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Laxmaiah Manchikanti,1,2 Kimberly A Cash,1 Carla D McManus,1 Vidyasagar Pampati11Pain Management Center of Paducah, Paducah, 2Department of Anesthesiology and Perioperative Medicine, University of Louisville, Louisville, KY, USABackground: Chronic low back pain without disc herniation is common. Various modalities of treatments are utilized in managing this condition, including epidural injections. However, there is continued debate on the effectiveness, indications, and medical necessity of any treatment modality utilized for managing axial or discogenic pain, including epidural injections.Methods: A randomized, double-blind, actively controlled trial was conducted. The objective was to evaluate the ability to assess the effectiveness of caudal epidural injections of local anesthetic with or without steroids for managing chronic low back pain not caused by disc herniation, radiculitis, facet joints, or sacroiliac joints. A total of 120 patients were randomized to two groups; one group did not receive steroids (group 1) and the other group did (group 2). There were 60 patients in each group. The primary outcome measure was at least 50% improvement in Numeric Rating Scale and Oswestry Disability Index. Secondary outcome measures were employment status and opioid intake. These measures were assessed at 3, 6, 12, 18, and 24 months after treatment.Results: Significant pain relief and functional status improvement (primary outcome) defined as a 50% or more reduction in scores from baseline, were observed in 54% of patients in group 1 and 60% of patients in group 2 at 24 months. In contrast, 84% of patients in group 1 and 73% in group 2 saw significant pain relief and functional status improvement in the successful groups at 24 months.Conclusion: Caudal epidural injections of local anesthetic with or without steroids are effective in patients with chronic axial low back pain of discogenic origin without facet joint pain, disc herniation, and/or radiculitis.Keywords: chronic axial low back pain, discogenic pain, disc herniation, caudal epidural injections

Laxmaiah Manchikanti,1,2 Kimberly A Cash,1 Carla D McManus,1 Vidyasagar Pampati,1 Ramsin Benyamin3,41Pain Management Center of Paducah, Paducah, KY; 2University of Louisville, Louisville, KY; 3Millennium Pain Center, Bloomington, IL; 4University of Illinois, Urbana-Champaign, IL, USAAbstract: Among the multiple causes of chronic low back pain, axial and discogenic pain are common. Various modalities of treatments are utilized in managing discogenic and axial low back pain including epidural injections. However, there is a paucity of evidence regarding the effectiveness, indications, and medical necessity of any treatment modality utilized for managing axial or discogenic pain, including epidural injections. In an interventional pain management practice in the US, a randomized, double-blind, active control trial was conducted. The objective was to assess the effectiveness of lumbar interlaminar epidural injections of local anesthetic with or without steroids for managing chronic low back pain of discogenic origin. However, disc herniation, radiculitis, facet joint pain, or sacroiliac joint pain were excluded. Two groups of patients were studied, with 60 patients in each group receiving either local anesthetic only or local anesthetic mixed with non-particulate betamethasone. Primary outcome measures included the pain relief-assessed by numeric rating scale of pain and functional status assessed by the, Oswestry Disability Index, Secondary outcome measurements included employment status, and opioid intake. Significant improvement or success was defined as at least a 50% decrease in pain and disability. Significant improvement was seen in 77% of the patients in Group I and 67% of the patients in Group II. In the successful groups (those with at least 3 weeks of relief with the first two procedures), the improvement was 84% in Group I and 71% in Group II. For those with chronic function-limiting low back pain refractory to conservative management, it is concluded that lumbar interlaminar epidural injections of local anesthetic with or without steroids may be an effective modality for managing chronic axial or discogenic pain. This treatment appears to be effective for those who have had facet joints as well as sacroiliac joints eliminated as the pain source.Keywords: lumbar disc herniation, axial or discogenic pain, lumbar interlaminar epidural injections, local anesthetic, steroids, controlled comparative local anesthetic blocks, NCT00681447

Background: While low back pain is the number one cause of disability in the United States, lumbar spinal stenosis along with intervertebral disc herniation and degenerative spondylolisthesis is one of the 3 most common diagnosis of low back and leg pain for which surgery is performed. Numerous modalities of treatments including drug therapy and complex surgical fusions have been recommended for treatment of central spinal stenosis. Epidural injections are one of the commonly performed nonsurgical interventions in managing central spinal stenosis; however, there has been paucity of literature in reference to efficacy of epidural injections in managing central spinal stenosis with lumbar interlaminar epidural injections., Study Design: A randomized, double-blind, active controlled trial., Setting: Private interventional pain management practice and specialty referral center in the United States., Objective: To assess the effectiveness of lumbar interlaminar epidural injections with or without steroids in providing effective and long-lasting pain relief with improvement in functional status for the management of chronic low back and lower extremity pain related to lumbar central spinal stenosis., Methods: A randomized, double-blind, active-control trial was designed with the inclusion of 120 patients assigned to 2 groups. Group I patients received lumbar interlaminar epidural injections of local anesthetic (lidocaine 0.5%) 6 mL, whereas Group II received lumbar interlaminar epidural injections with local anesthetic (lidocaine 0.5%) 5 mL mixed with 1 mL of steroids and 6 mg of betamethasone., Outcomes Assessment: Outcomes were assessed utilizing the numeric pain rating scale (NRS) and Oswestry Disability Index (ODI) at 3, 6, 12, 18, and 24 months post treatment. The primary outcome measure was significant improvement, defined as 50% improvement in pain and disability scores., Results: Significant relief and functional status improvement was seen in 72% and 73% of patients in Groups I and II at the end of 2 years considering all participants; however, this was 84% and 85% in the successful group. Overall significant improvement was achieved for 65.7 ± 37.3 weeks in Group 1 and 68.9 ± 37.7 weeks in Group II at the end of 2 years when all participants were considered; whereas, this was 77 ± 27.8 weeks and 77.9 ± 30.2 weeks when they were separated into successful categories. The average number of procedures per patient was 5 to 6 in both groups., Limitations: Limitations of this trial include lack of placebo control group and treatment of patients with multiple procedures over a period of 2 years., Conclusion: Lumbar interlaminar epidural injections of local anesthetic with or without steroids provide relief in a significant proportion of patients with lumbar central spinal stenosis., Clinical Trial: NCT00681447.

