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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(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
3.
Pain Physician ; 22(5): E435-E440, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31561655

RESUMO

BACKGROUND: Interlaminar and transforaminal epidural steroid injections (ILESI and TFESI) are commonly performed procedures. However, the United States Food and Drug Administration has required the addition of drug warning labels for injectable corticosteroids. Updated evidence and scrutiny from regulatory agencies may affect practice patterns. OBJECTIVE: To characterize TFESI practices as well as to provide an update on periprocedural practices for any type of epidural steroid injection (ESI), we surveyed pain medicine physicians in the United States. STUDY DESIGN AND SETTING: This was a cross-sectional survey of pain medicine physicians in the United States. METHODS: A web-based survey was distributed to pain medicine physicians in the United States selected from the Accreditation Council for Graduate Medical Education accredited pain medicine fellowship program list as well as the American Society of Interventional Pain Physicians membership database. Physicians were queried about TFESI practices, including needle size, use of image guidance, methods to detect vascular uptake, and preference for injectate. RESULTS: A total of 249 responses were analyzed. Only a minority of respondents reported performing cervical TFESI. There were variations in needle size, methods to detect vascular uptake, and choice of injectate. There were also variations in monitoring practices. LIMITATIONS: The response rate is a limitation. Thus the results may not be representative of all US pain medicine physicians. CONCLUSIONS: Though all respondents used image guidance for TFESI, variations in other TFESI practices exist. There are also differences in periprocedural practices. Since the closure of this survey, a multisociety pain workgroup published recommendations regarding ESI practices. Our survey findings support the need for more evidence-based guidelines regarding ESI. KEY WORDS: Epidrual steroid injections, transforaminal epidural steroid injection, steroids, local anesthetic, survey, interventional pain.


Assuntos
Injeções Epidurais/métodos , Manejo da Dor/métodos , Esteroides/administração & dosagem , Corticosteroides , Anestésicos Locais/uso terapêutico , Estudos Transversais , Feminino , Humanos , Pessoa de Meia-Idade , Médicos , Esteroides/uso terapêutico , Inquéritos e Questionários , Estados Unidos
4.
Clin J Pain ; 34(2): 138-144, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-28591082

RESUMO

OBJECTIVES: To report the opioid-sparing effects of SoluMatrix indomethacin, developed using SoluMatrix Fine Particle Technology, in a phase 3 study in patients with acute pain following bunionectomy. METHODS: This phase 3, placebo-controlled study randomized 462 patients with moderate-to-severe pain following bunionectomy surgery to receive SoluMatrix indomethacin 40 mg 3 times daily, SoluMatrix indomethacin 40 mg twice daily, SoluMatrix indomethacin 20 mg 3 times daily, celecoxib 400-mg loading dose followed by 200 mg twice daily, or placebo. Patients were permitted to receive opioid-containing rescue medication throughout the study. The proportion of patients who used rescue medication and the amount of rescue medication used on the first (0 to 24 h) and second (>24 to 48 h) days following initial dose of study medication, as well as time to first rescue medication use, were assessed. RESULTS: Significantly fewer patients who received SoluMatrix indomethacin 40 or 20 mg 3 times daily used opioid-containing rescue medication on day 1 compared with those receiving placebo (P≤0.034), and fewer patients in all active treatment groups used rescue medication during the second day compared with those in the placebo group (P<0.001). All active treatment groups used significantly fewer rescue medication tablets on days 1 and 2 following randomization compared with placebo (P<0.001). The most common adverse events were nausea, postprocedural edema, and headache. DISCUSSION: SoluMatrix indomethacin was associated with opioid-sparing effects in patients with acute postoperative pain.


Assuntos
Analgésicos Opioides/administração & dosagem , Anti-Inflamatórios não Esteroides/uso terapêutico , Indometacina/uso terapêutico , Dor Pós-Operatória/tratamento farmacológico , Adolescente , Adulto , Idoso , Anti-Inflamatórios não Esteroides/efeitos adversos , Anti-Inflamatórios não Esteroides/síntese química , Joanete/cirurgia , Cápsulas , Feminino , Humanos , Indometacina/efeitos adversos , Indometacina/síntese química , Masculino , Pessoa de Meia-Idade , Medição da Dor , Resultado do Tratamento , Adulto Jovem
5.
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
6.
Pain Physician ; 19(8): E1211-E1214, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27906952

