Challenges and concerns of persistent opioid use in cancer patients.

INTRODUCTION: As a result of advancements in the diagnosis and treatment of cancer, two-thirds of individuals suffering with cancer survive more than 5 years after diagnosis, resulting in a large proportion of patients with chronic cancer pain alone or associated with chronic noncancer pain. There is a paucity of literature in reference to diagnosis and management of chronic cancer pain, specifically in relation to persistent opioid use, its effectiveness, and adverse consequences. Areas covered: This review covers the prevalence of chronic cancer pain and its association with multiple comorbidities, persistent opioid use and related consequences, and challenges in managing persistent chronic cancer pain patients. In addition, discussion includes therapeutic opioid use, effectiveness of opioid therapy, assessment of risk of persistent opioid use, and guidance for responsible, persistent opioid prescribing for chronic cancer pain patients. Expert commentary: Despite extensive availability of opioids and related common adverse consequences, including the potential for escalating use, abuse, and deaths, greater awareness is needed to counteract the present atmosphere and appropriately manage patients with chronic cancer pain. Chronic cancer pain is a complex biopsychosocial phenomenon with multiple comorbidities. Opioid therapy has become extremely complex with negative connotations related to escalating abuse and related deaths.

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."

Efficacy of Percutaneous Adhesiolysis in the Treatment of Lumbar Post Surgery Syndrome.

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

Comparison of the efficacy of saline, local anesthetics, and steroids in epidural and facet joint injections for the management of spinal pain: A systematic review of randomized controlled trials.

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

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."

An update of evaluation of therapeutic thoracic facet joint interventions.

BACKGROUND: Chronic mid back and upper back pain caused by thoracic facet joints has been reported in 34% to 48% of patients based on responses to controlled diagnostic blocks. Systematic reviews have established moderate evidence for controlled comparative local anesthetic blocks of thoracic facet joints in the diagnosis of mid back and upper back pain, moderate evidence for therapeutic thoracic medial branch blocks, and limited evidence for radiofrequency neurotomy of thoracic medial branches. STUDY DESIGN: Systematic review of therapeutic thoracic facet joint interventions. OBJECTIVE: To determine the clinical utility of therapeutic thoracic facet joint interventions in the therapeutic management of chronic upper back and mid back pain. METHODS: The available literature for the utility of facet joint interventions in the therapeutic management of thoracic facet joint pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the criteria developed by the Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, and limited (or poor) based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to March 2012, and manual searches of the bibliographies of known primary and review articles. OUTCOME MEASURES: The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > 6 months). Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake. RESULTS: For this systematic review, 13 studies were identified. Of these, 7 studies were excluded, and a total of 4 studies (after removal of duplicate publication) met inclusion criteria for methodological quality assessment with one randomized trial and 3 non-randomized studies. The evidence is fair for therapeutic thoracic facet joint nerve blocks, limited for thoracic radiofrequency neurotomy, and not available for thoracic intraarticular injections. LIMITATIONS: The limitation of this systematic review includes a paucity of literature. The only positive studies were of medial branch blocks performed by the same group of authors. CONCLUSION: The evidence for therapeutic facet joint interventions is fair for medial branch blocks, whereas it is not available for intraarticular injections, and limited for radiofrequency neurotomy due to lack of literature.

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."

American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part 2--guidance.

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

Caudal epidural injections in the management of chronic low back pain: a systematic appraisal of the literature.

