Fluoroscopic caudal epidural injections with or without steroids in managing pain of lumbar spinal stenosis: one-year results of randomized, double-blind, active-controlled trial.

STUDY DESIGN: A randomized, double-blind, active-controlled trial. OBJECTIVE: To evaluate the effectiveness of caudal epidural injections with or without steroids in providing effective and long-lasting pain relief in the management of chronic low back pain related to lumbar spinal stenosis. SUMMARY OF BACKGROUND DATA: Multiple interventions including surgery and interventional techniques such as epidural injections and adhesiolysis are commonly performed in managing pain related to spinal stenosis. There is continuing debate on the effectiveness of all interventions, and a paucity of literature regarding effectiveness. METHODS: One-hundred participants were randomly assigned to 1 of the 2 groups, with Group I participants receiving caudal epidural injections of local anesthetic (lidocaine 0.5%), whereas Group II participants received caudal epidural injections with 0.5% lidocaine 9 mL mixed with 1 mL of steroid (nonparticulate Celestone). OUTCOMES ASSESSMENT: Multiple outcome measures were used, including the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3, 6, and 12 months posttreatment. Significant pain relief and improvement in disability were defined as 50% or more. RESULTS: Overall, significant pain relief and functional status improvement (≥50%) were demonstrated in 48% in Group I and 46% in Group II. However, significant pain relief and functional status improvement were seen in 60% of the participants in both groups in the successful category when the participants were separated into successful and failed categories. The overall number of procedures was 3.1±1.3 or 3.6±1.1 in the successful category in Group I, with overall 2.9±1.4 or 3.5±1.2 in the successful category in Group II. CONCLUSION: Caudal epidural injections of local anesthetic with or without steroids may be an effective treatment for a select group of patients with chronic function-limiting low back and lower extremity pain secondary to spinal stenosis.

Responsible, Safe, and Effective Use of Biologics in the Management of Low Back Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines.

BACKGROUND: Regenerative medicine is a medical subspecialty that seeks to recruit and enhance the body's own inherent healing armamentarium in the treatment of patient pathology. This therapy's intention is to assist in the repair, and to potentially replace or restore damaged tissue through the use of autologous or allogenic biologics. This field is rising like a Phoenix from the ashes of underperforming conventional therapy midst the hopes and high expectations of patients and medical personnel alike. But, because this is a relatively new area of medicine that has yet to substantiate its outcomes, care must be taken in its public presentation and promises as well as in its use. OBJECTIVE: To provide guidance for the responsible, safe, and effective use of biologic therapy in the lumbar spine. To present a template on which to build standardized therapies using biologics. To ground potential administrators of biologics in the knowledge of the current outcome statistics and to stimulate those interested in providing biologic therapy to participate in high quality research that will ultimately promote and further advance this area of medicine. METHODS: The methodology used has included the development of objectives and key questions. A panel of experts from various medical specialties and subspecialties as well as differing regions collaborated in the formation of these guidelines and submitted (if any) their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these guidelines. The literature pertaining to regenerative medicine, its effectiveness, and adverse consequences was thoroughly reviewed using a best evidence synthesis of the available literature. The grading for recommendation was provided as described by the Agency for Healthcare Research and Quality (AHRQ). SUMMARY OF EVIDENCE: Lumbar Disc Injections: Based on the available evidence regarding the use of platelet-rich plasma (PRP), including one high-quality randomized controlled trial (RCT), multiple moderate-quality observational studies, a single-arm meta-analysis and evidence from a systematic review, the qualitative evidence has been assessed as Level III (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best-evidence synthesis. Based on the available evidence regarding the use of medicinal signaling/ mesenchymal stem cell (MSCs) with a high-quality RCT, multiple moderate-quality observational studies, a single-arm meta-analysis, and 2 systematic reviews, the qualitative evidence has been assessed as Level III (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. Lumbar Epidural Injections Based on one high-quality RCT, multiple relevant moderate-quality observational studies and a single-arm meta-analysis, the qualitative evidence has been assessed as Level IV (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. Lumbar Facet Joint Injections Based on one high-quality RCT and 2 moderate-quality observational studies, the qualitative evidence for facet joint injections with PRP has been assessed as Level IV (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. Sacroiliac Joint Injection Based on one high-quality RCT, one moderate-quality observational study, and one low-quality case report, the qualitative evidence has been assessed as Level IV (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. CONCLUSION: Based on the evidence synthesis summarized above, there is Level III evidence for intradiscal injections of PRP and MSCs, whereas the evidence is considered Level IV for lumbar facet joint, lumbar epidural, and sacroiliac joint injections of PRP, (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis.Regenerative therapy should be provided to patients following diagnostic evidence of a need for biologic therapy, following a thorough discussion of the patient's needs and expectations, after properly educating the patient on the use and administration of biologics and in full light of the patient's medical history. Regenerative therapy may be provided independently or in conjunction with other modalities of treatment including a structured exercise program, physical therapy, behavioral therapy, and along with the appropriate conventional medical therapy as necessary. Appropriate precautions should be taken into consideration and followed prior to performing biologic therapy. Multiple guidelines from the Food and Drug Administration (FDA), potential limitations in the use of biologic therapy and the appropriate requirements for compliance with the FDA have been detailed in these guidelines. KEY WORDS: Regenerative medicine, platelet-rich plasma, medicinal signaling cells, mesenchymal stem cells, stromal vascular fraction, bone marrow concentrate, chronic low back pain, discogenic pain, facet joint pain, Food and Drug Administration, minimal manipulation, evidence synthesis.

