Assessment of methodologic quality of randomized trials of interventional techniques: development of an interventional pain management specific instrument.

BACKGROUND: A major component of a systematic review is an assessment of the methodological quality and bias of randomized trials. The most commonly utilized methodological quality assessment and bias assessment for randomized trials is by the Cochrane Review Group. While this is not a "gold standard," it is an indication of the current state-of-the-art review methodology. There is, however, no specific instrument to assess the methodological quality of manuscripts published for interventional techniques. OBJECTIVES: Our objective was to develop an instrument specifically for interventional pain management, to assess the methodological quality of randomized trials of interventional techniques. METHODS: Item generation for the instrument was based on a definition of quality, to the extent to which the design and conduct of the trial were congruent with the objectives of the trial. Applicability was defined as the extent to which the trial produced procedures could be applied with contemporary interventional pain management techniques. Multiple items based on Cochrane review criteria were utilized along with specific requirements for interventional techniques. RESULTS: A total of 22 items were developed which formed IPM-QRB or Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment tool. This included 9 of the 12 items from the Cochrane review criteria with definition of some items that were repetitive or duplicate, and the addition of 13 new items. The results were compared for inter-rater reliability of Cochrane review criteria and IPM-QRB, and inter-instrument reliability. The assessment was performed in multiple stages with an initial learning curve. The final assessment was for 4 randomized controlled trials (RCTs) utilizing both Cochrane review criteria and IPM-QRB criteria. The inter-rater agreement for Cochrane review criteria with overall intra-class correlation coefficient was 0.407 compared to an intra-class correlation coefficient of 0.833 for IPM-QRB criteria. The inter-rater agreement was superior for IPM-QRB criteria compared to Cochrane review criteria despite twice the items of Cochrane review criteria as IPM-QRB criteria with the detailed nature of assessment. LIMITATIONS: Limited validity or accuracy assessment of the instrument and the large number of items to be scored. CONCLUSION: We have developed a new comprehensive instrument to assess the methodological quality of randomized trials of interventional techniques. This instrument is superior to Cochrane review methodology criteria in that it provides more extensive and specific information for interventional techniques that will be useful in assessing the methodologic quality and bias of interventional techniques.

The effect of sedation on the accuracy and treatment outcomes for diagnostic injections: a randomized, controlled, crossover study.

BACKGROUND AND OBJECTIVE: Diagnostic injections are used to diagnose myriad pain conditions, but are characterized by a high false-positive rate. One potential cause of inaccurate diagnostic blocks is the use of sedation. We sought to determine the effect of sedation on the validity of diagnostic injections. DESIGN: Randomized, crossover study in which 73 patients were allocated to receive a diagnostic sacroiliac joint or sympathetic nerve block performed either with or without sedation using midazolam and fentanyl. Those who obtained equivocal relief, good relief lasting less than 3 months, or who were otherwise deemed good candidates for a repeat injection, received a subsequent crossover injection within 3 months (N = 46). SETTING AND PATIENTS: A tertiary care teaching hospital and a military treatment facility. RESULTS: In the primary crossover analysis, blocks performed with sedation resulted in a larger mean reduction in pain diary score than those done without sedation (1.2 [2.6]; P = 0.006), less procedure-related pain (difference in means 2.3 [2.5]; P < 0.0001), and a higher proportion of patients who obtained > 50% pain relief on their pain diaries (70% vs. 54%; P = 0.039). The increased pain reduction was not accompanied by increased satisfaction (sedation mean 3.9 [1.1] vs. 3.7 [1.3]; P = 0.26). Similar findings were observed for the parallel group (N = 73) and omnibus (all sedation vs. no sedation blocks, N = 110) analyses. No differences in outcomes were noted between the use and non-use of sedation at 1-month. CONCLUSIONS: The use of sedation during diagnostic injections may increase the rate of false-positive blocks and lead to misdiagnoses and unnecessary procedures, but has no effect on satisfaction or outcomes at 1-month.

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 the systematic assessment of mechanical lumbar disc decompression with nucleoplasty.

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

An update of the systematic appraisal of the accuracy and utility of lumbar discography in chronic low back pain.

