A randomized, double-blind controlled trial of lumbar interlaminar epidural injections in central spinal stenosis: 2-year follow-up.

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.

Effect of fluoroscopically guided caudal epidural steroid or local anesthetic injections in the treatment of lumbar disc herniation and radiculitis: a randomized, controlled, double blind trial with a two-year follow-up.

BACKGROUND: Lumbar disc herniation and radiculitis are common elements of low back and lower extremity pain. Among minimally invasive treatments, epidural injections are one of the most commonly performed interventions. However, the literature is mixed about their effectiveness in managing low back and lower extremity pain. In general, individual studies and systematic reviews of epidural steroid injections have been hampered by their study design, baseline differences between treatment groups, inadequate sample sizes, highly controlled settings, lack of validated outcome measures, and the inability to confirm the injectate location because fluoroscopy was not used. STUDY DESIGN: A randomized, controlled, double blind, active control trial. SETTING: A private, interventional pain management practice, specialty referral center in the United States. OBJECTIVES: To assess the effectiveness of fluoroscopically directed caudal epidural injections with local anesthetic with or without steroids in managing chronic low back and lower extremity pain in patients with disc herniation and radiculitis. METHODS: One hundred twenty patients were randomized to two groups: Group I received 10 mL caudal epidural injections of local anesthetic, lidocaine 0.5%; Group II patients received caudal epidural injections of 0.5% lidocaine, 9 mL, mixed with 1 mL of steroid. OUTCOME ASSESSMENT: Multiple outcome measures were utilized. The primary outcome measures were Numeric Rating Scale (NRS) and the Oswestry Disability Index 2.0 (ODI). Secondary outcome measures were employment status and opioid intake. Significant pain relief improvement was defined as 50% or more improvement in NRS and ODI scores. RESULTS: In the successful category, 77% of Group I had significant pain relief of >/= 50% and functional status improvement of >/= 50% reduction in ODI scores; in Group II it was 76%, whereas overall it was 60% and 65% in Groups I and II. Over the two years, Group I had an average number of procedures of 5.5 ± 2.8; Group II was 5.3 ± 2.4. Even though there was no significant difference in overall relief between the two groups, the average relief for each procedure was superior for steroids. LIMITATIONS: Presumed limitations of this evaluation include lack of a placebo group. CONCLUSION: Caudal epidural injections of local anesthetic with or without steroids might be an effective therapy for patients with disc herniation or radiculitis. The present evidence illustrates the potential superiority of steroids compared with local anesthetic at two year follow up based on average relief per procedure. TRIAL REGISTRATION: NCT00370799.

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."

Lumbar interlaminar epidural injections in central spinal stenosis: preliminary results of a randomized, double-blind, active control trial.

BACKGROUND: Chronic, persistent low back and lower extremity pain is often caused by spinal stenosis. Surgery and other interventions, including epidural injections, have been used to relieve this pain. However, there is little in the medical literature to support interlaminar, or transforaminal epidural injections under fluoroscopy for managing lumbar pain of central spinal stenosis, while the caudal epidural approach has been studied. STUDY DESIGN: A randomized, double-blind, active, control trial. SETTING: A private, interventional pain management practice, specialty referral center in the United States. OBJECTIVE: This study sought to determine if low back and lower extremity pain secondary to lumbar central stenosis can be managed and long-lasting pain relief can be achieved with interlaminar epidural injections of local anesthetic, with or without steroids. METHODS: The study comprised 2 groups: one that received local anesthetic only and another received local anesthetic combined with nonparticulate betamethasone. A total of 120 patients were randomized by a computer-generated random allocations sequence to one of the 2 groups. The results of 30 patients in each group were assessed. OUTCOMES ASSESSMENT: Sixty patients were included in this analysis. Outcomes measurements were taken at baseline and at 3, 6, and 12 months post-treatment. Measurements taken were Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status and opioid intake. A decrease in both the NRS and ODI of  >/= 50% was considered significant. RESULTS: Significant pain relief and improvement in ODI scores were seen in both groups at 12 months. Group I's significant pain relief was 70%; Group II's was 63%. The significant ODI improvement in Group I was 70%; in Group II it was 60%. Group I patients on average received 3.8 procedures a year; Group II patients received 4.0 procedures a year in successful group. Over 52 weeks in the successful group, total relief for Group I was 40.8 ± 11.7 weeks; for Group II it was 37.1 ± 12.6 weeks. Combined pain relief and functional status improvement were seen in 80% of patients in Group I and 72% in Group II in successful group. LIMITATIONS: The lack of a placebo group and preliminary results are limitations. CONCLUSION: Patients might benefit from receiving lumbar interlaminar injections with or without steroids for lumbar central spinal stenosis. CLINICAL TRIAL: NCT00681447.

