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The Balanced Budget Act which became law in 1997 was designed to help stem the increasing in costs of healthcare. The Sustainable Growth Rate (SGR) formula was incorporated into that law as a method of helping balance the budget through a complex formula tying reimbursement to the growth in the economy. Soon after its inception, the flawed nature of the formula, linking the balancing of the federal budget to physician professional fees was realized. Congress has provided multiple short-term fixes known as SGR patches over the years so as to avoid generally progressively larger negative corrections to professional reimbursement. The near annual SGR correction requirement has been compared to Groundhog Day in the legislative arena. Over the years, physician and other providers faced numerous looming, large cuts. Most recently, on April 1, 2015 physicians faced a 21.2% cut in provider payments. To the surprise of many, in April 2015 a bipartisan bicameral effort permanently repealed the Medicare SGR formula for controlling provider payment. The repeal of SGR means the temporary measures to override the growth rate formula will no longer dominate Medicare policy discussions and now the focus turns to continue payment reforms. The MACRA provides physicians and other health care professionals with stable fee update for 5 years and it follows with a new incentive program, termed the Merit-based Incentive Payment System (MIPS) replacing and consolidating pre-existing incentive payment programs: meaningful use of electronic health records (EHR), physician quality reporting system, and the value-based payment modified. Thus, payments to clinicians will be subjected to adjustments based on participation in MIPS or other approved alternative payment mechanisms. This legislation also creates numerous other regulations. The MACRA has been criticized for providing insufficient statutory updates, enacting a flawed quality and performance improvement program associated with MIPS and inappropriate use of utilization and payment data. Thus, the MACRA offers physicians a predictable schedule for Medicare rates - a carrot, and controls the physician behaviors with payment reforms analogous to a stick. Thus, it could be said that this legislation embodies some good, bad, and ugly aspects.

Background: Lumbar discogenic pain without pain mediated by a disc herniation, facet joints, or the sacroiliac joints, is common and often results in chronic, persistent pain and disability. After conservative treatment failure, injection therapy, such as an epidural injection, is frequently the next step considered in managing discogenic pain. The objective of this systematic review is to determine the efficacy of lumbar epidural injections in managing discogenic pain without radiculopathy, and compare this approach to lumbar fusion or disc arthroplasty surgery., Methods: A systematic review of randomized trials published from 1966 through October 2014 of all types of epidural injections and lumbar fusion or disc arthroplasty in managing lumbar discogenic pain was performed with methodological quality assessment and grading of evidence. The level of evidence was based on the grading of evidence criteria which, was conducted using 5 levels of evidence ranging from levels I to V., Results: Based on a qualitative assessment of the evidence for both approaches, there is Level II evidence for epidural injections, either caudal or lumbar interlaminar., Conclusions: The available evidence suggests fluoroscopically directed epidural injections provide long-term improvement in back and lower extremity pain for patients with lumbar discogenic pain. There is also limited evidence showing the potential effectiveness of surgical interventions compared to nonsurgical treatments.

Background: Since the descriptions by Mixter and Barr of surgical treatment for rupture of the intervertebral disc in 1934, open surgical procedures have become a common practice. Disc herniations are often classified as being contained or non-contained. The results of open surgical discectomy for contained disc herniation have been poor. Consequently, several less invasive techniques have been developed including percutaneous lumbar laser disc decompression., Study Design: A systematic review of the literature of percutaneous lumbar laser disc decompression., Objective: The objective of this systematic review is to evaluate and update the clinical effectiveness of percutaneous lumbar laser discectomy in managing radicular pain secondary to contained disc herniation., Methods: The available literature on lumbar laser disc decompression in managing chronic low back and lower extremity pain was reviewed. Quality assessment and clinical relevance of randomized trials were graded according to the Cochrane Musculoskeletal Review Group criteria for interventional techniques, and observational studies according to the Newcastle-Ottawa Scale criteria.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 was the primary outcome measure. Other outcome measures were functional improvement, improvement of psychological status, opioid intake, and return-to-work. Short-term effectiveness was defined as effectiveness lasting one year or less, whereas, long-term effectiveness was defined as benefit persisting for greater than one year., Results: Based on USPSTF criteria, the indicated level of evidence for percutaneous lumbar laser disc decompression is limited for short- and long-term relief., Limitations: Although laser discectomy has been utilized for many years, there is a paucity of randomized clinical trials., Conclusion: This systematic review shows limited evidence for percutaneous lumbar laser disc decompression.