RESUMO

BACKGROUND: For decades, epidural steroid injections have been an effective tool in the management of many pain related conditions, including lumbar radiculopathy. Transforaminal epidural steroid injections in particular have been reported to potentially result in central nervous system infarctions which have not been reported with interlaminar epidural steroid injections, while providing comparable efficacy. This rare, catastrophic complication has been attributed by some authors to be due to vascular injury secondary to vasospasm, thrombus formation, dissection, as well as concerns with placing the needle at the so-called "safe triangle." Others, however, have proposed it to be secondary to embolization of the vessel by particulate steroids. This has led to the recommendation of the use of soluble steroids such as dexamethasone when performing TFESI's, despite concerns over its efficacy and potential for neurotoxicity in the literature. Furthermore, there have also been multiple studies which have revealed that IV dexamethasone is analgesic and that peri-neural dexamethasone is no more effective than IV dexamethasone. CASE HISTORY: The present case involves a 60-year-old patient with right back and radicular leg pain for 3 years. Two right L4 TFESI's had been performed with betamethasone several years prior with satisfactory results, until the patient presented to the physician with a pain recurrence of 6 weeks of duration. The patient again underwent a right L4 TFESI with dexamethasone, which provided good relief after 2 weeks. The patient underwent a repeat right L4 TFESI with dexamethasone which was followed by a prompt onset of lower extremity numbness, weakness, and incontinence that was discovered to be related to a conus infarction. While this is the first publicly reported case of a conus medullaris infarction following a lumbar transforaminal injection utilizing dexamethasone, the incidence of these reports may rise as the prevalence of dexamethasone use increases in clinical practice. CONCLUSION: The spinal cord infarction with TFESI's may occur related to various mechanisms, regardless of the type of particulate or non-particulate steroid used during these procedures.


Assuntos
Sistema Nervoso Central/irrigação sanguínea , Dexametasona/efeitos adversos , Infarto/induzido quimicamente , Injeções Epidurais/efeitos adversos , Dexametasona/uso terapêutico , Humanos , Pessoa de Meia-Idade , Radiculopatia/tratamento farmacológico , Esteroides/uso terapêutico
7.
Anesth Pain Med ; 6(2): e26172, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-27574583

RESUMO

CONTEXT: Lumbar post-surgery syndrome is common and often results in chronic, persistent pain and disability, which can lead to multiple interventions. After failure of conservative treatment, either surgical treatment or a nonsurgical modality of treatment such as epidural injections, percutaneous adhesiolysis is often contemplated in managing lumbar post surgery syndrome. Recent guidelines and systematic reviews have reached different conclusions about the level of evidence for the efficacy of epidural injections and percutaneous adhesiolysis in managing lumbar post surgery syndrome. The objective of this systematic review was to determine the efficacy of all 3 percutaneous adhesiolysis anatomical approaches (caudal, interlaminar, and transforaminal) in treating lumbar post-surgery syndrome. DATA SOURCES: A literature search was performed from 1966 through October 2014 utilizing multiple databases. STUDY SELECTION: A systematic review of randomized trials published from 1966 through October 2014 of all types of epidural injections and percutaneous adhesiolysis in managing lumbar post-surgery syndrome was performed including methodological quality assessment utilizing Cochrane review criteria, Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB), and grading of evidence using 5 levels of evidence ranging from Level I to Level V. DATA EXTRACTION: The search strategy emphasized post-surgery syndrome and related pathologies treated with percutaneous adhesiolysis procedures. RESULTS: The search criteria yielded 16 manuscripts on percutaneous adhesiolysis assessing post-surgery syndrome. Of these, only 4 randomized trials met inclusion criteria for methodological quality assessment, 3 of them were of high quality; and the fourth manuscript was of low quality. Based on these 3 randomized controlled trials, 2 of them with one-day procedure and one with a 3-day procedure, the level of evidence for the efficacy of percutaneous adhesiolysis is Level II based on best evidence synthesis. CONCLUSIONS: Based on this systematic review, percutaneous adhesiolysis is effective in managing patients with lumbar post-surgery syndrome after the failure of conservative management including fluoroscopically directed epidural injections.

