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1.
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.

2.
Pain Physician ; 23(4S): S183-204, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32942785

RESUMO

BACKGROUND: The COVID-19 pandemic has worsened the pain and suffering of chronic pain patients due to stoppage of "elective" interventional pain management and office visits across the United States. The reopening of America and restarting of interventional techniques and elective surgical procedures has started. Unfortunately, with resurgence in some states, restrictions are once again being imposed. In addition, even during the Phase II and III of reopening, chronic pain patients and interventional pain physicians have faced difficulties because of the priority selection of elective surgical procedures.Chronic pain patients require high intensity care, specifically during a pandemic such as COVID-19. Consequently, it has become necessary to provide guidance for triaging interventional pain procedures, or related elective surgery restrictions during a pandemic. OBJECTIVES: The aim of these guidelines is to provide education and guidance for physicians, healthcare administrators, the public and patients during the COVID-19 pandemic. Our goal is to restore the opportunity to receive appropriate care for our patients who may benefit from interventional techniques. METHODS: The American Society of Interventional Pain Physicians (ASIPP) has created the COVID-19 Task Force in order to provide guidance for triaging interventional pain procedures or related elective surgery restrictions to provide appropriate access to interventional pain management (IPM) procedures in par with other elective surgical procedures. In developing the guidance, trustworthy standards and appropriate disclosures of conflicts of interest were applied with a section of a panel of experts from various regions, specialties, types of practices (private practice, community hospital and academic institutes) and groups. The literature pertaining to all aspects of COVID-19, specifically related to epidemiology, risk factors, complications, morbidity and mortality, and literature related to risk mitigation and stratification was reviewed. The evidence -- informed with the incorporation of the best available research and practice knowledge was utilized, instead of a simplified evidence-based approach. Consequently, these guidelines are considered evidence-informed with the incorporation of the best available research and practice knowledge. RESULTS: The Task Force defined the medical urgency of a case and developed an IPM acuity scale for elective IPM procedures with 3 tiers. These included urgent, emergency, and elective procedures. Examples of urgent and emergency procedures included new onset or exacerbation of complex regional pain syndrome (CRPS), acute trauma or acute exacerbation of degenerative or neurological disease resulting in impaired mobility and inability to perform activities of daily living. Examples include painful rib fractures affecting oxygenation and post-dural puncture headaches limiting the ability to sit upright, stand and walk. In addition, emergency procedures include procedures to treat any severe or debilitating disease that prevents the patient from carrying out activities of daily living. Elective procedures were considered as any condition that is stable and can be safely managed with alternatives. LIMITATIONS: COVID-19 continues to be an ongoing pandemic. When these recommendations were developed, different stages of reopening based on geographical regulations were in process. The pandemic continues to be dynamic creating every changing evidence-based guidance. Consequently, we provided evidence-informed guidance. CONCLUSION: The COVID-19 pandemic has created unprecedented challenges in IPM creating needless suffering for pain patients. Many IPM procedures cannot be indefinitely postponed without adverse consequences. Chronic pain exacerbations are associated with marked functional declines and risks with alternative treatment modalities. They must be treated with the concern that they deserve. Clinicians must assess patients, local healthcare resources, and weigh the risks and benefits of a procedure against the risks of suffering from disabling pain and exposure to the COVID-19 virus.


Assuntos
Dor Crônica/cirurgia , Infecções por Coronavirus , Manejo da Dor/métodos , Pandemias , Pneumonia Viral , Triagem/métodos , Betacoronavirus , Dor Crônica/classificação , Procedimentos Cirúrgicos Eletivos/classificação , Humanos , Estados Unidos
3.
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
4.
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
5.
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
6.
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
7.
Pain Physician ; 20(2S): S3-S92, 2017 02.
Artigo em Inglês | MEDLINE | ID: mdl-28226332