Background: Reports of prevalence of spinal pain indicate the prevalence of thoracic pain in approximately 13% of the general population compared to 32% of the population with neck pain and 43% of the population with low back pain during the past year. Even though, thoracic pain is less common than neck or low back pain, the degree of disability resulting from thoracic pain disorders seems to be similar to other painful conditions. Interventions in managing chronic thoracic pain are also less frequent, leading to the paucity of literature about various interventions in managing chronic thoracic pain. Thoracic intervertebral discs and thoracic facet joints have been shown to be pain generators, even though thoracic radicular pain is very infrequent. Thoracic epidural injections are one of the commonly performed procedures in managing thoracic pain. The efficacy of thoracic epidural injections has not been well studied., Study Design: A randomized, double-blind, active controlled trial., Setting:   Private interventional pain management practice and specialty referral center in the United States., Objective: The primary objective was to assess the effectiveness of thoracic interlaminar epidural injections in providing effective pain relief and improving function in patients with chronic mid and/or upper back pain., Methods: One hundred and ten patients were randomly assigned into 2 groups with 55 patients in each group receiving either local anesthetic alone (Group I) or local anesthetic with steroids (Group II). Randomization was performed by computer-generated random allocation sequence by simple randomization., Outcomes Assessment: Outcomes were assessed utilizing Numeric Rating Scale (NRS), the Oswestry Disability Index (ODI) 2.0, employment status, and opioid intake. The patients experiencing greater than 3 weeks of significant improvement with the first 2 procedures were considered as successful. Others were considered as failed participants. Significant improvement was defined as a decrease of greater than 50% NRS scores and ODI scores with measurements performed at baseline, 3, 6, 12, 18, and 24 months post treatment., Results: Significant improvement was seen in 71% in Group I and 80% in Group II at the end of 2 years with all participants; however, improvement was seen in 80% and 86% when only successful patients were considered. Therapeutic procedural characteristics showed 5 to 6 procedures per 2 years with total average relief of 80 weeks in Group I and 78 weeks in Group II in the successful patient category; whereas, it was 71 and 72 weeks when all patients were considered., Limitations: Limitations of this assessment include lack of a placebo group., Conclusions: Based on the results of this trial, it is concluded that chronic thoracic pain of non-facet joint origin may be managed conservatively with thoracic interlaminar epidural injections with or without steroids.

Background: Chronic low back with or without lower extremity pain is extremely common, expensive, and disabling. However, all modalities of treatments are directed towards disc herniation which is responsible for a very small proportion of the patients. Thus, chronic low back pain without disc herniation is common. Multiple modalities of treatments are utilized in managing axial or discogenic pain including surgery and epidural injections including surgery, intradiscal therapies, and epidural injections. However, there is continued debate on the effectiveness, indications, and medical necessity of all modalities treatments in managing axial or discogenic pain in the lumbar spine., Study Design: A randomized, double-blind, active control trial., Setting: A private practice, specialty referral, interventional pain management practice in the United States., Objectives: To evaluate the ability to assess the effectiveness of lumbar interlaminar epidural injections in managing chronic axial or discogenic low back pain with epidural injections of local anesthetic with or without steroids., Methods: In this study, a total of 120 patients were randomly allocated to one of the 2 groups receiving either local anesthetic alone or local anesthetic with steroids with 60 patients in each group. The primary outcome measure was at least 50% improvement in the numeric rating scale (NRS) and Oswestry Disability Index (ODI). Outcomes were assessed at 3, 6, 12, 18, and 24 months post treatment., Results: Significant pain relief and functional status improvement defined as at least 50% or more reduction in scores from baseline were observed in 72% of patients receiving local anesthetic alone and 67% of the patients receiving local anesthetic with steroids. Opioid intake was reduced from baseline in each group for 2 years., Limitations: The results of the study are limited by the lack of a placebo group., Conclusion: Lumbar interlaminar epidural injections of local anesthetic with or without steroids are effective in patients with chronic axial low back pain of discogenic origin without facet joint pain, disc herniation, and/or radiculitis., Trial Registration: NCT00681447.

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."