BACKGROUND: Epidural injections with local anesthetics and steroids are one of the most commonly used interventions in managing chronic low back pain and lower extremity pain of various causes. However, despite their extensive use, debate continues on their effectiveness due to the lack of well-designed, randomized, controlled studies to determine the effectiveness of epidural injections in general, and caudal epidural injections in particular. STUDY DESIGN: A systematic review of caudal epidural injections with or without steroids in managing chronic pain secondary to lumbar disc herniation or radiculitis, post lumbar laminectomy syndrome, spinal stenosis, and discogenic pain without disc herniation or radiculitis. OBJECTIVE: To evaluate the effect of caudal epidural injections with or without steroids in managing various types of chronic low back pain with or without lower extremity pain emanating as a result of disc herniation or radiculitis, post lumbar laminectomy syndrome, spinal stenosis, and chronic discogenic pain. METHODS: The available literature on caudal epidural injections with or without steroids in managing various types of chronic low back pain with or without lower extremity pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the criteria developed by the Newcastle-Ottawa Scale criteria for fluoroscopic observational studies. The level of evidence was classified as good, fair, 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 December 2011, and manual searches of the bibliographies of known primary and review articles. OUTCOME MEASURES: The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > 6 months). Secondary outcome measures of improvement in functional status, psychological status, return to work, and reduction in opioid intake were utilized. RESULTS: For this systematic review, 73 studies were identified. Of these, 51 were excluded and a total of 16 studies met inclusion criteria for methodological quality assessment with 11 randomized trials and 5 non-randomized studies. For lumbar disc herniation, the evidence is good for short- and long-term relief of chronic pain secondary to disc herniation or radiculitis with local anesthetic and steroids and fair relief with local anesthetic only. In managing chronic axial or discogenic pain, spinal stenosis, and post surgery syndrome, the indicated evidence is fair. LIMITATIONS: The limitations of this study include the paucity of literature, specifically for chronic pain without disc herniation. CONCLUSION: There was good evidence for short- and long-term relief of chronic pain secondary to disc herniation or radiculitis with local anesthetic and steroids and fair relief with local anesthetic only. Further, this systematic review also provided indicated evidence of fair for caudal epidural injections in managing chronic axial or discogenic pain, spinal stenosis, and post surgery syndrome.

Effectiveness of therapeutic lumbar transforaminal epidural steroid injections in managing lumbar spinal pain.

BACKGROUND: Among the multiple interventions used in managing chronic spinal pain, lumbar epidural injections have been used extensively to treat lumbar radicular pain. Among caudal, interlaminar, and transforaminal, transforaminal epidural injections have gained rapid and widespread acceptance for the treatment of lumbar and lower extremity pain. The potential advantages of transforaminal over interlaminar and caudal, include targeted delivery of a steroid to the site of pathology, presumably onto an inflamed nerve root. However, there are only a few well-designed, randomized, controlled studies on the effectiveness of steroid injections. Consequently, multiple systematic reviews with diverse opinions have been published. STUDY DESIGN: A systematic review of therapeutic transforaminal epidural injection therapy for low back and lower extremity pain. OBJECTIVE: To evaluate the effect of therapeutic transforaminal lumbar epidural steroid injections in managing low back and lower extremity pain. METHODS: The available literature on lumbar transforaminal epidural injections in managing chronic low back and lower extremity pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and by the Newcastle-Ottawa Scale criteria for observational studies. Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to December 2011, and manual searches of the bibliographies of known primary and review articles. The level of evidence was classified as good, fair, or poor based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). OUTCOME MEASURES: The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > 6 months). Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake. RESULTS: For this systematic review, 70 studies were identified. Of these, 43 studies were excluded and a total of 27 studies met inclusion criteria for methodological quality assessment with 15 randomized trials (with 2 duplicate publications) and 10 non-randomized studies. For lumbar disc herniation, the evidence is good for transforaminal epidural with local anesthetic and steroids, whereas it was fair for local anesthetics alone and the ability of transforaminal epidural injections to prevent surgery. For spinal stenosis, the available evidence is fair for local anesthetic and steroids. The evidence for axial low back pain and post lumbar surgery syndrome is poor, inadequate, limited, or unavailable. LIMITATIONS: The limitations of this systematic review include the paucity of literature. CONCLUSION: In summary, the evidence is good for radiculitis secondary to disc herniation with local anesthetics and steroids and fair with local anesthetic only; it is fair for radiculitis secondary to spinal stenosis with local anesthetic and steroids; and limited for axial pain and post surgery syndrome using local anesthetic with or without steroids.

Effectiveness of long-term opioid therapy for chronic non-cancer pain.

