Do Patients Accurately Recall Pain Levels Following Sacroiliac Joint Steroid Injection? A Cohort Study of Recall Bias in Patient-reported Outcomes.

BACKGROUND: Sacroiliac joint (SIJ) injections are crucial in the diagnostic toolkit for evaluating SIJ pathology. Recall bias is an important component in patient-reported outcomes that has not been well studied in SIJ injection. OBJECTIVE: The purpose of this study was to characterize the accuracy, direction, and magnitude of pain level recall bias following SIJ steroid injection and study the factors that affect patient recollection. STUDY DESIGN: Prospective cohort study. SETTING: Level 1 academic medical center. METHODS: Using standardized questionnaires, baseline Numeric Rating Scale (NRS-11) scores were recorded for patients undergoing SIJ steroid injections at preinjection, at 4 hours postinjection, and at 24 hours postinjection. At a minimum of 2 weeks postinjection, patients were asked to recall their preinjection, 4-hour, and 24-hour postinjection NRS-11 scores. Actual and recalled NRS-11 scores were compared using paired t tests for each time interval. Multivariable linear regression was used to identify factors that correlated with consistent recall. RESULTS: Sixty patients with a mean age of 66 years (65% women) were included. Compared to their preinjection pain score, patients showed considerable improvement at both 4 hours (mean difference [MD] = 3.28; 95% CI, 2.68 - 3.89), and 24 hours (MD = 3.23; 95% CI, 2.44 - 4.03) postinjection. Patient recollection of preinjection symptoms was more severe than actual (MD = 0.65; 95% CI, 0.31 - 0.99). Patient recollection of symptoms was also more severe than actual at 4 hours (MD = 0.50; 95% CI .04 - 1.04) as well as at 24 hours postinjection (MD = 0.80; 95% CI, 0.16 - 1.44). The magnitude of recall bias was mild and did not exceed the minimal clinically important difference. There was a moderate correlation between actual and recalled pain levels when comparing preinjection with the 4-hour postinjection NRS-11 score (correlation coefficient [r] =0.64; P < 0.001) and moderate correlation when comparing preinjection with the 24-hour postinjection NRS-11 score (r = 0.62; P < 0.001). Linear regression models showed that at preinjection, patients with a lower body mass index and the presence of coexisting psychiatric diagnoses were better at recalling their pain (P < 0.05). Patients with a higher body mass index also experienced less pain relief when comparing preinjection with the 4-hour postinjection NRS-11 score (P < 0.05). LIMITATIONS: Recall pain scores were obtained via telephone surveys, which can lead to interview bias. One patient died, and 3 were lost to follow-up. We did not control for patient use of adjunctive pain relief modalities, which may modulate the overall response to injection. SIJ injections can also be diagnostic, so some patients may not have shared the same indication for injection or pain-generating diagnosis. CONCLUSIONS: Patients had favorable pain level responses to their SIJ steroid injection for both actual and recall surveys. Although patients demonstrated poor recall of absolute pain scores at preinjection, 4-hour postinjection, and 24-hour postinjection, they demonstrated robust recall of their net pain score improvement at both 4- and 24-hours postinjection. These findings suggest that there is utility in using patient recollection to describe the magnitude of pain relief following treatment for sacroiliac joint dysfunction.

The Back Pain Consortium (BACPAC) Research Program Data Harmonization: Rationale for Data Elements and Standards.

OBJECTIVE: One aim of the Back Pain Consortium (BACPAC) Research Program is to develop an integrated model of chronic low back pain that is informed by combined data from translational research and clinical trials. We describe efforts to maximize data harmonization and accessibility to facilitate Consortium-wide analyses. METHODS: Consortium-wide working groups established harmonized data elements to be collected in all studies and developed standards for tabular and nontabular data (eg, imaging and omics). The BACPAC Data Portal was developed to facilitate research collaboration across the Consortium. RESULTS: Clinical experts developed the BACPAC Minimum Dataset with required domains and outcome measures to be collected by use of questionnaires across projects. Other nonrequired domain-specific measures are collected by multiple studies. To optimize cross-study analyses, a modified data standard was developed on the basis of the Clinical Data Interchange Standards Consortium Study Data Tabulation Model to harmonize data structures and facilitate integration of baseline characteristics, participant-reported outcomes, chronic low back pain treatments, clinical exam, functional performance, psychosocial characteristics, quantitative sensory testing, imaging, and biomechanical data. Standards to accommodate the unique features of chronic low back pain data were adopted. Research units submit standardized study data to the BACPAC Data Portal, developed as a secure cloud-based central data repository and computing infrastructure for researchers to access and conduct analyses on data collected by or acquired for BACPAC. CONCLUSIONS: BACPAC harmonization efforts and data standards serve as an innovative model for data integration that could be used as a framework for other consortia with multiple, decentralized research programs.