Background: Chronic persistent low back and lower extremity pain secondary to central spinal stenosis is common and disabling. Lumbar surgical interventions with decompression or fusion are most commonly performed to manage severe spinal stenosis. However, epidural injections are also frequently performed in managing central spinal stenosis. After failure of epidural steroid injections, the next sequential step is percutaneous adhesiolysis and hypertonic saline neurolysis with a targeted delivery. The literature on the effectiveness of percutaneous adhesiolysis in managing central spinal stenosis after failure of epidural injections has not been widely studied., Study Design: A prospective evaluation., Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States., Objective: To evaluate the effectiveness of percutaneous epidural adhesiolysis in patients with chronic low back and lower extremity pain with lumbar central spinal stenosis., Methods: Seventy patients were recruited. The initial phase of the study was randomized, double-blind with a comparison of percutaneous adhesiolysis with caudal epidural injections. The 25 patients from the adhesiolysis group continued with follow-up, along with 45 additional patients, leading to a total of 70 patients. All patients received percutaneous adhesiolysis and appropriate placement of the Racz catheter, followed by an injection of 5 mL of 2% preservative-free lidocaine with subsequent monitoring in the recovery room. In the recovery room, each patient also received 6 mL of 10% hypertonic sodium chloride solution, and 6 mg of non-particulate betamethasone, followed by an injection of 1 mL of sodium chloride solution and removal of the catheter., Outcomes Assessment: Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3, 6, and 12, 18 and 24 months post treatment. The primary outcome measure was 50% or more improvement in pain scores and ODI scores., Results: Overall, a primary outcome or significant pain relief and functional status improvement of 50% or more was seen in 71% of patients at the end of 2 years. The overall number of procedures over a period of 2 years were 5.7 ± 2.73., Limitations: The lack of a control group and a prospective design., Conclusions: Significant relief and functional status improvement as seen in 71% of the 70 patients with percutaneous adhesiolysis utilizing local anesthetic steroids and hypertonic sodium chloride solution may be an effective management strategy in patients with chronic function limiting low back and lower extremity pain with central spinal stenosis after failure of conservatie management and fluoroscopically directed epidural injections.

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."

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."

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

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.

Objective: To evaluate the prevalence of facet joint pain in patients with chronic low back pain (CLBP) after surgical intervention(s)., Design: A prospective, nonrandomized, consecutive study., Setting: An ambulatory interventional pain management setting., Participants: The prevalence of facet joint pain was evaluated in patients with CLBP after various surgical intervention(s) referred to an interventional pain management practice. The sample was derived from 282 patients with persistent CLBP after various surgical intervention(s). Of these, 242 patients consented to undergo interventional techniques. A total of 117 consecutive patients with chronic, nonspecific low back pain, after lumbar surgical intervention(s) were evaluated with controlled, comparative local anesthetic blocks., Interventions: Controlled, comparative local anesthetic blocks (1% lidocaine or 1% lidocaine followed by .25% bupivacaine) under fluoroscopic visualization using 0.5mL to block each facet joint nerve., Main Outcome Measures: A positive response was defined as at least 80% reduction of pain with ability to perform previously painful movements. A positive response was considered to be pain relief from the lidocaine block lasting at least 1 hour or at least 2 hours or greater than duration of relief with lidocaine when bupivacaine was used. Controlled, comparative local anesthetic blocks were used to eliminate false-positive results. Valid information is only obtained by performing controlled blocks in the form of comparative local anesthetic blocks, in which, on 2 separate occasions, the same joint is anesthetized by using local anesthetics with different durations of action. If patients obtained appropriate response with both blocks, they were considered a positive. If they obtained appropriate response with lidocaine but not with bupivacaine, they were considered false-positive, whereas if the response was negative with lidocaine, they were considered negative., Results: The prevalence of lumbar facet joint pain in patients with recurrent pain after various surgical intervention(s) was 16% (95% confidence interval, 9%-23%). The false-positive rate with a single block with lidocaine was 49%., Conclusions: Facet joints are clinically important pain generators in a small but significant proportion of patients with recurrent CLBP after various surgical intervention(s).

Background: Opioids are used extensively for chronic pain management in the United States. The frequency of opioid use prior to presenting to interventional pain management settings and in interventional pain management settings has been shown to be above 90%. Opioid abuse has been demonstrated in 9% to 41% of patients receiving chronic pain management. Illicit drug use has been reported in 14% to 34% of patients in chronic pain management settings., Objectives: To evaluate and correlate multiple variables with opioid abuse and illicit drug use., Design: A prospective, consecutive study., Setting: Interventional pain management practice setting in the United States., Methods: A total of 500 consecutive patients prescribed opioids, considered to be receiving stable doses of opioids supplemental to their interventional techniques were evaluated for opioid abuse and for illicit drug use. Abuse was defined as a patient receiving controlled substances from any source other than the prescribing physician at our center with the exception of controlled substances for acute injuries unrelated to the problem being treated, or for emergencies. Urine drug testing for illicit drugs was performed by urine rapid drug screen (Instant Technologies, iCup Norfolk, VA). Results were considered positive if one or more of the monitored illicit drugs including cocaine, marijuana (THC), phencycledane methamphetamine or amphetamines were detected., Results: Opioid abuse was seen in 9% of patients, with illicit drug use in 16% of patients. Significant differences were noted in the prevalence of opioid abuse in patients who developed chronic pain following motor vehicle accident(s) and in patients presenting with pain in three regions of the body. Illicit drug use (marijuana) was more common in females. Illicit drug use was also more common in patients younger than 45, after motor vehicle injury, and in patients with involvement of three regions of the body., Conclusion: Opioid abuse and illicit drug use were common in chronic pain patients with a prevalence of 9% and 16%, respectively. Age, pain after motor vehicle accident, involvement of multiple regions and past history of illicit drug use were identified as risk factors.