In the modern day environment, workers' compensation costs continue to be a challenge, with a need to balance costs, benefits, and quality of medical care. The cost of workers' compensation care affects all stakeholders including workers, employers, providers, regulators, legislators, and insurers. Consequently, a continued commitment to quality, accessibility to care, and cost containment will help ensure that workers are afforded accessible, high quality, and cost-effective care. In 2004, workers' compensation programs in all 50 states, the District of Columbia, and federal programs in the United States combined received an income of $87.4 billion while paying out only $56 billion in medical and cash benefits with $31.4 billion or 37% in administrative expenses and profit. Occupational diseases represented only 8% of the workers' compensation claims and 29% of the cost. The American College of Occupational and Environmental Medicine (ACOEM) has published several guidelines; though widely adopted by WCPs, these guidelines evaluate the practice of medicine of multiple specialties without adequate expertise and expert input from the concerned specialties, including interventional pain management. An assessment of the ACOEM guidelines utilizing Appraisal of Guidelines for Research and Evaluation (AGREE) criteria, the criteria developed by the American Medical Association (AMA), the Institute of Medicine (IOM), and other significantly accepted criteria, consistently showed very low scores (< 30%) in most aspects of the these guidelines. The ACOEM recommendations do not appear to have been based on a careful review of the literature, overall quality of evidence, standard of care, or expert consensus. Based on the evaluation utilizing appropriate and current evidence-based medicine (EBM) principles, the evidence ratings for diagnostic techniques of lumbar discography; cervical, thoracic, and lumbar facet joint nerve blocks and sacroiliac joint nerve blocks; therapeutic cervical and lumbar medial branch blocks and radiofrequency neurolysis; cervical interlaminar epidural steroid injections, caudal epidural steroid injections, and lumbar transforaminal epidural injections; caudal percutaneous adhesiolysis; abd spinal cord stimulation were found to be moderate with strong recommendation applying for most patients in most circumstances. The evidence ratings for intradiscal electrothermal therapy (IDET), an automated percutaneous disc decompression and also deserve further scrutiny and analysis. In conclusion, these ACOEM guidelines for interventional pain management have no applicability in modern patient care due to lack of expertise by the developing organization (ACOEM), lack of utilization of appropriate and current EBM principles, and lack of significant involvement of experts in these techniques resulting in a lack of clinical relevance. Thus, they may result in reduced medical quality of care; may severely hinder access to appropriate, medically needed and essential medical care; and finally, they may increase costs for injured workers, third party payors, and the government by transferring the injured worker into a non-productive disability system.

Intrathecal analgesia has emerged as a key therapeutic option for pain relief for patients who have failed other treatment avenues as well as patients with adequate analgesia on high dose enteral or parenteral therapy but with unacceptable side effects. Intrethecal infusions of analgesics have been increasingly utilized since the later 1980s for the treatment of persistent pain. The purpose of this review is to provide research based clinical insight regarding the safe and appropriate use of the intrathecal infusion modality. Long-term intrathecal infusion analgesia or long-term intrathecal or long-term intrathecal analgesic therapy has significantly progressed over the past 25 years. The evidence for implantable intrathecal infusion systems is strong for short-term improvement in pain of malignancy or neuropathic pain. The evidence is moderate for long-term management of persistent pain. Reasonably strong evidence exists for the use of ong-term intrathecal analgesic therapy in alleviation of cancer pain; however, the evidence supporting long-term efficacy in persistent noncancer pain is less convincing. Future studies are needed to better define the role of long-term intrathecal analgesic therapy in persistent pain, especially with respect to which pain conditions or subpopulations of patients are most responsive to long-term intrathecal analgesic therapy, and which agents or combination of agents are most appropriate for which pain conditions or subpopulations of patients. Novel combinations of intrathecal analgesics such as clonidine and gabapentin deserve future study. The current body of literature supports the use of intrathecal agents for the treatment of moderate or severe pain related to cancer and noncancer origins. Further clinical studies are needed to evaluate the efficacy and safety of new intrathecal drugs, the complications related to these devices, and the proper selection of patients to receive these treatments.

Objectives.  This study aims to assess the safety and efficacy of long-term intrathecal (IT) ziconotide infusion. Materials and Methods.  In this prospective study, 155 patients with severe chronic pain (48 with malignant pain, 107 with nonmalignant pain) who had been responsive to short-term IT ziconotide in a double-blind, placebo-controlled study received long-term, open-label IT ziconotide monotherapy. Efficacy assessments included the mean percentage change on the visual analog scale of pain intensity from baseline in the study of origin; safety was monitored by adverse event (AE) reports, periodic laboratory tests, and vital sign measurements. Results.  At the last available observation, the visual analog scale of pain intensity scores had decreased by a mean of 36.9% from baseline in the short-term trial (N = 144; 95% CI: 30.1-43.7%; p < 0.0001). The mean IT ziconotide dose remained stable over 12 months in the 31 patients who participated in the study for ≥ one year. Ziconotide-related AEs were reported in 147 out of 155 patients (94.8%); 39.4% of patients discontinued treatment because of AEs, the majority of which were considered ziconotide related. Conclusions.  Ziconotide IT monotherapy provided patients with analgesia for 12 months in this open-label study, with an acceptable benefit/risk profile and no evidence of tolerance.