An Interventional Response Phenotyping Study in Chronic Low Back Pain: Protocol for a Mechanistic Randomized Controlled Trial.

Evidence-based treatments for chronic low back pain (cLBP) typically work well in only a fraction of patients, and at present there is little guidance regarding what treatment should be used in which patients. Our central hypothesis is that an interventional response phenotyping study can identify individuals with different underlying mechanisms for their pain who thus respond differentially to evidence-based treatments for cLBP. Thus, we will conduct a randomized controlled Sequential, Multiple Assessment, Randomized Trial (SMART) design study in cLBP with the following three aims. Aim 1: Perform an interventional response phenotyping study in a cohort of cLBP patients (n = 400), who will receive a sequence of interventions known to be effective in cLBP. For 4 weeks, all cLBP participants will receive a web-based pain self-management program as part of a run-in period, then individuals who report no or minimal improvement will be randomized to: a) mindfulness-based stress reduction, b) physical therapy and exercise, c) acupressure self-management, and d) duloxetine. After 8 weeks, individuals who remain symptomatic will be re-randomized to a different treatment for an additional 8 weeks. Using those data, we will identify the subsets of participants that respond to each treatment. In Aim 2, we will show that currently available, clinically derived measures, can predict differential responsiveness to the treatments. In Aim 3, a subset of participants will receive deeper phenotyping (n = 160), to identify new experimental measures that predict differential responsiveness to the treatments, as well as to infer mechanisms of action. Deep phenotyping will include functional neuroimaging, quantitative sensory testing, measures of inflammation, and measures of autonomic tone.

Theoretical Schemas to Guide Back Pain Consortium (BACPAC) Chronic Low Back Pain Clinical Research.

BACKGROUND: Chronic low back pain (cLBP) is a complex with a heterogenous clinical presentation. A better understanding of the factors that contribute to cLBP is needed for accurate diagnosis, optimal treatment, and identification of mechanistic targets for new therapies. The Back Pain Consortium (BACPAC) Research Program provides a unique opportunity in this regard, as it will generate large clinical datasets, including a diverse set of harmonized measurements. The Theoretical Model Working Group was established to guide BACPAC research and to organize new knowledge within a mechanistic framework. This article summarizes the initial work of the Theoretical Model Working Group. It includes a three-stage integration of expert opinion and an umbrella literature review of factors that affect cLBP severity and chronicity. METHODS: During Stage 1, experts from across BACPAC established a taxonomy for risk and prognostic factors (RPFs) and preliminary graphical depictions. During Stage 2, a separate team conducted a literature review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to establish working definitions, associated data elements, and overall strength of evidence for identified RPFs. These were subsequently integrated with expert opinion during Stage 3. RESULTS: The majority (∼80%) of RPFs had little strength-of-evidence confidence, whereas seven factors had substantial confidence for either a positive association with cLBP (pain-related anxiety, serum C-reactive protein, diabetes, and anticipatory/compensatory postural adjustments) or no association with cLBP (serum interleukin 1-beta / interleukin 6, transversus muscle morphology/activity, and quantitative sensory testing). CONCLUSION: This theoretical perspective will evolve over time as BACPAC investigators link empirical results to theory, challenge current ideas of the biopsychosocial model, and use a systems approach to develop tools and algorithms that disentangle the dynamic interactions among cLBP factors.

Do Patients Accurately Recall Their Pain Levels Following Epidural Steroid Injection? A Cohort Study of Recall Bias in Patient-Reported Outcomes.