Influence of psychological variables on the diagnosis of facet joint involvement in chronic spinal pain.

BACKGROUND: Facet or zygapophysial joint pain is one of the common conditions responsible for chronic spinal pain. Controlled diagnostic blocks are considered the only means of reliable diagnosis of facet joint pain, due to the inability of physical examination, clinical symptoms, radiologic evaluation, and nerve conduction studies to provide a reliable diagnosis. The prevalence of facet joint pain has been established to be 15% to 45% of patients with low back pain, 39% to 67% of patients with neck pain, and 34% to 48% of patients with thoracic pain. However, using only a single block, false-positive rates of 27% to 63% in the cervical spine, 42% to 58% in the thoracic spine, and 17% to 50% in the lumbar spine have been reported. While there are multiple reasons for false-positive results, psychological variables may also contribute to false-positive results. A lack of influence of psychological factors on the validity of controlled diagnostic local anesthetic blocks of lumbar facet joints has been demonstrated. However, no such studies have been performed in the thoracic or cervical spine. OBJECTIVE: To study the influence of psychopathology (depression, generalized anxiety disorder, and somatization individually or in combinations of multiple psychopathologic conditions) on the ability of controlled, comparative local anesthetic blocks to accurately identify facet joint pain and false-positive rates with a single block. METHODS: Four hundred thirty-eight patients undergoing controlled, comparative local anesthetic blocks were included in the study. Patients were allocated based on their psychological profiles - each diagnostic group or combination was divided into distinct categories. Primary groups consisted of patients with major depression, generalized anxiety disorder, and somatization disorder. Combination groups consisted of 4 categories based on multiple combinations. All the patients were treated with controlled, comparative local anesthetic blocks either with 1% lidocaine or 1% lidocaine and 0.25% bupivacaine. A positive response was defined as at least an 80% reduction in pain and the ability to perform previously painful movements with appropriate relief with 2 separate local anesthetics. RESULTS: The prevalence of facet joint pain in chronic spinal pain ranged from 25% to 40% in patients without psychopathology, whereas it ranged from 28% to 43% in patients with a positive diagnosis of major depression, generalized anxiety disorder, and somatization disorder, respectively, compared to 23% to 39% in patients with a negative diagnosis. Regional facet joint pain prevalence and false-positive rates were higher in the cervical region in patients with major depression. In the lumbar and thoracic regions, no significant differences were noted. CONCLUSION: This study demonstrated that, based on patient psychopathology, there were no significant differences among the patients either in terms of prevalence or false-positive rates in the lumbar and thoracic regions. A higher prevalence and lower false-positive rates in the cervical region were established in patients with major depression.

Responsible, Safe, and Effective Prescription of Opioids for Chronic Non-Cancer Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines.

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

Prevalence of illicit drug use among individuals with chronic pain in the Commonwealth of Kentucky: an evaluation of patterns and trends.