Background: The evidence-based practice guidelines for the management of chronic spinal pain with interventional techniques were developed to provide recommendations to clinicians in the United States., Objective: To develop evidence-based clinical practice guidelines for interventional techniques in the diagnosis and treatment of chronic spinal pain, utilizing all types of evidence and to apply an evidence-based approach, with broad representation by specialists from academic and clinical practices., Design: Study 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, and blinded peer review. Methodologic quality evaluation criteria utilized included the Agency for Healthcare Research and Quality (AHRQ) criteria, Quality Assessment of Diagnostic Accuracy Studies (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: Among the diagnostic interventions, the accuracy of facet joint nerve blocks is strong in the diagnosis of lumbar and cervical facet joint pain, whereas, it is moderate in the diagnosis of thoracic facet joint pain. The evidence is strong for lumbar discography, whereas, the evidence is limited for cervical and thoracic discography. The evidence for transforaminal epidural injections or selective nerve root blocks in the preoperative evaluation of patients with negative or inconclusive imaging studies is moderate. The evidence for diagnostic sacroiliac joint injections is moderate. The evidence for therapeutic lumbar intraarticular facet injections is moderate for short-term and long-term improvement, whereas, it is limited for cervical facet joint injections. The evidence for lumbar and cervical medial branch blocks is moderate. The evidence for medial branch neurotomy is moderate. The evidence for caudal epidural steroid injections is 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 is strong for short-term relief and limited for long-term relief in managing lumbar radiculopathy, whereas, for cervical radiculopathy the evidence is moderate. The evidence for transforaminal epidural steroid injections is strong for short-term and moderate for long-term improvement in managing lumbar nerve root pain, whereas, it is moderate for cervical nerve root pain and limited in managing pain secondary to lumbar post laminectomy syndrome and spinal stenosis. The evidence for percutaneous epidural adhesiolysis is strong. For spinal endoscopic adhesiolysis, the evidence is strong for short-term relief and moderate for long-term relief. For sacroiliac intraarticular injections, the evidence is moderate for short-term relief and limited for long-term relief. The evidence for radiofrequency neurotomy for sacroiliac joint pain is limited. The evidence for intradiscal electrothermal therapy is moderate in managing chronic discogenic low back pain, whereas for annuloplasty the evidence is limited. Among the various techniques utilized for percutaneous disc decompression, the evidence is moderate for short-term and limited for long-term relief for automated percutaneous lumbar discectomy, and percutaneous laser discectomy, whereas it is limited for nucleoplasty and for DeKompressor technology. For vertebral augmentation procedures, the evidence is moderate for both vertebroplasty and kyphoplasty. The evidence for spinal cord stimulation in failed back surgery syndrome and complex regional pain syndrome is strong for short-term relief and moderate for long-term relief. The evidence for implantable intrathecal infusion systems is strong for short-term relief and moderate for long-term relief., Conclusion: These guidelines include 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 also do not represent a "standard of care."

Objective.  The safety and efficacy of intrathecal (IT) ziconotide was studied in a randomized, double-blind, placebo-controlled trial. Materials and Methods.  Patients (169 ziconotide, 86 placebo) with severe chronic nonmalignant pain unresponsive to conventional therapy and a visual analog scale of pain intensity (VASPI score) ≥ 50 mm were treated over a 6-day period in an inpatient hospital setting. Initial starting dose was 0.4 µg/hour and was titrated to analgesia or intolerance (maximum dose 7.0 µg/hour). The starting and maximum doses were reduced to 0.1 µg/hour and 2.4 µg/hour, respectively, due to adverse events (AEs). Results.  The mean percent reduction in VASPI score from baseline was 31.2% and 6.0% for ziconotide- and placebo-treated patients, respectively (p ≤ 0.001). During the initial titration phase, a significantly greater percentage of patients in the ziconotide group compared to the placebo group reported AEs, including abnormal gait, amblyopia, dizziness, nausea, nystagmus, pain, urinary retention, and vomiting. Conclusion.  Ziconotide provided significant analgesia in patients for whom conventional therapy failed. However, there was a considerable incidence of ziconotide-associated AEs due to the rapid titration and high doses administered.

Background: The randomized clinical trial of implantable drug delivery systems (IDDS) plus comprehensive medical management (CMM) versus CMM alone showed better clinical success at 4 weeks for IDDS patients. This 'as treated' analysis assessed if improvements in pain control, drug toxicity and survival were maintained over time., Patients and Methods: We compared those who received IDDS with those who did not receive IDDS (non-IDDS). All patients had Visual Analogue Scores (VAS) for pain > or =5/10 on at least 200 mg morphine or equivalent daily., Results: At 4 weeks, 46 of 52 (88.5%) IDDS patients achieved clinical success compared with 65 of 91 (71.4%; P=0.02) non-IDDS patients, and more often achieved > or =20% reduction in both pain VAS and toxicity [35 of 52 (67.3%) versus 33 of 91 patients (36.3%); P=0.0003]. By 12 weeks, 47 of 57 (82.5%) IDDS patients had clinical success compared with 35 of 45 (77.8%; P=0.55) non-IDDS patients, and more often had a > or =20% reduction in both pain VAS and toxicity [33 of 57 (57.9%) versus 15 of 45 patients (33.3%); P=0.01]. At 12 weeks the IDDS VAS pain scores decreased from 7.81 to 3.89 (47% reduction) compared with 7.21 to 4.53 for non-IDDS patients (42% reduction; P=0.23). The 12 week drug toxicity scores for IDDS patients decreased from 6.68 to 2.30 (66% reduction), and for non-IDDS patients from 6.73 to 4.13 (37% reduction; P=0.01). All individual drug toxicities improved with IDDS at both 4 and 12 weeks. At 6 months, only 32% of the group randomized to CMM and who did not cross over to IDDS were alive, compared with 52%-59% for patients in those groups who received IDDS., Conclusions: IDDS improved clinical success, reduced pain scores, relieved most toxicity of pain control drugs, and was associated with increased survival for the duration of this 6 month trial.