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(6): E939-1004, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-26606031

RESUMO

BACKGROUND: Epidural injections have been used since 1901 in managing low back pain and sciatica. Spinal pain, disability, health, and economic impact continue to increase, despite numerous modalities of interventions available in managing chronic spinal pain. Thus far, systematic reviews performed to assess the efficacy of epidural injections in managing chronic spinal pain have yielded conflicting results. OBJECTIVE: To evaluate and update the clinical utility of the efficacy of epidural injections in managing chronic spinal pain. STUDY DESIGN: A systematic review of randomized controlled trials of epidural injections in managing chronic spinal pain. METHODS: In this systematic review, randomized trials with a placebo control or an active-control design were included. The outcome measures were pain relief and functional status improvement. The quality of each individual article was assessed by Cochrane review criteria, as well as the Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB). Best evidence synthesis was conducted based on the qualitative level of evidence (Level I to V). Data sources included relevant literature identified through searches of PubMed for a period starting in 1966 through August 2015; Cochrane reviews; and manual searches of the bibliographies of known primary and review articles. RESULTS: A total of 52 trials met inclusion criteria. Meta-analysis was not feasible. The evidence in managing lumbar disc herniation or radiculitis is Level II for long-term improvement either with caudal, interlaminar, or transforaminal epidural injections with no significant difference among the approaches. The evidence is Level II for long-term management of cervical disc herniation with interlaminar epidural injections. The evidence is Level II to III in managing thoracic disc herniation with an interlaminar approach. The evidence is Level II for caudal and lumbar interlaminar epidural injections with Level III evidence for lumbar transforaminal epidural injections for lumbar spinal stenosis. The evidence is Level II for cervical spinal stenosis management with an interlaminar approach. The evidence is Level II for axial or discogenic pain without facet arthropathy or disc herniation treated with caudal or lumbar interlaminar injections in the lumbar region; whereas it is Level II in the cervical region treated with cervical interlaminar epidural injections. The evidence for post lumbar surgery syndrome is Level II with caudal epidural injections and for post cervical surgery syndrome it is Level II with cervical interlaminar epidural injections. LIMITATIONS: Even though this is a large systematic review with inclusion of a large number of randomized controlled trials, the paucity of high quality randomized trials literature continues to confound the evidence. CONCLUSION: This systematic review, with an assessment of the quality of manuscripts and outcome parameters, shows the efficacy of epidural injections in managing a multitude of chronic spinal conditions.


Assuntos
Analgésicos/administração & dosagem , Dor Crônica/tratamento farmacológico , Medicina Baseada em Evidências/métodos , Dor Lombar/tratamento farmacológico , Manejo da Dor/métodos , Anestesia Epidural/métodos , Raquianestesia/métodos , Dor Crônica/diagnóstico , Dor Crônica/epidemiologia , Humanos , Injeções Epidurais , Deslocamento do Disco Intervertebral/diagnóstico , Deslocamento do Disco Intervertebral/tratamento farmacológico , Deslocamento do Disco Intervertebral/epidemiologia , Dor Lombar/diagnóstico , Dor Lombar/epidemiologia , Radiculopatia/diagnóstico , Radiculopatia/tratamento farmacológico , Radiculopatia/epidemiologia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Reprodutibilidade dos Testes , Estenose Espinal/diagnóstico , Estenose Espinal/tratamento farmacológico , Estenose Espinal/epidemiologia , Resultado do Tratamento
10.
Pain Physician ; 18(4): E535-82, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26218948