The abuse of prescription-controlled substances is a common phenomenon, associated with illicit drug use, in patients suffering with chronic pain and receiving controlled substances for the management of pain. Prescription drug abuse in Kentucky has led to an increase in Medicare and Medicaid fraud, as well as physician indictments for unscrupulous practices and increased vigilance and prosecution by the authorities. This study was undertaken to evaluate 400 consecutive patients receiving controlled substances in an interventional pain management practice in Western Kentucky to evaluate the prevalence of illicit drug use and opioid abuse and noncompliance with opioid therapy. Results indicated that patients covered by third-party insurance showed 17% (95% CI, 10%-24%) prevalence of illicit drug use, with patients on Medicare, with or without third-party insurance, showing 10% (95% CI, 4%-6%) prevalence, compared to patients on Medicare and Medicaid with 24% (95% CI, 16%-32%) prevalence, and patients with only Medicaid with 39% (95% CI, 29%-49%) prevalence of illicit drug use. In addition, combined use of illicit drugs and misuse of prescription drugs was also seen in a substantially greater proportion of patients in Groups III and IV, with the highest (60%) in Group IV with Medicaid only, followed by Group III with Medicaid supplementation of Medicare insurance in 40% of the patients. Overall illicit drug use, opioid abuse, and noncompliance of opioids is significant in patients in Western Kentucky receiving Medicaid as a primary insurance or as a supplemental insurance to Medicare, despite extensive monitoring, written agreement, and education.

Reliability of psychological evaluation in chronic pain in an interventional pain management setting.

BACKGROUND: Psychological disorders may be associated with poor pain related treatment outcomes. However, there may be limitations with studies evaluating the relationship between pain and psychopathology. OBJECTIVE: To assess the reliability of psychological evaluations in interventional pain management by MCMI-III(R) and P-3(R). STUDY DESIGN: Prospective evaluation of consecutive patients in an interventional pain management center. METHODS: Patients were evaluated using a DSM-IV-TR(R) questionnaire with a physician interview as an integral part of their comprehensive evaluation. In addition, all the patients participating in this study also underwent psychological evaluation with MCMI-III and P-3. A positive diagnosis of major depression or generalized anxiety disorder based on DSM-IV-TR criteria was considered as the criterion standard. All of the patients presented for treatment of chronic pain. The data based on the criterion standard were compared with results of the diagnostic impression from the MCMI-III and the P-3 evaluation utilizing criteria for average, and above average, patient pain scores. RESULTS: Major depression was diagnosed in a total of 59 of 100 patients using DSM-IV-TR criteria, in 32 patients based on MCMI-III criteria, and in 55 patients based on P-3 evaluations utilizing average pain patient criteria. Generalized anxiety disorder was diagnosed in 55 patients by means of DSM-IV-TR, 45 patients by MCMI-III, and 55 patients by P-3 Profile utilizing average pain patient scores. The specificity of MCMI-III was 100% with a sensitivity of 54% for diagnosis of depression; whereas it was 78% specificity and sensitivity for P-3, with average pain patient scores. For generalized anxiety disorder, specificity of MCMI-III was 89% with a sensitivity of 73% compared to specificity of 80% and sensitivity of 84% for average pain patient scores for P-3. CONCLUSION: MCMI-III and P-3 are highly specific in diagnosing depression and generalized anxiety disorder, with variable sensitivity. A DSM-IV-TR questionnaire evaluation incorporated into the pain management questionnaire, along with a short clinical interview, is a reliable means of assessing depression and anxiety in patients suffering with chronic pain.

Understanding psychological aspects of chronic pain in interventional pain management.

There is no doubt that chronic pain is recognized as a biopsychosocial phenomenon in which biological, psychological, and social factors dynamically interact with each other. Thus, the role of psychological factors and understanding chronic, persistent disabling pain has been well recognized, but poorly understood. Approximately 1/2 to 2/3 of all patients diagnosed with chronic pain manifest to various levels of psychological distress. Chronic pain and psychological disorders are the two most common elements in the United States. Statistics show that, approximately 22% of Americans suffer from a diagnosable mental disorder in a given year. In addition, 28% of the American population suffers with chronic pain. Depression in chronic pain is the most common condition, followed by generalized anxiety disorder, somatization disorder, and drug dependence. However, psychogenic pain appears to be the least prevalent of all psychopathological issues. Chronic pain disability is a complex psychosocial economic phenomenon. There is no data in the literature with regards to treatment of personality disorders, anxiety disorders, and somatization disorders in managing chronic pain. In contrast, treatment of depression and the influence of treatment on outcomes have been studied to some extent. In conclusion, patients with chronic pain frequently have psychopathology - most often common depressive disorders, anxiety disorders, somatization disorders, drug dependence and occasionally personality disorders. This review discusses various issues involved with psychopathology in chronic pain including epidemiology; relationship of psychopathology to pain; influence of depression, generalized anxiety disorder, somatization, and personality disorders on chronic pain, along with diagnosis and management in interventional pain management.