BACKGROUND: The intervertebral disc has been implicated as a major cause of chronic lumbar spinal pain based on clinical, basic science, and epidemiological research. There is, however, a lack of consensus regarding the diagnosis and treatment of intervertebral disc disorders. Based on controlled evaluations, lumbar intervertebral discs have been shown to be the source of chronic back pain without disc herniation in 26% to 39% of patients. Lumbar provocation discography, which includes disc stimulation and morphological evaluation, is often used to distinguish a painful disc from other potential sources of pain. Despite the extensive literature, intense debate continues about lumbar discography as a diagnostic tool. STUDY DESIGN: A systematic review of the diagnostic accuracy of lumbar provocation and analgesic discography literature. OBJECTIVE: To systematically assess and re-evaluate the diagnostic accuracy of lumbar discography. METHODS: The available literature on lumbar discography was reviewed. A methodological quality assessment of included studies was performed using the Quality Appraisal of Reliability Studies (QAREL) checklist. Only diagnostic accuracy studies meeting at least 50% of the designated inclusion criteria were included in the analysis. However, studies scoring less than 50% are presented descriptively and critically analyzed. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to September 2012, and manual searches of the bibliographies of known primary and review articles. RESULTS: Over 160 studies were considered for inclusion. Of these, 33 studies compared discography with other diagnostic tests, 30 studies assessed the diagnostic accuracy of discography, 22 studies assessed surgical outcomes for discogenic pain, and 3 studies assessed the prevalence of lumbar discogenic pain. The quality of the overall evidence supporting provocation discography based on the above studies appears to be fair. The prevalence of internal disc disruption is estimated to be 39% to 42%, whereas the prevalence of discogenic pain without assessing internal disc disruption is 26%. CONCLUSION: This systematic review illustrates that lumbar provocation discography performed according to the International Association for the Study of Pain (IASP) criteria may be a useful tool for evaluating chronic lumbar discogenic pain.

An update of the effectiveness of therapeutic lumbar facet joint interventions.

BACKGROUND: Therapeutic lumbar facet joint interventions are implemented to provide long-term pain relief after the facet joint has been identified as the basis for low back pain. The therapeutic lumbar facet joint interventions generally used for the treatment of low back pain of facet joint origin are intraarticular facet joint injections, lumbar facet joint nerve blocks, and radiofrequency neurotomy. OBJECTIVE: To evaluate and update the effect of therapeutic lumbar facet joint interventions in managing chronic low back pain. STUDY DESIGN: A systematic review of therapeutic lumbar facet joint interventions for the treatment of chronic low back pain. METHODS: The available literature on lumbar facet joint interventions in managing chronic low back 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. Preventative Services Task Force. Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 through June 2012, and manual searches of the bibliographies of known primary and review articles. OUTCOME MEASURES: The primary outcome measure was pain relief with short-term relief defined as up to 6 months and long-term relief as 12 months. Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake. RESULTS: For this systematic review, 122 studies were identified. Of these, 11 randomized trials and 14 observational studies met inclusion criteria for methodological quality assessment. The evidence for radiofrequency neurotomy is good and fair to good for lumbar facet joint nerve blocks for short- and long-term improvement; whereas the evidence for intraarticular injections and pulsed radiofrequency neurotomy is limited. LIMITATIONS: The limitations of this systematic review include the continued paucity of evidence, specifically for intraarticular injection therapy. CONCLUSION: In summary, there is good evidence for the use of conventional radiofrequency neurotomy, and fair to good evidence for lumbar facet joint nerve blocks for the treatment of chronic lumbar facet joint pain resulting in short-term and long-term pain relief and functional improvement. There is limited evidence for intraarticular facet joint injections and pulsed radiofrequency thermoneurolysis.

Effectiveness of cervical epidural injections in the management of chronic neck and upper extremity pain.

BACKGROUND: Chronic persistent neck pain with or without upper extremity pain is common in the general adult population with prevalence of 48% for women and 38% for men, with persistent complaints in 22% of women and 16% of men. Multiple modalities of treatments are exploding in managing chronic neck pain along with increasing prevalence. However, there is a paucity of evidence for all modalities of treatments in managing chronic neck pain. Cervical epidural injections for managing chronic neck pain are one of the commonly performed interventions in the United States. However, the literature supporting cervical epidural steroids in managing chronic pain problems has been scant. STUDY DESIGN: A systematic review of cervical interlaminar epidural injections for cervical disc herniation, cervical axial discogenic pain, cervical central stenosis, and cervical postsurgery syndrome. OBJECTIVE: To evaluate the effect of cervical interlaminar epidural injections in managing various types of chronic neck and upper extremity pain emanating as a result of cervical spine pathology. METHODS: The available literature on cervical interlaminar epidural injections in managing chronic neck and upper extremity pain were 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 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 were improvement in functional status, psychological status, return to work, and reduction in opioid intake. RESULTS: For this systematic review, 34 studies were identified. Of these, 24 studies were excluded and a total of 9 randomized trials, with 2 duplicate studies, met inclusion criteria for methodological quality assessment. For cervical disc herniation, the evidence is good for cervical epidural with local anesthetic and steroids; whereas, it was fair with local anesthetic only. For axial or discogenic pain, the evidence is fair for local anesthetic, with or without steroids. For spinal stenosis, the evidence is fair for local anesthetic, with or without steroids. For postsurgery syndrome, the evidence is fair for local anesthetic, with or without steroids. LIMITATIONS: The limitations of this systematic review continue to be the paucity of literature. CONCLUSION: The evidence is good for radiculitis secondary to disc herniation with local anesthetics and steroids, fair with local anesthetic only; whereas, it is fair for local anesthetics with or without steroids, for axial or discogenic pain, pain of central spinal stenosis, and pain of post surgery syndrome.