BACKGROUND: Although patient-reported outcomes (PROs) have become important in the evaluation of spine surgery patients, the accuracy of patient recall of pre- or post-intervention  symptoms following epidural steroid injection remains unknown. OBJECTIVES: The purpose of this study was to: 1) characterize the accuracy of patient recollection of back/leg pain following epidural steroid injection; 2) characterize the direction and magnitude of recall bias; and 3) characterize factors that impact patient recollection. STUDY DESIGN: A prospective cohort study. SETTING: Level 1 Academic Medical Center. METHODS: Using standardized questionnaires, we recorded numeric pain scores for patients undergoing lumbar epidural steroid injections at our institution. Baseline pain scores were obtained prior to injection, 4-hours and 24-hours postinjection. At a minimum of 2 weeks following the injection, patients were asked to recall their symptoms preinjection and at 4 hours and 24-hours postinjection. Actual and recalled scores, at each time point, were compared using paired t tests. Multivariable linear regression was used to identify factors that impacted recollection. RESULTS: Sixty-one patients with a mean age of 61.4 years (56% women) were included. Compared to their preinjection pain score, patients showed considerable improvement at both 4 hours (Mean Difference [MD] = 2.18, 95% Confidence Interval [CI] 1.42 to 2.94) and 24 hours (MD = 2.64, 95% CI 1.91 to 3.34) postinjection. Patient recollection of preinjection symptoms was significantly more severe than actual at the 2-week time point (MD = 1.39, 95% CI 4.82 to 6.08). The magnitude of recall bias was mild and exceeded the minimal clinically important difference (MCID). No significant recall bias was noted on patient recollection of postinjection symptoms at 4 hours (MD = 0.41, 95% CI -1.05 to 0.23). Patient recollection of symptoms was also significantly more severe than actual at 24 hours (MD = 0.63, 95% CI -1.17 to -0.07), mild magnitude of bias that did not exceed MCID. Linear regression models for differences between actual and recalled pain scores reveal that for recall at 4 hours postinjection, older patients were better at recalling pain. LIMITATIONS: Baseline pain scores were completed in person, in front of a provider. The short-term pain scores were completed while at home, and then recalled scores were obtained by phone call encounter. Telephone surveys can lead to interview bias. All patients received incentive for completion of study. It is unclear if patient incentives have any impact on patient recall. Patients were contacted 2 weeks postinjection; this time point is standard at our institution, but could vary depending on practice location. Lastly, the enrolled patients did not all share the same indication for injection, and pain was not stratified between back and leg pain. CONCLUSIONS: Relying on patient recollection does not provide an accurate measure of preinjection status after lumbar epidural steroid injection, although patients did recall their 4-hour postinjection status. These findings support previous studies indicating that relying on patient recollection does not provide an accurate measure of preintervention symptoms. Patient recollection of postintervention symptoms, however, may have some clinical utility and requires further study.

Discrepancies Between Perceived Benefit of Opioids and Self-Reported Patient Outcomes.

Objective: There is little empirical evidence supporting the long-term use of opioid therapy for chronic pain, suggesting the need to reevaluate the role of opioids in chronic pain management. Few studies have considered opioid use and opioid cessation from the perspective of the patient. Methods: This prospective structured interview study included 150 new patients seeking treatment for chronic pain at an outpatient tertiary care pain clinic. Results: Of the 150 patients, 56% (N = 84) reported current opioid use. Opioids users reported higher pain severity (t(137) = -3.75, P < 0.001), worse physical functioning (t(136) = -3.82, P < 0.001), and more symptoms of depression (t(136) = -1.98, P = 0.050) than nonusers. Among opioid users, 45.6% reported high pain (>7), 60.8% reported low functioning (>7), and 71.4% reported less than a 30% reduction in pain severity since starting opioids, suggesting that many patients are unlikely to be receiving adequate benefit. Overall, 66.3% of current opioid users reported moderate to high opioid-related difficulties on the prescribed opioids difficulties scale, and patients with depression were more likely to report greater difficulties. There was no association between helpfulness of opioids over the past month and opioid-related difficulties (r(75) = -0.07, P = 0.559), current pain severity (r(72)=0.05, P = 0.705), or current pain interference (r(72) = 0.20, P = 0.095). Conclusions: Despite clinical indicators that question the benefit, patients may continue to report that their opioids are helpful. Such discrepancies in patients' perceptions will likely pose significant barriers for implementing opioid cessation guidelines in clinical practice.

Pressure sensitivity and phenotypic changes in patients with suspected opioid-induced hyperalgesia being withdrawn from full mu agonists.