Evaluation of influence of gender, occupational injury, and smoking on chronic low back pain of facet joint origin: a subgroup analysis.

The prevalence of persistent low back pain secondary to involvement of lumbosacral facet joints has been described in controlled studies as varying from 15% to 52% based on types of population and settings studied. Previous studies have shown variances in elderly populations, and postlumbar laminectomy patients. But no variations were observed in obese patients or patients with somatization disorder. Based on the individual results, it appears that facet joint pain may be less prevalent in patients with occupational injury and more prevalent in women and smokers. This analysis was based on a combination of the results of two previous studies with a total number of 320 patients to evaluate the influence of gender, occupational injury and smoking on prevalence of facet joint pain. Facet joints were investigated with diagnostic blocks initially using lidocaine 1%, followed by bupivacaine 0.25%, usually 2 to 4 weeks apart in these studies. The prevalence of facet joint pain in men was 38% (95% CI, 29% to 47%) compared to 43% (95% CI, 36% to 50%) in women; 43% (95% CI, 33% to 53%) in non-smokers, compared to 41% (95% CI, 30% to 52%) in heavy smokers; and 28% (95% CI, 18% to 38%) in occupational injury patients compared to 44% (95% CI, 36% to 52%) with a history of gradual onset. False-positive rates varied from 28% to 46%. In conclusion, based on the results of this evaluation, women and men, smokers and nonsmokers suffer with similar prevalence rates of facet joint pain in chronic low back pain; whereas occupational injury patients suffer with lesser prevalence (28%) compared to patients with gradual onset (44%) of low back pain.

Correlates of non-physiological behavior in patients with chronic low back pain.

It is widely believed that the extent of a patient's subjective complaints are often based on developmental, psychological, social, and cultural factors rather than structural or physical pathology. In patients presenting with chronic low back pain, underlying behavioral problems may not be immediately apparent. These behavioral or non-physiological issues may be secondary to a deliberate deception or may be associated with psychological distress. Waddell et al developed a standardized assessment of behavioral or non-organic signs and symptoms in hopes that such an evaluation of the patient could lead to better utilization of surgical and diagnostic procedures. Multiple authors have described varying results correlating excessive pain behavior with psychological disorders. This study was designed to evaluate psychological correlates of pain behavior in 120 chronic low back pain patients in an interventional pain management setting with 60 men and 60 women. Patients were evaluated with completion of a physical examination, which included Waddell's non-physiological symptoms and signs, and psychological evaluation by Pain Patient Profile (P-3). Results showed that 27 patients (22%) presented with non-physiological symptoms, 34 patients (28%) with non-physiological signs, and 19 patients (16%) with combined presence of non-physiological signs and symptoms. Overall there was significant correlation of non-physiological signs with depression, anxiety, and somatization, both by diagnosis of depression, diagnosis of anxiety and elevated scores. However, correlation was present for non-physiological symptoms only with elevated scores of anxiety and somatization.

Comparison of psychological status of chronic pain patients and the general population.

This study was designed to evaluate the psychological status of 50 individuals without chronic pain and without psychotherapeutic drug therapy, Group I, the control group; and Group II, a chronic pain group with 100 chronic pain patients. All the participants were tested utilizing Millon Clinical Multiaxial Inventory III (MCMI-III). Results were analyzed and compared for various clinical personality patterns, including personality traits and personality disorders; severe personality pathology for schizotypal, borderline and paranoid personality pathology; and multiple clinical syndromes, including generalized anxiety disorder, somatization disorder, major depression, bipolar manic disorder and dysthymic disorder, etc. There were no significant differences noted in clinical personality patterns or severe personality pathology. In the analysis of clinical syndromes, generalized anxiety disorder (40% vs 14%), somatization disorder (26% vs 0%), and major depression (22% vs 4%) were seen in a greater proportion of patients in the chronic pain group. The prevalence of psychological disorders in the control group was 24%, compared to 55% in chronic pain group. In conclusion, this evaluation showed that clinical personality patterns are present in both groups of patients. Psychological abnormalities such as generalized anxiety disorder, somatization disorder, and major depression are commonly seen in chronic pain patients.

A prospective evaluation of psychotherapeutic and illicit drug use in patients presenting with chronic pain at the time of initial evaluation.