Objectives  The objective of this paper is to report the clinical protocols that we have developed and used for titrating constant flow implantable pumps to an effective dose in de novo pain and spasticity pump patients and, thereby, highlight the similarities and differences in our techniques. As a group, we have implanted over 1600 pumps and currently manage over 800 pump patients. Materials and Methods  We used our collective experience of implanting over 1600 pumps to create protocols for performing the drug trial and the initial titration of constant flow implantable pumps in de novo patients. Results  In creating our protocols, we found that constant flow pumps can be titrated to an effective dose with two to six adjustments over a period of 1-6 months. This compares favorably to reports of programmable pumps requiring 5.3 ± 3.5 adjustments over a period of 3-6 months to reach an effective dose. Conclusions  A comparison of our protocols shows that after an initial stabilization period, dose adjustments can be made at subsequent refill, that it is not necessary to adjust the dose by prematurely emptying and filling constant flow pumps, and that it is not necessary to adjust the dose as often as has been done with programmable pumps.

The development of chronic pain after thoracic surgery is a particularly undesirable yet common complication. As the study of the pathophysiology of chronic pain with regard to the plasticity of the central nervous system advances, new insights are being gained into not only the potential origins of chronic postthoracotomy pain, but also its potential treatment options. Pain that is originally nociceptive in nature in the acute postoperative period after thoracotomy may become neuropathic in time, requiring a different paradigm for its treatment. The ongoing research into the development of chronic pain, including that observed after thoracic surgery, portends the development of further advances in options for its control. The employment of multidisciplinary strategies of pharmacologic, behavioral, and interventional procedural techniques provides the current foundation for the management of this challenging condition.

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".

Intraspinal drug infusion using fully implantable pump and catheter systems is a safe and effective therapy for selected patients with chronic pain. The options for this approach are increasing, as drugs that are commercially available for systemic administration are adapted to this use and other drugs that are in development specifically for intraspinal administration become available. In 2000 a Polyanalgesic Consensus Conference was organized to evaluate the existing literature and develop guidelines for drug selection. The major outcome of this effort, an algorithm for drug selection, was based on the best available evidence at the time. Rapid changes have occurred in the science and practice of intraspinal infusion and a Polyanalgesic Consensus Conference 2003 was organized to pursue the following goals: 1) to review the literature on intraspinal drug infusion since 1999, 2) to revise the 2000 drug-selection algorithm, 3) to develop guidelines for optimizing drug dosage and concentration, 4) to create a process for documenting minimum evidence supporting the use of a drug for intraspinal infusion, and 5) to clarify issues pertaining to compounding of drugs. Based on the best available evidence and expert opinion, consensus recommendations were developed in all these areas. The panel's conclusions may provide a foundation for clinical practice and a rational basis for new research.

Few placebo-controlled trials have investigated the treatment of breakthrough pain (BTP) in patients with chronic pain. We evaluated the efficacy and safety of intranasal ketamine for BTP in a randomized, double-blind, placebo-controlled, crossover trial. Twenty patients with chronic pain and at least two spontaneous BTP episodes daily self-administered up to five doses of intranasal ketamine or placebo at the onset of a spontaneous BTP episode (pain intensity > or =5 on a 0-10 scale). Two BTP episodes at least 48 h apart were treated with either ketamine or placebo. Patients reported significantly lower BTP intensity following intranasal ketamine than after placebo (P < 0.0001) with pain relief within 10 min of dosing and lasting for up to 60 min. No patient in the ketamine group required his/her usual rescue medication to treat the BTP episode, while seven out of 20 (35%) patients in placebo group did (P = 0.0135). Intranasal ketamine was well tolerated with no serious adverse events. After ketamine administration, four patients reported a transient change in taste, one patient reported rhinorrhea, one patient reported nasal passage irritation, and two patients experienced transient elevation in blood pressure. A side effect questionnaire administered 60 min and 24 h after drug or placebo administration elicited no reports of auditory or visual hallucinations. These data suggest that intranasal administration of ketamine provides rapid, safe and effective relief for BTP.

Background: Opioid therapy plays a key role in the management of chronic pain. Constipation is one of the more frequently occurring adverse effects associated with opioid therapy., Methods: A retrospective cohort design study was conducted to determine the incidence of constipation in chronic pain patients who received three different long-acting opioids (transdermal fentanyl, oxycodone HCl controlled-release [CR], or morphine CR) for malignant or nonmalignant chronic pain. The data source was claims data (January 1996 through March 2001) from a 20% random sample of the California Medicaid (Medi-Cal) database. Claims data were from adult patients with chronic pain (malignant or nonmalignant) who had no prior diagnosis of constipation and no prior usage of long-acting opioids for at least 3 months before the observation period. Patients were followed for at least 3 months after the initiation of opioid therapy. ICD-9 code for diagnosis of constipation was the main outcome variable. Crude rates of constipation, annual incidence density, relative risk, and adjusted odds ratios were compared., Results: A total of 1,836 patients (601 receiving transdermal fentanyl, 721 receiving oxycodone CR, and 514 receiving morphine CR) were included in the analysis. Crude (unadjusted) rates of constipation were 3.7% for transdermal fentanyl, 6.1% for oxycodone CR, and 5.1% for morphine CR (P > 0.05). Transdermal fentanyl had a lower annual incidence density and risk of constipation than oxycodone CR and morphine CR (P > 0.05). After adjusting for confounding variables, including race and supplemental opioid use, the adjusted risk of constipation was 78% greater in the oxycodone CR group (P = 0.0337) and 44% greater in the morphine CR group (P = 0.2242) than in the transdermal fentanyl group., Conclusion: In this population, patients receiving transdermal fentanyl had a lower risk of developing constipation compared with those receiving oxycodone CR or morphine CR.