RESUMO

BACKGROUND: The therapeutic spinal facet joint interventions generally used for the treatment of axial spinal pain of facet joint origin are intraarticular facet joint injections, facet joint nerve blocks, and radiofrequency neurotomy. Despite interventional procedures being common as treatment strategies for facet joint pathology, there is a paucity of literature investigating these therapeutic approaches. Systematic reviews assessing the effectiveness of various therapeutic facet joint interventions have shown there to be variable evidence based on the region and the modality of treatment utilized. Overall, the evidence ranges from limited to moderate. OBJECTIVE: To evaluate and update the clinical utility of therapeutic lumbar, cervical, and thoracic facet joint interventions in managing chronic spinal pain. STUDY DESIGN: A systematic review of therapeutic lumbar, cervical, and thoracic facet joint interventions for the treatment of chronic spinal pain. METHODS: The available literature on lumbar, cervical, and thoracic facet joint interventions in managing chronic spinal pain was reviewed. The quality assessment criteria utilized were the Cochrane Musculoskeletal Review Group criteria and Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB) for randomized trials and Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM-QRBNR) for observational studies. The level of evidence was classified at 5 levels from Level I to Level V. Data sources included relevant literature identified through searches on PubMed and EMBASE from 1966 through March 2015, and manual searches of the bibliographies of known primary and review articles. OUTCOME MEASURES: The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > 6 months). Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake consumption. RESULTS: A total of 21 randomized controlled trials meeting appropriate inclusion criteria were assessed in this evaluation. A total of 5 observational studies were assessed. In the lumbar spine, for long-term effectiveness, there is Level II evidence for radiofrequency neurotomy and lumbar facet joint nerve blocks, whereas the evidence is Level III for lumbosacral intraarticular injections. In the cervical spine, for long-term improvement, there is Level II evidence for cervical radiofrequency neurotomy and cervical facet joint nerve blocks, and Level IV evidence for cervical intraarticular injections. In the thoracic spine there is Level II evidence for thoracic facet joint nerve blocks and Level IV evidence for radiofrequency neurotomy for long-term improvement. LIMITATIONS: The limitations of this systematic review include an overall paucity of high quality studies and more specifically the lack of investigations related to thoracic facet joint injections. CONCLUSION: Based on the present assessment for the management of spinal facet joint pain, the evidence for long-term improvement is Level II for lumbar and cervical radiofrequency neurotomy, and therapeutic facet joint nerve blocks in the cervical, thoracic, and lumbar spine; Level III for lumbar intraarticular injections; and Level IV for cervical intraarticular injections and thoracic radiofrequency neurotomy.


Assuntos
Dor Lombar/cirurgia , Manejo da Dor/métodos , Articulação Zigapofisária/cirurgia , Medicina Baseada em Evidências , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
11.
Pain Physician ; 18(4): E497-533, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26218947

RESUMO

BACKGROUND: Spinal zygapophysial, or facet, joints are a source of axial spinal pain and referred pain in the extremities. Conventional clinical features and other noninvasive diagnostic modalities are unreliable in diagnosing zygapophysial joint pain. STUDY DESIGN: A systematic review of the diagnostic accuracy of spinal facet joint nerve blocks. OBJECTIVE: To determine the diagnostic accuracy of spinal facet joint nerve blocks in chronic spinal pain. METHODS: A methodological quality assessment of included studies was performed using Quality Appraisal of Reliability Studies (QAREL). Only diagnostic accuracy studies meeting at least 50% of the designated inclusion criteria were utilized for analysis. The level of evidence was classified as Level I to V based on the grading of evidence utilizing best evidence synthesis. Data sources included relevant literature identified through searches of PubMed and other electronic searches published from 1966 through March 2015, Cochrane reviews, and manual searches of the bibliographies of known primary and review articles. OUTCOME MEASURES: Studies must have been performed utilizing controlled local anesthetic blocks. The criterion standard must have been at least 50% pain relief from baseline scores and the ability to perform previously painful movements. RESULTS: The available evidence is Level I for lumbar facet joint nerve blocks with the inclusion of a total of 17 studies with dual diagnostic blocks, with at least 75% pain relief with an average prevalence of 16% to 41% and false-positive rates of 25% to 44%. The evidence for diagnosis of cervical facet joint pain with cervical facet joint nerve blocks is Level II based on a total of 11 controlled diagnostic accuracy studies, with significant variability among the prevalence in a heterogenous population with internal inconsistency. The prevalence rates ranged from 36% to 67% with at least 80% pain relief as the criterion standard and a false-positive rate of 27% to 63%. The level of evidence for the diagnostic accuracy of thoracic facet joint nerve blocks is Level II with 80% or higher pain relief as the criterion standard with a prevalence ranging from 34% to 48% and false-positive rates ranging from 42% to 48%. LIMITATIONS: The shortcomings of this systematic review include a paucity of literature related to the thoracic spine, continued debate on an appropriate gold standard, appropriateness of diagnostic blocks, and utility. CONCLUSION: The evidence is Level I for the diagnostic accuracy of lumbar facet joint nerve blocks, Level II for cervical facet joint nerve blocks, and Level II for thoracic facet joint nerve blocks in assessment of chronic spinal pain.