BACKGROUND: Reports of chronic pain and associated opioid use, abuse, and fatalities continue to increase at an alarming rate, not only in the United States but also across the globe. In light of the many resultant fatalities, multiple authors and authorities have cautioned against the excessive use of opioids. Consequently, the Food and Drug Administration, Drug Enforcement Administration, and multiple state authorities have been proposing and implementing a plethora of regulations to curb opioid overuse and abuse. In the majority of cases, pain physicians have been portrayed as the perpetrators responsible for escalating use and abuse and resultant fatalities. OBJECTIVES: To assess the patterns of psychotherapeutic drug use and illicit drug use at the time of initial evaluation. STUDY DESIGN: A prospective evaluation. SETTING: A private, specialty referral interventional pain management clinic in the United States. METHODS: Participants were all new patients presenting to interventional pain management evaluated by one physician. Inclusion criteria was patients over 18 years of age with chronic spinal pain of at least one year duration. RESULTS: The results of this evaluation indicate that 94% of patients were on long-term opioids prior to presenting to interventional pain management. Illicit drug use is also common, although it has declined significantly. While a large proportion of individuals (45.7%) have used illicit drugs at some point in the past, current illicit drug use is present in only 7.9% of patients, both past and current use are similar to that of the general population. More importantly, a significant proportion of patients have been on opioids (high doses of more than 40 mg equivalents of morphine 48.8%) on a long-term basis, initiated and maintained by primary care physicians, prior to presenting to interventional pain management. Further, 35% were on benzodiazepines, and 9.2% on carisoprodol prior to presenting to interventional pain management. LIMITATIONS: The limitations of this evaluation include that it is a prospective, single center evaluation by one physician that is partially dependent on subjective recall of the patient. CONCLUSION: This study shows an overwhelming majority of patients were initiated and maintained with opioids in managing chronic noncancer pain. They were frequently on high doses over a long period of time with multiple drug combinations prescribed by primary care physicians.

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

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

Results of 2-year follow-up of a randomized, double-blind, controlled trial of fluoroscopic caudal epidural injections in central spinal stenosis.

BACKGROUND: Lumbar spinal stenosis is one of the most common causes of low back pain among older adults and can cause significant disability. Despite its prevalence, there is a paucity of literature concerning the treatment of spinal stenosis symptoms. Multiple interventions, including surgery and interventional techniques such as epidural injections and adhesiolysis, are commonly utilized in managing pain related to central spinal stenosis. However, there is a paucity of literature from randomized, controlled trials about the effectiveness of epidural injections for lumbar central spinal stenosis. OBJECTIVE: This study sought to assess the effectiveness of caudal epidural injections with or without steroids in providing effective and long-lasting pain relief for the management of chronic low back pain related to lumbar central stenosis. STUDY DESIGN: A randomized, double-blind, active-controlled trial. METHODS: One hundred patients were randomly assigned to one of 2 groups, with Group I patients receiving caudal epidural injections of local anesthetic (lidocaine 0.5%), whereas Group II patients received caudal epidural injections with 0.5% lidocaine 9 mL mixed with 1 mL of steroid, 6 mg (non-particulate betamethasone). OUTCOMES ASSESSMENT: Multiple outcome measures, including the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake were utilized. Assessments were carried out at 3, 6, 12, 18, and 24 months posttreatment. The primary outcome was defined as pain relief and improvement in disability scores of 50% or more. Successful treatment was considered as at least 3 weeks of relief following the first 2 injections, categorizing these patients into a successful group, and others into a failed group. RESULTS: Significant pain relief and functional status improvement were seen in 51% in Group I and 57% in Group II at the end of 2 years in the successful group when the participants were separated into successful and failed groups. However, overall, significant pain relief and functional status improvement (≥ 50%) was demonstrated in 38% in Group I and 44% in Group II at the end of 2 years. The overall number of procedures for 2 years were 4 in both groups, with 5 procedures on average in the successful groups, and approximately 60 weeks of relief in Group I and 54 weeks of relief in Group II at 2 years in the successful group. CONCLUSION: Caudal epidural injections of local anesthetic with or without steroids provide relief in a modest proportion of patients undergoing the treatment and may be considered as an effective treatment for a select group of patients who have chronic function-limiting low back and lower extremity pain secondary to central spinal stenosis.

A prospective evaluation of complications of 10,000 fluoroscopically directed epidural injections.