BACKGROUND: Opioids have been utilized for thousands of years to treat pain and their use continues to escalate. It is estimated that 90% of the patients who present to pain centers and receive treatment in such facilities are on opioids. However, in contrast to increasing opioid use and the lack of evidence supporting long-term effectiveness in chronic non-cancer pain, is the escalating misuse of prescription opioids, including abuse and diversion. There is also uncertainty about the incidence and clinical salience of multiple, poorly characterized adverse drug events, including endocrine dysfunction, immunosuppression, infectious disease, opioid-induced hyperalgesia, overdoses, deaths, and psychosocial and economic implications. STUDY DESIGN: A comprehensive review of the literature. OBJECTIVE: The objective of this comprehensive review is to evaluate the clinical effectiveness and safety of chronic opioid therapy in chronic non-cancer pain. METHODS: A comprehensive review of the literature relating to chronic opioid therapy in chronic non-cancer pain. The literature was collected from various electronic and other sources. The literature that was evaluated included randomized trials, observational studies, case reports, systematic reviews, and guidelines. OUTCOME MEASURES: Pain relief was the primary outcome measure. The secondary outcome measures were functional improvement and adverse effects. Short-term effectiveness was considered to be less than 6 months; long-term effectiveness was considered to be at least one year. RESULTS: Given the complexity and widespread nature of opioid therapy, there is a paucity of qualitative and/or quantitative literature. The available evidence is weak for pain relief combined with improvement in functional status. Only one drug, tramadol, is effective for pain relief and improvement of functional status. LIMITATIONS: This is a narrative review without application of methodologic quality assessment criteria. Even so, a paucity of literature exists concerning both controlled and observational literature for multiple drugs and multiple conditions of chronic non-cancer pain. CONCLUSIONS: This comprehensive review illustrates the lack of literature on long-term opioid therapy; thus, opioid therapy should be provided with great restraint and caution, based on the weak evidence available.

Appalachian residents' experiences with and management of multiple morbidity.

Approximately three fourths of middle-aged and older adults have at least two simultaneously occurring chronic conditions ("multiple morbidity," or MM), a trend expected to increase dramatically throughout the world. Rural residents, who tend to have fewer personal and health resources, are more likely to experience MM. To improve our understanding of the ways in which vulnerable, rural residents in the United States experience and manage MM, we interviewed 20 rural Appalachian residents with MM. We identified the following themes: (a) MM has multifaceted challenges and is viewed as more than the sum of its parts; (b) numerous challenges exist to optimal MM self-management, particularly in a rural, underresourced context; however, (c) participants described strategic methods of managing MM, including prioritizing certain conditions and management strategies and drawing heavily on assistance from informal and formal sources.

Prevalence of side effects of prolonged low or moderate dose opioid therapy with concomitant benzodiazepine and/or antidepressant therapy in chronic non-cancer pain.

BACKGROUND: Opioid use in the management of chronic pain is widespread in chronic pain settings. Opioid prescriptions for non-cancer pain and overall opioid sales have been soaring with the increasing nonmedical use of opioids in the United States. Prolonged use of high dose opioids has been associated with adverse consequences including tolerance, abuse, addiction, hyperalgesia, hormonal effects, and immunosuppression. Studies of high dose therapy have shown pain relief with a 30% decrease in the intensity of pain and that only 44% of the patients continue the treatment between 7 and 24 months. However, there is no data available on the prevalence of side effects associated with low or moderate dose opioid use in chronic non-cancer pain when administered in conjunction with interventional techniques. OBJECTIVE: To evaluate the prevalence of side effects, of low or moderate dose opioid therapy with or without benzodiazepines, antidepressants, and their combinations. METHODS: The evaluation was conducted by interviewing 1,000 patients on stable doses of opioids, with or without benzodiazepines, antidepressants, and their combinations. Patients were categorized into 4 groups with Group 1 receiving opioids only (n = 143), Group 2 receiving opioids and benzodiazepines (n = 159), Group 3 receiving opioids and antidepressants (n = 113), and Group 4 received opioids, benzodiazepines, and antidepressants (n = 118). RESULTS: Inclusion criteria was met in 533 patients receiving opioid therapy for longer than 6 months. The incidence of side effects in Group 1 was 18%, in Group 2 was 8%, in Group 3 was 17%, and in Group 4 was 14%. The most frequent complications were in patients receiving methadone (52%) followed by oxycodone (41%) and morphine (36%). Patients receiving hydrocodone had the least incidences of side effects with 7.5%. There were no significant differences noted based on the duration of therapy, age of the patient, and gender. Severe side effects accounted for only 14 of 137 instances. LIMITATIONS: Limitations of this study include the inability to incorporate multiple other drugs due to complicated nature with multiple groups and data collection and analysis. The other limitation is that the proportion of patients receiving methadone, oxycodone, morphine, and propoxyphene was low compared to hydrocodone with 77% of the patients. CONCLUSION: Moderate or low dose opioid therapy in conjunction with or without benzodiazepines, antidepressants, or in combinations are associated with minor side effects.