Background: Prescription drug abuse and illicit drug use are common in chronic pain patients. Adherence monitoring with screening tests, and urine drug testing, periodic monitoring with prescription monitoring programs, has become a common practice in recent years. Random drug testing for appropriate use of opioids and use of illicit drugs is often used in pain management practices. Thus, it is expected that random urine drug testing will deter use of illicit drugs, and also improve compliance., Objectives: To study the prevalence of illicit drug use in patients receiving opioids for chronic pain management and to compare the results of illicit drug use with the results from a previous study., Design: A prospective, consecutive study., Setting: Interventional pain management practice setting in the United States., Methods: A total of 500 consecutive patients on opioids, considered to be receiving stable doses of opioids supplemental to their interventional techniques, were studied by random drug testing. Testing was performed by rapid drug screen. Results were considered positive if one or more of the monitored illicit drugs including cocaine, marijuana (THC), methamphetamine or amphetamines were present., Results: Illicit drug use was evident in 80 patients, or 16%, with marijuana in 11%, cocaine in 5%, and methamphetamine and/or amphetamines in 2%. When compared with previous data, the overall illicit drug use was significantly less. Illicit drug use in elderly patients was absent., Conclusion: The prevalence of illicit drug abuse in patients with chronic pain receiving opioids continues to be a common occurence. This study showed significant reductions in overall illicit drug use with adherence monitoring combined with random urine drug testing.

Background: Opioids are used extensively for chronic pain management in the United States. The frequency of opioid use prior to presenting to interventional pain management settings and in interventional pain management settings has been shown to be above 90%. Given that controlled substance abuse and illicit drug use are prevalent phenomena, adherence monitoring of patients that are prescribed opioids is becoming common. Adherence monitoring is carried out by an appropriate history, periodic evaluation of appropriate intake of drugs, random drug testing, and pill counts. Crucial to adherence monitoring is an initial controlled substance agreement and repeated review of the terms of this agreement with on-going education. However, the effect of adherence monitoring on drug abuse is unclear., Objective: To identify controlled substance abuse through implementation of the terms of a controlled substance agreement, including periodic review and monitoring outside the organization., Study Design: Prospective evaluation with historical controls., Methods: Five hundred consecutive patients receiving prescription controlled substances were followed in a prospective manner. The evaluation consisted of a chart review to monitor controlled substance intake, with special attention to drugs obtained from outside the organization. Data collection for this purpose included information from records, pharmacies, referring physicians, and all the physicians involved in the treatment of the patient., Results: Results from 500 consecutive patients were evaluated. Controlled substance abuse was seen in 9% of patients; overall, 5% of patients were obtaining controlled substances from other physicians, and 4% from illegal sources., Conclusion: Adherence monitoring, including controlled substance agreements and various periodic measures of compliance was associated with a 50% reduction in opioid abuse.

Background: Zygapophysial or facet joint pain in patients suffering with chronic spinal pain without disc herniation or radiculopathy may be diagnosed with certainty by the use of controlled diagnostic blocks. But, in patients suffering with either lumbar or cervical facet joint pain, even this diagnostic approach may be confounded by false-positives when using a single diagnostic block. It may also be confounded by the administration of anxiolytics and narcotics prior to, or during, the controlled diagnostic facet joint blocks. The effect of sedation on the validity and potential differential results in patients suffering with combined cervical and lumbar facet joint pain has not been evaluated., Objective: To assess the effects of midazolam and fentanyl on the diagnostic validity of facet joint blocks in patients suffering with both cervical and lumbar facet joint pain., Study Design: Randomized, double-blind, placebo-controlled study., Methods: The design consisted of a placebo group receiving a sodium chloride solution and two experimental groups receiving either midazolam or fentanyl. Patients included in the study had been diagnosed with facet joint pain using controlled comparative local anesthetic blocks of the medial branches and L5 dorsal rami. They had been treated with lumbar and cervical facet joint nerve blocks and experienced good pain relief; and were presenting for repeat treatment after a period of symptom relief. The study was performed in an interventional pain management practice in the United States; a total of 60 patients participated with 20 patients randomly allocated into each group. Outcome measures included numeric pain scores, proportion of pain relief, and ability to perform prior painful movements., Outcome Measures: Outcomes were assessed at baseline and after the administration of 1 of the 3 solutions (Group I, sodium chloride solution; Group II, midazolam; or Group III, fentanyl)., Results: Overall, 50% of the patients were relaxed or sedated in the placebo group, while 100% of the patients in the midazolam and fentanyl groups were relaxed or sedated. As many as 10% of the patients reported significant relief (>= 80%) with the ability to perform prior painful movements., Conclusions: Perioperative administration of sodium chloride, midazolam, or fentanyl can confound results in the diagnosis of combined cervical and lumbar facet joint pain. False-positive results with placebo or sedation may be seen in a small proportion of patients.

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

Background: Postoperative epidural fibrosis may contribute to between 5% to 60% of the poor surgical outcomes following decompressive surgery. Correlations have been reported between epidural scarring and radicular pain, poor surgical outcomes, and a lack of any form of surgical treatment. The use of spinal endoscopic adhesiolysis in recent years in the management of chronic refractory low back and lower extremity pain has been described., Methods: A prospective, randomized, double-blind trial was conducted to determine the outcome of spinal endoscopic adhesiolysis to reduce pain and improve function and psychological status in patients with chronic refractory low back and lower extremity pain. A total of 83 patients were evaluated, with 33 patients in Group I and 50 patients in Group II. Group I served as the control, with endoscopy into the sacral level without adhesiolysis, followed by injection of local anesthetic and steroid. Group II received spinal endoscopic adhesiolysis, followed by injection of local anesthetic and steroid., Results: Among the 50 patients in the treatment group receiving spinal endoscopic adhesiolysis, significant improvement without adverse effects was shown in 80% at 3 months, 56% at 6 months, and 48% at 12 months. The control group showed improvement in 33% of the patients at one month and none thereafter. Based on the definition that less than 6 months of relief is considered short-term and longer than 6 months of relief is considered long-term, a significant number of patients obtained long-term relief with improvement in pain, functional status, and psychological status., Conclusion: Spinal endoscopic adhesiolysis with targeted delivery of local anesthetic and steroid is an effective treatment in a significant number of patients with chronic low back and lower extremity pain without major adverse effects.