Context: Ziconotide (formerly SNX-111) selectively blocks N-type voltage-sensitive calcium channels and may be effective in patients with pain that is refractory to opioid therapy or those with intolerable opioid-related adverse effects., Objective: To assess the safety and efficacy of intrathecal ziconotide in patients with pain that is refractory to conventional treatment., Design, Setting, and Patients: Double-blind, placebo-controlled, randomized trial conducted from March 12, 1996, to July 11, 1998, at 32 study centers in the United States, Australia, and the Netherlands. Patients were 111 individuals ages 24 to 85 years with cancer or AIDS and a mean Visual Analog Scale of Pain Intensity (VASPI) score of 50 mm or greater. Patients were randomly assigned in a 2:1 ratio to receive ziconotide or placebo treatment., Interventions: Intrathecal ziconotide was titrated over 5 to 6 days, followed by a 5-day maintenance phase for responders and crossover of nonresponders to the opposite treatment group., Main Outcome Measure: Mean percentage change in VASPI score from baseline to the end of the initial titration period., Results: Of the evaluable population, 67 (98.5%) of 68 patients receiving ziconotide and 38 (95%) of 40 patients receiving placebo were taking opioids at baseline (median morphine equivalent dosage of 300 mg/d for the ziconotide group and 600 mg/d for the placebo group; P =.63, based on mean values), and 36 had used intrathecal morphine. Mean (SD) VASPI scores were 73.6 (1.8) mm in the ziconotide group and 77.9 (2.3) mm in the placebo group (P =.18). Mean VASPI scores improved 53.1% (95% confidence interval [CI], 44.0%-62.2%) in the ziconotide group and 18.1% (95% CI, 4.8%-31.4%) in the placebo group (P<.001), with no loss of efficacy of ziconotide in the maintenance phase. Pain relief was moderate to complete in 52.9% of patients in the ziconotide group compared with 17.5% in the placebo group (P<.001). Five patients receiving ziconotide achieved complete pain relief, and 50.0% of patients receiving ziconotide responded to therapy compared with 17.5% of those receiving placebo (P =.001)., Conclusion: Intrathecal ziconotide provided clinically and statistically significant analgesia in patients with pain from cancer or AIDS.

The psychological behaviorism theory of pain unifies biological, behavioral, and cognitive-behavioral theories of pain and facilitates development of a common vocabulary for pain research across disciplines. Pain investigation proceeds in seven interacting realms: basic biology, conditioned learning, language cognition, personality differences, pain behavior, the social environment, and emotions. Because pain is an emotional response, examining the bidirectional impact of emotion is pivotal to understanding pain. Emotion influences each of the other areas of interest and causes the impact of each factor to amplify or diminish in an additive fashion. Research based on this theory of pain has revealed the ameliorating impact on pain of (1) improving mood by engaging in pleasant sexual fantasies, (2) reducing anxiety, and (3) reducing anger through various techniques. Application of the theory to therapy improved the results of treatment of osteoarthritic pain. The psychological behaviorism theory of the placebo considers the placebo a stimulus conditioned to elicit a positive emotional response. This response is most powerful if it is elicited by conditioned language. Research based on this theory of the placebo that pain is ameliorated by a placebo suggestion and augmented by a nocebo suggestion and that pain sensitivity and pain anxiety increase susceptibility to a placebo.

For patients suffering various diseases, increased pain hastens death by interfering with life-enhancing activities; if it hurts to eat, patients won't eat; if it hurts to move, they won't move. But survival simply cannot be enhanced by reducing pain because, even as some pain treatments have a beneficial effect on disease (spinal cord stimulation on coronary artery disease, for example), other pain treatments can have an adverse effect on survival. Thus, we must continue to investigate pain and its treatment even as we use the best possible techniques available to treat pain as aggressively as we would any other disease.

SCS is a viable option for treating angina pectoris and inoperable PVD. Its mechanism of action remains controversial, but successful pain relief has been consistently reported in various studies. Many clinicians are foregoing a formal trial, choosing instead to obtain an adequate area of paresthesia and implant in one session. Long-term follow-up of SCS patients treated for angina pectoris shows continued pain relief, increase in activities, and decreased use of medications. Emerging literature supports the finding that SCS is cost-effective in this patient population relative to CABG. SCS does not mask the ischemic pain that signals impending further damage of the myocardium. In patients with inoperable PVD, SCS relieves pain and improves microcirculatory blood flow. Quality of life and mobility can be improved with SCS. The beneficial effects of SCS on ulcer healing are controversial, and evidence suggests that the best candidates for the procedure are those with ischemic rest pain without tissue loss. Patients with diabetes mellitus and hypertension may have the least favorable outcomes with regard to limb salvage. No convincing data have been published on the cost-effectiveness of SCS in this patient population. SCS is a safe procedure that is minimally invasive, reversible, and associated with only infrequent side effects, the most common of which include lead migration and infection. SCS is clearly an option for the improvement of pain and the quality of life in this carefully selected subset of patients.