OBJECTIVES: To assess changes in phenotype and pressure sensitivity in patients with suspected opioid-induced-hyperalgesia (OIH) after transitioning to buprenorphine. METHODS: Twenty patients with suspected OIH were enrolled to transition to buprenorphine therapy. Patients completed validated self-report measures at baseline and at 1, 4, 8 weeks, and 6 months after initiation of buprenorphine along with quantitative sensory testing including measures of pressure pain threshold, pain tolerance and Pain 50 (a pain intensity rating). RESULTS: 20 patients were enrolled, 17 were treated with buprenorphine and 11 completed all assessment points. We found that after transitioning to buprenorphine, patients on higher opioid doses (≥100mg oral morphine equivalents) had significant improvements for some measures including decreased pain severity and fibromyalgia survey scores, fewer neuropathic pain features, less catastrophizing, fewer depressive symptoms, and improved functioning 1-week after transitioning to buprenorphine with an eventual return back to baseline. Although not statistically significant, patients on high dose opioids (≥100mg OME) also showed a trend of decreased pressure sensitivity 1-week after transitioning to buprenorphine with a gradual return back to baseline. CONCLUSIONS: Our study is the first to look at pressure pain sensitivity in patients who were taking opioids and transitioned to buprenorphine. These results suggest that the patients most likely to benefit from buprenorphine therapy are those on higher doses. In addition, the eventual return back to baseline on measures of pain phenotype and pressure sensitivity suggests that buprenorphine may over time result in a return of the hyperalgesic effects of a full mu agonist.

Can Ceftazidime-Avibactam and Aztreonam Overcome ß-Lactam Resistance Conferred by Metallo-ß-Lactamases in Enterobacteriaceae?

Based upon knowledge of the hydrolytic profile of major ß-lactamases found in Gram-negative bacteria, we tested the efficacy of the combination of ceftazidime-avibactam (CAZ-AVI) with aztreonam (ATM) against carbapenem-resistant enteric bacteria possessing metallo-ß-lactamases (MBLs). Disk diffusion and agar-based antimicrobial susceptibility testing were initially performed to determine the in vitro efficacy of a unique combination of CAZ-AVI and ATM against 21 representative Enterobacteriaceae isolates with a complex molecular background that included blaIMP, blaNDM, blaOXA-48, blaCTX-M, blaAmpC, and combinations thereof. Time-kill assays were conducted, and the in vivo efficacy of this combination was assessed in a murine neutropenic thigh infection model. By disk diffusion assay, all 21 isolates were resistant to CAZ-AVI alone, and 19/21 were resistant to ATM. The in vitro activity of CAZ-AVI in combination with ATM against diverse Enterobacteriaceae possessing MBLs was demonstrated in 17/21 isolates, where the zone of inhibition was ≥21 mm. All isolates demonstrated a reduction in CAZ-AVI agar dilution MICs with the addition of ATM. At 2 h, time-kill assays demonstrated a ≥4-log10-CFU decrease for all groups that had CAZ-AVI with ATM (8 µg/ml) added, compared to the group treated with CAZ-AVI alone. In the murine neutropenic thigh infection model, an almost 4-log10-CFU reduction was noted at 24 h for CAZ-AVI (32 mg/kg every 8 h [q8h]) plus ATM (32 mg/kg q8h) versus CAZ-AVI (32 mg/kg q8h) alone. The data presented herein require us to carefully consider this new therapeutic combination to treat infections caused by MBL-producing Enterobacteriaceae.

The Effectiveness and Risks of Fluoroscopically Guided Lumbar Interlaminar Epidural Steroid Injections: A Systematic Review with Comprehensive Analysis of the Published Data.

Objective: To determine the effectiveness and risks of fluoroscopically guided lumbar interlaminar epidural steroid injections. Design: Systematic review of the literature with comprehensive analysis of the published data. Interventions: Three reviewers with formal training in evidence-based medicine searched the literature on fluoroscopically guided lumbar interlaminar epidural steroid injections. A larger team consisting of five reviewers independently assessed the methodology of studies found and appraised the quality of the evidence presented. Outcome Measures: The primary outcome assessed was pain relief. Other outcomes such as functional improvement, reduction in surgery rate, decreased use of opioids/medications, and complications were noted, if reported. The evidence on each outcome was appraised in accordance with the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) system of evaluating evidence. Results: The search yielded 71 primary publications addressing fluoroscopically guided lumbar interlaminar epidural steroid injections. There were no explanatory studies and all pragmatic studies identified were of low quality, yielding evidence comparable to observational studies. Conclusions: The body of evidence regarding effectiveness of fluoroscopically guided interlaminar epidural steroid injection is of low quality according to GRADE. Studies suggest a lack of effectiveness of fluoroscopically guided lumbar interlaminar epidural steroid injections in treating primarily axial pain regardless of etiology. Most studies on radicular pain due to lumbar disc herniation and stenosis do, however, report statistically significant short-term improvement in pain.

Interventional Therapies for Chronic Low Back Pain: A Focused Review (Efficacy and Outcomes).

