Showing papers in "Pain Physician in 2013"

An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations.

Abstract: Objective To develop evidence-based clinical practice guidelines for interventional techniques in the diagnosis and treatment of chronic spinal pain. Methodology Systematic assessment of the literature. Evidence I. Lumbar Spine • The evidence for accuracy of diagnostic selective nerve root blocks is limited; whereas for lumbar provocation discography, it is fair. • The evidence for diagnostic lumbar facet joint nerve blocks and diagnostic sacroiliac intraarticular injections is good with 75% to 100% pain relief as criterion standard with controlled local anesthetic or placebo blocks. • The evidence is good in managing disc herniation or radiculitis for caudal, interlaminar, and transforaminal epidural injections; fair for axial or discogenic pain without disc herniation, radiculitis or facet joint pain with caudal, and interlaminar epidural injections, and limited for transforaminal epidural injections; fair for spinal stenosis with caudal, interlaminar, and transforaminal epidural injections; and fair for post surgery syndrome with caudal epidural injections and limited with transforaminal epidural injections. • The evidence for therapeutic facet joint interventions is good for conventional radiofrequency, limited for pulsed radiofrequency, fair to good for lumbar facet joint nerve blocks, and limited for intraarticular injections. • For sacroiliac joint interventions, the evidence for cooled radiofrequency neurotomy is fair; limited for intraarticular injections and periarticular injections; and limited for both pulsed radiofrequency and conventional radiofrequency neurotomy. • For lumbar percutaneous adhesiolysis, the evidence is fair in managing chronic low back and lower extremity pain secondary to post surgery syndrome and spinal stenosis. • For intradiscal procedures, the evidence for intradiscal electrothermal therapy (IDET) and biaculoplasty is limited to fair and is limited for discTRODE. • For percutaneous disc decompression, the evidence is limited for automated percutaneous lumbar discectomy (APLD), percutaneous lumbar laser disc decompression, and Dekompressor; and limited to fair for nucleoplasty for which the Centers for Medicare and Medicaid Services (CMS) has issued a noncoverage decision. II. Cervical Spine • The evidence for cervical provocation discography is limited; whereas the evidence for diagnostic cervical facet joint nerve blocks is good with a criterion standard of 75% or greater relief with controlled diagnostic blocks. • The evidence is good for cervical interlaminar epidural injections for cervical disc herniation or radiculitis; fair for axial or discogenic pain, spinal stenosis, and post cervical surgery syndrome. • The evidence for therapeutic cervical facet joint interventions is fair for conventional cervical radiofrequency neurotomy and cervical medial branch blocks, and limited for cervical intraarticular injections. III. Thoracic Spine • The evidence is limited for thoracic provocation discography and is good for diagnostic accuracy of thoracic facet joint nerve blocks with a criterion standard of at least 75% pain relief with controlled diagnostic blocks. • The evidence is fair for thoracic epidural injections in managing thoracic pain. • The evidence for therapeutic thoracic facet joint nerve blocks is fair, limited for radiofrequency neurotomy, and not available for thoracic intraarticular injections. IV. Implantables • The evidence is fair for spinal cord stimulation (SCS) in managing patients with failed back surgery syndrome (FBSS) and limited for implantable intrathecal drug administration systems. V. ANTICOAGULATION • There is good evidence for risk of thromboembolic phenomenon in patients with antithrombotic therapy if discontinued, spontaneous epidural hematomas with or without traumatic injury in patients with or without anticoagulant therapy to discontinue or normalize INR with warfarin therapy, and the lack of necessity of discontinuation of nonsteroidal anti-inflammatory drugs (NSAIDs), including low dose aspirin prior to performing interventional techniques. • There is fair evidence with excessive bleeding, including epidural hematoma formation with interventional techniques when antithrombotic therapy is continued, the risk of higher thromboembolic phenomenon than epidural hematomas with discontinuation of antiplatelet therapy prior to interventional techniques and to continue phosphodiesterase inhibitors (dipyridamole, cilostazol, and Aggrenox). • There is limited evidence to discontinue antiplatelet therapy with platelet aggregation inhibitors to avoid bleeding and epidural hematomas and/or to continue antiplatelet therapy (clopidogrel, ticlopidine, prasugrel) during interventional techniques to avoid cerebrovascular and cardiovascular thromboembolic fatalities. • There is limited evidence in reference to newer antithrombotic agents dabigatran (Pradaxa) and rivaroxan (Xarelto) to discontinue to avoid bleeding and epidural hematomas and are continued during interventional techniques to avoid cerebrovascular and cardiovascular thromboembolic events. Conclusions Evidence is fair to good for 62% of diagnostic and 52% of therapeutic interventions assessed. Disclaimer The authors are solely responsible for the content of this article. No statement on this article should be construed as an official position of ASIPP. The guidelines do not represent "standard of care."

Percutaneous endoscopic lumbar discectomy for L5-S1 disc herniation: transforaminal versus interlaminar approach.

Abstract: Background Percutaneous endoscopic lumbar discectomy (PELD) is a minimally invasive spinal technique. The unique anatomic features of the L5-S1 space include a large facet joint, narrow foramen, small disc space, and a wide interlaminar space. PELD can be performed via 2 routes, transforaminal (TF-PELD) or interlaminar (IL-PELD). However, it is questionable that the decision of the endoscopic route for L5-S1 discs only depends on the surgeon's preference and anatomic relation between iliac bone and disc space. Thus far, no study has compared TF-PELD with IL-PELD for L5-S1 disc herniation. Objective The goal of this study was to compare the radiologic features and results of TF-PELD and IL-PELD. We have clarified the patient selection for the PELD route for L5-S1 disc herniation. Study design Retrospective evaluation. Methods Thirty consecutive patients each were treated with TF-PELD and IL-PELD for L5-S1 disc herniation in 2 institutes, respectively. Radiological assessments were performed pre- and postoperatively. The disc type, disc size, location, migration, disc height, foraminal height, iliolumbar angle, iliac height, and interlaminar space were analyzed. Clinical data were compared with a 2-year follow-up period. Pre- and postoperative pain was measured using a visual analog scale (VAS; 0 - 10) and functional status was assessed using the Oswestry Disability Index (ODI; 0 - 100%) and the time to return to work. Results In the 2 groups, the mean VAS scores for back and leg pain, as well as the ODI, were significantly improved. The mean time to return to work was 4.9 weeks with TF-PELD and 4.4 weeks with IL-PELD. Incomplete removal, resulting in the need for subsequent open surgery, occurred in one case (3.3%) of TF-PELD and in 2 cases (6.6%) of IL-PELD. Postoperative dysesthesia developed in 2 patients (6.7%) after IL-PELD; however, there was no dysesthesia after TF-PELD. Recurrence occurred in 3.3% with TF-PELD and in 6.7% with IL-PELD during the 2-year follow-up. A significant difference between groups was demonstrated in terms of disc type, location, and migration. The prevalence of axillary disc herniation (20 cases, 66.7%) was higher than that of shoulder disc herniation (10 cases, 33.3%) in the IL-PELD group. On the other hand, in the TF-PELD group, shoulder disc herniation (20 cases, 66.7%) was more prevalent than the axillary type (10 cases, 33.3%; P = 0.01). A higher number of patients in the TF-PELD group had central disc herniation (10 cases, 33.3%) compared with that in the IL-PELD group (2 cases, 6.7%; P = 0.01). Eleven cases (36.7%) of high grade migration were removed using IL-PELD and one case (6.7%) was removed using TF-PELD (P = 0.01). TF-PELD was used to remov only 3 cases of recurrent disc herniation. There were no significant differences of radiologic parameters between the iliac bone and L5-S1 disc space between the 2 groups. Limitations This study has a relatively small sample size and a short follow-up period. Conclusion This study demonstrated that TF-PELD is preferred for shoulder type, centrally located, and recurrent disc herniation, while IL-PELD is preferred for axillary type and migrated discs, especially those of a high grade.

The current state of endoscopic disc surgery: review of controlled studies comparing full-endoscopic procedures for disc herniations to standard procedures.