A randomized, controlled, double-blind trial of fluoroscopic caudal epidural injections in the treatment of lumbar disc herniation and radiculitis.

STUDY DESIGN: A randomized, controlled, double-blind trial. OBJECTIVE: To assess the effectiveness of fluoroscopically directed caudal epidural injections in managing chronic low back and lower extremity pain in patients with disc herniation and radiculitis with local anesthetic with or without steroids. SUMMARY OF BACKGROUND DATA: The available literature on the effectiveness of epidural injections in managing chronic low back pain secondary to disc herniation is highly variable. METHODS: One hundred twenty patients suffering with low back and lower extremity pain with disc herniation and radiculitis were randomized to one of the two groups: group I received caudal epidural injections with an injection of local anesthetic, lidocaine 0.5%, 10 mL; group II patients received caudal epidural injections with 0.5% lidocaine, 9 mL, mixed with 1 mL of steroid. The Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake were utilized with assessment at 3, 6, and 12 months posttreatment. RESULTS: The percentage of patients with significant pain relief of 50% or greater and/or improvement in functional status with 50% or more reduction in ODI scores was seen in 70% and 67% in group I and 77% and 75% in group II with average procedures per year of 3.8 ± 1.4 in group I and 3.6 + 1.1 in group II. However, the relief with first and second procedures was significantly higher in the steroid group. The number of injections performed was also higher in local anesthetic group even though overall relief was without any significant difference among the groups. There was no difference among the patients receiving steroids. CONCLUSION: Caudal epidural injection with local anesthetic with or without steroids might be effective in patients with disc herniation or radiculitis. The present evidence illustrates potential superiority of steroids compared with local anesthetic at 1-year follow-up.

A prospective evaluation of bleeding risk of interventional techniques in chronic pain.

BACKGROUND: The role of antithrombotic therapy is well known for primary and secondary prevention of cardiovascular disease to decrease the incidence of acute cerebral and cardiovascular events. Data shows that the risk of coronary thrombosis after antiplatelet drug withdrawal is much higher than that of surgical bleeding if the antiplatelet drug therapy were continued. However, it has been a common practice to discontinue antiplatelet therapy prior to performing interventional techniques, which may potentially increase the risk of acute cerebral and cardiovascular events. STUDY DESIGN: A prospective study of 3,179 patients undergoing interventional techniques with 12,000 encounters and 18,472 procedures from May 2008 to December 2009. STUDY SETTING: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. OBJECTIVE: To assess the rates of adverse events in patients undergoing interventional techniques on antithrombotic therapy with cessation or without cessation and compare them to a group of patients without antithrombotic therapy. METHODS: Measurable outcomes employed were intravascular entry of the needle, bruising, local bleeding, profuse bleeding, local hematoma, oozing, and postoperative soreness.The prospective evaluation was performed utilizing the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement which was developed with recommendations to improve the quality of reporting observational studies. RESULTS: The results of this study illustrated that in one-quarter (3,087) of patient encounters utilizing interventional pain management techniques, antithrombotic therapy was included. Among these, for approximately 55%, or 1,711 encounters, antithrombotic therapy was continued during the interventional techniques, whereas, for 45%, or 1376 encounters, antithrombotic therapy was discontinued. Overall, these results illustrate that while intravascular penetration and oozing were higher in patients with continued antithrombotic therapy, bruising and local bleeding were higher in patients with discontinued antithrombotic therapy without any difference either statistical or clinical in any of the other aspects, either intraoperative, post procedure in the recovery room, or postoperative period. LIMITATIONS: Limitations include the nonrandomized observational nature of the study and that antiplatelet therapy was limited to aspirin and clopidogrel (Plavix). CONCLUSION: No significant prevalence of adverse events was observed in those who continued with or ceased antithrombotic therapy.

Protocol for accuracy of point of care (POC) or in-office urine drug testing (immunoassay) in chronic pain patients: a prospective analysis of immunoassay and liquid chromatography tandem mass spectometry (LC/MS/MS).