Assuntos
Dor nas Costas/tratamento farmacológico , Bloqueio Nervoso/métodos , Articulação Zigapofisária , Humanos , Injeções , Manejo da Dor , Reprodutibilidade dos Testes
12.
Surg Neurol Int ; 6(Suppl 4): S194-235, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26005584

RESUMO

BACKGROUND: The efficacy of epidural and facet joint injections has been assessed utilizing multiple solutions including saline, local anesthetic, steroids, and others. The responses to these various solutions have been variable and have not been systematically assessed with long-term follow-ups. METHODS: Randomized trials utilizing a true active control design were included. The primary outcome measure was pain relief and the secondary outcome measure was functional improvement. The quality of each individual article was assessed by Cochrane review criteria, as well as the criteria developed by the American Society of Interventional Pain Physicians (ASIPP) for assessing interventional techniques. An evidence analysis was conducted based on the qualitative level of evidence (Level I to IV). RESULTS: A total of 31 trials met the inclusion criteria. There was Level I evidence that local anesthetic with steroids was effective in managing chronic spinal pain based on multiple high-quality randomized controlled trials. The evidence also showed that local anesthetic with steroids and local anesthetic alone were equally effective except in disc herniation, where the superiority of local anesthetic with steroids was demonstrated over local anesthetic alone. CONCLUSION: This systematic review showed equal efficacy for local anesthetic with steroids and local anesthetic alone in multiple spinal conditions except for disc herniation where the superiority of local anesthetic with steroids was seen over local anesthetic alone.

14.
Pain Physician ; 17(4): E451-74, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-25054397

RESUMO

On April 23, 2014, the Food and Drug Administration (FDA) issued a letter of warning that injection of corticosteroids into the epidural space of the spine may result in rare, but serious adverse events, including "loss of vision, stroke, paralysis, and death." The advisory also advocated that patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments. In addition, the FDA stated that the effectiveness and safety of the corticosteroids for epidural use have not been established, and the FDA has not approved corticosteroids for such use. To raise awareness of the risks of epidural corticosteroid injections in the medical community, the FDA's Safe Use Initiative convened a panel of experts including pain management experts to help define the techniques for such injections with the aim of reducing preventable harm. The panel was unable to reach an agreement on 20 proposed items related to technical aspects of performing epidural injections. Subsequently, the FDA issued the above referenced warning and a notice that a panel will be convened in November 2014. This review assesses the inaccuracies of the warning and critically analyzes the available literature. The literature has been assessed in reference to alternate techniques and an understanding of the risk factors when performing transforaminal epidural injections in the cervical, thoracic, and lumbar regions, ultimately resulting in improved safety. The results of this review show the efficacy of epidural injections, with or without steroids, in a multitude of spinal ailments utilizing caudal, cervical, thoracic, and lumbar interlaminar approaches as well as lumbar transforaminal epidural injections . The evidence also shows the superiority of steroids in managing lumbar disc herniation utilizing caudal and lumbar interlaminar approaches without any significant difference as compared to transforaminal approaches, either with local anesthetic alone or local anesthetic and steroids combined. In conclusion, the authors request that the FDA modify the warning based on the evidence.


Assuntos
Dor nas Costas/tratamento farmacológico , Glucocorticoides/efeitos adversos , Injeções Epidurais/efeitos adversos , Dor Crônica , Controle de Medicamentos e Entorpecentes , Glucocorticoides/administração & dosagem , Política de Saúde , Humanos , Injeções Epidurais/métodos , Guias de Prática Clínica como Assunto , Fatores de Risco , Estados Unidos , United States Food and Drug Administration
15.
Pain Physician ; 17(4): E475-88, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-25054398