RESUMO

BACKGROUND: Opioid use, abuse, and adverse consequences, including death, have escalated at an alarming rate since the 1990s. In an attempt to control opioid abuse, numerous regulations and guidelines for responsible opioid prescribing have been developed by various organizations. However, the US opioid epidemic is continuing and drug dose deaths tripled during 1999 to 2015. Recent data show a continuing increase in deaths due to natural and semisynthetic opioids, a decline in methadone deaths, and an explosive increase in the rates of deaths involving other opioids, specifically heroin and illicit synthetic fentanyl. Contrary to scientific evidence of efficacy and negative recommendations, a significant proportion of physicians and patients (92%) believe that opioids reduce pain and a smaller proportion (57%) report better quality of life. In preparation of the current guidelines, we have focused on the means to reduce the abuse and diversion of opioids without jeopardizing access for those patients suffering from non-cancer pain who have an appropriate medical indication for opioid use. OBJECTIVES: To provide guidance for the prescription of opioids for the management of chronic non-cancer pain, to develop a consistent philosophy among the many diverse groups with an interest in opioid use as to how appropriately prescribe opioids, to improve the treatment of chronic non-cancer pain and to reduce the likelihood of drug abuse and diversion. These guidelines are intended to provide a systematic and standardized approach to this complex and difficult arena of practice, while recognizing that every clinical situation is unique. METHODS: The methodology utilized included the development of objectives and key questions. The methodology also utilized trustworthy standards, appropriate disclosures of conflicts of interest, as well as a panel of experts from various specialties and groups. The literature pertaining to opioid use, abuse, effectiveness, and adverse consequences was reviewed, with a best evidence synthesis of the available literature, and utilized grading for recommendation as described by the Agency for Healthcare Research and Quality (AHRQ).Summary of Recommendations:i. Initial Steps of Opioid Therapy 1. Comprehensive assessment and documentation. (Evidence: Level I; Strength of Recommendation: Strong) 2. Screening for opioid abuse to identify opioid abusers. (Evidence: Level II-III; Strength of Recommendation: Moderate) 3. Utilization of prescription drug monitoring programs (PDMPs). (Evidence: Level I-II; Strength of Recommendation: Moderate to strong) 4. Utilization of urine drug testing (UDT). (Evidence: Level II; Strength of Recommendation: Moderate) 5. Establish appropriate physical diagnosis and psychological diagnosis if available. (Evidence: Level I; Strength of Recommendation: Strong) 6. Consider appropriate imaging, physical diagnosis, and psychological status to collaborate with subjective complaints. (Evidence: Level III; Strength of Recommendation: Moderate) 7. Establish medical necessity based on average moderate to severe (≥ 4 on a scale of 0 - 10) pain and/or disability. (Evidence: Level II; Strength of Recommendation: Moderate) 8. Stratify patients based on risk. (Evidence: Level I-II; Strength of Recommendation: Moderate) 9. Establish treatment goals of opioid therapy with regard to pain relief and improvement in function. (Evidence: Level I-II; Strength of Recommendation: Moderate) 10. Obtain a robust opioid agreement, which is followed by all parties. (Evidence: Level III; Strength of Recommendation: Moderate)ii. Assessment of Effectiveness of Long-Term Opioid Therapy 11. Initiate opioid therapy with low dose, short-acting drugs, with appropriate monitoring. (Evidence: Level II; Strength of Recommendation: Moderate) 12. Consider up to 40 morphine milligram equivalent (MME) as low dose, 41 to 90 MME as a moderate dose, and greater than 91 MME as high dose. (Evidence: Level II; Strength of Recommendation: Moderate) 13. Avoid long-acting opioids for the initiation of opioid therapy. (Evidence: Level I; Strength of Recommendation: Strong) 14. Recommend methadone only for use after failure of other opioid therapy and only by clinicians with specific training in its risks and uses, within FDA recommended doses. (Evidence: Level I; Strength of Recommendation: Strong) 15. Understand and educate the patients of the effectiveness and adverse consequences. (Evidence: Level I; Strength of Recommendation: Strong) 16. Similar effectiveness for long-acting and short-acting opioids with increased adverse consequences of long-acting opioids. (Evidence: Level I-II; Strength of recommendation: Moderate to strong) 17. Periodically assess pain relief and/or functional status improvement of ≥ 30% without adverse consequences. (Evidence: Level II; Strength of recommendation: Moderate) 18. Recommend long-acting or high dose opioids only in specific circumstances with severe intractable pain. (Evidence: Level I; Strength of Recommendation: Strong)iii. Monitoring for Adherence and Side Effects 19. Monitor for adherence, abuse, and noncompliance by UDT and PDMPs. (Evidence: Level I-II; Strength of Recommendation: Moderate to strong) 20. Monitor patients on methadone with an electrocardiogram periodically. (Evidence: Level I; Strength of Recommendation: Strong). 21. Monitor for side effects including constipation and manage them appropriately, including discontinuation of opioids when indicated. (Evidence: Level I; Strength of Recommendation: Strong)iv. Final Phase 22. May continue with monitoring with continued medical necessity, with appropriate outcomes. (Evidence: Level I-II; Strength of Recommendation: Moderate) 23. Discontinue opioid therapy for lack of response, adverse consequences, and abuse with rehabilitation. (Evidence: Level III; Strength of Recommendation: Moderate) CONCLUSIONS: These guidelines were developed based on comprehensive review of the literature, consensus among the panelists, in consonance with patient preferences, shared decision-making, and practice patterns with limited evidence, based on randomized controlled trials (RCTs) to improve pain and function in chronic non-cancer pain on a long-term basis. Consequently, chronic opioid therapy should be provided only to patients with proven medical necessity and stability with improvement in pain and function, independently or in conjunction with other modalities of treatments in low doses with appropriate adherence monitoring and understanding of adverse events.Key words: Chronic pain, persistent pain, non-cancer pain, controlled substances, substance abuse, prescription drug abuse, dependency, opioids, prescription monitoring, drug testing, adherence monitoring, diversionDisclaimer: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a "standard of care."