CONTEXT: Lower back pain is considered to be one of the most common complaints that brings a patient to a pain specialist. Several modalities in interventional pain management are known to be helpful to a patient with chronic low back pain. Proper diagnosis is required for appropriate intervention to provide optimal benefits. From simple trigger point injections for muscular pain to a highly complex intervention such as a spinal cord stimulator are very effective if chosen properly. The aim of this article is to provide the reader with a comprehensive reading for treatment of lower back pain using interventional modalities. EVIDENCE ACQUISITION: Extensive search for published literature was carried out online using PubMed, Cochrane database and Embase for the material used in this manuscript. This article describes the most common modalities available to an interventional pain physician along with the most relevant current and past references for the treatment of lower back pain. All the graphics and images were prepared by and belong to the author. RESULTS: This review article describes the most common modalities available to an interventional pain physician along with the most relevant current and past references for the treatment of lower back pain. All the graphics and images belong to the author. Although it is beyond the scope of this review article to include a very detailed description of each procedure along with complete references, a sincere attempt has been made to comprehensively cover this very complex and perplexing topic. CONCLUSION: Lower back pain is a major healthcare issue and this review article will help educate the pain practitioners about the current evidence based treatment options.

Pressure Pain Sensitivity in Patients With Suspected Opioid-Induced Hyperalgesia.

BACKGROUND AND OBJECTIVES: This study was designed to test whether a brief quantitative sensory testing assessment could be used to detect hyperalgesia in patients with suspected opioid-induced hyperalgesia (OIH). METHODS: Twenty patients on long-term opioid therapy with suspected OIH were recruited along with 20 healthy controls. Pressure pain threshold, Pain50, a measure of intermediate suprathreshold pressure pain sensitivity, and tolerance levels were evaluated. As a secondary outcome, changes in pressure pain sensitivity after intravenous administration of placebo (saline) and fentanyl (1.5 µg/kg) were assessed. RESULTS: There were no significant differences in pain measures between healthy controls and patients. However, there was an association between higher doses of opioids and having a lower pain tolerance (r = -0.46, P = 0.041) and lower Pain50 (r = -0.46, P = 0.044), which was consistent with the hypothesis. Patients on more than 100 mg oral morphine equivalents displayed decreased pressure pain tolerance compared with patients taking less than 100 mg oral morphine equivalents (P = 0.042). In addition, male patients showed a hyperalgesic response to fentanyl administration, which was significant for the Pain50 measure (P = 0.002). CONCLUSIONS: Whereas there were no differences between patients suspected of having OIH and the healthy controls, the finding that higher doses of opioids were associated with more sensitivity suggests that dose might be an important factor in the development of hyperalgesia. In addition, male patients demonstrated a hyperalgesic response after a bolus of fentanyl. Future studies are needed to develop better diagnostics for detecting hyperalgesia in the clinical setting.

Characteristics of chronic pain patients who take opioids and persistently report high pain intensity.

BACKGROUND AND OBJECTIVES: The use of self-report questionnaires to detect characteristics of altered central pain processing, as seen in centralized pain disorders such as fibromyalgia, allow for the epidemiological studies of pain patients. Here, we assessed the relationship between reporting high levels of pain while taking opioids and the presence of characteristics associated with centralized pain. METHODS: We evaluated 582 patients taking opioid medications using validated measures of clinical pain, neuropathic pain symptoms, mood, and functioning. A multivariate linear regression model was used to assess the association between levels of pain while taking opioids and presenting with characteristics consistent with having centralized pain. RESULTS: We found that 49% of patients taking opioids continued to report severe pain (≥ 7/10). In multivariate analysis, factors associated with having higher levels of pain in opioid users included higher fibromyalgia survey scores (P = 0.001), more neuropathic pain symptoms (P < 0.001), and higher levels of depression (P = 0.002). Although only 3.2% were given a primary diagnosis of fibromyalgia by their physician, 40.8% met American College of Rheumatology survey criteria for fibromyalgia. CONCLUSIONS: Our findings suggest that patients with persistently high pain scores despite opioid therapy are more likely than those with lower levels of pain to present with characteristics associated with having centralized pain. This study cannot determine whether these characteristics were present before (fibromyalgia-like patient) or after the initiation of opioids (opioid-induced hyperalgesia). Regardless, patients with a centralized pain phenotype are thought to be less responsive to opioids and may merit alternative approaches.

Prevalence of the fibromyalgia phenotype in patients with spine pain presenting to a tertiary care pain clinic and the potential treatment implications.

