that discontinuation of antiplatelet therapy (clopidogrel [Plavix®], ticlopidine [Ticlid®], Ticagrelor [Brilinta®] and prasugrel [Effient®]) avoids complications of significant bleeding and epidural hematomas.13. There is very limited evidence supporting the continuation or discontinuation of most NSAIDs, excluding aspirin, for 1 to 2 days and some 4 to 10 days, since these are utilized for pain management without cardiac or cerebral protective effect. LIMITATIONS: The continued paucity of the literature with discordant recommendations. CONCLUSION: Based on the survey of current literature, and published clinical guidelines, recommendations for patients presenting with ongoing antithrombotic therapy prior to interventional techniques are variable, and are based on comprehensive analysis of each patient and the risk-benefit analysis of intervention. KEY WORDS: Perioperative bleeding, bleeding risk, practice patterns, anticoagulant therapy, antithrombotic therapy, interventional techniques, safety precautions, pain.


Assuntos
Anticoagulantes/administração & dosagem , Fibrinolíticos/administração & dosagem , Manejo da Dor/métodos , Manejo da Dor/normas , Dor Crônica , Hemorragia/tratamento farmacológico , Humanos
18.
Can Assoc Radiol J ; 70(1): 37-43, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30691561

RESUMO

Back pain is the second most common reason for primary-care physician visits after the common cold. New understanding of the spine pathophysiology and biomechanics led to the development of novel injectable biomaterials to treat those pain generators. Although not all biomaterials are currently ready for common use, there is significant interest by the medical community to invest time, resources, and energy to optimize these injectables. This review introduces basic concepts and advancements in the field of bioinjectables tailored for the vertebral body. Also, we highlight advances in injectable biomaterials which were presented at the Groupe de Recherche Interdisciplinaire sur les Biomatériaux Ostéoarticulaires Injectables (GRIBOI) (Interdisciplinary Research Society for Injectable Osteoarticular Biomaterials) meeting in March 2018 in Los Angeles, CA. Indeed, multidisciplinary translational research and international meetings such as GRIBOI bring together scientists and clinicians with different backgrounds/expertise to discuss injectable biomaterials innovations tailored for the interventional pain management field.


Assuntos
Dor nas Costas/tratamento farmacológico , Materiais Biocompatíveis/uso terapêutico , Manejo da Dor/métodos , Doenças da Coluna Vertebral/tratamento farmacológico , Materiais Biocompatíveis/administração & dosagem , Humanos , Injeções Espinhais
19.
Neurosurgery ; 84(1): 169-178, 2019 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-29547939

RESUMO

BACKGROUND: Osteoporotic and neoplastic vertebral compression fractures (VCF) are common and painful, threatening quality of life and increasing risk of morbidity and mortality. Balloon kyphoplasty is a percutaneous option for treating painful cancer- and osteoporosis-related VCFs, supported by 2 randomized trials demonstrating efficacy benefits of BKP over nonsurgical care. OBJECTIVE: To investigate 12-mo disability, quality of life, and safety outcomes specifically in a Medicare-eligible population, representing characteristic patients seen in routine clinical practice. METHODS: A total of 354 patients with painful VCFs were enrolled at 24 US sites with 350 undergoing kyphoplasty. Four coprimary endpoints-Numerical Rating Scale (NRS) back pain, Oswestry Disability Index (ODI), Short Form-36 Questionnaire Physical Component Summary (SF-36v2 PCS), EuroQol-5-Domain (EQ-5D)-were evaluated for statistically significant improvement 3 mo after kyphoplasty. Data were collected at baseline, 7 d, and 1, 3, 6, and 12 mo (www.clinicaltrials.gov registration NCT01871519). RESULTS: At the 3-mo primary endpoint, NRS improved from 8.7 to 2.7 and ODI improved from 63.4 to 27.1; SF-36 PCS was 24.2 at baseline improving to 36.6, and EQ-5D improved from 0.383 to 0.746 (P < .001 for each). These outcomes were statistically significant at every follow-up time point. Five device-/procedure-related adverse events, intraoperative asymptomatic balloon rupture, rib pain, and aspiration pneumonia, and a new VCF 25 d postprocedure, and myocardial infarction 105 d postprocedure were reported and each resolved with proper treatment. CONCLUSION: This large, prospective, clinical study demonstrates that kyphoplasty is a safe, effective, and durable procedure for treating patients with painful VCF due to osteoporosis or cancer.


Assuntos
Fraturas por Compressão/cirurgia , Cifoplastia/métodos , Fraturas por Osteoporose/cirurgia , Fraturas da Coluna Vertebral/cirurgia , Atividades Cotidianas , Idoso , Idoso de 80 Anos ou mais , Feminino , Fraturas por Compressão/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/complicações , Estudos Prospectivos , Qualidade de Vida , Fraturas da Coluna Vertebral/etiologia , Resultado do Tratamento , Estados Unidos
20.
J Neurointerv Surg ; 11(9): e7, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-29444963

RESUMO

A 71-year-old man who had a L1/S1 posterior fusion revision surgery complained of increasing back pain 5 weeks after the open surgical procedure. The pain was initially estimated at 9/10 on the visual analog scale (VAS) and thought to be related to a right-sided L2 screw loosening. A right parapedicular vertebroplasty was performed and polymethylmethacrylate cement was instilled around the right pedicle screw, filling the anterior two-thirds of the vertebral body. On postvertebroplasty day 1, the patient had significant improvement in his low back pain. The pain further decreased at 1 and 3 months after the intervention (2/10 on the VAS). Vertebroplasty is a minimally invasive, accessible, effective, and long lasting treatment for compression fractures. We believe that this technique could also be indicated to treat pain related to low grade screw loosening in properly selected patients.


Assuntos
Cimentos para Ossos/uso terapêutico , Dor Lombar/cirurgia , Parafusos Pediculares , Polimetil Metacrilato/administração & dosagem , Vertebroplastia/métodos , Idoso , Seguimentos , Humanos , Dor Lombar/diagnóstico por imagem , Vértebras Lombares/diagnóstico por imagem , Vértebras Lombares/cirurgia , Masculino , Reoperação/instrumentação , Reoperação/métodos , Sacro/diagnóstico por imagem , Sacro/cirurgia , Vertebroplastia/instrumentação
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