Context: Facet or zygapophysial joint blocks are used extensively in the evaluation of chronic spinal pain. However, there is a continuing debate about the value and validity of facet joint blocks in the diagnosis of chronic spinal pain. The value of diagnostic facet joint injections may have been overlooked in the medical literature., Objectives: To determine the accuracy of facet joint blocks in the diagnosis of chronic spinal pain of facet joint origin and also determine the rationale, principles, false-positive rate, and diagnostic utility of facet joint blocks as well as prevalence of facet joint pain., Methods: Relevant literature was identified through searches of MEDLINE, EMBASE (Jan 1966- Mar 2003), manual searches of bibliographies of known primary and review articles, and abstracts from scientific meetings. Studies were selected if they were either placebo-controlled or comparative local anesthetic blocks and met 3 of the 5 criteria established by the Agency for Healthcare Research and Quality. Information extracted from each study included the details about the study, type, design, patient eligibility criteria, and statistical analysis. Studies were excluded from analysis if they were simply a review or descriptive or involved only a single-block., Results: The data showed that there was conclusive evidence demonstrating that facet joints have a nerve supply and are capable of causing pain with provocation in normal volunteers that reproduces typical pain attribution clinically to facet joints. The studies demonstrated a prevalence of facet joint pain in chronic spinal pain patients of 15% to 45% in lumbar spine, up to 48% in thoracic spine, and 54% to 67% in the cervical spine. Single diagnostic blocks showed a false-positive rate of 27% to 63%., Conclusion: The diagnostic accuracy of controlled local anesthetic facet joint blocks is high in the diagnosis of chronic spinal pain.

Evidence-based practice guidelines for interventional techniques in the management of chronic spinal pain are systematically developed and professionally derived statements and recommendations that assist both physicians and patients in making decisions about appropriate health care in the diagnosis and treatment of chronic or persistent pain. The guidelines were developed utilizing an evidence-based approach to increase patient access to treatment, to improve outcomes and appropriateness of care, and to optimize cost-effectiveness. All types of relevant and published evidence and consensus were utilized. The guidelines include a discussion of their purpose, rationale, and importance, including descriptions of the patient population served, the methodology, and the pathophysiologic basis for intervention. Multiple diagnostic and therapeutic interventional techniques are included in this document. Strong evidence was shown for diagnostic facet joint blocks for the diagnosis of facet joint pain, and lumbar provocative discography for discogenic pain. Moderate evidence was shown for sacroiliac joint blocks in the diagnosis of sacroiliac joint pain, and for transforaminal epidural injections in the preoperative evaluation of patients with negative or inconclusive imaging studies, but with clinical findings of nerve root irritation. Moderate to strong evidence was shown for multiple therapeutic interventional techniques including medial branch blocks and medial branch neurotomy; caudal epidural steroid injections and transforaminal epidural steroid injections; lumbar percutaneous adhesiolysis; and implantable therapies. These guidelines do not constitute inflexible treatment recommendations. It is expected that a provider will establish a plan of care on a case-by-case basis, taking into account an individual patient's medical condition, personal needs, and preferences, and the physician's experience. Based on an individual patient's needs, treatment different from that outlined here could be warranted. These guidelines do not represent "standard of care."

Objectives: In a companion article, we synthesized current clinical and preclinical data to formulate hypotheses about the etiology of drug administration catheter-tip inflammatory masses. In this article, we communicate our recommendations for the detection, treatment, mitigation, and prevention of such masses., Methods: We reviewed published and unpublished case reports and our own experiences to find methods to diagnose and treat catheter-tip inflammatory masses in a manner that minimized adverse neurological sequelae. We also formulated hypotheses about theoretical ways to mitigate, and possibly, prevent the formation of such masses., Results: Human cases have occurred only in patients with chronic pain who received intrathecal opioid drugs, alone or mixed with other drugs, or in patients who received agents that were not labeled for long-term intrathecal use. Most patients had noncancer pain owing to their large representation among the population with implanted pumps. Such patients also had a longer life expectancy and exposure to intrathecal drugs, and they received higher daily doses than patients with cancer pain. Clues to diagnosis included the loss of analgesic drug effects accompanied by new, gradually progressive neurological symptoms and signs. When a mass was diagnosed before it filled the spinal canal or before it caused severe neurological symptoms, open surgery to remove the mass often was not required. Anecdotal reports and the authors' experiences suggest that cessation of drug administration through the affected catheter was followed by shrinkage or disappearance of the mass over a period of 2-5 months., Conclusions: Attentive follow-up and maintenance of an index of suspicion should permit timely diagnosis, minimally invasive treatment, and avoidance of neurological injury from catheter-tip inflammatory masses. Whenever it is feasible, positioning the catheter in the lumbar thecal sac and/or keeping the daily intrathecal opioid dose as low as possible for as long possible may mitigate the seriousness, and perhaps, reduce the incidence of such inflammatory masses.