OBJECTIVE: Injections for spinal pain have high failure rates, emphasizing the importance of patient selection. It is possible that detecting the presence of a fibromyalgia (FM)-like phenotype could aid in prediction, because in these individuals a peripheral injection would not address pain due to alterations in central neurotransmission. We undertook this study to test the hypothesis that patients who have spine pain meeting survey criteria for FM would be phenotypically distinct from those who do not. METHODS: We studied 548 patients diagnosed as having primary spine pain. All patients completed validated self-report questionnaires, including the Brief Pain Inventory, the PainDETECT questionnaire, the Hospital Anxiety and Depression Scale, measures of physical function, and the FM criteria and severity scales. RESULTS: Forty-two percent of the patients were FM positive according to the FM criteria and severity scales. Compared with FM-negative patients, FM-positive patients were more likely to be younger, unemployed, and receiving compensation for pain and to have greater pain severity and pain interference and more neuropathic pain descriptors as well as higher levels of depression and anxiety and a lower level of physical function (P < 0.002 for each comparison). Female sex, neuropathic pain, pain interference, and anxiety were independently predictive of FM status in a multivariate analysis (P < 0.01 for all variables). Receiver operating characteristic curve analysis showed a strength of association of 0.80 as measured by the cross-validated C statistic. CONCLUSION: Using the FM criteria and severity scales, we demonstrated profound phenotypic differences in a population of patients with spine pain. Although centralized pain cannot be confirmed with a self-report instrument alone, the pathophysiology of FM may help explain a portion of the variability of responses to spine interventions.

Longitudinal assessment of pain outcomes in the clinical setting: development of the "APOLO" electronic data capture system.

Data to fully evaluate the effectiveness of many commonly used interventions in the clinical pain management setting are inadequate. Clinical data collected for patient management often are not based on validated instruments, and this impedes the ability to conduct longitudinal research. To address these needs, modified patient intake and return visit forms were established and the Assessment of Pain Outcomes Longitudinal Electronic Data Capture system was developed. Data collection has been underway since November 22, 2010. As of December 7, 2011, 951 New Patient and 688 Return Visit forms had been entered. The forms have been well received, with less than 6.5% failing to complete at least 90% of the data requested. Accuracy of data entry is excellent, with an error rate of 1 in 11,250 potential data points. Data output converts easily to standard statistical programs. The creation of a pain outcomes database using validated measures and clinically relevant data is feasible.

Seizures during pegylated interferon and ribavirin therapy for chronic Hepatitis C: observations from the WIN-R trial.

BACKGROUND: Seizures are reported as an uncommon side effect of interferon therapy. AIM: To determine the frequency and presentation of seizures occurring during pegylated interferon-α (PEG-IFNα) and ribavirin therapy for chronic hepatitis C. METHODS: Patients were identified using data from the WIN-R trial database, a US multicenter study comparing fixed (800 mg) versus weight-based (800 to 1400 mg) daily dosing of ribavirin in combination with PEG-IFNα-2b (1.5 µg/kg/wk). RESULTS: Of the 4913 enrolled patients, 8 (0.16%) had a seizure. Three patients had a grand mal seizure and the seizure type was unknown in 5 patients. At the time of seizure, 6 patients were taking antidepressants (including 3 on bupropion), 1 was hyponatremic, and 1 had consumed a significant amount of alcohol. One patient had a history of seizures. Neuroimaging and electroencephalographic studies were negative. Antiepileptic medications were continued in the patient with a history of seizures and initiated in 1 patient. PEG-IFNα-2b plus ribavirin therapy was continued in 2 patients following seizure and neither experienced a recurrent seizure. CONCLUSIONS: Seizures occur infrequently in patients receiving PEG-IFNα-2b plus ribavirin, and appear to be associated with other risk factors including antidepressant use.

The value of infectious diseases specialists: non-patient care activities.

Recent developments in health care have focused efforts on both the national and local levels to reduce unnecessary health care costs and the number of hospital stays while increasing the quality of care, particularly in the context of hospital-associated infections. Infectious diseases specialists who contract to oversee infection-control and antibiotic-stewardship programs are uniquely positioned to play a pivotal role in helping hospitals to prosper in this new environment. This article will detail the available data supporting the value of infectious diseases specialists in their roles of directing antimicrobial-management and infection-control programs, maintaining health care workers' well-being, and minimizing exposure. The evidence in support of the influence of infectious diseases specialists to achieve cost-savings, decrease the length of hospital stays, and improve outcomes is robust and can be used as the framework for negotiating appropriate compensation from hospital management for these activities. Presenting this information in an amicable but definitive framework may be the linchpin to the overall success of the movement to improve quality of care while minimizing hospital costs and antimicrobial use. Developing this ability is critical to infectious diseases specialists' success as they redefine their role in the quality-of-care and risk-management arenas.

