Faculty Bibliography

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."

OBJECTIVE: Identify the risk factors for prescription opioid misuse among patients taking prescription opioids to deal with chronic pain. METHODS: We examined the literature for a variety of dynamic risk factors associated with opioid misuse among the chronic pain population in order to present a narrative review. Considered were: taking single or multiple opioids, pain intensity, mental health disorders, including a history of preadolescent sexual abuse, personal and familial history of substance abuse, a history of legal problems, being a crime victim, drug-seeking behaviors, drug craving, and age. RESULTS: A variety of risk factors have been studied in the literature. Risk factors in chronic opioid therapy patients are dynamic in that they can change with disease progression, tolerance, changes in pain quality, mental health, comorbidities, other drug therapies or drug interactions, and changes in the patient's lifestyle. CONCLUSION: Opioid analgesic therapy must be tailored to carefully monitor all patients in order to minimize misuse and abuse, since the risk is constant and dynamic and therefore every patient is at some degree of risk for opioid misuse.

Objective: Determine the incidence of injection-related provocation during transforaminal epidural steroid injection and relationship between injection-related concordant versus discordant provocation and pain reduction at follow-up. Our hypothesis is that provocative concordance is a predictor of pain reduction. Method: IRBapproved study was based on patients referred to large tertiary hospital for Transforaminal Epidural Steroid Injections (TFESI). Forty-seven patients with radicular lumbosacral pain due to discal and degenerative etiology were treated with fluoroscopically guided lumbar TFESI. Subjects were administered 80mg DepoMedrol and 1cc of 0.25% bupivicaine at two separate levels and follow-up assessment. Concordant or discordant provocation were assessed during injections. The primary outcome measure was self-rated percentage of pain reduction from baseline at follow-up. Secondary outcome measures are differences in activity level and daily analgesic consumption. Results: Forty-seven subjects received fluoroscopically guided lumbar TFESI. There was 100% incidence of injection-related provocation, which was further subclassified as concordant versus discordant. At 2 weeks post-injection follow-up, discordant group achieved a statistically greater decrease in self-reported pain (76%) compared to the concordant group (58%; t = 2.1; df (45); p < 0.04). There were no statistically significant differences between concordant and discordant groups with respect to improvements in functional outcome and decreased use of daily oral pain medications. Conclusion: Incidence of provocation was 100%. Concordant provocation did not predict better outcomes. Discordant group had significantly higher self-reported pain reduction in comparison to concordant group without concomitant functional improvements and reduction in medications. Concordant provocation is not a predictor of response to TFESI

Background: Pain is one of the most undertreated healthcare problems in the world. Many patients treat their pain using a variety of OTC analgesics, such as acetaminophen, NSAIDs, and topical creams. Many topical products contain menthol, a derivative of peppermint oil, which has an analgesic effect associated with its cooling/warming sensation. It is unknown whether adding other known topical analgesics to menthol would enhance the analgesic effect. Essential oxygen oil is a novel topical preparation derived from naturally occurring ingredients that is commercially available OTC in Europe and the United States for treating minor aches and pains. In this study, the additive analgesic effect of combining essential oxygenated oil with menthol was analyzed for its effectiveness as a pain reliever. Methods: This study compared a topical analgesic product containing menthol to the same product with the addition of oxygenated glycerol triesters (OGTs) in 66 healthy adult subjects with acute musculoskeletal pain. Patients were randomized in a singlecenter, double-blind study to receive mentholated cream only (MC) or mentholated cream containing OGTs (OGT-MC) for a total of 7 days, applied three times a day. Patients self-reported their pain intensity, lifestyle limitations, and evaluated the mobility of the painful joint or muscle on a 100 mm visual analog scale. IRB approval was received before study was conducted. Results: Patients in both groups (MC and OGT-MC) experienced statistically significant pain relief on Day 8 over baseline, with the OGT-MC group reporting statistically significant greater pain relief than the MC group. Patients treated with OGT-MC experienced an incremental decrease of pain during each of the 7 days of treatment, indicating a cumulative analgesic effect due to continuous treatment. The OGT-MC group had lower VAS scores for the lifestyle and mobility examinations than the MC group. Both products were well tolerated with no serious adverse events and no signs of significant skin reactions. Conclusions: Essential oxygen oil (OGT-MC) is safe, effective, and provided significantly better pain relief than the mentholated cream alone. Continuous use of OGT-MC can be an effective alternative for other OTC treatments for reducing pain associated with minor aches or muscle pain