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."

A systematic evaluation of the therapeutic effectiveness of sacroiliac joint interventions.

BACKGROUND: The contribution of the sacroiliac joint to low back and lower extremity pain has been a subject of debate with extensive research. It is generally accepted that approximately 10% to 25% of patients with persistent low back pain may have pain arising from the sacroiliac joints. In spite of this, there are currently no definite conservative, interventional, or surgical management options for managing sacroiliac joint pain. In addition, there continue to be significant variations in the application of various techniques as well as a paucity of literature. STUDY DESIGN: A systematic review of therapeutic sacroiliac joint interventions. OBJECTIVE: To evaluate the accuracy of therapeutic sacroiliac joint interventions. METHODS: The available literature on therapeutic sacroiliac joint interventions 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 for randomized trials of interventional techniques and the criteria developed by the Newcastle-Ottawa Scale for 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 published from 1966 through December 2011 that was identified through searches of PubMed and EMBASE, 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, 56 studies were considered for inclusion. Of these, 45 studies were excluded and a total of 11 studies met inclusion criteria for methodological quality assessment with 6 randomized trials and 5 non-randomized studies. The evidence for cooled radiofrequency neurotomy in managing sacroiliac joint pain is fair.The evidence for effectiveness of intraarticular steroid injections is poor.The evidence for periarticular injections of local anesthetic and steroid or botulinum toxin is poor. The evidence for effectiveness of conventional radiofrequency neurotomy is poor.The evidence for pulsed radiofrequency is poor. LIMITATIONS: The limitations of this systematic review include a paucity of literature on therapeutic interventions, variations in technique, and variable diagnostic standards for sacroiliac joint pain. CONCLUSIONS: The evidence was fair in favor of cooled radiofrequency neurotomy and poor for short-term and long-term relief from intraarticular steroid injections, periarticular injections with steroids or botulin toxin, pulsed radiofrequency, and conventional radiofrequency neurotomy.

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.

A systematic evaluation of prevalence and diagnostic accuracy of sacroiliac joint interventions.

BACKGROUND: The contributions of the sacroiliac joint to low back and lower extremity pain have been a subject of considerable debate and research. It is generally accepted that 10% to 25% of patients with persistent mechanical low back pain below L5 have pain secondary to sacroiliac joint pathology. However, no single historical, physical exam, or radiological feature can definitively establish a diagnosis of sacroiliac joint pain. Based on present knowledge, a proper diagnosis can only be made using controlled diagnostic blocks. The diagnosis and treatment of sacroiliac joint pain continue to be characterized by wide variability and a paucity of the literature. OBJECTIVE: To evaluate the accuracy of diagnostic sacroiliac joint interventions. STUDY DESIGN: A systematic review of diagnostic sacroiliac joint interventions. METHODS: Methodological quality assessment of included studies was performed using Quality Appraisal of Reliability Studies (QAREL). Only diagnostic accuracy studies meeting at least 50% of the designated inclusion criteria were utilized for analysis. Studies scoring less than 50% are presented descriptively and analyzed critically. The level of evidence was classified as good, fair, or poor based on the quality of evidence developed by the United States 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: In this evaluation we utilized controlled local anesthetic blocks using at least 50% pain relief as the reference standard. RESULTS: The evidence is good for the diagnosis of sacroiliac joint pain utilizing controlled comparative local anesthetic blocks. The prevalence of sacroiliac joint pain is estimated to range between 10% and 62% based on the setting; however, the majority of analyzed studies suggest a point prevalence of around 25%, with a false-positive rate for uncontrolled blocks of approximately 20%. The evidence for provocative testing to diagnose sacroiliac joint pain was fair. The evidence for the diagnostic accuracy of imaging is limited. LIMITATIONS: The limitations of this systematic review include a paucity of literature, variations in technique, and variable criterion standards for the diagnosis of sacroiliac joint pain. CONCLUSIONS: Based on this systematic review, the evidence for the diagnostic accuracy of sacroiliac joint injections is good, the evidence for provocation maneuvers is fair, and evidence for imaging is limited.