Assuntos
Analgésicos Opioides/uso terapêutico , Dor Crônica/tratamento farmacológico , Prescrições de Medicamentos , Dor/tratamento farmacológico , Dor Crônica/psicologia , Prescrições de Medicamentos/normas , Humanos , Dor/psicologia , Qualidade de Vida , Estados Unidos
8.
Pain Pract ; 16(4): E70-3, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-26896050

RESUMO

INTRODUCTION: There is very strong evidence for the efficacy of transforaminal epidural steroid injection (TFESI) in relieving lumbar radicular pain due to a herniated disk. However, case studies have documented paralysis as a potential complication from this approach as the artery of Adamkiewicz may traverse within the subpedicular "safe triangle." Kambin's retrodiscal approach has been postulated as a safe means to the transforaminal approach to avoid the artery of Adamkiewicz. CASE PRESENTATION: A 51-year-old woman presented with right-sided lumbar radicular pain at the L3-L4 and L4-L5 level secondary to a herniated disk. As conservative therapies failed to improve her radicular back pain, the patient opted to proceed with an epidural steroid injection. She subsequently underwent a right L3-L4 and L4-L5 transforaminal epidural steroid injection via Kambin's retrodiscal approach. Although anteroposterior and lateral views revealed optimal needle placement, live and postcontrast fluoroscopy revealed an unavoidable and inadvertent intradiscal spread. CONCLUSION: Kambin's approach is at the level of the intervertebral disk and may increase the incidence of intradiscal needle entry and injection.


Assuntos
Corticosteroides/administração & dosagem , Injeções Epidurais/efeitos adversos , Injeções Epidurais/métodos , Disco Intervertebral/efeitos dos fármacos , Radiculopatia/tratamento farmacológico , Feminino , Humanos , Deslocamento do Disco Intervertebral/complicações , Dor Lombar/tratamento farmacológico , Vértebras Lombares , Pessoa de Meia-Idade , Radiculopatia/etiologia
9.
Pain Physician ; 18(5): E713-56, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26431129