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

Background: Lumbar facet (zygapophysial) joints have been implicated as the source of chronic pain in 15% to 45% of patients with chronic low back pain. Diagnosis may be confounded by false-positive results with a single diagnostic block and administration of anxiolytics and narcotics prior to or during the diagnostic facet joint blocks., Objective: To evaluate the effect of midazolam and fentanyl on the diagnostic validity of of lumbar facet joint pain., Study Design: Randomized, prospective, double-blind, placebo-controlled evaluation., Methods: The design consisted of a placebo group receiving sodium chloride solution and two experimental groups receiving either midazolam or fentanyl. The patients included in the study were diagnosed with facet joint pain with controlled comparative local anesthetic blocks of medial branches or L5 dorsal rami. They had been treated with lumbar facet joint nerve blocks with good pain relief, and were presenting for repeat treatment after a period of symptom relief. The study was undertaken in an interventional pain management practice., Outcome Measures: Outcomes were assessed at baseline and after the administration of 1 of the 3 solutions (Group I, sodium chloride solution; Group II, midazolam; or Group III, fentanyl). Outcome measures included numeric pain scale, proportion of pain relief, and ability to perform prior painful movements., Results: Pain relief of > or =80% was noted in 2% of the patients in Group I, 5% of the patients in Group II, and 7% in Group III. Pain relief of > or =50% was noted in 7% of the patients in Group I, 5% of the patients in Group II, and 13% of the patients in Group III. There were no significant differences among the groups., Conclusion: The administration of sedation with midazolam or fentanyl is a confounding factor in the diagnosis of lumbar facet joint pain in patients with chronic low back pain. However, this study suggests that if strict criteria including pain relief and ability to perform prior painful movements is used as the standard for evaluating the effect of controlled local anesthetic blocks, the diagnostic validity of lumbar facet joint nerve blocks may be preserved.

Background: Over the years, there has been a shift toward the increased reliance on opioids for the treatment of chronic pain. It is well known that some patients do not provide an appropriate history or underestimate their drug intake, and may exaggerate reported pain levels. Numerous studies have documented the incidence of illicit drug use and abuse of opioids in chronic pain patients. It is not known what proportion of patients have already been exposed to controlled substances prior to presenting for interventional pain management., Objective: To evaluate and identify the prevalence of controlled substance use, demographic characteristics, and psychological characteristics of patients presenting for interventional pain management along with illicit drug use., Study Design: A prospective, observational study., Methods: A total of 100 patients presenting at an interventional pain management setting for initial evaluation were evaluated by detailed history and urine drug testing for controlled substance use and illicit drug use., Results: Duration of pain on average was 9.3 years, 57% of the patients had involvement of more than one body region, 90% were taking opioids, 47% had been seen by 5 or more providers, and more than 70% presented with psychological problems. Twenty-three patients tested positive for illicit drugs and 12 patients were positive for opioids even though they had no prescription and denied taking opioids. Twenty-seven patients either under-reported (16) or over-reported (11) opioid use., Conclusion: Ninety percent of these patients were taking opioids. Twenty-seven patients incorrectly reported opioid use, either underuse or overuse, with 23 patients using illicit drugs, 12 using non-prescription opioids, and with 35 of 100 patients at initial evaluation exhibiting one of the abuse behaviors.

Background: Multiple aberrant behaviors have been described to identify patients abusing opioids and using illicit drugs. However, patient behavior encompassing aggressive seeking or complaining about the need for higher doses of opioids has not yet been evaluated with regards to misuse or abuse patterns of prescription drugs and illicit drug usage., Objective: The objective of this study was to evaluate and identify the prevalence of illicit drug use and prescription drug abuse or misuse in patients seeking higher doses of opioids and compare to a group of patients not seeking higher doses of opioids., Design: A prospective, non-randomized, consecutive, observational study., Methods: A total of 200 patients from an interventional pain management setting with 100 consecutive patients in each group either not seeking additional opioids (Group I) or seeking higher doses of opioids (Group II) were evaluated with urine testing for illicit drug use, and/or misuse or abuse of opioids. Drug testing was carried out by Rapid Drug Screen., Results: Results of this study showed a significantly greater proportion of patients in Group II using illicit drugs (15% vs 32% P = 0.005). Combined use of illicit drugs and abuse of non-prescribed opioids was also present in a significantly greater proportion of patients in Group II (15% vs 39% P = 0.000). A significant number of patients in Group I (32%) and Group II (30%) failed to show the prescribed drug in their urine., Conclusion: A significant proportion of patients, whether they were seeking additional opioids or not, used illicit drugs. Further, a greater proportion of patients in Group II used illicit drugs and non-prescribed opioids.