BACKGROUND: Therapeutic use, overuse, abuse, and diversion of controlled substances in managing chronic non-cancer pain continues to be an issue for physicians and patients. It has been stated that physicians, along with the public and federal, state, and local government; professional associations; and pharmaceutical companies all share responsibility for preventing abuse of controlled prescription drugs. The challenge is to eliminate or significantly curtail abuse of controlled prescription drugs while still assuring the proper treatment of those patients. A number of techniques, instruments, and tools have been described to monitor controlled substance use and abuse. Thus, multiple techniques and tools available for adherence monitoring include urine drug testing in conjunction with prescription monitoring programs and other screening tests. However, urine drug testing is associated with multiple methodological flaws. Multiple authors have provided conflicting results in relation to diagnostic accuracy with differing opinions about how to monitor adherence in a non-systematic fashion. Thus far, there have not been any studies systematically assessing the diagnostic accuracy of immunoassay with laboratory testing. STUDY DESIGN: A diagnostic accuracy study of urine drug testing. STUDY SETTING: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. OBJECTIVE: To compare the information obtained by point of care (POC) or in-office urine drug testing (index test) to the information found when all drugs and analytes are tested by liquid chromatography tandem mass spectroscopy (LC/MS/MS) reference test in the same urine sample. METHODS: The study is designed to include 1,000 patients with chronic pain receiving controlled substances. The primary outcome measure is the diagnostic accuracy. Patients will be tested for various controlled substances, including opioids, benzodiazepines, and illicit drugs. The diagnostic accuracy study is performed utilizing the Standards for Reporting of Diagnostic Accuracy Studies (STARD) initiative which established reporting guidelines for diagnostic accuracy studies to improve the quality of reporting. The prototypical flow diagram of diagnostic accuracy study as described by STARD will be utilized. RESULTS: Results of diagnostic accuracy and correlation of clinical factors in relation to threshold levels, prevalence of abuse, false-positives, false-negatives, influence of other drugs, and demographic characteristics will be calculated. LIMITATIONS: The limitations include lack of availability of POC testing with lower cutoff levels. CONCLUSION: This article presents a protocol for a diagnostic accuracy study of urine drug testing. The protocol also will permit correlation of various clinical factors in relation to threshold levels, prevalence of abuse, false-positives, false-negatives, influence of other drugs, and demographic characteristics. CLINICAL TRIAL REGISTRATION: NCT 01052155.

Preliminary results of a randomized, equivalence trial of fluoroscopic caudal epidural injections in managing chronic low back pain: Part 2--Disc herniation and radiculitis.

BACKGROUND: The pathophysiology of lumbar radicular pain is a subject of ongoing research. The prevalence of sciatica or radiculitis ranges from 1.2% to 43%. Epidural injections are one of the most commonly performed interventions in the United States in managing chronic low back and lower extremity pain secondary to disc herniation and radiculitis. There is a paucity of evidence with contemporary methodology used in performing epidural injections under fluoroscopy and based on pain relief and functional status improvement. STUDY DESIGN: A randomized, double-blind, equivalence trial. SETTING: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. OBJECTIVE: To evaluate the effectiveness of caudal epidural injections with or without steroids in managing chronic low back and lower extremity pain secondary to disc herniation or radiculitis in providing effective and long-lasting pain relief and evaluate the differences between local anesthetic with or without steroids. METHODS: Patients were assigned to one of 2 groups; Group I patients received caudal epidural injections with an injection of local anesthetic (lidocaine 0.5%), whereas, Group II patients received caudal epidural injections with 0.5% lidocaine 9 mL mixed with 1 mL of steroid. Randomization was performed by computer-generated random allocations sequence by simple randomization. OUTCOMES ASSESSMENT: Multiple outcome measures were utilized which included the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3 months, 6 months, and 12 months post-treatment. Significant pain relief was defined as 50% or more, whereas significant improvement in disability score was defined as a reduction of 40% or more. RESULTS: The percentage of patients with significant pain relief of 50% or greater at 12 months was 79% in Group I and 81% in Group II. Reduction of Oswestry scores of at least 40% was seen in 83% of the patients in Group I and 91% in Group II. The overall average procedures per year were 3.9 +/- 1.26 in Group I and 3.6 +/- 1.08 in Group II with an average total relief per year of 35.2 +/- 17.18 weeks in Group I and 35.9 +/- 15.34 weeks in Group II over a period of 52 weeks. LIMITATIONS: The results of this study are limited by lack of a placebo group and a preliminary report of 42 patients in each group. CONCLUSION: Caudal epidural injections with or without steroids may be effective in patients with disc herniation or radiculitis with between 79% to 91% of patients showing significant pain relief and improvement in functional status.

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

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

Prevalence of facet joint pain in chronic low back pain in postsurgical patients by controlled comparative local anesthetic blocks.

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).