Abstract: Background Neuropathic pain originating from spinal disc herniations is a very common problem. The majority of disc surgeries are performed to alleviate this pain once conservative measures and targeted injections have failed. Endoscopic spinal surgery is increasingly popular because it minimizes access trauma and hastens recovery from the intervention. This clinically oriented review evaluates controlled studies that investigate the clinical results and the complications of full-endoscopic lumbar and cervical procedures for symptomatic disc herniations in comparison to a microsurgical standard procedure. This review focuses exclusively on modern, full-endoscopic disc surgery irrespective of the specific access technique (e.g., interlaminar vs. transforaminal) and irrespective of the spinal region. Study design Comprehensive review of the literature. Objective To assess the clinical outcomes and complication rates of full-endoscopic disc surgery compared to the microsurgical standard procedures. Methods A PubMed and Embase search was performed, considering entries up to January 2013. All 504 results were screened and categorized. Only 4 randomized controlled trials (RCTs) and one controlled studies (CS) could finally be considered for evaluation. All 5 manuscripts were meticulously analyzed with regards to randomization mode, inclusion/exclusion criteria, clinical results, and complication rates. Results Overall, the endoscopic techniques had shorter operating times, less blood loss, less operative site pain, and faster postoperative rehabilitation/shorter hospital stay/faster return to work than the microsurgical techniques. There were no significant differences in the main clinical outcome criteria between the endoscopic and the microsurgical techniques in any of the trials. All 5 studies had fewer complications with the endoscopic technique and this was statistically significant in 2 of the studies. One study showed a lower rate of revision surgeries requiring arthrodesis with the endoscopic technique. Limitations All 5 studies that could be considered originate from experienced investigators and all 4 RCTs came from one group. This limits the transferability of their results to surgeons less experienced in endoscopic disc surgery. Conclusions The studies show that full-endoscopic disc surgery can achieve the same clinical results in symptomatic cervical and lumbar disc herniations as the microsurgical standard techniques. This does not appear to come at the price of higher complication rates.

An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part I: introduction and general considerations.

Abstract: In 2011, the Institute of Medicine (IOM) re-engineered its definition of clinical guidelines as follows: "clinical practice guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefit and harms of alternative care options." This new definition departs from a 2-decade old definition from a 1990 IOM report that defined guidelines as "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances." The revised definition clearly distinguishes between the term "clinical practice guideline" and other forms of clinical guidance derived from widely disparate development processes, such as consensus statements, expert advice, and appropriate use criteria. The IOM committee acknowledged that for many clinical domains, high quality evidence was lacking or even nonexistent. Even though the guidelines are important decision-making tools, along with expert clinical judgment and patient preference, their value and impact remains variable due to numerous factors. Some of the many factors that impede the development of clinical practice guidelines include bias due to a variety of conflicts of interest, inappropriate and poor methodological quality, poor writing and ambiguous presentation, projecting a view that these are not applicable to individual patients or too restrictive with elimination of clinician autonomy, and overzealous and inappropriate recommendations, either positive, negative, or non-committal. Consequently, a knowledgeable, multidisciplinary panel of experts must develop guidelines based on a systematic review of the existing evidence, as recently recommended by the IOM. Chronic pain is a complex and multifactorial phenomenon associated with significant economic, social, and health outcomes. Interventional pain management is an emerging specialty facing a disproportionate number of challenges compared to established medical specialties, including the inappropriate utilization of ineffective and unsafe techniques. In 2000, the American Society of Interventional Pain Physicians (ASIPP) created treatment guidelines to help practitioners. There have been 5 subsequent updates. These guidelines address the issues of systematic evaluation and ongoing care of chronic or persistent pain, and provide information about the scientific basis of recommended procedures. These guidelines are expected to increase patient compliance; dispel misconceptions among providers and patients, manage patient expectations reasonably; and form the basis of a therapeutic partnership between the patient, the provider, and payers.

Assessment of the growth of epidural injections in the medicare population from 2000 to 2011.

Abstract: BACKGROUND Among the many diagnostic and therapeutic interventions available for the management of chronic pain, epidural steroid injections are one of the most commonly used modalities. The explosive growth of this technique is relevant in light of the high cost of health care in the United States and abroad, the previous literature assessing the effectiveness of epidural injections has been sparse with highly variable outcomes based on technique, outcome measures, patient selection, and methodology. However, the recent assessment of fluoroscopically directed epidural injections has shown improved evidence with proper inclusion criteria, methodology, and outcome measures. The exponential growth of epidural injections is illustrated in multiple reports. The present report is an update of the analysis of the growth of epidural injections in the Medicare population from 2000 to 2011 in the United States. STUDY DESIGN Analysis of utilization patterns of epidural procedures in the Medicare population in the United States from 2000 to 2011. OBJECTIVES The primary purpose of this assessment was to evaluate the use of all types of epidural injections (i.e., caudal, interlaminar, and transforaminal in the lumbar, cervical, and thoracic regions) with an assessment of specialty and regional characteristics. METHODS This assessment was performed utilizing the Centers for Medicare and Medicaid Services (CMS) Physician/Supplier Procedure Summary (PSPS) Master data from 2000 to 2011. RESULTS Epidural injections in Medicare beneficiaries increased significantly from 2000 to 2011. Overall, epidural injections increased 130% per 100,000 Medicare beneficiaries with an annual increase of 7.5%. The increases per 100,000 Medicare recipients were 123% for cervical/thoracic interlaminar epidural injections; 25% for lumbar/sacral interlaminar, or caudal epidural injections; 142% for cervical/thoracic transforaminal epidural injections; and 665% for lumbar/sacral transforaminal epidural injections. The use of epidurals increased 224% in the radiologic specialties (interventional radiology and diagnostic radiology) and 145% in psychiatric settings, whereas and physical medicine and rehabilitation physicians' use of epidurals increased 520%. LIMITATIONS Study limitatations include lack of inclusion of Medicare Advantage patients. In addition, the statewide data is based on claims which may include the contiguous or other states. CONCLUSIONS Epidural injections in Medicare recipients increased significantly. The growth was significant for some specialties (radiology, physical medicine and rehabilitation, and psychiatry) and for certain procedures (lumbosacral transforaminal epidural injections).

Central sensitization in urogynecological chronic pelvic pain: a systematic literature review.

Abstract: Background: Chronic pelvic pain (CPP) is a complex pain syndrome. Since its pathogenesis is still poorly understood and structural alterations in pain related brain regions may be present, there is a greater acceptance that sensitization of the central nervous system (CNS) plays an important role in the development and maintenance of chronicity. Objective: The purpose of this study is to systematically review the scientific evidence regarding central sensitization (CS) in female patients with urogynecological CPP. Study Design: Systematic review of the literature. Methods: A systematic literature search was conducted in PubMed and Web of Science using different keyword combinations related to urogynecological CPP and central sensitization. Full text clinical reports addressing CS in adult women with urogynecological CPP were included and assessed for methodological quality by 2 independent reviewers. Results: After screening for the eligibility, a total of 29 full-text articles with low to good methodological quality were retained. All studies were observational, 27 of which were case-control and 2 of which were cohorts. Sensitivity of the CNS was investigated by using a variety of methods. Although different central mechanisms seem to be involved in pain processing, the present evidence suggests hyperexcitability of the CNS in patients with urogynecological CPP. Altered brain morphology and function, generalized hyperalgesia to different type of stimuli, overactive bottom-up nociceptive mechanisms, and autonomic dysregulation were established in patients with urogynecological CPP. Nevertheless, diffuse noxious inhibitory control seemed normal, and therefore the contribution of an impaired endogenous pain inhibition mechanism to CPP requires further study. The same goes for the contribution of psychological factors. Limitations: The level of evidence of retained studies is low due to the observational study designs and a wide range of diagnoses and assessment methods. Conclusion: Although the majority of the literature provides evidence for the presence of CS in urogynecological CPP with changes in brain morphology/function and sensory function, it is unclear whether these changes in central pain processing are secondary or primary to CPP, especially since evidence regarding the function of endogenous pain inhibition and the role of psychosocial pain facilitation is scarce. Further studies with good methodological quality are needed in order to clarify exact mechanisms.

Cost utility analysis of caudal epidural injections in the treatment of lumbar disc herniation, axial or discogenic low back pain, central spinal stenosis, and post lumbar surgery syndrome.