Purpose: Implantable intrathecal drug delivery systems (IDDSs) have been used to manage refractory cancer pain, but there are no randomized clinical trial (RCT) data comparing them with comprehensive medical management (CMM)., Patients and Methods: We enrolled 202 patients on an RCT of CMM versus IDDS plus CMM. Entry criteria included unrelieved pain (visual analog scale [VAS] pain scores >/= 5 on a 0 to 10 scale). Clinical success was defined as >/= 20% reduction in VAS scores, or equal scores with >/= 20% reduction in toxicity. The main outcome measure was pain control combined with change of toxicity, as measured by the National Cancer Institute Common Toxicity Criteria, 4 weeks after randomization., Results: Sixty of 71 IDDS patients (84.5%) achieved clinical success compared with 51 of 72 CMM patients (70.8%, P =.05). IDDS patients more often achieved >/= 20% reduction in both pain VAS and toxicity (57.7% [41 of 71] v 37.5% [27 of 72], P =.02). The mean CMM VAS score fell from 7.81 to 4.76 (39% reduction); for the IDDS group, the scores fell from 7.57 to 3.67 (52% reduction, P =.055). The mean CMM toxicity scores fell from 6.36 to 5.27 (17% reduction); for the IDDS group, the toxicity scores fell from 7.22 to 3.59 (50% reduction, P =.004). The IDDS group had significant reductions in fatigue and depressed level of consciousness (P <.05). IDDS patients had improved survival, with 53.9% alive at 6 months compared with 37.2% of the CMM group (P =.06)., Conclusion: IDDSs improved clinical success in pain control, reduced pain, significantly relieved common drug toxicities, and improved survival in patients with refractory cancer pain.

Clinicians currently base decisions regarding the use of intrathecal drug therapy for chronic pain on reports from uncontrolled and retrospective studies that fail to rely on standardized outcome measures. In this article, we summarize what is known about currently administered intrathecal therapies, including opioids, gamma-aminobutyric acid agonists, alpha-2 adrenoreceptor agonists, local anesthetics (sodium channel antagonists), calcium channel antagonists, miscellaneous agents, and drug combination therapy. In addition, we offer a brief look at novel approaches that may revolutionize intrathecal drug delivery.

Objective: We investigated the effects of pain anxiety and a placebo/nocebo/neutral intervention on ice water-induced pain., Design: We divided 72 volunteers into high- and low-anxiety groups before randomly assigning them to experimental and control subgroups., Method: Participants completed preimmersion tests of pain anxiety, pain worry, and mood. We scored first immersion pain behavior, experience, and intensity. Each subgroup then received an instruction designed to elicit a positive (placebo), negative (nocebo), or neutral response. After repeating the pain worry test, we gathered second immersion pain scores, and participants repeated the mood test, completed the treatment credibility measure, and were debriefed., Outcome Measures: We used the Pain Anxiety Symptom Scale; self-rating Likert-type scales for pain worry, pain intensity, and pain-coping; the Multiple Affect Adjective Checklist (mood); timed measurements for pain threshold and pain tolerance; and a treatment credibility scale., Results: Pain anxiety and the placebo interventions significantly altered participants' pain scores, with best-to-worse scores reported by the low pain-anxiety/placebo, high anxiety/placebo, low anxiety/neutral, low anxiety/nocebo, high anxiety neutral, and high anxiety/nocebo groups. The high pain-anxiety group demonstrated the greatest response to the placebo/nocebo intervention in the expected directions in pain, worry, and anxious mood scores and in decreased self-confidence in managing pain (this was also negatively affected by the nocebo in each pain-anxiety group)., Conclusion: This study demonstrates that the interaction of the personality variable of pain anxiety with the placebo/nocebo response has an impact on pain, worry, and mood.

This case study describes the therapeutic result of intrathecal administration of ziconotide, a new synthetic neurotoxin derived from the venom of the Philippine marine snail, Conus Magus, to a 48-year-old male with chronic, and previously untreatable, neuropathic pain of an undeterminable etiology. The patient suffered tactile allodynia and reported his baseline pain intensity to be 80 mm on the 100 mm Visual Analog Scale for Pain Intensity. After responding affirmatively to treatment in a blinded placebo-controlled trial, the patient enrolled in a long-term, open-label trial. Currently, the patient rates his pain at 16 mm and enjoys an improved quality of life. This result suggests that treatment with ziconotide may provide outstanding relief to patients with chronic pain while sparing them the unpleasant side effects associated with other treatments.

Objective: This additional analysis of data from a previously reported prospective trial comparing the effect of intraoperative alcohol or saline placebo neurolytic block in patients with pancreatic cancer was conducted in response to the development of a new theory, which explores the relationship of negative mood states to pain, pain-related behavior, and ultimately, longevity., Methods: The original study used a double-blind procedure to randomly assign 139 patients with histologically proven, unresectable pancreatic cancer to receive either an alcohol or a saline block. Data on visual analog pain, mood, and interference with activity were collected preoperatively and every 2 months postoperatively until death. The current analysis was conducted on the complete data sets received from 130 patients. Demographic data were submitted to chi-square analysis and to univariate and multivariate analysis of variance. Univariate and multivariate analyses of variance also compared 1) the effect of alcohol versus saline on pain, mood, interference of pain with activities, and longevity and 2) the impact of mood on pain with longevity as the dependent variable. Correlation and regression analyses examined the impact of mood on life expectancy., Results: The alcohol intervention had a significant positive effect on life duration and mood scores. High negative mood states correlated significantly with an increase in visual analog pain, the rating of pain intensity at its worse, and pain interference with patients' activities., Conclusion: In these subjects, the neurolytic block, as compared with medical management alone, improved pain, elevated mood, reduced pain interference with activity, and was associated with an increase in life expectancy.