BACKGROUND: Among the multiple modalities of treatments available in managing chronic spinal pain, including surgery and multiple interventional techniques, epidural injections by various routes, such as interlaminar epidural injections, caudal epidural injections, transforaminal epidural injections, and percutaneous adhesiolysis are common. Even though the complications of fluoroscopically directed epidural injections are fewer than blind epidural injections, and have better effectiveness, multiple complications have been reported in scattered case reports, with only minor complications in randomized or non-randomized studies and systematic reviews. Thus, prospective studies with large patient series are essential to determine the types and incidences of complications. STUDY DESIGN: A prospective, non-randomized study of patients undergoing interventional techniques from May 2008 to December 2009. SETTING: A private interventional pain management practice, a specialty referral center in the United States. OBJECTIVES: To assess the complication rate of fluoroscopically directed epidural injections. METHODS: This study was carried out over a period of 20 months and included over 10,000 procedures: 39% caudal epidurals, 23% cervical interlaminar epidurals, 14% lumbar interlaminar epidurals, 13% lumbar transforaminal epidurals, 8% percutaneous adhesiolysis, and 3% thoracic interlaminar epidural procedures. All of the interventions were performed under fluoroscopic guidance in an ambulatory surgery center by one of 3 physicians. The complications encountered during the procedure and postoperatively were prospectively evaluated. OUTCOMES ASSESSMENT: Measurable outcomes employed were intravascular entry of the needle, profuse bleeding, local hematoma, bruising, dural puncture and headache, nerve root or spinal cord irritation with resultant injury, infectious complications, vasovagal reactions, and facial flushing. RESULTS: Intravascular entry was higher for adhesiolysis (11.6%) and lumbar transforaminal (7.9%) procedures compared to other epidurals which ranged from 0.5% for lumbar, 3.1% for caudal, 4% for thoracic, and 4.1% for cervical epidurals. Dural puncture was observed in a total of 0.5% of the procedures with 1% in the cervical region, 1.3% in the thoracic region, 0.8% with lumbar interlaminar epidurals, and 1.8% with adhesiolysis. LIMITATIONS: Limitations of this study include a single-center study even though it included a large number of patients. CONCLUSION: This study illustrates that major complications are rare and minor side effects are common.

Complications of fluoroscopically directed facet joint nerve blocks: a prospective evaluation of 7,500 episodes with 43,000 nerve blocks.

BACKGROUND: Chronic spinal pain is common along with numerous modalities of diagnostic and therapeutic interventions utilized, creating a health care crisis. Facet joint injections and epidural injections are the 2 most commonly utilized interventions in managing chronic spinal pain. While the literature addressing the effectiveness of facet joint nerve blocks is variable and emerging, there is paucity of literature on adverse effects of facet joint nerve blocks. STUDY DESIGN: A prospective, non-randomized study of patients undergoing interventional techniques from May 2008 to December 2009. SETTING: A private interventional pain management practice, a specialty referral center in the United States. OBJECTIVES: Investigation of the incidence in characteristics of adverse effects and complications of facet joint nerve blocks. The study was carried out over a period of 20 months including almost 7,500 episodes of 43,000 facet joint nerve blocks with 3,370 episodes in the cervical region, 3,162 in the lumbar region, and 950 in the thoracic region. All facet joint nerve blocks were performed under fluoroscopic guidance in an ambulatory surgery center by 3 physicians. The complications encountered during the procedure and postoperatively were evaluated prospectively. METHODS: This study was carried out over a period of 20 months and included over 7,500 episodes or 43,000 facet joint nerve blocks. All of the interventions were performed under fluoroscopic guidance in an ambulatory surgery center by one of 3 physicians. The complications encountered during the procedure and postoperatively were prospectively evaluated. OUTCOMES ASSESSMENT: Measurable outcomes employed were intravascular entry of the needle, profuse bleeding, local hematoma, dural puncture and headache, nerve root or spinal cord irritation with resultant injury, and infectious complications. RESULTS: There were no major complications. Multiple side effects and complications observed included overall intravascular penetration in 11.4% of episodes with 20% in cervical region, 4% in lumbar region, and 6% in thoracic region; local bleeding in 76.3% of episodes with highest in thoracic region and lowest in cervical region; oozing with 19.6% encounters with highest in cervical region and lowest in lumbar region; with local hematoma seen only in 1.2% of the patients with profuse bleeding, bruising, soreness, nerve root irritation, and all other effects such as vasovagal reactions observed in 1% or less of the episodes. LIMITATIONS: Limitations of this study include lack of contrast injection, use of intermittent fluoroscopy and also an observational nature of the study. CONCLUSION: This study illustrate that major complications are extremely rare and minor side effects are common.