RESUMO

BACKGROUND: The sacroiliac joint is well known as a cause of low back and lower extremity pain. Prevalence estimates are 10% to 25% in patients with persistent axial low back pain without disc herniation, discogenic pain, or radiculitis based on multiple diagnostic studies and systematic reviews. However, at present there are no definitive management options for treating sacroiliac joint pain. OBJECTIVE: To evaluate the diagnostic accuracy and therapeutic effectiveness of sacroiliac joint interventions. STUDY DESIGN: A systematic review of the diagnostic accuracy and therapeutic effectiveness of sacroiliac joint interventions. METHODS: The available literature on diagnostic and therapeutic sacroiliac joint interventions was reviewed. The quality assessment criteria utilized were the Quality Appraisal of Reliability Studies (QAREL) checklist for diagnostic accuracy studies, Cochrane review criteria to assess sources of risk of bias, and Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB) criteria for randomized therapeutic trials and Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM-QRBNR) for observational therapeutic assessments. The level of evidence was based on a best evidence synthesis with modified grading of qualitative evidence from Level I to Level V. Data sources included relevant literature published from 1966 through March 2015 that were identified through searches of PubMed and EMBASE, manual searches of the bibliographies of known primary and review articles, and all other sources. OUTCOME MEASURES: For the diagnostic accuracy assessment, and for the therapeutic modalities, the primary outcome measure of pain relief and improvement in functional status were utilized. RESULTS: A total of 11 diagnostic accuracy studies and 14 therapeutic studies were included. The evidence for diagnostic accuracy is Level II for dual diagnostic blocks with at least 70% pain relief as the criterion standard and Level III evidence for single diagnostic blocks with at least 75% pain relief as the criterion standard. The evidence for cooled radiofrequency neurotomy in managing sacroiliac joint pain is Level II to III. The evidence for conventional radiofrequency neurotomy, intraarticular steroid injections, and periarticular injections with steroids or botulinum toxin is limited: Level III or IV. LIMITATIONS: The limitations of this systematic review include inconsistencies in diagnostic accuracy studies with a paucity of high quality, replicative, and consistent literature. The limitations for therapeutic interventions include variations in technique, variable diagnostic standards for inclusion criteria, and variable results. CONCLUSION: The evidence for the accuracy of diagnostic and therapeutic effectiveness of sacroiliac joint interventions varied from Level II to Level IV.


Assuntos
Dor Lombar/diagnóstico , Dor Lombar/terapia , Avaliação de Processos e Resultados em Cuidados de Saúde , Manejo da Dor/métodos , Articulação Sacroilíaca , Humanos , Manejo da Dor/normas
10.
Pain Physician ; 17(3): 247-53, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24850106

RESUMO

BACKGROUND: Interlaminar epidural steroid injection is a well-established intervention for the treatment of radicular pain. Pain is commonly reported during the injection into the epidural space; this provocation is typically either concordant or discordant with the patient's baseline pain. It is not well known how this provocation pain relates to treatment outcomes. OBJECTIVE: To determine the relationship between concordant versus discordant provocation during interlaminar epidural steroid injection and its effects on pain reduction at follow-up. STUDY DESIGN: Secondary analysis of a single center, prospective randomized double-blind study. METHODS: Interlaminar epidural steroid injections under fluoroscopic guidance were performed on 48 patients with radicular lumbosacral pain. After injection with 80 mg methylprednisolone and 2 mL of normal saline at a single level, patients were asked to report if pain was provoked, and whether the pain was concordant or discordant with their baseline pain. The primary outcome measure was self-rated percentage of pain reduction from baseline at 2-week follow-up. Secondary outcomes included improvement in activity level and decreased analgesic consumption. RESULTS: Provocation was observed in 37 out of 48 patients (77%). This was further classified as concordant (22/37, 60%) or discordant (15/37, 40%) pain. The concordant group achieved a significant decrease in self-reported pain as compared to the discordant group at 2-week follow-up (61%, t = 2.45, P < 0.01). There were also significantly more patients in the concordant group who reported 75% pain reduction as compared to the discordant group (X = 6.44, df(1), P < 0.05). There were no significant differences between concordant and discordant groups in regard to improvements in activity level (X = 2.56) and decreased analgesic use (X = 3.28). LIMITATIONS: The secondary analysis did not examine long-term outcomes. CONCLUSIONS: The concordant group demonstrated significantly higher pain reduction as compared to the discordant group. There were no significant differences between the 2 groups in terms of improved function or reduced analgesic requirements. Concordant provocation during interlaminar epidural injection may be a predictor of outcome.