Abstract: Background In this era of escalating health care costs and the questionable effectiveness of multiple interventions, cost effectiveness or cost utility analysis has become the cornerstone of evidence-based medicine, and has an influence coverage decisions. Even though multiple cost effectiveness analysis studies have been performed over the years, extensive literature is lacking for interventional techniques. Cost utility analysis studies of epidural injections for managing chronic low back pain demonstrated highly variable results including a lack of cost utility in randomized trials and contrasting results in observational studies. There has not been any cost utility analysis studies of epidural injections in large randomized trials performed in interventional pain management settings. Objectives To assess the cost utility of caudal epidural injections in managing chronic low back pain secondary to lumbar disc herniation, axial or discogenic low back pain, lumbar central spinal stenosis, and lumbar post surgery syndrome. Study design This analysis is based on 4 previously published randomized trials. Setting A private, specialty referral interventional pain management center in the United States. Methods Four randomized trials were conducted assessing the clinical effectiveness of caudal epidural injections with or without steroids for lumbar disc herniation, lumbar discogenic or axial low back pain, lumbar central spinal stenosis, and post surgery syndrome. A cost utility analysis was performed with direct payment data for a total of 480 patients over a period of 2 years from these 4 trials. Outcome included various measures with significant improvement defined as at least a 50% improvement in pain reduction and disability status. Results The results of 4 randomized controlled trials of low back pain with 480 patients with a 2 year follow-up with the actual reimbursement data showed cost utility for one year of quality-adjusted life year (QALY) of $2,206 for disc herniation, $2,136 for axial or discogenic pain without disc herniation, $2,155 for central spinal stenosis, and $2,191 for post surgery syndrome. All patients showed significant improvement clinically and showed positive results in the cost utility analysis with an average cost per one year QALY of $2,172.50 for all patients and $1,966.03 for patients judged to be successful. The results of this assessment show a better cost utility or lower cost of managing chronic, intractable low back pain with caudal epidural injections at a QALY that is similar or lower in price than medical therapy only, physical therapy, manipulation, and surgery in most cases. Limitations The limitations of this cost utility analysis include that it is a single center evaluation, even though 480 patients were included in the analysis. Further, only the costs of interventional procedures and physician visits were included. The benefits of returning to work were not assessed. Conclusion This cost utility analysis of caudal epidural injections in the treatment of disc herniation, axial or discogenic low back pain, central spinal stenosis, and post surgery syndrome in the lumbar spine shows the clinical effectiveness and cost utility of these injections at less than $2,200 per one year of QALY.

Pulsed radiofrequency modulates pain regulatory gene expression along the nociceptive pathway.

Abstract: Background Pulsed radiofrequency (PRF) therapy is a clinical treatment utilizing electromagnetic energy aimed to relieve neuropathic pain. This is the first study examining the modulated expression of pain regulatory genes following the induction of the spared nerve injury (SNI) pain model and subsequently treated with PRF therapy. Objectives The present study investigated the behavioral efficacy of PRF therapy in rats exhibiting sciatic nerve injury and examined gene expression changes in the sciatic nerve, ipsilateral L5 dorsal root ganglia (DRG), and spinal cord. Study design A randomized, experimental trial. Setting Department of Biological Sciences, Illinois State University and Department of Psychology, Illinois Wesleyan University. Methods An SNI model was used in male Sprague-Dawley rats (weight 260-310 g). A sham surgery was also performed as a control group. After 3 days development of the SNI model, an RF electrode was applied to the sciatic nerve proximal to the site of injury and stimulated for 3 minutes. The response to mechanical stimuli was assessed throughout the duration of the study. Furthermore, changes in gene expression along the nociceptive tract (sciatic nerve, DRG, and spinal cord) were assessed 24 hours post-PRF therapy. Results It was observed that the mechanical allodynia, induced by SNI model, was reversed to control values within 24 hours post-PRF therapy. Additionally, modulated expression of pain regulatory genes was observed after induction of the SNI model. Following PRF therapy, expression of many of these genes returned to control values (sham) in each of the tissues tested. Increased proinflammatory gene expression, such as TNF-α and IL-6, observed in the sciatic nerve (site of injury) in the SNI group was returned to baseline values following PRF therapy. Up-regulation of GABAB-R1, Na/K ATPase, and 5-HT3r as well as down regulation of TNF-α and IL-6 were also observed in the DRG in the SNI-PRF group relative to the SNI group. Up-regulation of Na/K ATPase and c-Fos was found in the spinal cord following PRF treatment relative to the SNI group. Limitations Immediate changes in gene expression were observed at 24 hours to better determine the mechanism with no long-term data at this time. Protein expression was not assessed in addition to gene expression changes. Conclusion These results indicate that the electromagnetic energy applied via PRF therapy influences the reversal of behavioral and molecular effects of hypersensitivity developed from a peripheral nerve injury.

Accountable interventional pain management: a collaboration among practitioners, patients, payers, and government.

Abstract: The prevalence, costs, and disability associated with chronic pain continue to escalate. So too, the numerous modalities of treatments applied in managing these patients continue to increase as well. In the period from 2000 to 2011 interventional techniques increased 228%. In addition, analysis of utilization trends and expenditures for spinal interventional techniques alone from 2000 to 2008 illustrated an increase in Medicare fee-for-service expenditures of 240% in terms of dollars spent in the United States. The Office of Inspector General (OIG) of the Department of Health and Human Services showed an increase in facet joint and transforaminal epidural injections, with a significant proportion of these services did not meet the medical necessity criteria.The increasing utilization of interventional techniques is also associated with significant variations among specialty groups and regional variations among states. Overall procedures have increased by 173%, with rate of 130% per 100,000 Medicare beneficiaries for epidural injections; 383%, with a rate of 308% for facet joint interventions; and overall 410%, or a rate of 331% for sacroiliac joint interventions. Certain high volume interventions such as lumbar transforaminal epidural injections and lumbar facet joint neurolysis have actually increased a staggering 806% and 662%.Coverage policies across ambulatory settings and by multiple payers are highly variable. Apart from variability in the development of coverage policies, payments also substantially vary by site of service. In general, amongst the various ambulatory settings the highest payments are made to hospital outpatient departments (HOPDs) the lowest to in-office procedures, and payment to ambulatory surgery centers (ASCs) falling somewhere in the middle.This manuscript describes the many differences that exist between the various settings, and includes suggestions for accountable interventional pain management with coverage for techniques with evidence, addressing excessive use of specific techniques, and equalizing payments across multiple ambulatory settings.

Percutaneous Epidural Lysis of Adhesions in Chronic Lumbar Radicular Pain: A Randomized, Double-Blind Placebo Controlled Trial

Abstract: BACKGROUND Chronic radicular pain can occur after disc pathology and failed back surgery. An evidence-based effective therapeutic option is not available nor does a gold standard exist. OBJECTIVES A randomized controlled trial to analyze the clinical efficacy of percutaneous epidural lysis of adhesions in chronic radicular pain. STUDY DESIGN Prospective randomized placebo controlled interventional trial. Power calculation based on a feasibility trial. SETTING Medical university centers. METHODS Within 4 years a total of 381 patients with chronic radicular pain lasting longer than 4 months which failed to respond to conservative treatments were screened and 90 patients were enrolled. They were randomly assigned to receive either percutaneous neurolysis or placebo with concealed allocation in permuted blocks of 4 to 8, stratified by treatment center. The primary outcome measure was the differences in percent change of Oswestry Disability Index (ODI) scores 3 months after intervention. Secondary outcome measures were difference in percent change of ODI scores and Visual Analog Scale (VAS) 6 and 12 months after intervention and success rates defined as at least 50% reduction in ODI scores and VAS scores (mean change from baseline) at 3, 6, and 12 months after treatment. Explorative, 2-sided group comparisons for baseline characteristics between active treatment and controls were done using the t-test for 2 independent samples for quantitative data and Fisher's exact test for binary data. RESULTS The ODI and VAS scores as well as the success rates for ODI vs VAS were significantly better 3, 6, and 12 months in the lysis group vs the control group. The ODI in the lysis group improved from 55.3 ± 11.6 to 26.4 ± 10.8 after 3 months. The placebo group improved from 55.4 ± 11.5 to 41.8 ± 14.6 (P < 0.01). VAS improved from 6.7 ± 1.1 to 2.9 ± 1.9 in the active group and from 6.7 ± 1.1 to 4.8 ± 2.2 (P < 0.01) after placebo. Twelve month follow-up shows further improvement, the differences remain significant. In multiple linear regression, forward and backward variable selection methods resulted in the same covariate model confirming the univariate result for group comparison in the primary analysis. No severe side effects occurred but minor transient neurological effects such as partial sensomotoric deficits did. One dura puncture and one catheter displacement were found. LIMITATIONS Specific effects of single treatment components cannot be specified because there was no imaging examination after treatment. CONCLUSION Based on the findings of our study as well as other studies, we believe the minimally invasive percutaneous adhesiolysis procedure should be the first choice treatment option for patients with chronic lumbosacral radicular pain who present with clinical history and findings similar to those of the patients enrolled in our study.

Needle position analysis in cases of paralysis from transforaminal epidurals: consider alternative approaches to traditional technique.