Utilization of interventional techniques in managing chronic pain in the Medicare population: analysis of growth patterns from 2000 to 2011.

BACKGROUND: Reports from the United States Government Accountability Office (GAO), the Institute of Medicine (IOM), the Medicare Payment Advisory Commission (MedPAC), and the Office of Inspector General (OIG) continue to express significant concern with the overall fiscal sustainability of Medicare and the exponential increase in costs for chronic pain management. STUDY DESIGN: The study is an analysis of the growth of interventional techniques in managing chronic pain in Medicare beneficiaries from 2000 to 2011. OBJECTIVE: To evaluate the use of all interventional techniques in chronic pain management. METHODS: The study was performed utilizing the Centers for Medicare and Medicaid Services (CMS) Physician Supplier Procedure Summary Master Data from 2000 to 2011. RESULTS: Interventional techniques for chronic pain have increased dramatically from 2000 to 2011. Overall, the increase of interventional pain management (IPM) procedures from 2000 to 2011 went up 228%, with 177% per 100,000 Medicare beneficiaries. The increases were highest for facet joint interventions and sacroiliac joint blocks with a total increase of 386% and 310% per 100,000 Medicare beneficiaries, followed by 168% and 127% for epidural and adhesiolysis procedures, 150% and 111% for other types of nerve blocks and finally, 28% and 8% increases for percutaneous disc procedures. The geometric average of annual increases was 9.7% overall with 13.7% for facet joint interventions and sacroiliac joint blocks and 7.7% for epidural and adhesiolysis procedures. LIMITATIONS: The limitations of this study included a lack of inclusion of Medicare participants in Medicare Advantage plans, as well as potential documentation, coding, and billing errors. CONCLUSION: Interventional techniques increased significantly in Medicare beneficiaries from 2000 to 2011. Overall, there was an increase of 177% in the utilization of IPM services per 100,000 Medicare beneficiaries, with an annual geometric average increase of 9.7%. The study also showed an exponential increase in facet joint interventions and sacroiliac joint blocks.

Assessment of practice patterns of perioperative management of antiplatelet and anticoagulant therapy in interventional pain management.

BACKGROUND: The role of antithrombotic therapy is well known for its primary and secondary prevention of cardiovascular disease by decreasing the incidence of acute cerebral, cardiovascular, peripheral vascular, and other thrombotic events. The overwhelming data show that the risk of thrombotic events is significantly higher than that of bleeding during surgery after antiplatelet drug discontinuation. It has been assumed that discontinuing antiplatelet therapy prior to performing interventional pain management techniques is a common practice, even though doing so may potentially increase the risk of acute cerebral and cardiovascular events. There are no data available concerning these events, specifically in relation to the occurrence of thromboembolic events, even though some data are available concerning bleeding complications. Even then, interventionalists seem to routinely discontinue all antithrombotic therapy prior to all interventional pain management techniques. OBJECTIVE: To assess the perioperative antiplatelet and anticoagulant practice patterns of US interventional pain management physicians as well as adverse events in patients on antithrombotic therapy who undergo interventional pain management techniques when that therapy is continued or stopped. STUDY DESIGN: An online survey of interventional pain management physicians. STUDY SETTING: Interventional pain management practices in the United States. METHODS: An online survey was commissioned among 2,300 members of the American Society of Interventional Pain Physicians. The survey was designed to assess practice patterns and complications encountered. RESULTS: Of the 2,300 members surveyed, 325 responded. These results showed that all physicians discontinued warfarin therapy; whereas, 97% discontinued clopidogrel; 96% ticlopidine; 95% Aggrastat (tirofiban); 93% cilostazol, 85% dipyridamole, 60% aspirin 350 mg; 39% aspirin 81 mg; and 39% other nonsteroidal anti-inflammatory drugs (NSAIDs) prior to performing interventional pain management techniques. The majority of physicians accepted an international normalized ratio of 1.5 or less as a safe level. An assessment of serious complications showed thromboembolic events were 3 times more frequent than bleeding complications: 162 thromboembolic events and 55 serious bleeding complications from epidural hematomas. Thromboembolic complications were severe and higher when antiplatelet therapy was discontinued. Bleeding complications from epidural hematomas were similar whether antiplatelet therapy was continued or discontinued (26 versus 29). LIMITATIONS: This study was limited by its being an online survey of the membership of one organization in one country and that there was a 14% response rate. Underreporting in surveys is common. Further, the incidence of thromboembolic events or epidural hematomas may be misrepresented as a percentage since these drugs were continued in a very small percentage of patients. Consequently, the incidences described in this manuscript may not show appropriate percentages. CONCLUSION: The results illustrate an overwhelming pattern of discontinuing antiplatelet and warfarin therapy as well as aspirin and other NSAIDs prior to performing interventional pain management techniques. However, thromboembolism complications may be 3 times more prevalent than epidural hematomas (162 versus 55 events). It is concluded that clinicians must balance the risks of thromboembolism and bleeding in each patient prior to the routine discontinuation of antiplatelet therapy.