Background: Based on responses to controlled diagnostic blocks of cervical facet joints, the prevalence of cervical facet joint pain in chronic neck pain has been shown to range from 54% to 67%, with false-positive results of 27% to 63% with a single diagnostic block. Other confounding factors claimed to influence the diagnostic validity of cervical facet joint blocks include administration of anxiolytics and narcotics prior to or during the procedure., Objective: To evaluate the effect of midazolam and fentanyl on the validity of diagnosis of cervical facet joint pain., Study Design: Randomized, prospective, double-blind, placebo-controlled evaluation., Methods: The study was undertaken in an interventional pain management practice. The design consisted of a placebo group receiving sodium chloride solution and two experimental groups receiving either midazolam or fentanyl. The patients included in the study were treated in the past and were presenting for repeat treatment after a significant period of symptom relief., Outcome Measures: Outcomes were assessed at baseline and after the administration of 1 of the 3 solutions (Group I, sodium chloride solution; Group II, midazolam; or Group III, fentanyl). Outcome measures included numeric pain scale, proportion of pain relief, and ability to perform prior painful movements., Results: Pain relief of > or = 80% was noted in 5% of the patients in Group I, 8% in Group II, and 8% in Group III. However, > or = 50% relief was noted in 8% of the patients in Group I, 13% in Group II, and 27% in Group III. Overall, 8% of the patients in Group I, 13% in Group II, and 27% in Group III were able to perform movements which were painful prior to injection., Conclusion: The administration of sedation with midazolam or fentanyl is a confounding factor in the diagnosis of cervical facet joint pain in patients with chronic neck pain. However, if > or = 80% pain relief with ability to perform prior painful movements is used as the standard for evaluating the effect of controlled local anesthetic blocks, the diagnostic validity of cervical facet joint nerve blocks may be preserved.

Background: Transforaminal epidural steroid injection is one of the commonly employed modalities of treatment in managing nerve root pain. However, there have been no controlled prospective evaluations of epidural and nerve root contrast distribution patterns and other aspects of fluoroscopically directed lumbosacral transforaminal epidural steroid injections., Objectives: To evaluate contrast flow patterns and intravascular needle placement of fluoroscopically guided lumbosacral transforaminal epidural injections., Design: A prospective, observational study., Methods: A total of 100 consecutive patients undergoing fluoroscopically guided transforaminal epidural steroid injections were evaluated. The contrast flow patterns, ventral or dorsal epidural filling, nerve root filling, C-arm time, and intravascular needle placement were evaluated., Results: Ventral epidural filling was seen in 88% of the procedures, in contrast to dorsal filling noted in 9% of the procedures. Nerve root filling was seen in 97% of the procedures. Total intravenous placement of the needle was noted in 22% of the procedures, whereas negative flashback and aspiration was noted in 5% of the procedures., Conclusion: Lumbosacral transforaminal epidural injections, performed under fluoroscopic visualization, provide excellent nerve root filling and ventral epidural filling patterns. However, unrecognized intravascular needle placement with negative flashback or aspiration was noted in 5% of the procedures.

Background: Chronic, refractory low back pain is a common problem. Percutaneous adhesiolysis with hypertonic saline neurolysis was described in the management of chronic refractory low back pain, non-responsive to conservative modalities of management., Objective: To determine the ability of percutaneous adhesiolysis and hypertonic saline administration to reduce pain and improve functional and psychological status in patients with chronic low back pain., Design: Randomized, double-blind, controlled trial., Methods: A total of 75 patients were studied, with 25 patients in each group. Three types of interventions were included, with Group I serving as control with catheterization without adhesiolysis, followed by injection of local anesthetic, normal saline, and steroid. Group II consisted of catheterization and adhesiolysis, followed by injection of local anesthetic, normal saline, and steroid. Group III consisted of adhesiolysis followed by injection of local anesthetic, hypertonic saline, and steroid. Statistical analysis incorporated intent-to-treat analysis., Outcome Measures: Visual Analogue Scale pain scores, Oswestry Disability Index, work status, opioid intake, range of motion measurement, and P-3 (R). Significant pain relief was defined as average relief of 50% or greater., Results: Significant improvement was seen in patients in Group II and III, at 3 months, 6 months, and 12 months, compared to baseline measurements, as well as compared to Group I without adhesiolysis. Seventy-two percent of patients in Group III (adhesiolysis and hypertonic neurolysis), 60% of patients in Group II (adhesiolysis only), compared to 0% in Group I (control) showed significant improvement at 12-month follow up. The average number of treatments for one year were 2.76 in Group II and 2.16 in Group III. Duration of significant relief with the first procedure was 2.8 +/- 1.49 months in Group II and 3.8 +/- 3.37 months in Group III., Conclusion: Percutaneous adhesiolysis, with or without hypertonic saline neurolysis, is an effective treatment for chronic low back pain.

Study Design: A retrospective, case-controlled study., Objective: To identify variables in patients with or without illicit drug use., Background Information: Studies documenting a high incidence of controlled substance abuse in chronic pain continue to increase. Over the years, multiple evaluation tools have been proposed. The need to identify predictors of aberrant drug related behavior and addiction in patients being treated with controlled substances for pain has been emphasized., Methods: A total of 150 patients were included in the study. One hundred consecutive urine tests without the presence of illicit drugs and 50 consecutive urine tests with the presence of illicit drugs of patients receiving controlled substances, were selected for evaluation of multiple variables of illicit drug use. They were divided into four groups with Group I with no controlled substance abuse and no illicit drug abuse with 70 patients; Group II with no controlled substance abuse, however, with positive illicit drug use with 33 patients; Group III with positive controlled abuse, however, with no illicit drug use with 30 patients; and Group IV with controlled substance abuse and illicit drug use with 17 patients., Results: Results of this study showed that of the eight variables described in a previous study in identifying controlled substance abuse, four variables were crucial. The four significant items identified in this evaluation were excessive opiate needs, deception or lying to obtain controlled substances, current or prior intentional doctor shopping, and current or prior use of illicit drugs and denial. These four variables were accurate in identifying controlled substance abuse. However, they failed to identify illicit drug use., Conclusion: The presently available and validated screening tool for controlled substance abuse failed to identify illicit drug use in patients receiving controlled substances.