Abstract: Background Transforaminal technique for epidural steroid injections, unlike other approaches, is uniquely associated with permanent, bilateral, lower extremity paralysis. Objective To review the literature and analyze the reported cases of paralysis from lumbar transforaminal epidural steroid injections to possibly establish a cause and to prevent this complication. Study design Eighteen cases of paralysis from transforaminal epidural injection have been reported. We could analyze the position of the needle within the neural foramen based on the available images and/or description among 10 of these 18 cases. Five cases were performed with computed tomography guidance and 12 cases were performed with fluoroscopic guidance [unknown in one case]. Additionally, other variables associated with the procedure, including the technique, were also examined. Methods Analysis of the needle position in the neural foramen in cases of paralysis from transforaminal epidural steroid injections. This analysis is based on images and/or description provided in published reports. Results Paralysis in these cases seems to be associated with a well performed traditional safe triangle approach with good epidural contrast spreads. Analyzed data shows that 77.7% of the time, the needle was in the superior part of the foramen. In 71.4% of the cases, the needle was in the anterior part of the foramen. This coincides with the location of the radicular artery in the foramen. In 22.2%, the needle was in the midzone (neither in the superior nor inferior zone). No level was spared as this event occurred at every foramen from T12 to S1. Ten of these events happened during a left-sided procedure and 8 during a right-sided procedure. No relation to this complication was noted when other variables like type and size of the needles, side of the injection, local anesthetic, contrast, or volume of injectate were taken into consideration. Limitations Only 18 cases of paralysis from transforaminal epidurals have been reported. Out of these, only 10 cases included images or descriptions which could be evaluated for our study. Conclusion In light of the anatomical and radiological evidence in the literature that radicular arteries dwell in the superior part of the foramen and along with our needle position analysis, we suggest that the traditional technique of placing the needle in the superior and anterior part of the foramen must be reexamined. Alternative, safer techniques must be considered, one of which is described.

Pain and its interference with daily activities in medical oncology outpatients.

Abstract: BACKGROUND: Pain prevalence at various stages of cancer ranges from 27% to 60% for outpatients. Yet, how pain is managed in this patient group is poorly understood. OBJECTIVES: The primary objective was to assess pain prevalence and intensity, and its interference with daily activities, in medical oncology outpatients. The secondary objectives were the adequacy of analgesic pain treatment and to identify independent predictors for moderate to severe pain. STUDY DESIGN: A cross-sectional study. SETTING: Oncology outpatient clinics of 7 Dutch regional hospitals. METHODS: Four hundred twenty-eight medical oncology outpatients were assigned to the study. Pain prevalence and interference of pain with daily activities were assessed using the Brief Pain Inventory. Adequacy of analgesic treatment was determined by calculating the Pain Management Index (PMI). Descriptive statistics, non-parametric tests, and logistic regression analysis were conducted. RESULTS: More than one third of all participants reported pain (39%). Eighty-three patients (20%) had moderate to severe pain (NRS 5-10). Analgesic treatment was inadequate in more than half of the patients with pain (62%). Interference of pain with daily activities increased with increased intensity, yet even 10%-33% of patients suffering mild pain reported high interference with daily activities. High current pain intensity and high interference with general daily activities predicted moderate to severe pain. LIMITATIONS: No characteristics of nonparticipants were available. CONCLUSION: Pain remains a significant problem in medical oncology outpatients, and often pain is insufficiently managed. Patients with a high pain intensity were more at risk to experience pain related interference with daily activities, but even some patients suffering mild pain experienced this. As adequate pain relief for up to 86% of the patients with cancer should be feasible, pain in medical oncology outpatients is still undertreated. Taking into account the interference of pain with daily activities and predictors of pain will facilitate cancer pain management. The study has been approved by the Medical Ethics Committee (CMO) in all 7 hospitals (METC protocol number 2011/020) and has been registered by the Dutch Trial register (NTR): NTR2739.

Efficacy of tapentadol ER for managing moderate to severe chronic pain.

Abstract: Background Chronic non-cancer-related pain affects a large proportion of the adult population and is often difficult to manage effectively. Although opioid analgesics have been used to relieve chronic pain of different etiologies, opioids are associated with a range of side effects that may reduce patient quality of life and lead to reduced compliance with treatment.Tapentadol is a centrally acting analgesic with 2 mechanisms of action, μ-opioid receptor agonism and norepinephrine reuptake inhibition, that is available in an extended-release formulation for the management of chronic pain. Objective To review the efficacy of tapentadol extended release (ER) for the management of moderate to severe chronic nociceptive and neuropathic pain. Methods Efficacy results are summarized for four 15-week phase 3 studies of tapentadol ER in patients with moderate to severe chronic osteoarthritis knee pain (2 studies; ClinicalTrials.gov Identifiers: NCT00421928 and NCT00486811), low back pain (NCT00449176), and pain related to diabetic peripheral neuropathy (DPN; NCT00455520); a one-year phase 3 study of tapentadol ER in patients with moderate to severe chronic osteoarthritis pain or low back pain (NCT00361504); and a pooled analysis of data from the 15-week studies in patients with osteoarthritis knee pain or low back pain. A summary of the comparative tolerability for tapentadol ER and the active comparator used in these studies, oxycodone controlled release (CR), is provided. Results Results of these studies showed that tapentadol ER (100 - 250 mg bid) was effective for the management of moderate to severe chronic osteoarthritis knee pain, low back pain, and pain related to DPN. Tapentadol ER (100 - 250 mg bid) has been shown to provide comparable pain relief to oxycodone HCl CR (20 - 50 mg bid) for chronic osteoarthritis knee pain and low back pain over up to one year of treatment. Tapentadol ER (100 - 250 mg bid) was associated with an improved tolerability profile, particularly gastrointestinal tolerability profile, and with lower rates of treatment discontinuations and adverse event-related discontinuations compared with oxycodone HCl CR (50 - 250 mg bid) over up to one year of treatment in patients with osteoarthritis knee pain and low back pain. Limitations Differences in the design and duration of these phase 3 studies may limit comparisons of the efficacy results; nevertheless, this summary of efficacy results demonstrates the broad efficacy of tapentadol ER for different types of nociceptive and neuropathic pain. Conclusions Tapentadol ER (100 - 250 mg bid) is effective for moderate to severe osteoarthritis pain, low back pain, and pain related to DPN and provides efficacy similar to that of oxycodone HCl CR (20 - 50 mg bid) for patients with osteoarthritis and low back pain. Tapentadol ER treatment has been associated with better gastrointestinal tolerability and compliance with therapy than oxycodone CR, which suggests that tapentadol ER may be a better option for the long-term management of chronic pain.

Efficacy of pulsed radiofrequency in the treatment of thoracic postherpetic neuralgia from the angulus costae: a randomized, double-blinded, controlled trial.

Abstract: Background Postherpetic neuralgia (PHN) is often refractory to existing treatments. Pulsed radiofrequency (PRF) is known to be effective for treating neuropathic pain. In common, the targets of PRF treatment were the segmental dorsal root ganglion (DRG) neurons responsible for the pain. A potential complication that can occasionally occur with PRF treatment is damage to the adjacent tissue and organ. The effectiveness of the angulus costae as a puncture site for PRF has not been tested in thoracic PHN treatment. Objective The goal of this study was to investigate the therapeutic efficacy and safety of PRF for treating thoracic PHN through the puncture of the angulus costae. Study design Prospective, randomized, double-blinded study. Setting Department of Anesthesiology, Xinhua Hospital, Shanghai Jiaotong University School of Medicine. Methods Ninety-six patients with thoracic (T2-11) PHN were equally randomized assigned into 2 groups. The electrode needle punctured through the angulus costae of each patient guided by x-ray; PRF at 42° C for 120 seconds was applied after inducing paresthesia involving the affected dermatome area. PRF was applied in the PRF group (n = 48) twice. It was also applied in the sham group (n = 48) twice without radiofrequency energy output. The treatment was done once a week for 3 weeks. Tramadol was used for flare pain when the visual analog scale (VAS) ≥ 3. Outcomes assessment The therapeutic effect was evaluated by VAS, SF-36 health survey questionnaire, side effects (type, frequency, and onset time) before treatment, at days 3, 7, and 14, and at months one, 2, 3 and 6 after PRF. The average of tramadol (mg/d) administered within the first month after treatment was also recorded. Results The postprocedure VAS scores in the PRF group were significantly lower than those in the sham group and lasted for 6 months after treatment (P 0.05). Limitations Single center study, relatively small number of patients. Conclusions The strategy that the angulus costae be used as the PRF puncture point of an electrode needle and the final localization of the needle tip as determined by sensory testing is an effective and safe therapeutic alternative for thoracic PHN treatment. Benefits include that the procedure is minimally invasive, provides short-term pain relief, and improves quality of life. Clinical trial registration NO ISRCTN25588650.

Infectious complications related to intrathecal drug delivery system and spinal cord stimulator system implantations at a comprehensive cancer pain center.