Updated perspectives on occipital nerve stimulator lead migration: case report and literature review.

OBJECTIVES: Patients with occipital neuralgia are often refractory to or intolerant of standard pharmacological and interventional management strategies. Although occipital nerve stimulation (ONS) may provide a unique alternative for such cases, a steep technical learning curve still exists. Lead migration (LM) is among the most challenging issues facing implanters performing ONS implantation. We present an unusual case of LM after ONS implantation and discuss technical aspects for successful revision. METHODS: A retrospective review of medical records and fluoroscopic images was conducted to provide a case report of ONS LM and revision. A PubMed online search for the keywords occipital, stimulation, migration, and revision was also performed for literature review. CASE REPORT: A 35-year-old man with refractory occipital neuralgia had loss of greater occipital nerve paresthesia coverage and worsened occipital headaches 11 months after ONS implantation using a midline approach. Fluoroscopic imaging confirmed lateral LM. Although most LMs occur in the lateral-to-medial trajectory, this case was unique in that LM occurred from a medial-to-lateral trajectory despite using current standard safeguards. DISCUSSION: In an era in which reducing health care expenditures is becoming increasingly important, current complication rates could curtail future acceptance and utilization of ONS. This fact and our case report underscore the importance of a continued drive toward technical advances and a reduction in complications associated with this important treatment modality. Further prospective investigation into the mechanism of action, mechanism of complications, optimization of surgical techniques, and long-term efficacy is warranted.

Effective treatments for pain in the older patient.

By 2050, the number of older persons across the globe will exceed the number of younger people for the first time in history. Chronic conditions, especially pain, will rise in prevalence as the population ages. Controlling pain in this unique subset of the population demands careful attention to pharmacokinetic and pharmacodynamic factors and their specific impact on pharmacotherapies, relevant complementary and alternative medicine therapies, and interventional strategies.

The effect of morphine on glial cells as a potential therapeutic target for pharmacological development of analgesic drugs.

Opioids have played a critical role in achieving pain relief in both modern and ancient medicine. Yet, their clinical use can be limited secondary to unwanted side effects such as tolerance, dependence, reward, and behavioral changes. Identification of glial-mediated mechanisms inducing opioid side effects include cytokine receptors, kappa-opioid receptors, N-methyl-D-aspartate receptors, and the recently elucidated Toll-like receptors. Newer agents targeting these receptors such as AV411, MK-801, AV333, and SLC022, and older agents used outside the United States or for other disease conditions, such as minocycline, pentoxifylline, and UV50488H, all show varied but promising profiles for providing significant relief from opioid side effects, while simultaneously potentiating opioid analgesia.

Pain management in pancreatic cancer.

A majority of pancreatic cancer patients present with pain at the time of diagnosis. Pain management can be challenging in light of the aggressive nature of this cancer. Apart from conventional pharmacotherapy, timely treatment with neurolytic celiac plexus block (NCPB) has been shown to be of benefit. NCPB has demonstrated efficacious pain control in high quality studies with analgesic effects lasting one to two months. NCPB has also shown to decrease the requirements of narcotics, and thus decrease opioid related side effects. Another option for the control of moderate to severe pain is intrathecal therapy (IT). Delivery of analgesic medications intrathecally allows for lower dosages of medications and thus reduced toxicity. Both of the above mentioned interventional procedures have been shown to have low complication rates, and be safe and effective. Ultimately, comprehensive pancreatic cancer pain management necessitates understanding of pain mechanisms and delivery of sequential validated therapeutic interventions within a multidisciplinary patient care model.

Independent Medical Examinations: facts and fallacies.

BACKGROUND: Independent Medical Examinations (IMEs) have protected the rights of workers in the United States since the first laws protecting employees were established in the early 1900s. There have been many social advancements and a great collective struggle over the last 100 years that have ultimately lead to justice for the injured or disabled worker. OBJECTIVE: We describe the origins of the IME as well as the evolution of both medical and social processes that have provided the legal framework for the correct practice of IMEs. This article will summarize the current medical principles, legal process, and social controversy embodying the modern IME. DISCUSSION: Medical professionals must adhere to the same principles of impartial and ethical conduct that they uphold in general patient care when dealing with IMEs. Although previously controversial, it is now clear following successful litigation of many physician examiners that at least a 'limited doctor-patient relationship' is created during an IME. LIMITATIONS: The limitations of this manuscript include a paucity of the literature, lack of IME updates, and certain conflicts with guidelines by various organizations. CONCLUSION: IMEs represent a valuable mechanism for determining alleged impairment and/or disability. In the current economic environment of declining reimbursement to physicians, IMEs exist outside the scope of traditional payment methods and offer competitive compensation.