RESUMO

Randomized controlled trials are considered the hallmark of evidence-based medicine. This conveys the idea that up-to-date evidence applied consistently in clinical practice, in combination with clinicians' individual expertise and patients own preference/expectations are enjoined to achieve the best possible outcome. Since its inception in 1990s, evidence-based medicine has evolved in conjunction with numerous changes in the healthcare environment. However, the benefits of evidence-based medicine have not materialized for spinal pain including surgical interventions. Consequently, the debate continues on the efficacy and medical necessity of multiple interventions provided in managing spinal pain. Friedly et al published a randomized controlled trial of epidural glucocorticoid injections for spinal stenosis in the July 2014 edition of the highly prestigious New England Journal of Medicine. This was accompanied by an editorial from Andersson. This manuscript provided significant sensationalism for the media and confusion for the spine community. This randomized trial of epidural glucocorticoid injections for spinal stenosis and accompanying editorial concluded that epidural injections of glucocorticoids plus lidocaine offered minimal or no short-term benefit as compared with epidural injections of lidocaine alone, with the editorial emphasizing proceeding directly to surgical intervention. In addition media statements by the authors also emphasized the idea that exercise or surgery might be better options for patients suffereing from narrowing of the spinal canal. The interventional pain management community believes that there are severe limitations to this study, manuscript, and accompanying editorial. The design, inclusion criteria, outcomes assessment, analysis of data and interpretation, and conclusions of this trial point to the fact that this highly sophisticated and much publicized randomized trial may not be appropriate and lead to misinformation. The design of the trial was inappropriate with failure to include existing randomized trials, with inclusion criteria that did not incorporate conservative management,or caudal epidural injections. Simultaneously, acute pain patients were included, multilevel stenosis and various other factors were not identified. The interventions included lumbar interlaminar and transforaminal epidural injections with highly variable volumes of medication being injected per patient. Outcomes assessment was not optimal with assessment of the patients at 3 and 6 weeks for a procedure which provides on average 3 weeks of relief and utilizing an instrument which is more appropriately utilized in acute and subacute low back pain. Analysis of the data was hampered by inadequate subgroup analysis leading to inappropriate interpretation. Based on the available data epidural local anesthetic with steroids was clearly superior at 3 weeks and potentially at 6 weeks. Further, both treatments were effective considering the baseline to 3 week and 6 week assessment, appropriate subgroup analysis seems to have yielded significant superiority for interlaminar epidural injections compared to transforaminal epidural injections with local anesthetic with or without steroids specifically with proportion of patients achieving greater than 50% improvement at 3 and 6 week levels. This critical assessment shows that this study suffers from a challenging design, was premised on the exclusion of available high-quality literature, and had inadequate duration of follow-up for an interventional technique with poor assessment criteria and reporting. Finally the analysis and interpretation of data has led to inaccurate and inappropriate conclusions which we do not believe is based on scientific evidence.


Assuntos
Glucocorticoides/administração & dosagem , Dor Lombar/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Estenose Espinal/complicações , Anestésicos Locais/administração & dosagem , Dor Crônica , Interpretação Estatística de Dados , Humanos , Injeções Epidurais , Lidocaína/administração & dosagem , Dor Lombar/etiologia , Projetos de Pesquisa/normas
16.
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
18.
Pain Physician ; 15(3 Suppl): S1-65, 2012 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-22786448

RESUMO

BACKGROUND: Opioid abuse has continued to increase at an alarming rate since the 1990 s. As documented by different medical specialties, medical boards, advocacy groups, and the Drug Enforcement Administration, available evidence suggests a wide variance in chronic opioid therapy of 90 days or longer in chronic non-cancer pain. Part 1 describes evidence assessment. OBJECTIVES: The objectives of opioid guidelines as issued by the American Society of Interventional Pain Physicians (ASIPP) are to provide guidance for the use of opioids for the treatment of chronic non-cancer pain, to produce consistency in the application of an opioid philosophy among the many diverse groups involved, to improve the treatment of chronic non-cancer pain, and to reduce the incidence of abuse and drug diversion. The focus of these guidelines is to curtail the abuse of opioids without jeopardizing non-cancer pain management with opioids. RESULTS: 1) There is good evidence that non-medical use of opioids is extensive; one-third of chronic pain patients may not use prescribed opioids as prescribed or may abuse them, and illicit drug use is significantly higher in these patients. 2) There is good evidence that opioid prescriptions are increasing rapidly, as the majority of prescriptions are from non-pain physicians, many patients are on long-acting opioids, and many patients are provided with combinations of long-acting and short-acting opioids. 3) There is good evidence that the increased supply of opioids, use of high dose opioids, doctor shoppers, and patients with multiple comorbid factors contribute to the majority of the fatalities. 4) There is fair evidence that long-acting opioids and a combination of long-acting and short-acting opioids contribute to increasing fatalities and that even low-doses of 40 mg or 50 mg of daily morphine equivalent doses may be responsible for emergency room admissions with overdoses and deaths. 5) There is good evidence that approximately 60% of fatalities originate from opioids prescribed within the guidelines, with approximately 40% of fatalities occurring in 10% of drug abusers. 6) The short-term effectiveness of opioids is fair, whereas the long-term effectiveness of opioids is limited due to a lack of long-term (> 3 months) high quality studies, with fair evidence with no significant difference between long-acting and short-acting opioids. 7) Among the individual drugs, most opioids have fair evidence for short-term and limited evidence for long-term due to a lack of quality studies. 8) The evidence for the effectiveness and safety of chronic opioid therapy in the elderly for chronic non-cancer pain is fair for short-term and limited for long-term due to lack of high quality studies; limited in children and adolescents and patients with comorbid psychological disorders due to lack of quality studies; and the evidence is poor in pregnant women. 9) There is limited evidence for reliability and accuracy of screening tests for opioid abuse due to lack of high quality studies. 10) There is fair evidence to support the identification of patients who are non-compliant or abusing prescription drugs or illicit drugs through urine drug testing and prescription drug monitoring programs, both of which can reduce prescription drug abuse or doctor shopping. DISCLAIMER: 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 , Transtornos Relacionados ao Uso de Opioides/prevenção & controle , Adolescente , Idoso , Criança , Feminino , Humanos , Lactente , Masculino , Gravidez
19.
Pain Physician ; 15(3 Suppl): S67-116, 2012 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-22786449