Abstract: Background Intrathecal drug delivery (IDD) and spinal cord stimulator (SCS) systems are implantable devices for the management of both chronic and cancer pain. Although these therapies have favorable long-term outcomes, they are associated with occasional complications including infection. The incidence of infectious complications varies from 2 - 8% and frequently requires prolonged antibiotics and device revision or removal. Cancer patients are particularly susceptible to infectious complications because they are immunocompromised, malnourished, and receiving cytotoxic cancer-related therapies. Objective Determine if cancer pain patients have a higher incidence of infectious complications following implantation of IDD or SCS systems than non-cancer pain patients. Study design Retrospective chart review. Setting Single tertiary comprehensive cancer hospital. Methods Following local Institutional Review Board (IRB) approval, we collected data on infectious complications for IDD and SCS systems implanted at MD Anderson Cancer Center for the treatment of cancer and chronic pain. The examined implants were performed from July 15, 2006, to July 14, 2009. In addition, we obtained data regarding patient comorbidities and perioperative risk factors to assess their impact on infectious complications. Results One hundred forty-two devices were implanted in 131 patients during the examined period. Eighty-three of the devices were IDD systems and 59 were SCS systems. Eighty percent of the patients had a diagnosis of cancer. Four infectious complications were noted with an overall infectious risk of 2.8%. The infection rate was 2.4% for IDD systems versus 3.4% for SCS systems (P = 1). All infections were at the implantable pulse generator (IPG) or pump pocket site. The rate of infection was 2.7% for cancer patients and 3.3% for non-cancer patients (P = 1). Neither the perioperative administration of prophylactic antibiotics (P = 0.4) nor the National Nosocomial Infection Surveillance (NNIS) risk level for individual patients (P = 0.15) were statistically associated with infectious complication. The mean surgical time was longer for cases with infection at 215 ± 93 minutes versus 132 ± 52 minutes for those without infection which was statistically significant (P = 0.02). Limitations The major limitation of this study is that it was a retrospective analysis. An additional limitation is that 51(38.9%) of our patients either died or were lost to follow-up during the year following implantation which may have led to an underestimation of our infection rates. Conclusions The experience of this tertiary cancer pain center demonstrates that infectious complications following implantation of IDD and SCS systems are relatively rare events in cancer patients. Contrary to our initial hypothesis, no difference was found in the infection rate between cancer and non-cancer patients. The main factor associated with increased risk of infectious complications was increased surgical time, indicating a need to minimize patient time in the operating room. The low infectious complication rate seen in this series compared to previous reports in non-cancer patients is likely multifactorial in nature.

Intravenous infusions in chronic pain management.

Abstract: In the United States, millions of Americans are affected by chronic pain, which adds heavily to national rates of morbidity, mortality, and disability, with an ever-increasing prevalence. According to a 2011 report titled Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research by the Institute of Medicine of the National Academies, pain not only exacts its toll on people’s lives but also on the economy with an estimated annual economic cost of at least $560 - 635 billion in health care costs and the cost of lost productivity attributed to chronic pain. Intravenous infusions of certain pharmacologic agents have been known to provide substantial pain relief in patients with various chronic painful conditions. Some of these infusions are better, and although not necessarily the first therapeutic choice, have been widely used and extensively studied. The others show promise, however are in need of further investigations. This article will focus on non-opiate intravenous infusions that have been utilized for chronic painful disorders such as fibromyalgia, neuropathic pain, phantom limb pain, post-herpetic neuralgia, complex regional pain syndromes (CRPS), diabetic neuropathy, and central pain related to stroke or spinal cord injuries. The management of patients with chronic pain conditions is challenging and continues to evolve as new treatment modalities are explored and tested. The following intravenous infusions used to treat the aforementioned chronic pain conditions will be reviewed: lidocaine, ketamine, phentolamine, dexmedetomidine, and bisphosphonates. This overview is intended to familiarize the practitioner with the variety of infusions for patients with chronic pain. It will not, however, be able to provide guidelines for their use due to the lack of sufficient evidence.

A randomized, double-blind, active-controlled trial of fluoroscopic lumbar interlaminar epidural injections in chronic axial or discogenic low back pain: results of 2-year follow-up.

Abstract: BACKGROUND Chronic low back with or without lower extremity pain is extremely common, expensive, and disabling. However, all modalities of treatments are directed towards disc herniation which is responsible for a very small proportion of the patients. Thus, chronic low back pain without disc herniation is common. Multiple modalities of treatments are utilized in managing axial or discogenic pain including surgery and epidural injections including surgery, intradiscal therapies, and epidural injections. However, there is continued debate on the effectiveness, indications, and medical necessity of all modalities treatments in managing axial or discogenic pain in the lumbar spine. STUDY DESIGN A randomized, double-blind, active control trial. SETTING A private practice, specialty referral, interventional pain management practice in the United States. OBJECTIVES To evaluate the ability to assess the effectiveness of lumbar interlaminar epidural injections in managing chronic axial or discogenic low back pain with epidural injections of local anesthetic with or without steroids. METHODS In this study, a total of 120 patients were randomly allocated to one of the 2 groups receiving either local anesthetic alone or local anesthetic with steroids with 60 patients in each group. The primary outcome measure was at least 50% improvement in the numeric rating scale (NRS) and Oswestry Disability Index (ODI). Outcomes were assessed at 3, 6, 12, 18, and 24 months post treatment. RESULTS Significant pain relief and functional status improvement defined as at least 50% or more reduction in scores from baseline were observed in 72% of patients receiving local anesthetic alone and 67% of the patients receiving local anesthetic with steroids. Opioid intake was reduced from baseline in each group for 2 years. LIMITATIONS The results of the study are limited by the lack of a placebo group. CONCLUSION Lumbar interlaminar epidural injections of local anesthetic with or without steroids are effective in patients with chronic axial low back pain of discogenic origin without facet joint pain, disc herniation, and/or radiculitis. TRIAL REGISTRATION NCT00681447.

Comparative efficacy and safety of six antidepressants and anticonvulsants in painful diabetic neuropathy: a network meta-analysis.

Abstract: Background Anticonvulsants and antidepressants are mostly used in management of painful diabetic neuropathy (PDN). However there are few direct comparisons between drugs of these classes, making evidence-based decision-making in the treatment of painful diabetic neuropathy difficult. Objectives This study aimed to perform a network meta-analysis and benefit-risk analysis to evaluate the comparative efficacy and safety of these drugs in PDN treatment. Study design Comparative effectiveness study. Setting Medical Education and Research facility in India. Methods A comprehensive data search was done in PubMed, Cochrane, and Embase up to August 2012. We then systematically reviewed the studies which compared any of 6 drugs for the management of PDN: amitriptyline, duloxetine, gabapentin, pregabalin, valproate, and venlafaxine or any of their combinations. We performed a random-effects network meta-analysis to rank treatments in terms of efficacy and safety. We chose the number of patients experiencing = 50% reduction in pain and number of patient withdrawals due to adverse events (AE) as primary outcomes for efficacy and safety, respectively. We also performed benefit-risk analysis, taking efficacy outcome as benefit and safety outcome as risk. Analysis was intention-to-treat. Results We included 21 published trials in the analysis. Duloxetine, gabapentin, pregabalin, and venlafaxine were shown to be significantly efficacious compared to placebo with odds ratios (OR) of 2.12, 3.98, 2.78, and 4.43, respectively. Amitriptyline (OR: 7.03, 95% confidence interval [CI]: 1.87, 29.05) and duloxetine (OR: 3.26, 95% CI: 1.04, 9.97) caused more withdrawals than gabapentin. The ranking order of efficacy was gabapentin, venlafaxine, pregabalin, duloxetine/gabapentin, duloxetine, amitriptyline, and placebo and the ranking order of safety was placebo, gabapentin, pregabalin, venlafaxine, duloxetine/gabapentin combination, duloxetine, and amitriptyline. Benefit-risk balance favored the order: gabapentin, venlafaxine, pregabalin, duloxetine/gabapentin combination, duloxetine, placebo, and amitriptyline. Limitations We could not include valproate in our analysis owing to the lack of studies reporting the dichotomous efficacy and safety outcomes. Conclusion Gabapentin was found to be most efficacious and amitriptyline to be least safe among the treatments included in the study. Gabapentin showed most favorable balance between efficacy and safety.

Doctor shopping reveals geographical variations in opioid abuse.