Increasing deaths from opioid analgesics in the United States: an evaluation in an interventional pain management practice.

OBJECTIVE: To assess the prevalence of opioid-related deaths in patients in an interventional pain management tertiary referral center. METHODS: Patient deaths from March 2003 to February 2007 were evaluated. RESULTS: From March 2003 to February 2007, 2,179 patients were receiving opioids in 2003, 2,445 in 2004, 2,804 in 2005, and 2,965 in 2006, respectively. Overall, 86 percent of the patients were referred by a physician and 90 percent of patients received interventional techniques. There were a total of 91 deaths, of which 60 were categorized as natural deaths, 25 were characterized as accidental deaths, and 6 were characterized as suicidal. Of the 18 drug poisoning deaths, 5 deaths were positively related to prescription drugs, 7 deaths were probably related to prescription drugs, and 6 deaths had no relation to the prescription drugs provided. Total opioid-related deaths were 12 over this 4-year period with 0.46 in 2003, 2.04 in 2004, 2.85 in 2005, and 1.35 in 2006 per 1,000 population. In contrast, deaths definitely related to prescription opioids were 5 (0.92 per 1,000) over a period of 4 years. In the suicidal group, there were a significantly higher proportion of patients with generalized anxiety disorder. CONCLUSIONS: In an interventional pain management practice (a tertiary referral center), the total prevalence of opioid-related deaths varied from 0.46 to 1.78 per 1,000 from 2003 to 2006 with a total of 12 deaths over a period of 4 years. The deaths definitely related to opioidprescriptions were 5 with a rate of 0 to 1.43 per 1,000 over a period of 4 years.

Age-related prevalence of facet-joint involvement in chronic neck and low back pain.

BACKGROUND: Spinal pain is common in all age groups. While the research has focused primarily on incidence and prevalence in younger working adults, there is evidence that spinal pain is one of the most frequent complaints in older persons and is responsible for functional limitations. While facet arthrosis is a common radiographic finding, which has been suggested to be a potential cause of spinal pain, nearly 10% of all adults show signs of degeneration by the time they reach age 30. Radiographic changes of osteoarthritis have been shown to be equally common in patients with and without low back or neck pain. The studies of low back pain have shown the prevalence of facet joint involvement to be approximately 15% to 45%. However, age related prevalence of facet joint neck pain has not been studied. OBJECTIVE: To assess age-related prevalence and false-positive rates of facet-joint involvement in chronic spinal pain using controlled comparative local anesthetic blocks. DESIGN: Retrospective analysis of 424 patients, divided into 6 groups based upon age (Group I: aged 18 - 30 years, Group II: aged 31 - 40 years, Group III: aged 41 - 50 years, Group IV: aged 51 - 60, Group V: 61 - 70 years, and Group VI: greater than 70 years of age). RESULTS: The prevalence of cervical facet joint-related pain was the lowest (33%) in Group VI and highest (42%) in Group I. False-positive rates for cervical facet joint blocks ranged from 39% (Group III) to 58% (Group V) with an overall false-positive rate of 45%. The prevalence of facet joint involvement in lumbar spinal pain ranged from 18% (in Group II) to 44% (in Group IV), with significant differences noted when Group II and Group III were compared to other groups and with higher rates in Group V. CONCLUSION: This study demonstrated a variable age-related prevalence of facet joint pain in chronic low back pain, whereas in the cervical spine it was similar among all the age groups.

The prevalence of facet-joint-related chronic neck pain in postsurgical and nonpostsurgical patients: a comparative evaluation.

BACKGROUND: Facet (zygapophysial) joints may be clinically important sources of chronic cervical spinal pain. Previous studies have demonstrated the value and validity of controlled, comparative local anesthetic blocks in the diagnosis of facet joint pain, and reported an overall prevalence of 36% to 67% facet joint involvement in cervical spinal pain. The reports of lumbar facet joint-involvement in postsurgery syndrome have been shown to be highly variable with prevalence ranging from 8% to 32%. To date, however, the prevalence of postsurgical facet joint-related pain in the cervical spine has not been evaluated. In light of this, the present retrospective study was conducted to assess and compare the prevalence of chronic postsurgical facet joint cervical spinal pain to nonsurgical, chronic cervical facet joint pain. METHODS: Patients presenting with chronic neck pain were studied. The procedures were performed by a single physician in an interventional pain management ambulatory surgery center. The prevalence of cervical facet joint pain in postsurgical patients was assessed and compared to nonsurgical patients. RESULTS: A total of 251 patients (45 postsurgery vs. 206 nonsurgical patients) with chronic persistent neck pain were evaluated using controlled, comparative local anesthetic blocks in accordance with IASP criteria. The prevalence of the cervical facet joint pain and false-positive rate of single blocks in postsurgical patients were 36% and 50% compared with 39% and 43% in nonsurgical patients. CONCLUSIONS: Cervical facet joints are clinically important pain generators in a significant proportion of patients with chronic persistent neck pain after surgical intervention(s). The prevalence of cervical facet joint pain was similar in both postsurgical and nonsurgical patients.