Subdural hematoma following spinal cord stimulator implant.

Headache following interventional procedures is a diagnostic challenge due to the multitude of possible etiologies involved. Presentation can be simple (PDPH alone) or complex (exacerbation of pre-existing chronic headache along with PDPH) or headache associated with a new onset intracranial process. Subdural hematoma is a rare complication of cranio-spinal trauma. Cranial subdural hematoma may present in an acute, sub-acute, or chronic fashion. Diagnosis of a subdural hematoma in the wake of a PDPH is difficult, requiring a high level of suspicion. Delayed diagnosis of subdural hematoma is usually related to failure to consider it in the differential diagnosis. Thorough history, assessment of the evolution of symptoms, and imaging studies may identify the possible cause and help direct treatment. Change in the character of initial presenting symptoms may be a sign of resolution of the headache or the onset of a secondary process. We report a case of acute intracranial subdural hematoma secondary to unintentional dural puncture during placement of a permanent spinal cord stimulator lead for refractory angina. There is need for careful follow-up of patients with a known post-dural tear. Failure to identify uncommon adverse events in patients with complicated spinal cord stimulator implantation may lead to permanent injury.

Pulsed radiofrequency of the median nerve under ultrasound guidance.

Neuropathy of the median nerve within the carpal tunnel (carpal tunnel syndrome) has an age adjusted incidence of 105 cases per 100,000 person years. Treatment of carpal tunnel syndrome ranges from conservative management with medication and exercise to surgical release of the median nerve. Conservative treatment accounts for a significant portion of resources utilized and includes splinting, nerve gliding, ultrasound, and carpal bone mobilization. Recurrent symptoms of carpal tunnel syndrome have been shown to occur in 0% to 19% of patients following carpal tunnel release, with up to 12% requiring re-exploration. Prognosis for re-exploration is not as good as for primary carpal tunnel release, with a high recurrence rate in some populations. Ultrasound has seen increasing use in regional anesthesia and has been shown to improve the quality of regional anesthetic blocks. Pulsed radiofrequency was developed with the goal of providing reduction in pain from the use of electrical fields in the absence of neural injury. The use of ultrasound guidance for positioning radiofrequency probes over peripheral nerves has not been reported. This case report describes the use of ultrasound guided pulsed radiofrequency in the treatment of recurrent carpal tunnel syndrome. Following revision carpal tunnel surgery, the patient in this report was unable to obtain relief of pain in either hand with medication therapy alone. After a successful diagnostic median nerve block at the cubital fossa, pulsed radiofrequency of the median nerve was performed on the left side at the cubital fossa, under ultrasound guidance. Radiofrequency probe adjustment around the nerve was conducted under live ultrasound guidance and multiple pulsed treatments were applied at anatomically distinct sites over the nerve. A 70% reduction in pain was reported over the follow up period of 12 weeks.

A Phase II, multicenter, randomized, double-blind, placebo-controlled crossover study of CJC-1008--a long-acting, parenteral opioid analgesic--in the treatment of postherpetic neuralgia.

INTRODUCTION: CJC-1008 is a chemical modification of the opioid peptide dynorphin A (1-13) (Dyn A) that promotes dynorphin's covalent attachment to human serum albumin in vivo after administration, thus prolonging its duration of action. The primary objective of this study was to evaluate the preliminary efficacy and safety of CJC-1008 as compared with placebo in patients with postherpetic neuralgia (PHN). METHODS: Patients with PHN were assigned 1:1 to receive active study medication or placebo. After dosing, measurements were made every 15 minutes for the first hour; at two, three, four, six, and eight hours postdose; and during return visits to the study site after two, seven, and 28 days (as necessary), as well as during precrossover and exit visits. These measurements examined: 1) overall pain intensity, 2) pain intensity for each individual PHN type, 3) categorical overall pain intensity, 4) categorical pain relief and 5) adverse events (AEs). When PHN pain intensity returned to baseline and/or at patients' first request for rescue analgesia other than acetaminophen (typically around 28 days after dosing but sometimes as soon as two days postdose), patients were to cross over to the alternative treatment and be monitored on the same schedule. RESULTS: A substantial placebo response was observed, but the analgesic effect observed in the active group was greater than that in the placebo group for the first eight hours. By 24 hours, the difference was not significant. A total of 29 out of 30 patients (96 percent) experienced at least one treatment-emergent AE during active drug treatment, while 14 of 27 patients (52 percent) reported such AEs during placebo treatment. Of the AEs occurring within the first eight hours after dosing, 97 percent were reported during treatment with active drug and 3 percent were reported during treatment with placebo. The majority of these AEs were mild in intensity. DISCUSSION: This study provides evidence of a greater analgesic effect when using CJC-1008 compared to placebo in patients with PHN. However, the effect only lasted through eight hours postdose and diminished by 24 hours. This study provides evidence of a peripheral action of dynorphin, since CJC-1008 does not cross the blood-brain barrier.