Abstract: BACKGROUND Prescription opioid abuse is not homogeneous due to varying patterns of use and different geographic preferences. Because doctor shopping is one of the main sources of diversion, it has previously been used to estimate drug abuse. OBJECTIVES The aim of this study was to describe and compare opioid abuse in 2008 using doctor shopping to estimate abuse in 3 French regions. SETTING Data for this study came from the General Health Insurance (GHI) reimbursement database, which covers 77% of the French population. All individuals living in Provence-Alpes-Cote d'Azur-Corse (PACA), Rhone-Alpes (RA), or Midi-Pyrenees (MP) that received at least one reimbursement for oral opioids from the GHI in 2008 were included. METHODS Oral opioids under study were opioids for mild to moderate pain (dextropropoxyphene, codeine, tramadol, dihydrocodeine), opoids for moderately severe to severe pain (oral morphine, oxycodone, buprenorphine painkiller, hydromorphone), and opioid maintenance treatments (buprenorphine maintenance, methadone). For a given opioid, the Doctor Shopping Quantity (DSQ) is the quantity obtained by overlapping prescriptions from several prescribers. It is used to estimate the magnitude of abuse. The Doctor Shopping Indicator (DSI) is the DSQ divided by the total dispensed quantity. It is used to estimate the abuse corrected for use. RESULTS The total DSQ for opioids in PACA (213.3 DDD/1,000 inhabitants) was twofold superior to that in RA (115.1 DDD/1,000) and in MP (106.2 DDD/1,000). The DSQ of opioids for mild to moderate pain was 75.5DDD/1000 (DSI=1.1%), 19.7DDD/1,000 (DSI=5.0%) for opioids for moderately severe to severe pain, and 55.3DDD/1,000 (DSI=6.2%) for opioid maintenance treatments. Emergent signals of abuse have been observed at a regional level for oxycodone in MP and dihydrocodeine in RA and MP. LIMITATIONS The main limitation of this study is that the GHI reimbursement database provides information about dispensed and reimbursed prescription drugs, and not necessarily the actual quantity used. CONCLUSION These results confirm important variations in the 3 French regions despite them being geographically close. Besides, they highlight different rates of opioid abuse between opioids for mild to moderate pain, opioids for moderately severe to severe pain, and opioid maintenance treatments, as well as differences within these groups.

Assessment of bleeding risk of interventional techniques: a best evidence synthesis of practice patterns and perioperative management of anticoagulant and antithrombotic therapy.

Abstract: Background Interventional pain management is a specialty that utilizes invasive procedures to diagnose and treat chronic pain. Patients undergoing these treatments may be receiving exogenous anticoagulants and antithrombotics. Even though the risk of major bleeding is very small, the consequences can be catastrophic. However, the role of antithrombotic therapy for primary and secondary prevention of cardiovascular disease to decrease the incidence of acute cerebral and cardiovascular events is also crucial. Overall, there is a paucity of literature on the subject of bleeding risk in interventional pain management along with practice patterns and perioperative management of anticoagulant and anti-thrombotic therapy. Study design Best evidence synthesis. Objective To critically appraise and synthesize the literature with assessment of the bleeding risk of interventional techniques including practice patterns and perioperative management of anticoagulant and antithrombotic therapy. Methods The available literature on the bleeding risk of interventional techniques and practice patterns and perioperative management of anticoagulant and antithrombotic therapy was reviewed. Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 through December 2012 and manual searches of the bibliographies of known primary and review articles. Results There is good evidence for the risk of thromboembolic phenomenon in patients who discontinue antithrombotic therapy, spontaneous epidural hematomas occur with or without traumatic injury in patients with or without anticoagulant therapy associated with stressors such as chiropractic manipulation, diving, and anatomic abnormalities such as ankylosing spondylitis, and the lack of necessity of discontinuation of nonsteroidal anti-inflammatory drugs (NSAIDs), including low dose aspirin prior to performing interventional techniques. There is fair evidence that excessive bleeding, including epidural hematoma formation may occur with interventional techniques when antithrombotic therapy is continued, the risk of thromboembolic phenomenon is higher than the risk of epidural hematomas with discontinuation of antiplatelet therapy prior to interventional techniques, to continue phosphodiesterase inhibitors (dipyridamole [Persantine], cilostazol [Pletal], and Aggrenox [aspirin and dipyridamole]), and that anatomic conditions such as spondylosis, ankylosing spondylitis and spinal stenosis, and procedures involving the cervical spine; multiple attempts; and large bore needles increase the risk of epidural hematoma; and rapid assessment and surgical or nonsurgical intervention to manage patients with epidural hematoma can avoid permanent neurological complications. There is limited evidence to discontinue antiplatelet therapy with platelet aggregation inhibitors to avoid bleeding and epidural hematomas and/or to continue antiplatelet therapy clopidogrel (Plavix), ticlopidine (Ticlid), or prasugrel (Effient) during interventional techniques to avoid cerebrovascular and cardiovascular thromboembolic fatalities. There is limited evidence in reference to newer antithrombotic agents dabigatran (Pradaxa) and rivaroxaban (Xarelto) to discontinue to avoid bleeding and epidural hematomas during interventional techniques and to continue to avoid cerebrovascular and cardiovascular thromboembolic events. Recommendations The recommendations derived from the comprehensive assessment of the literature and guidelines are to continue NSAIDs and low dose aspirin, and phosphodiesterase inhibitors (dipyridamole, cilostazol, Aggrenox) during interventional techniques. However, the recommendations for discontinuation of antiplatelet therapy with platelet aggregation inhibitors (clopidogrel, ticlopidine, prasugrel) is variable with clinical judgment to continue or discontinue based on the patient's condition, the planned procedure, risk factors, and desires, and the cardiologist's opinion. Low molecular weight heparin (LMWH) or unfractionated heparin may be discontinued 12 hours prior to performing interventional techniques. Warfarin should be discontinued or international normalized ratio (INR) be normalized to 1.4 or less for high risk procedures and 2 or less for low risk procedures based on risk factors. It is also recommended to discontinue Pradaxa for 24 hours for paravertebral interventional techniques in 2 to 4 days for epidural interventions in patients with normal renal function and for longer periods of time in patients with renal impairment, and to discontinue rivaroxaban for 24 hours prior to performing interventional techniques. Limitations The paucity of the literature. Conclusion Based on the available literature including guidelines, the recommendations in patients with antithrombotic therapy for therapy prior to interventional techniques are provided.

Ultrasound-guided trigeminal nerve block via the pterygopalatine fossa: an effective treatment for trigeminal neuralgia and atypical facial pain.

Abstract: Background Patients presenting with facial pain often have ineffective pain relief with medical therapy. Cases refractory to medical management are frequently treated with surgical or minimally invasive procedures with variable success rates. We report on the use of ultrasound-guided trigeminal nerve block via the pterygopalatine fossa in patients following refractory medical and surgical treatment. Objective To present the immediate and long-term efficacy of ultrasound-guided injections of local anesthetic and steroids in the pterygopalatine fossa in patients with unilateral facial pain that failed pharmacological and surgical interventions. Setting Academic pain management center. Study design Prospective case series. Methods Fifteen patients were treated with ultrasound-guided trigeminal nerve block with local anesthetic and steroids placed into the pterygopalatine fossa. Results All patients achieved complete sensory analgesia to pin prick in the distribution of the V2 branch of the trigeminal nerve and 80% (12 out of 15) achieved complete sensory analgesia in V1, V2, V3 distribution within 15 minutes of the injection. All patients reported pain relief within 5 minutes of the injection. The majority of patients maintained pain relief throughout the 15 month study period. No patients experienced symptoms of local anesthetic toxicity or onset of new neurological sequelae. Limitations Prospective case series. Conclusion We conclude that the use of ultrasound guidance for injectate delivery in the pterygopalatine fossa is a simple, free of radiation or magnetization, safe, and effective percutaneous procedure that provides sustained pain relief in trigeminal neuralgia or atypical facial pain patients who have failed previous medical interventions.

Pharmacovigilance: a review of opioid-induced respiratory depression in chronic pain patients.

Abstract: Background Opioids may induce life-threatening respiratory depression, but limited knowledge is available on factors that contribute to opioid-induced respiratory depression (OIRD). This is especially true for patients with chronic pain on prolonged opioid therapy. There are no good quality case control studies or randomized controlled trials available on this topic. Here we present and analyze all case series since 1980 on OIRD in chronic pain patients extracted from PubMed. Objective To describe and understand clinically identified factors involved in life-threatening OIRD in patients receiving opioids for chronic pain relief. Study design A literature search was performed for all relevant case reports on OIRD in chronic pain. Methods We searched PubMed (www.ncbi.nlm.nih.gov) for all available case reports/series on OIRD in adolescent (12 years and older) and adult patients treated with opioids for chronic pain, from which we identified specific commonalities that contributed to OIRD (akin to closed claims analyses). The dataset was post-hoc divided into 2 distinct categories: cases published from 1980 to 1999 and those from 2000 to 2012. Results Thirty-four reports describing 42 chronic pain patients experiencing OIRD were retrieved. Cases published before the year 2000 (pre-2000) predominantly involved morphine in cancer patients, whereas cases since 2000 (post-2000) predominantly involved methadone or transdermal fentanyl in non-cancer pain patients. Specific factors that contributed to OIRD were elevated opioid plasma levels due to renal impairment and sensory deafferentiation in pre-2000 cases, and elevated plasma levels due to drug interactions on the cytochrome P450 in post-2000 cases. Limitations The case series analysis of published case reports imposes limitations in terms of the types of cases presented (only severe cases are published or cases with specific precipitating factors), the journal-related publication strategy, and changes in clinical practice. Conclusions Our case review confirms that life-threatening OIRD in chronic pain patients involves a series of complex often-interacting factors. In spite of the factors identified in this cases series, OIRD remains unpredictable and safe opioid prescribing requires careful titration of opioid dosages and continuous monitoring to prevent life-threatening OIRD.