RESUMO

RESULTS: Part 2 of the guidelines on responsible opioid prescribing provides the following recommendations for initiating and maintaining chronic opioid therapy of 90 days or longer. 1. A) Comprehensive assessment and documentation is recommended before initiating opioid therapy, including documentation of comprehensive history, general medical condition, psychosocial history, psychiatric status, and substance use history. ( EVIDENCE: good) B) Despite limited evidence for reliability and accuracy, screening for opioid use is recommended, as it will identify opioid abusers and reduce opioid abuse. ( EVIDENCE: limited) C) Prescription monitoring programs must be implemented, as they provide data on patterns of prescription usage, reduce prescription drug abuse or doctor shopping. ( EVIDENCE: good to fair) D) Urine drug testing (UDT) must be implemented from initiation along with subsequent adherence monitoring to decrease prescription drug abuse or illicit drug use when patients are in chronic pain management therapy. ( EVIDENCE: good) 2. A) Establish appropriate physical diagnosis and psychological diagnosis if available prior to initiating opioid therapy. ( EVIDENCE: good) B) Caution must be exercised in ordering various imaging and other evaluations, interpretation and communication with the patient, to avoid increased fear, activity restriction, requests for increased opioids, and maladaptive behaviors. ( EVIDENCE: good) C) Stratify patients into one of the 3 risk categories - low, medium, or high risk. D) A pain management consultation, may assist non-pain physicians, if high-dose opioid therapy is utilized. ( EVIDENCE: fair) 3. Essential to establish medical necessity prior to initiation or maintenance of opioid therapy. ( EVIDENCE: good) 4. Establish treatment goals of opioid therapy with regard to pain relief and improvement in function. ( EVIDENCE: good) 5. A) Long-acting opioids in high doses are recommended only in specific circumstances with severe intractable pain that is not amenable to short-acting or moderate doses of long-acting opioids, as there is no significant difference between long-acting and short-acting opioids for their effectiveness or adverse effects. ( EVIDENCE: fair) B) The relative and absolute contraindications to opioid use in chronic non-cancer pain must be evaluated including respiratory instability, acute psychiatric instability, uncontrolled suicide risk, active or history of alcohol or substance abuse, confirmed allergy to opioid agents, coadministration of drugs capable of inducing life-limiting drug interaction, concomitant use of benzodiazepines, active diversion of controlled substances, and concomitant use of heavy doses of central nervous system depressants. ( EVIDENCE: fair to limited) 6. A robust agreement which is followed by all parties is essential in initiating and maintaining opioid therapy as such agreements reduce overuse, misuse, abuse, and diversion. ( EVIDENCE: fair) 7. A) Once medical necessity is established, opioid therapy may be initiated with low doses and short-acting drugs with appropriate monitoring to provide effective relief and avoid side effects. ( EVIDENCE: fair for short-term effectiveness, limited for long-term effectiveness) B) Up to 40 mg of morphine equivalent is considered as low dose, 41 to 90 mg of morphine equivalent as a moderate dose, and greater than 91 mg of morphine equivalence as high dose. ( EVIDENCE: fair) C) In reference to long-acting opioids, titration must be carried out with caution and overdose and misuse must be avoided. ( EVIDENCE: good) 8. A) Methadone is recommended for use in late stages after failure of other opioid therapy and only by clinicians with specific training in the risks and uses. ( EVIDENCE: limited) B) Monitoring recommendation for methadone prescription is that an electrocardiogram should be obtained prior to initiation, at 30 days and yearly thereafter. ( EVIDENCE: fair) 9. In order to reduce prescription drug abuse and doctor shopping, adherence monitoring by UDT and PMDPs provide evidence that is essential to the identification of those patients who are non-compliant or abusing prescription drugs or illicit drugs. ( EVIDENCE: fair) 10. Constipation must be closely monitored and a bowel regimen be initiated as soon as deemed necessary. ( EVIDENCE: good) 11. Chronic opioid therapy may be continued, with continuous adherence monitoring, in well-selected populations, in conjunction with or after failure of other modalities of treatments with improvement in physical and functional status and minimal adverse effects. ( EVIDENCE: fair). DISCLAIMER: 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 , Transtornos Relacionados ao Uso de Opioides/prevenção & controle , Adolescente , Idoso , Criança , Feminino , Humanos , Lactente , Masculino , Gravidez
20.
Pain Physician ; 14(6): 499-511, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-22086091