Therapeutic cervical medial branch blocks in managing chronic neck pain: a preliminary report of a randomized, double-blind, controlled trial: clinical trial NCT0033272.

BACKGROUND: Based on the criteria established by the International Association for the Study of Pain, the prevalence of persistent neck pain, secondary to involvement of cervical facet or zygapophysial joints has been described in controlled studies as varying from 54% to 67%. Intraarticular injections, medial branch nerve blocks and neurolysis of medial branch nerves have been described in managing chronic neck pain of facet joint origin. OBJECTIVES: To determine the clinical effectiveness of therapeutic cervical medial branch blocks in managing chronic neck pain of facet joint origin and to evaluate the effectiveness of the addition of Sarapin and steroids to local anesthetics. DESIGN: A double-blind, randomized, controlled 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 the 4 groups. Thirty patients were in a non-steroid group (combined Group I and II); and 30 patients were in a steroid group (combined Group III and IV). All of the patients met the diagnostic criteria of cervical facet joint pain by means of comparative, controlled diagnostic blocks. Four types of interventions were included. Group I served as control, receiving medial branch blocks using bupivacaine. Group II consisted of cervical medial branch blocks with bupivacaine and Sarapin. Group III consisted of cervical medial branch blocks with bupivacaine and betamethasone. Group IV consisted of cervical medial branch blocks with bupivacaine, Sarapin and betamethasone. OUTCOME MEASURES: Numeric pain scores, Neck Pain Disability Index, opioid intake, and work status were evaluated at baseline, 3 months, 6 months and 12 months. RESULTS: Significant pain relief (> or =50%), and functional status improvement was observed at 3 months, 6 months and 12 months. The average number of treatments for 1 year was 3.8 +/- 0.7 in the non-steroid group and 3.4 +/- 1.0 in the steroid group with no significant difference among the groups. Duration of average pain relief with each procedure was 13.4 +/- 3.5 weeks in the nonsteroid group, and it was 15.9 +/- 8.0 weeks in the steroid group with no significant difference among the groups. CONCLUSION: Therapeutic cervical medial branch nerve blocks, with or without Sarapin or steroids, may provide effective management for chronic neck pain of facet joint origin.

Controlled substance abuse and illicit drug use in chronic pain patients: An evaluation of multiple variables.

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.

Does random urine drug testing reduce illicit drug use in chronic pain patients receiving opioids?

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.

The effect of sedation on diagnostic validity of facet joint nerve blocks: an evaluation to assess similarities in population with involvement in cervical and lumbar regions (ISRCTNo: 76376497).

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.

Does adherence monitoring reduce controlled substance abuse in chronic pain patients?

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.

[ISRCTN 16558617] A randomized, controlled trial of spinal endoscopic adhesiolysis in chronic refractory low back and lower extremity 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.

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

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

The role of placebo and nocebo effects of perioperative administration of sedatives and opioids in interventional pain management.

BACKGROUND: The role of nonspecific treatment effects in the outcomes of patients receiving interventions for pain has been the subject of controversy and interest. While the administration of placebo and its effects have been widely studied, the role of placebo and nocebo effects of active agents administered prior to or during interventional techniques has not been explored. OBJECTIVES: The evaluation of placebo and nocebo effects of sodium chloride solution and active agents (midazolam and fentanyl) administered during interventional techniques. STUDY DESIGN: Randomized, placebo-controlled, evaluation. METHODS: A total of 360 patients were divided into three groups, with Group I receiving placebo, Group II receiving midazolam, and Group III receiving fentanyl. At 3 months, information was obtained with regards to their impressions or the experience of the study, compared to their previous experiences with the treatment and sedation. They were asked to rate their experience as better, worse, or no change compared to their previous experience. RESULTS: Between 13% to 30% of patients across all three groups of the study, rated their pain relief following injection as better than their previous experience. A smaller proportion, 3% to 8%, of patients in all three groups rated their experience following injection as worse than their previous experience. The majority of patients, 67% to 79%, regardless of group, described no significant differences as compared to their previous experiences with sedation and treatment for cervical or lumbar facet joint pain. CONCLUSION: In patients undergoing interventional procedures, sodium chloride solution, midazolam, and fentanyl produced placebo effects in 13% to 15%, 15% to 20%, and 18% to 30% of the patients respectively. Similarly, a nocebo effect was seen in 5% to 8% of the patients in the sodium chloride group, 8% of the patients in the midazolam group, and 3% to 8% of the patients in the fentanyl group. It is concluded that positive and negative effects may be seen either with placebo or active agents in 13% to 30% of the patients.

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

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