Drug therapy for the treatment of chronic nonspecific low back pain: systematic review and meta-analysis.

Abstract: Background: Low back pain (LBP) is one of the most common health problems in adults. The impact of LBP on the individual can cause loss of health status in the form of symptoms and loss of function related to pain in the back; limitation of daily, leisure, and/or strenuous activities, and disability. LBP also poses an economic burden to society, mainly in terms of one of the most common reasons for seeking medical care (direct treatment costs), and accounts for the large number of work days lost (indirect costs). To reduce the impact of LBP on adults, drug therapy is the most frequently recommended intervention. Over the last decade, a substantial number of randomized clinical trials of drug therapy for LBP have been published. Objective: To determine the effectiveness of drug therapy for the treatment of chronic nonspecific low back pain (CNLBP). Study Design: Systematic review and meta-analysis Methods: A systematic review and meta-analysis of randomized controlled trials was conducted. Five databases (Medline, CINAHL, Science Direct, CAJ Full-text Database, and Cochrane databases) were searched for articles published from 2002 to 2012. The eligibility criteria were randomized trials and double-blind controlled trials of oral or injection drug therapy for CNLBP in subjects who were aged at least 18 years old, published in English or Chinese. Two independent reviewers extracted the data. Results: A total of 25 drug therapy trials were included. cyclo-oxygenase-2 (COX-2) nonsteroidal anti-inflammatory drugs (NSAIDs), tramadol, and opioids were commonly used. Only 5 trials studied the efficacy of adjuvant analgesics of antiepileptics (n = 1) and antidepressants (n = 4) for CNLBP. The standardized mean difference (SMD) for COX-2 NSAIDs in pain relief was -12.03 (95% confidence interval [CI]: -15.00 to -9.06). The SMD for tramadol in pain relief was -1.72 (95% CI: -3.45 to 0.01). As the 95% CI crossed 0, this effect size was not considered statistically significant. The SMD for the overall effects of opioids in pain relief was -5.18 (95% CI: -8.30 to -2.05). The SMD for the partial opioid agonist drug in pain relief was -7.46 (95% CI: -11.87 to -3.04). Limitations: The follow-up periods of these included trials in the meta-analysis ranged from 4 to 24 weeks. The difference of follow-up periods influenced how study outcomes were recorded. These included trials also had significant differences in patient selections. Some trials may actually include CNLBP patients with neuropathic pain, as not having focal neurological findings or signs does not mean that the pain is not neuropathic. Consequently, different pain conditions may influence patients who responded to the same drug and then influence pooled estimates of treatment effect size. Conclusion: This review endorses the use of COX-2 NSAIDs as the first-line drugs for CNLBP. Tramadol shows no statistically significant effect on pain relief, but has small effect sizes in improving functioning. Among included opioid therapy studies, the overall effects of opioids and the partial opioids agonist drug had statistically significant treatment effects in pain relief for CNLBP patients.

A randomized, double-blind, active control trial of fluoroscopic cervical interlaminar epidural injections in chronic pain of cervical disc herniation: results of a 2-year follow-up.

Abstract: BACKGROUND A recent evaluation of the state of U.S. health from 1990 to 2010 placed neck pain as the fourth condition leading to disability, with low back pain being the number one. Multiple treatment modalities have been described in managing neck and upper extremity pain secondary to cervical disc herniation after the failure of conservative management. The treatment modalities for chronic persistent pain of cervical disc herniation include surgery and epidural injections. The growth of interventional techniques in managing chronic spinal pain in recent years has been enormous. Evidence for the efficacy of cervical interlaminar epidural injections, however, continues to be debated, despite positive evidence derived from controlled randomized trials and systematic reviews. STUDY DESIGN A randomized, double-blind, active control trial. SETTING A private, specialty referral, interventional pain management practice in the United States. OBJECTIVES To evaluate the effectiveness of epidural injections in managing chronic pain related to cervical disc herniation. METHODS Patients were randomly assigned to one of 2 groups of 60, with a total of 120 patients. Group I patients received cervical epidural injections with lidocaine 0.5% preservative-free, 5 mL, whereas Group II patients received 0.5% preservative-free lidocaine mixed with 1 mL or 6 mg of non-particulate betamethasone. OUTCOME ASSESSMENT Multiple outcome measures included the numeric rating pain scale (NRS), the Neck Disability Index (NDI), employment status, opioid intake with assessment at 3, 6, 12, 18, and 24 months post treatment. Significant improvement was described as pain relief with a 50% improvement in functional status. RESULTS This evaluation showed significant improvement as 50% pain relief and improvement in functional status in 72% of the patients at 2 year follow-up in the local anesthetic group and 68% in those patients receiving local anesthetic and steroid. In the successful group of participants however, significant improvement was seen in 77% in Group I and 80% in Group II. Overall, the average number of procedures was 5 to 6 in both groups. The average total relief for 2 years was 75.9 ± 29.9 weeks in Group I and 72.7 ± 31.1 in Group II, the successful group of participants. Taking into consideration all of the participants, the average total relief for 2 years was 69.6 ± 35 weeks in Group I and 62.1 ± 38.4 weeks in Group II. LIMITATIONS The results of the study are limited by the lack of a placebo group. CONCLUSION Cervical epidural injections with local anesthetic with or without steroids. [corrected].

Comparative assessment of different percutaneous endoscopic interlaminar lumbar discectomy (PEID) techniques.

Abstract: Background Percutaneous endoscopic lumbar discectomy is a common surgical treatment for lumbar disc herniation, and percutaneous endoscopic interlaminar lumbar discectomy (PEID) is commonly used for direct decompression of L5-S1. Like microdiscectomy, recurrence of herniation after endoscopic discectomy is an important problem. In this study, we aimed to decrease the recurrence after PEID using a new surgical technique. Objectives We propose a new surgical technique for reducing the recurrence after PEID for lumbar disc herniation. The new technique uses annular sealing after fragmentectomy. We compared clinical results and recurrent lumbar disc herniation (had radiculopathy and confirmed by MRI) between patients who underwent surgery with and without annular sealing during PEID. Study design Retrospective cohort study of patients undergoing PEID. Methods A total of 224 patients with radiculopathy due to L5-S1 disc herniation who were treated by PEID with (91 patients) or without annular sealing (133) were included in this study. We compared the demographic characteristics (age, sex, height, weight, BMI, smoking status, and occupation), clinical results, and recurrence rates between the 2 groups. We classified recurrence according to time period (early recurrence ≤ 6 months, late recurrence > 6 months). Results The study groups were demographically similar, and substantial improvement in clinical results was noted. There were 5 recurrences (5.5%) (2 early, 3 late recurrences) in the group with annular sealing, and 18 (13.5%) (13 early, 5 late recurrences) in the group without annular sealing. Early recurrence rates were significantly higher in the group without sealing (2 vs. 13, P = 0.029). Increasing age was associated with overall recurrence (P = 0.004) and late recurrence (P = 0.008), while operative technique correlated with early recurrence (P = 0.026). Limitations First, this study incorporates a retrospective design. Second, the operations were performed by 2 surgeons. Additionally, this is relatively a short-term follow-up study (mean 19.5 ± 5.0 months). Conclusions Though a learning curve is needed in order to become familiar with PEID, recurrence after PEID was associated with advanced age, and PEID with annular sealing resulted in lower early recurrence rates than without annular sealing. Thus, PEID with annular sealing may be a useful technique for reducing early recurrence.

Recommendations of the Medicare Payment Advisory Commission (MEDPAC) on the Health Care Delivery System: the impact on interventional pain management in 2014 and beyond.