RESUMO

BACKGROUND: There is uncertainty in the literature over the relative effectiveness of lumbar epidural interlaminar (IL) steroid injection versus transforaminal (TF) steroid injection for lumbar radiculopathy. Most studies to date have been retrospective, or technically focused. OBJECTIVE: To complete a randomized, blinded, prospective outcome study of the short-term benefit for IL versus TF epidural steroids for the treatment of subacute lumbar radicular pain. STUDY DESIGN: Prospective, randomized, blinded, subacute efficacy trial. SETTING: Tertiary care pain management center, major metropolitan city, United States. METHODS: After institutional review board approval, 42 age-matched patients with similar lower back pain and unilateral radicular symptoms were enrolled and randomized in a patient and evaluating physician blinded trial to IL or TF epidural steroids from 2007 through 2009. Prior to intervention and 10-16 days after injection, each participant was evaluated by questionnaire and physical exam by an independent physician. All injections were performed by the same physician. Thirty-eight participants completed the study, 18 in the IL group and 20 in the TF group. Four participants required a repeat injection, and 2 participants crossed over to the alternative injection type (IL to TF). RESULTS: Overall, physical exam, diagnostic testing, disability, activity, depression measures, and opioid pill use were similar between the 2 groups, both pre-injection baseline and post-injection improvement. In primary outcomes, the post-injection follow-up Numeric Rating Scale (NRS) was more greatly reduced in the TF group. The NRS decreased from 7.0 ± 1.9 to 3.9 ± 3.1 (mean values +/- standard deviation) in the IL group and 6.4 ± 2.1 to 1.7 ± 1.4 in the TF group. The Oswestry Disability Index was reduced from 37.5 ± 12.6 to 19.0 ± 16.7 in the IL group and 38.3 ± 6.4 to 21.6 ± 16.8 in the TF group. In secondary outcomes, the depression scale was reduced from 4.39 ± 3.22 to 2.28 ± 3.20 in the IL group and 4.10 ± 1.94 to 1.65 ± 1.63 in the TF group. Walking tolerance was increased from 8.1 ± 4.6 blocks to 10.6 ± 4.4 in the IL group and 8.9 ± 5.3 blocks to 11.8 ± 4.2 in the TF group. LIMITATIONS: The study did not examine long-term outcomes. A single experienced interventionalist performed all injections. CONCLUSION: Results suggest that patients may experience greater subjective relief, at least initially, from TF epidural steroid injections over IL. However, more objective, and likely subacute, therapeutic effects are similar.


Assuntos
Injeções Epidurais/métodos , Dor Lombar/tratamento farmacológico , Vértebras Lombares/cirurgia , Radiculopatia/tratamento farmacológico , Esteroides/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Método Duplo-Cego , Feminino , Humanos , Vértebras Lombares/anatomia & histologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento
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