Objective: To evaluate accuracy of needle placement and flow patterns of fluoroscopically guided caudal epidural injections., Design: A prospective observational study of patients with low back pain undergoing caudal epidural injections under fluoroscopy., Background: Epidural administration of corticosteroids is one of the commonly used interventions in managing chronic low back pain. Sacral or caudal epidural placement of the needle is one of the commonly used means to access the lumbar epidural space for administration of various drugs., Methods: A total of 100 consecutive patients underwent fluoroscopically guided caudal epidural injections. Needle insertion was performed blindly (without the use of fluoroscopic guidance) based on palpable landmarks, palpation of subcutaneous airflow, subjective impression that the needle was in a satisfactory position, and ease of injection of contrast. These clinical criteria were compared with the position of the needle as seen under fluoroscopy and the spread of radiopaque contrast in the epidural space. The contrast flow patterns, ventral or dorsal epidural filling, nerve root filling, and correlation of filling to the side of pain were evaluated., Results: Successful injection placement without fluoroscopic visualization was confirmed on subsequent fluoroscopic visualization in 77% of the patients. Various filling and flow patterns showed that with injection of 10 mL of contrast, filling was noted up to S1 in 70% of the patients, followed by L5 nerve root filling in 12% of the patients. Ventral epidural filling was seen in 69% of the patients, in contrast to dorsal filling in 92% of the patients. Nerve root filling correlated with leg pain in only 43% of the patients. Intravenous placement of the needle was noted in 14% of the patients with positive flashback and aspiration in 50% of the patients., Conclusion: Caudal epidural injections are ideally performed with fluoroscopic guidance as the gold standard for accurate needle placement. However, this does not assure either targeted delivery or accurate placement of the drug.

Objective: To demonstrate the effectiveness of Sarapin in prolonging the action of neural blockade with improved pain relief., Design: Prospective, continuous, double-blind trial including 500 consecutive patients undergoing either caudal epidural injections; cervical, thoracic, lumbosacral facet joint nerve blocks; and/or intercostal nerve blocks or a combination thereof., Background: Sarapin has been reported as an agent to provide pain relief without motor weakness with an excellent risk/ benefit ratio in neural blockade. Sarapin is a suspension of powdered Sarracenia purpurin (pitcher plant) in alkaline solution. Researchers theorize that the distillate contained an unidentified biological substance that potentiates the action of the ammonium ion. Modest but significant benefits were demonstrated with diagnostic blocks, with diagnostic lumbar medial branch blocks, therapeutic lumbar medial branch blocks, and caudal epidural injections. In an experimental study in the horse, no benefits were seen by injection of Sarapin. The authors proposed that there may not be any benefits in other species as well. Multiple therapeutic agents utilized in neural blockade, including local anesthetics, steroids, and neurolytic agents, have been evaluated extensively. Sarapin has not been evaluated in controlled trials., Methods: Five hundred consecutive patients undergoing either caudal epidural injections; cervical, thoracic, or lumbosacral facet joint nerve blocks; or intercostal nerve blocks or a combination thereof were included in the study. Each patient was treated with two blocks. The treatments were dou-ble-blind and prospective. Each patient acted as their own control., Results: The results showed that 500 patients received a total of 828 treatments, once with Sarapin and once without. There were no significant differences between these groups, either with pain relief measured by numeric pain scale or duration of significant relief defined as 50% or greater relief., Conclusion: This prospective, double-blind trial of 500 patients undergoing 828 treatments, one time with Sarapin and a subsequent time without, with each patient acting as their own control, showed no significant differences in the pain relief or duration of significant relief with the addition of Sarapin.

The vascular responses to neuropeptide Y (NPY) and peptide YY (PYY) were tested in several species of elasmobranchs to assess whether changes in sequence in these neuropeptides from elasmobranchs to mammals are associated with different physiological responses. NPY-like immunoreactivity was detected in the gut and in nerve fibres surrounding some, but not all, blood vessels of six species. Intravenous injection of dogfish, frog and human NPY in anaesthetised fish caused similar vasopressor effects in the three species tested, except human NPY which lowered blood pressure in one of the three. Dogfish NPY and PYY were equipotent pressor agents in two species, but PYY was significantly more potent than NPY in one species. NPY and PYY both contracted isolated gut arteries from three species, but had no effect on isolated efferent arteries tested. In conclusion, differential vascular responses in elasmobranchs are not associated with changes in NPY sequence across vertebrates, but may be with changes in PYY in some species.

Galanin is found in perivascular sympathetic neurons in a wide range of vertebrate species. In placental mammals, galanin has either no effect on blood pressure, or weak depressor effects, but in other vertebrates it has been shown to be a potent pressor agent. To investigate how extensive the vasoconstrictor effects of galanin may be in the vertebrates, the vascular effects of galanin were tested in two species of shark, Heterodontus portusjacksoni, and Hemiscyllium ocellatum, and a ray, Rhinobatos typus. Nerve fibres showing immunoreactivity to galanin were located surrounding gut blood vessels, but were absent from branchial efferent arteries in all three species. Intravenous injection of galanin caused a significant rise in caudal arterial blood pressure in H. portusjacksoni and H. ocellatum, but no change in R. typus. Contraction of segments of pancreatico-mesenteric artery were measured in an organ bath also. Galanin (10(-6) M) caused 21-38% of the maximum K+ induced contraction in all species, but no response in efferent branchial arteries from R. typus. In conclusion, in three elasmobranchs, a galanin-like peptide is present in perivascular nerve fibres, and galanin causes differential vasoconstriction in vascular beds. These data extend the number of vertebrate groups in which galanin has been shown to be a vasoconstrictor peptide.