Abstract: Continuing rise in health care costs in the United States, the Affordable Care Act (ACA), and a multitude of other regulations impact providers in 2013. Despite federal spending slowing in the past 2 years, the Board of Medicare Trustees believes that cost savings are only achievable if health care providers are able to realize productivity improvements at a quicker pace than experienced historically. Consequently, the re-engineering of U.S. health care and bridging of the divide between health and health care have been proposed beyond affordable care. Thus, the Medicare Payment Advisory Commission (MedPAC) envisions alignment of Medicare payment systems to eliminate variable rates for the same ambulatory services provided to similar patients in different settings, such as the physician's office, hospital outpatient departments (HOPDs), and ambulatory surgery centers (ASCs). MedPAC believes that if the same service can be safely provided in different settings, a prudent purchaser should not pay more for that service in one setting than in another. MedPAC is also concerned that payment variations across settings encourage arrangements among providers that result in care being provided in high paid settings. MedPAC recommends that payment rates be based on the resources needed to treat patients in the most efficient setting, adjusting for differences in patient severity, to the extent the severity differences affect costs. MedPAC has analyzed the costs of evaluation and management (E&M) services and the differences between providing them in a HOPD setting compared to a physician office setting, echocardiography services, and multiple services provided in ASCs and HOPDs. MedPAC has shown that for an established patient office visit (CPT 99213) provided in a free-standing physician's office, the program pays the physician 70% less than in HOPD setting with a payment for physician practice of $72.50 versus $123.38 for HOPD setting. Similarly, for a Level II echocardiogram, HOPD costs 141% more for the same service than a free-standing office ($188.31 versus $452.89). For interventional techniques, Medicare payments vary from physician office to HOPD setting, with $211.96 in an office setting, $407.28 in ASC setting, and $655.62 in HOPD for procedures such as epidural injections. The MedPAC proposal for changing HOPD payment rates for services would reduce program spending and result in beneficiary cost sharing by $900 million in one year. On average, hospitals' overall Medicare revenue will decline by 0.6% and HOPD revenue would fall by 2.7%. Further, MedPAC provided a specific example that aligning payment rates between HOPDs and free-standing offices only for cardiac imaging services would reduce program spending and beneficiary cost sharing by $500 million in one year. In estimating the savings that would be realized by equalizing payment rates between HOPDs and ASCs for certain ambulatory surgical procedures, MedPAC have shown potential Medicare program spending and beneficiary cost savings to be about $590 million per year. The impact of the proposed policies that are discussed in this manuscript would result in savings of approximately $1.5 billion per year for Medicare. MedPAC also has recommended a stop-loss policy that would limit the loss of Medicare revenue for those hospitals.

Targeted nanoparticles that mimic immune cells in pain control inducing analgesic and anti-inflammatory actions: a potential novel treatment of acute and chronic pain condition.

Abstract: Background: The peripheral immune-derived opioid analgesic pathway has been well established as a novel target in the clinical pain management of a number of painful pathologies, including acute inflammatory pain, neuropathic pain, and rheumatoid arthritis

Intravesical botulinum toxin a injections do not benefit patients with ulcer type interstitial cystitis.

Abstract: BACKGROUND: Ulcer type and non-ulcer type interstitial cystitis/bladder pain syndromes (IC/BPS) are considered different disease entities. Thus, intravesical botulinum toxin A (BoNT-A) treatment outcomes could differ for each entity. OBJECTIVES: To evaluate and compare the treatment outcomes of BoNT-A injections for treatment of each IC/BPS type. STUDY DESIGN: Prospective interventional study. SETTING: Tertiary medical center affiliated with Buddhist Tzu Chi General Hospital and Tzu Chi University, Taiwan. METHODS: Forty-four consecutive patients with IC/BPS for whom conventional treatments failed were prospectively enrolled in this study. Patients were classified as having ulcer (n = 10) or non-ulcer (n = 30) IC/BPS based on their previous cystoscopic findings. INTERVENTION: All patients received 4 sets of intravesical BoNT-A injections (100 U in 40 suburothelial injections) every 6 months. The primary end-point was the global response assessment (GRA) 6 months after the fourth set of BoNT-A injections. Secondary end-points included the O'Leary-Sant score (OSS) including symptom indexes (ICSI) and problem indexes (ICPI), visual analog scale (VAS) pain score, voiding diary, and urodynamics variables. RESULTS: After 4 sets of BoNT-A injections, 15 patients with non-ulcer IC/BPS had GRA scores >= 2, while the other 15 had GRA scores = 2 or < 2 all had significantly decreased ICSI, ICPI, OSS, VAS pain scores, frequency episodes, and increased functional bladder capacity. However, patients with ulcer IC/BPS showed no significant change in any clinical or urodynamic variable. After failure of repeated BoNT-A injections, all 10 patients with ulcer IC/BPS underwent transurethral electrocauterization of their ulcers, which resulted in immediate pain relief. LIMITATIONS: Lack of a control arm in this study. CONCLUSION: Repeated intravesical BoNT-A injections provided effective treatment outcomes at the end-point in half of the patients with non-ulcer IC/BPS, but did not benefit any patient with ulcer type IC/BPS. Ulcer type IC/BPS should be treated as a different disease than non-ulcer IC/BPS. INSTITUTIONAL REVIEW: This study was approved by the Institutional Review Board of the Tzu-chi General Hospital (TCGH 100-06).

Prevalence of vitamin D deficiency in patients with lumbar spinal stenosis and its relationship with pain.

Abstract: BACKGROUND Patients with lumbar spinal stenosis (LSS) are at a great risk of a fall and fracture, which vitamin D protects against Vitamin D deficiency is expected to be highly prevalent in LSS patient, and pain is thought to have a profound effect on vitamin D status by limiting activity and sunlight exposure OBJECTIVE To identify the prevalence of vitamin D deficiency (serum 25-hydroxyvitamin D [25-OHD] < 20ng/mL) and its relationship with pain STUDY DESIGN Nonblinded, cross-sectional clinical study SETTING University-based outpatient clinic of the Department of Orthopedic Surgery, Yonsei University College of Medicine, Korea METHODS Consecutive patients who visited the orthopedic outpatient clinic for chronic low back pain and leg pain and were diagnosed as LSS between May 2012 and October 2012 were included Pain was categorized into 4 groups based on location and severity: 1) mild to moderate back or leg pain; 2) severe back pain; 3) severe leg pain; and 4) severe back and leg pain Covariates for vitamin D deficiency included age, sex, body mass index, level of education, medical history, season, region of residence, sunlight exposure score and functional disability 25-OHD level was measured by radioimmunoassay, and bone metabolic status including bone mineral density and bone turnover markers was also measured Multivariable logistic regression modeling was used to adjust all risk estimates for covariates RESULTS The study had 350 patients enrolled Mean serum 25-OHD level was 159 ± 71 ng/mL (range, 25 ~ 366) of the 350 patients, 260 patients out of 350 (743%) were vitamin D deficient Univariate logistic regression analysis showed a significantly higher prevalence of vitamin D deficiency in the following patients: 1) medical comorbidity; 2) urban residence rather than rural; 3) lower score for sunlight exposure; and 4) severe leg pain, or severe back and leg pain rather than mild to moderate pain Pain category was significantly associated with lower sunlight exposure; however, the association between pain category and vitamin D deficiency remained significant even after adjustment for the sunlight exposure Furthermore, severe back pain, and severe back and leg pain were also associated with higher incidence of osteoporosis and higher level of bone resorption marker (serum CTx) LIMITATIONS The limitation of our study is that due to its cross-sectional design, causal relationships between pain and vitamin D deficiency could not be established CONCLUSION Vitamin D deficiency was highly prevalent in LSS patients (743%), and severe pain was associated with higher prevalence of vitamin D deficiency and osteoporosis which could be potential risk factors or a fall and fracture As evidenced by the present study, assessment of serum 25-OHD and bone mineral density are recommended in LSS patients with severe pain, and active treatment combining vitamin D, calcium, or bisphosphonate should be considered according to the status of the bone metabolism

An update of the systematic assessment of mechanical lumbar disc decompression with nucleoplasty.

Abstract: BACKGROUND Lumbar disc prolapse, protrusion, and extrusion account for less than 5% of all low back problems, but are the most common causes of nerve root pain and surgical interventions. The primary rationale for any form of surgery for disc prolapse is to relieve nerve root irritation or compression due to herniated disc material. The primary modality of treatment continues to be either open or microdiscectomy, although several alternative techniques are also utilized, including nucleoplasty, automated percutaneous discectomy and laser discectomy. There is a paucity of evidence for all decompression techniques, specifically alternative techniques including nucleoplasty. STUDY DESIGN A systematic review of the literature of mechanical lumbar disc decompression with nucleoplasty. OBJECTIVE To determine the effectiveness and update the effectiveness of mechanical lumbar disc decompression with nucleoplasty. METHODS The available literature on mechanical lumbar disc decompression with nucleoplasty was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the criteria developed by the Newcastle-Ottawa Scale criteria for observational studies.The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF) . Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to September 2012, and manual searches of the bibliographies of known primary and review articles. OUTCOME MEASURES Pain relief and functional improvement were the primary outcome measures. Other outcome measures were improvement of psychological status, reduction in opioid intake, and return to work. Short-term effectiveness was defined as one year or less, whereas long-term effectiveness was defined as greater than one year. RESULTS For this systematic review, 37 studies were considered for inclusion. Of these, there was one randomized trial and 14 observational studies meeting inclusion criteria for methodological quality assessment.Based on USPSTF criteria, the level of evidence for nucleoplasty is limited to fair in managing radicular pain due to contained disc herniation. LIMITATIONS A paucity of literature with randomized trials. CONCLUSIONS This systematic review illustrates limited to fair evidence for nucleoplasty in managing radicular pain due to contained disc herniation.