The role of thoracic medial branch blocks in managing chronic mid and upper back pain: a randomized, double-blind, active-control trial with a 2-year followup.

Study Design. A randomized, double-blind, active-control trial. Objective. To determine the clinical effectiveness of therapeutic thoracic facet joint nerve blocks with or without steroids in managing chronic mid back and upper back pain. Summary of Background Data. The prevalence of thoracic facet joint pain has been established as 34% to 42%. Multiple therapeutic techniques utilized in managing chronic thoracic pain of facet joint origin include medial branch blocks, radiofrequency neurotomy, and intraarticular injections. Methods. This randomized double-blind active controlled trial was performed in 100 patients with 50 patients in each group who received medial branch blocks with local anesthetic alone or local anesthetic and steroids. Outcome measures included the numeric rating scale (NRS), Oswestry Disability Index (ODI), opioid intake, and work status, at baseline, 3, 6, 12, 18, and 24 months. Results. Significant improvement with significant pain relief and functional status improvement of 50% or more were observed in 80% of the patients in Group I and 84% of the patients in Group II at 2-year followup. Conclusions. Therapeutic medial branch blocks of thoracic facets with or without steroids may provide a management option for chronic function-limiting thoracic pain of facet joint origin.

Opioid epidemic in the United States.

Over the past two decades, as the prevalence of chronic pain and health care costs have exploded, an opioid epidemic with adverse consequences has escalated. Efforts to increase opioid use and a campaign touting the alleged undertreatment of pain continue to be significant factors in the escalation. Many arguments in favor of opioids are based solely on traditions, expert opinion, practical experience and uncontrolled anecdotal observations. Over the past 20 years, the liberalization of laws governing the prescribing of opioids for the treatment of chronic non-cancer pain by the state medical boards has led to dramatic increases in opioid use. This has evolved into the present stage, with the introduction of new pain management standards by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) in 2000, an increased awareness of the right to pain relief, the support of various organizations supporting the use of opioids in large doses, and finally, aggressive marketing by the pharmaceutical industry. These positions are based on unsound science and blatant misinformation, and accompanied by the dangerous assumptions that opioids are highly effective and safe, and devoid of adverse events when prescribed by physicians. Results of the 2010 National Survey on Drug Use and Health (NSDUH) showed that an estimated 22.6 million, or 8.9% of Americans, aged 12 or older, were current or past month illicit drug users, The survey showed that just behind the 7 million people who had used marijuana, 5.1 million had used pain relievers. It has also been shown that only one in 6 or 17.3% of users of non-therapeutic opioids indicated that they received the drugs through a prescription from one doctor. The escalating use of therapeutic opioids shows hydrocodone topping all prescriptions with 136.7 million prescriptions in 2011, with all narcotic analgesics exceeding 238 million prescriptions. It has also been illustrated that opioid analgesics are now responsible for more deaths than the number of deaths from both suicide and motor vehicle crashes, or deaths from cocaine and heroin combined. A significant relationship exists between sales of opioid pain relievers and deaths. The majority of deaths (60%) occur in patients when they are given prescriptions based on prescribing guidelines by medical boards, with 20% of deaths in low dose opioid therapy of 100 mg of morphine equivalent dose or less per day and 40% in those receiving morphine of over 100 mg per day. In comparison, 40% of deaths occur in individuals abusing the drugs obtained through multiple prescriptions, doctor shopping, and drug diversion. The purpose of this comprehensive review is to describe various aspects of crisis of opioid use in the United States. The obstacles that must be surmounted are primarily inappropriate prescribing patterns, which are largely based on a lack of knowledge, perceived safety, and inaccurate belief of undertreatment of pain.

American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part I--evidence assessment.

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