Diverse digital methods have been advanced previously to remove power line (AC) interference in the ECG. Representative notch filters, adaptive filters and a globally derived filter are surveyed in this study; their performances are compared on artificial signals as well as actual ECGs. The ECGs, recorded at four European medical centers, are from the Common Standards in Electrocardiography (CSE) ECG tape library. AC interference in these ECGs is shown to exhibit two qualities especially relevant to filter design: considerable deviations from a nominal 50 Hz frequency and substantial noise at higher harmonics. Some criteria and useful quantitative measures are suggested to evaluate AC digital filters.

The AVA program combines a thirty-year history with an approach that remains innovative; namely: multivariate statistical analysis on orthogonal ECG leads. Its diagnostic reference base includes only diagnoses independently verified by non-ECG criteria. The diagnostic module assesses probabilities of nine alternative disease categories, based on QRS-T parameters; or four other categories in case of conduction defects. Probabilities of left or right atrial overload are also computed. The program also recognizes wall injury, T-wave abnormalities, electrolyte disturbances, myocardial ischemia, and makes differential diagnoses between strain and digitalis effects. An arrhythmia classification module can generate any of 40 rhythm statements. Signal recognition is based on the spatial velocity function. The program has been translated to a microcomputer version.

Medical information, diagnostic technology, and modes of therapeutic intervention available for treatment of head and neck cancer have increased exponentially. The concurrent explosion of microcomputer technology has created an ideal instrument for organizing, storing, and reporting the expanded data the head and neck oncologist must now consider. This paper presents the principles, design, and operation of a recently developed head and neck oncological database program (HNODB). Details of implementation on a microcomputer are also described. A historical review of currently used prominent cancer registration programs is presented. It defines the fundamental elements of cancer registration. A review of cancer registration in the United States shows that current systems have various deficiencies and have not kept pace with the evolution of diagnostics, treatments, and computer technologies. The HNODB database program, however, is a valuable model for cancer data management, for it can be applied to small or extensive data collection needs, and it provides an accurate system to identify risk factors, numbers of patients treated and types of treatment given. The program allows for rapid analysis of treatment, results, follow-up, and survival rates of patients with carcinoma of the head and neck.

Estimation procedures for baseline drift have been developed using cubic spline, polynomial, and rational functions. In a test set of 50 electrocardiograms (ECGs), each of 2.5-sec duration, baseline stability was significantly improved by application of any of these methods, except rational function approximation. Amplitude histograms of clinical ECGs after subtraction of estimated baseline distortions showed only small baseline variations over the recording period. For a quantitative validation of the estimation procedures, 10 ECGs with artificial baseline drift were constructed and analyzed by correlation and mean square error calculations. From these comparisons, the polynomial approximation emerged as the most efficient method.

Global filtering of AC interference in the digitized ECG is introduced as a new concept. Two different filters embodying a global approach are presented. One is based on a least-squares error fit, the other uses a special summation method. Both methods are compared with a local predictive filter by applying each filter to artificial signals and to real ECGs. A critical evaluation of the results is given.

In a prospective study on Coronary Heart Disease (CHD) orthogonal electrocardiograms (Frank) were recorded annually for ten years from 1,444 asymptomatic, middle-aged males with a mean age of 57.4 +/- 10.6 years. Cases with overt or suspected CHD were excluded. The purpose of the study was to identify risk indicators in electrocardiograms and to compare them with other known risk factors used for prediction of acute CHD events such as myocardial infarction (MI) and/or cardiac death (CD). Such acute events occurred in 88 cases. Pre-event ECGs of these acute events were compared with all others without events, using logistic regression analysis. Identified ECG risk indicators were then compared with other known risk factors such as smoking, blood pressure, cholesterol, age, weight, etc. The predictive power of the ECG, derived mainly from the ST-T complex, exceeded all others by a wide margin. The amplitude of the first 1/8 of the ST-T complex in lead x (similar to V5-V6) together with relative body weight proved best when one pre-event record was available. Prediction improved when ECG changes between two pre-event recordings were included. Precision of measurements by computer appeared essential for improvements in CHD prediction.

Precordial maps have been used for some 15 years to estimate the extent of myocardial injury in patients with acute anterior or lateral wall infarction. Estimates have been based on various QRS- and ST-T-derived parameters, including amplitude sum of ST elevations. Application of the electrodes, commonly 35, is cumbersome and time-consuming with the critically ill. A subset of 5 or 7 selected leads can be applied instead, and the remaining leads calculated from that subset with minimal loss of QRS and ST-T information. Maps were recorded from 100 patients within 72 hours of onset of anterior or lateral infarct. Optimal lead subsets for QRS and ST-T feature extraction were found by the sequential selection method of Lux. Subsets numbering between 2 and 15 leads were derived, with their lead-transform coefficients. Measures to estimate goodness of fit for reconstructed leads included correlations, error-to-signal ratios and root-mean-square errors. These measures were calculated separately over the QRS and ST-T complexes. Reconstructions from a 7-lead subset had a mean 0.92 correlation with ST-T in the original leads and root-mean-square error of only 0.04 mV. Sum of ST elevation differed by only 2% between original leads and reconstructions based on 5 or more leads. To confirm repeatability, lead-transform coefficients were also calculated from a training population of 50 patients and applied to the maps of the other 50.