Facet joint pain in chronic spinal pain: an evaluation of prevalence and false-positive rate of diagnostic blocks.

STUDY DESIGN: A retrospective review. OBJECTIVES: Evaluation of the prevalence of facet or zygapophysial joint pain in chronic spinal pain of cervical, thoracic, and lumbar origin by using controlled, comparative local anesthetic blocks and evaluation of false-positive rates of single blocks in the diagnosis of chronic spinal pain of facet joint origin. SUMMARY OF BACKGROUND DATA: Facet or zygapophysial joints are clinically important sources of chronic cervical, thoracic, and lumbar spine pain. The previous studies have demonstrated the value and validity of controlled, comparative local anesthetic blocks in the diagnosis of facet joint pain, with a prevalence of 15% to 67% variable in lumbar, thoracic, and cervical regions. False-positive rates of single diagnostic blocks also varied from 17% to 63%. METHODS: Five hundred consecutive patients receiving controlled, comparative local anesthetic blocks of medial branches for the diagnosis of facet or zygapophysial joint pain were included. Patients were investigated with diagnostic blocks using 0.5 mL of 1% lidocaine per nerve. Patients with lidocaine-positive results were further studied using 0.5 mL of 0.25% bupivacaine per nerve on a separate occasion. Medial branch blocks were performed with intermittent fluoroscopic visualization, at 2 levels to block a single joint. A positive response was considered as one with at least 80% pain relief from a block of at least 2 hours duration when lidocaine was used, and at least 3 hours or longer than the duration of relief with lidocaine when bupivacaine was used, and also the ability to perform prior painful movements. RESULTS: A total of 438 patients met inclusion criteria. The prevalence of facet joint pain was 39% in the cervical spine [95% confidence interval (CI), 32%-45%]; 34% (95% CI, 22%-47%) in the thoracic pain; and 27% (95% CI, 22%-33%) in the lumbar spine. The false-positive rate with a single block in the cervical region was 45%, in the thoracic region was 42%, and in the lumbar region 45%. CONCLUSIONS: This retrospective review once again confirmed the significant prevalence of facet joint pain in chronic spinal pain.

Evaluation of lumbar facet joint nerve blocks in the management of chronic low back pain: preliminary report of a randomized, double-blind controlled trial: clinical trial NCT00355914.

BACKGROUND: The prevalence of persistent low back pain with the involvement of lumbar facet or zygapophysial joints has been described in controlled studies as varying from 15% to 45% based on the criteria of the International Association for the Study of Pain. Therapeutic interventions utilized in managing chronic low back pain of facet joint origin include intraarticular injections, medial branch nerve blocks, and neurolysis of medial branch nerves. OBJECTIVE: To determine the clinical effectiveness of therapeutic lumbar facet joint nerve blocks in managing chronic low back pain of facet joint origin. DESIGN: A prospective, randomized, double-blind trial. SETTING: An interventional pain management setting in the United States. METHODS: In this preliminary analysis, data from a total of 60 patients were included, with 15 patients in each of 4 groups. Thirty patients were in a non-steroid group consisting of Groups I (control, with lumbar facet joint nerve blocks using bupivacaine ) and II (with lumbar facet joint nerve blocks using bupivacaine and Sarapin); another 30 patients were in a steroid group consisting of Groups III (with lumbar facet joint nerve blocks using bupivacaine and steroids) and IV (with lumbar facet joint nerve blocks using bupivacaine, Sarapin, and steroids). All patients met the diagnostic criteria of lumbar facet joint pain by means of comparative, controlled diagnostic blocks. OUTCOME MEASURES: Numeric Rating Scale (NRS) pain scale, the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake. RESULTS: Significant improvement in pain and functional status were observed at 3 months, 6 months, and 12 months, compared to baseline measurements. The average number of treatments for 1 year was 3.7 with no significant differences among the groups. Duration of average pain relief with each procedure was 14.8 +/- 7.9 weeks in the non-steroid group, and 12.5 +/- 3.3 weeks in the steroid group, with no significant differences among the groups. CONCLUSION: Therapeutic lumbar facet joint nerve blocks with local anesthetic, with or without Sarapin or steroids, may be effective in the treatment of chronic low back pain of facet joint origin.