Neuraxial infusion therapy is an excellent option for selected patients with severe pain. Both epidural and intrathecal systems can be effective for multiple pains and are titratable, nondestructive, and very safe. Intraspinal therapy requires low opioid doses, has no motor, sensory, or sympathetic effects, and may have a lower side-effect liability than systemic therapy. Although most oncologists do not refer patients for intrathecal therapy, a recent study indicated that more oncologists would if they knew more about the therapy and if patients requested it. When permanent systems are used, close follow-up is essential. To obtain the maximum benefit from intraspinal therapy, pain management physicians and oncologists must communicate with each other and work together as partners.

Unlabelled: Complex regional pain syndromes (CRPS) and neuropathic pain are often poorly controlled by conventional pharmacologic interventions. We administered 8-methyl-N-vanillyl-noneamide (capsaicin) at doses of 5%-10% to individuals with such disorders in this trial. Previous limitations to trials with larger-dose, topical concentrations of capsaicin included intense burning sensations experienced after application. To enable patients to tolerate the high concentrations, we first performed regional anesthesia. All patients reported at least some relief. Of 10 patients, 9 obtained substantial analgesia that lasted 1-18 wk. At Week 1 after therapy, the mean verbal analog scale (VAS) scores decreased from 8.0 to 3.0. At Week 4 after therapy, mean VAS score was 4.5. Analgesia lasted from < 1 wk (1 patient) to more than 50 wk (1 patient). Patients received one to eight treatments. With one exception, patients receiving more than one treatment obtained additional relief with subsequent treatment. Pain responsive to opioids was the only side effect of treatment. Large-dose capsaicin administered with regional anesthesia may effectively minimize refractory CRPS and neuropathic pain. A double-blind, placebo-controlled study in patients with bilateral peripheral neuropathy using epidural anesthesia with and without large-dose topical capsaicin is in progress., Implications: Sensory neuropathies are associated with many diseases. Pain from these disorders can produce greater disability than the primary disease processes themselves. Currently available therapies are limited. However, the intermittent application of large-dose topical capsaicin may provide significant pain relief, decrease chronic analgesic dependence, and decrease aggregate health care expenditures.

The treatment of pain in children, the elderly, and intensive care unit patients presents some unique problems. Here a unifying theme is emphasized: the difficulty in adequately assessing pain in patients who are often unable to communicate. Also addressed are the differences in pharmacokinetics and pharmacodynamics from neonates to the elderly. Finally, common pain syndromes in each group, the associated treatments, and recent controversies are discussed. Because of changing demographics, pain treatment for these groups will become increasingly important. Only in the past 10 years has pediatric pain been treated with the same energy as adult pain; application of the newest techniques still lags far behind these patients' adult counterparts. Pain treatment in the elderly will inevitably become a larger problem as our population ages. Finally, recent advances in technology enable us to sustain patients with increasingly severe illnesses. Thus, pain management in these special populations will take on progressively greater importance.

Centers for Disease Control (CDC) data indicate that the incidence of tetanus in the United States is highest among the elderly. Conventional therapies for the control of accompanying generalized muscle spasms include large doses of oral or intravenous GABA agonists as antispasticity agents. We describe a case of an elderly patient with severe symptoms of tetanus who developed a prolonged encephalopathy and ventilatory insufficiency with oral baclofen and benzodiazepine therapy. Intrathecal baclofen adequately controlled her severe extensor spasms, facilitated her ventilatory management, and did not compromise her mental status during her extended convalescence. Accordingly, we report the first placement of a permanent implanted infusion pump for this disease. This modality offers advantage for continuous long-term titration of medication for spasms or rigidity control without the systemic sedative effects of conventional therapy., (1998 Blackwell Science, Inc.)

Background and Objectives: Local anesthetic agents with a duration of action longer than the currently available local anesthetics could have widespread clinical application for the treatment of both chronic and acute pain. Over the last several decades, several different approaches have been used in the development of ultra-long-acting agents. There are currently promising preparations in development which may prove clinically useful in the near future., Methods: A Medline search was conducted for relevant articles published in peer-reviewed journals between 1971 and 1996. Investigations related to prolongation of the effect of local anesthetics either by alterations in the local anesthetic molecule, use of new or novel agents, or use of new delivery systems were reviewed. In addition, bibliographies of relevant articles were searched to capture any articles that were missed by the Medline search., Results: Over the last several decades, numerous attempts have been made to prolong the duration of action of local anesthetics. Initially, research focused on alterations in the local anesthetic molecule or the identification of new agents with local anesthetic action. Recently, the focus of much of the work has shifted to new drug-delivery systems such as polymers and liposomes., Conclusions: Although encouraging results have been reported in the literature, there is currently no agent or delivery system that has shown reliable and practical prolongation of local anesthetic effect in humans. There have been several encouraging reports in animals that have shown local anesthetic effects lasting up to several days, but these results must be validated and then performed in human studies before a clinically useful agent is found. Further research is warranted.