Interventional techniques in the management of chronic spinal pain: evidence-based practice guidelines.

BACKGROUND: The lifetime prevalence of spinal pain has been reported as 54% to 80%, with as many as 60% of patients continuing to have chronic pain five years or longer after the initial episode. Spinal pain is associated with significant economic, societal, and health impact. Available evidence documents a wide degree of variance in the definition and the practice of interventional pain management. OBJECTIVE: To develop evidence-based clinical practice guidelines for interventional techniques in the management of chronic spinal pain, with utilization of all types of evidence, applying an evidence-based approach, with broad representation of specialists from academic and clinical practices. DESIGN: A systematic review of diagnostic and therapeutic interventions applied in managing chronic spinal pain by a policy committee. Design consisted of formulation of essentials of guidelines and a series of potential evidence linkages representing conclusions, and statements about relationships between clinical interventions and outcomes. METHODS: The elements of the guideline preparation process included literature searches, literature synthesis, systematic review, consensus evaluation, open forum presentation, formal endorsement by the Board of Directors of the American Society of Interventional Pain Physicians (ASIPP), and blinded peer review. Methodologic quality evaluation criteria utilized included AHRQ criteria, QUADAS criteria, and Cochrane review criteria. The designation of levels of evidence was from Level I (conclusive), Level II (strong), Level III (moderate), Level IV (limited), to Level V (indeterminate). RESULTS: The accuracy of facet joint nerve blocks was strong in the diagnosis of lumbar and cervical facet joint pain, whereas, it was moderate in the diagnosis of thoracic facet joint pain. The evidence was strong for lumbar discography, whereas, the evidence was limited for cervical and thoracic discography. The evidence was moderate for transforaminal epidural injections or selective nerve root blocks in the preoperative evaluation of patients with negative or inconclusive imaging studies. The evidence was moderate for sacroiliac joint injections in the diagnosis of sacroiliac joint pain. The evidence for therapeutic lumbar intraarticular facet injections of local anesthetics and steroids was moderate for short-term improvement and limited for long-term improvement, whereas, it was negative for cervical facet joint injections. The evidence for lumbar and cervical medial branch blocks was moderate. The evidence for medial branch neurotomy was moderate to strong for relief of chronic low back and neck pain. The evidence for caudal epidural steroid injections was strong for short-term relief and moderate for long-term relief in managing chronic low back and radicular pain, and limited in managing pain of postlumbar laminectomy syndrome. The evidence for interlaminar epidural steroid injections was strong for short-term relief and limited for long-term relief in managing lumbar radiculopathy, whereas, for cervical radiculopathy the evidence was moderate. The evidence for transforaminal epidural steroid injections was strong for short-term and moderate for long-term improvement in managing lumbar nerve root pain, whereas, it was moderate for cervical nerve root pain and limited for lumbar post laminectomy syndrome and spinal stenosis. The evidence for percutaneous epidural adhesiolysis was strong. For spinal endoscopic adhesiolysis, the evidence was strong for short-term relief and moderate for long-term relief. For sacroiliac intraarticular injections, the evidence was moderate for short-term relief and limited for long-term relief. The evidence for radiofrequency neurotomy for sacroiliac joint pain was indeterminate. The evidence for intradiscal electrothermal therapy was strong for short-term relief and moderate for long-term relief in managing chronic discogenic low back pain, whereas, for nucleoplasty, the evidence was limited. The evidence for spinal cord stimulation in failed back surgery syndrome and complex regional pain syndrome was strong for short-term relief and moderate for long-term relief. The evidence for implantable intrathecal infusion systems was moderate to strong. CONCLUSION: These guidelines included the evaluation of evidence for diagnostic and therapeutic procedures in managing chronic spinal pain and recommendations for managing spinal pain. However, these guidelines do not constitute inflexible treatment recommendations. These guidelines do not represent "a standard of care".