Assuntos
Injeções Epidurais/efeitos adversos , Dor Lombar/tratamento farmacológico , Região Lombossacral , Dor/epidemiologia , Esteroides/administração & dosagem , Esteroides/uso terapêutico , Adulto , Idoso , Método Duplo-Cego , Fluoroscopia , Humanos , Pessoa de Meia-Idade , Dor/etiologia , Medição da Dor , Prognóstico , Estudos Prospectivos , Radiografia Intervencionista , Esteroides/efeitos adversos , Resultado do Tratamento
11.
PM R ; 2(9): 842-51, 2010 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-20869684

RESUMO

Radiofrequency ablation (RFA) has become an option for those with chronic or refractory sacroiliac (SI) joint pain. The purpose of this critical review is to assess the existing literature and conduct a meta-analysis to assess the effectiveness of RFA of the SI joint for pain relief at 3 and 6 months' after an RFA procedure. An electronic search of PubMed, OVID, Medline, and CINAHL were conducted with keywords; sacroiliac joint, sacroiliac pain, sacroiliac syndrome, sacroiliac radiofrequency ablation, sacroiliac neurolysis, sacroiliac injection, and low back pain. Articles that addressed RFA of the SI joint were reviewed. Ten articles ranging from inception to January 1, 2010, were found. The main outcome measure was a reduction of pain by ≥50% post-RFA procedure. At 3 months, 7 groups met the criteria and at 6 months, 6 groups met the criteria. A meta-analysis with a forest plot was done at the 3- and 6-month patient follow-up intervals. The associated standard error was calculated for each study group. An overall weighted average with respective standard error was also obtained. A calculation of 95% confidence intervals (95% CI) was then derived. A test for heterogeneity, publication bias, and file drawer effect was also done at the 3- and 6-month intervals. At 3 months, a range of 0.538-0.693 was found to have a 95% CI, with a pooled mean of 0.616. At 6 months, a 95% CI of 0.423-0.576 was found, with a pooled mean of 0.499. The meta-analysis demonstrated that RFA is an effective treatment for SI joint pain at 3 months and 6 months. This study is limited by the available literature and lack of randomized controlled trials. Further standardization of RFA lesion techniques needs to be established, coupled with prospective randomized controlled trials.


Assuntos
Artralgia/cirurgia , Ablação por Cateter , Articulação Sacroilíaca/cirurgia , Ablação por Cateter/métodos , Humanos , Bloqueio Nervoso , Medição da Dor , Articulação Sacroilíaca/inervação , Resultado do Tratamento
12.
Pain Med ; 6(3): 266-8, 2005.
Artigo em Inglês | MEDLINE | ID: mdl-15972091

RESUMO

Phantom limb pain has been well described in the literature. However, new-onset lumbar radicular pain superimposed on baseline lower extremity phantom pain is a clinical scenario that can be challenging to recognize. Furthermore, literature on recognition and treatment of phantom radiculopathy is all but lacking. We present a patient who experienced new-onset lumbar radiculopathy superimposed on her phantom pain that was successfully treated with fluoroscopic interlaminar and transforaminal epidural steroid injections.


Assuntos
Corticosteroides/administração & dosagem , Injeções Epidurais , Membro Fantasma/fisiopatologia , Radiculopatia/tratamento farmacológico , Idoso , Feminino , Fluoroscopia , Humanos , Deslocamento do Disco Intervertebral/complicações , Deslocamento do Disco Intervertebral/tratamento farmacológico , Vértebras Lombares/patologia , Radiculopatia/etiologia
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