Evaluation of therapeutic thoracic medial branch block effectiveness in chronic thoracic pain: a prospective outcome study with minimum 1-year follow up.

BACKGROUND: The prevalence of persistent upper back and mid back pain due to involvement of thoracic facet joints has been described in controlled studies as varying from 43% to 48% based on IASP criteria. Therapeutic intraventions utilized in managing chronic neck pain and low back pain of facet joint origin include intraarticular injections, medial branch nerve blocks, and neurolysis of medial branch nerves by means of radiofrequency. These interventions have not been evaluated in managing chronic thoracic pain of facet joint origin. OBJECTIVE: To determine the clinical effectiveness of therapeutic thoracic medial branch blocks in managing chronic upper back and mid back pain of facet joint origin. DESIGN: A prospective outcome study. SETTING: Interventional pain management setting in the United States. METHODS: Fifty-five consecutive patients meeting the diagnostic criteria of thoracic facet joint pain by means of comparative, controlled diagnostic blocks were included in this evaluation. All medial branch blocks were performed in a sterile operating room under fluoroscopic visualization with mild sedation with midazolam and/or fentanyl. Statistical methods incorporated intent-to-treat analysis. OUTCOME MEASURES: Numeric pain scores, significant pain relief > or = 50%), Oswestry Disability Index, work status and Pain Patient Profile (P-3). Significant pain relief was defined as an average 50% or greater reduction of numeric pain rating scores. RESULTS: The results showed significant differences in numeric pain scores and significant pain relief (50% or greater) in 71% of the patients at three months and six months, 76% at 12 months, 71% at 24 months, and 69% at 36 months, compared to baseline measurements. Functional improvement was demonstrated at one year, two years, and three years from baseline. There was significant improvement with increase in employment among the patients eligible for employment (employed and unemployed) from baseline to one year, two years, and three years (61% vs 96% to 100%) and improved psychological functioning. CONCLUSION: Therapeutic thoracic medial branch blocks were an effective modality of treatment in managing chronic thoracic pain secondary to facet joint involvement confirmed by controlled, comparative local anesthetic blocks.

Effectiveness of cervical medial branch blocks in chronic neck pain: a prospective outcome study.

BACKGROUND: The high prevalence of persistent neck pain due to involvement of cervical facet joints has been described in controlled studies. Therapeutic interventions utilized in managing chronic neck pain of facet joint origin include intraarticular injections, medial branch nerve blocks, and neurolysis of medial branch nerves by means of radiofrequency. OBJECTIVE: The objective of this prospective evaluation was to determine the clinical effectiveness of cervical medial branch blocks for therapeutic purposes. DESIGN: A prospective, non-randomized, outcome study. METHODS: One hundred consecutive patients meeting the diagnostic criteria of facet joint pain by means of comparative, controlled diagnostic blocks were included in this evaluation. All medial branch blocks were performed in a sterile operating room under fluoroscopic visualization with mild sedation with midazolam and/or fentanyl. Statistical methods incorporated intent-to-treat analysis. OUTCOME MEASURES: Numeric pain scores, Oswestry Disability Index, work status, and Pain Patient Profile (P-3(R)). Significant pain relief was defined as average relief of 50% or greater. RESULTS: The results showed significant differences in numeric pain scores and significant pain relief (50% or greater) at 3 months, 6 months, and 12 months, compared to baseline measurements. Functional improvement was demonstrated at 12 months from baseline. There was significant improvement with increase in employment among the patients eligible for employment (employed and unemployed) from baseline to 12 months, and improved psychological functioning. CONCLUSION: Cervical medial branch blocks were an effective modality of treatment in managing chronic neck pain secondary to facet joint involvement confirmed by controlled, comparative local anesthetic blocks.