Background: An estimated 50 million Americans live with chronic pain brought on by disease, disorder or accident with an additional 25 million Americans suffering from acute pain. Pain is complex because it has both physical and mental components and must be assessed subjectively. Medication that is effective in one patient may not be in another. Therefore, healthcare professionals need access to a range of therapeutic options to manage pain patients. Topical preparations therefore offer a useful alternative to systemic medications like opioids and NSAIDs. Essential oxygenated oil is a novel topical analgesic currently commercially available in Europe and in the US. It has been subject of several important clinical trials and it represents an important alternative to other treatments (NSAIDs, opioids) for managing moderate to severe acute and chronic pain. Methods: Overview of the novel analgesic including review of new data, existing unpublished data and a review of the literature. Studies referring to new and existing data received IRB approval before study was conducted. Results/Conclusions: A total of 5 studies ranging from 10 to 450 patients were analyzed in order to determine the efficacy and safety of the novel topical analgesic. Pain assessment was conducted in a variety of different pain models including arthritis, post-traumatic pain, postoperative pain, tendonitis, back pain, and sprains. In addition to pain assessment, mobility and stiffness were analyzed. Based on the studies completed, essential oxygen oil has not shown any serious adverse outcomes, has demonstrated positive analgesic effects for the treatment of acute and chronic pain, and has improved oxygen content in the skin as well as other dermatological parameters

BACKGROUND: There is uncertainty in the literature over the relative effectiveness of lumbar epidural interlaminar (IL) steroid injection versus transforaminal (TF) steroid injection for lumbar radiculopathy. Most studies to date have been retrospective, or technically focused. OBJECTIVE: To complete a randomized, blinded, prospective outcome study of the short-term benefit for IL versus TF epidural steroids for the treatment of subacute lumbar radicular pain. STUDY DESIGN: Prospective, randomized, blinded, subacute efficacy trial. SETTING: Tertiary care pain management center, major metropolitan city, United States METHODS: After institutional review board approval, 42 age-matched patients with similar lower back pain and unilateral radicular symptoms were enrolled and randomized in a patient and evaluating physician blinded trial to IL or TF epidural steroids from 2007 through 2009. Prior to intervention and 10-16 days after injection, each participant was evaluated by questionnaire and physical exam by an independent physician. All injections were performed by the same physician. Thirty-eight participants completed the study, 18 in the IL group and 20 in the TF group. Four participants required a repeat injection, and 2 participants crossed over to the alternative injection type (IL to TF). RESULTS: Overall, physical exam, diagnostic testing, disability, activity, depression measures, and opioid pill use were similar between the 2 groups, both pre-injection baseline and post-injection improvement. In primary outcomes, the post-injection follow-up Numeric Rating Scale (NRS) was more greatly reduced in the TF group. The NRS decreased from 7.0 +/- 1.9 to 3.9 +/- 3.1 (mean values +/- standard deviation) in the IL group and 6.4 +/- 2.1 to 1.7 +/- 1.4 in the TF group. The Oswestry Disability Index was reduced from 37.5 +/- 12.6 to 19.0 +/- 16.7 in the IL group and 38.3 +/- 6.4 to 21.6 +/- 16.8 in the TF group. In secondary outcomes, the depression scale was reduced from 4.39 +/- 3.22 to 2.28 +/- 3.20 in the IL group and 4.10 +/- 1.94 to 1.65 +/- 1.63 in the TF group. Walking tolerance was increased from 8.1 +/- 4.6 blocks to 10.6 +/- 4.4 in the IL group and 8.9 +/- 5.3 blocks to 11.8 +/- 4.2 in the TF group. LIMITATIONS: The study did not examine long-term outcomes. A single experienced interventionalist performed all injections. CONCLUSION: Results suggest that patients may experience greater subjective relief, at least initially, from TF epidural steroid injections over IL. However, more objective, and likely subacute, therapeutic effects are similar

Argument in the literature exists over lumbar epidural interlaminar steroid injection (LESI) verses transforminal (TF) technique as the most effective therapy in lumbar radiculopathy. However, all studies to date have been retrospective. After IRB approval, 42 age matched patients with similar lower back pain and unilateral radicular symptoms were enrolled and randomized in a double blind trial to LESI or TF from 2007 to 2009. Prior to intervention and 10-16 days after injection, each patient was evaluated by patient questionnaire and physical exam by an independent physician. 38 patients completed the study, 18 in the LESI and 20 in the TF group. In both groups, 2 patients required repeat injection, and 1 patient crossed over to the alternative injection type. Overall, physical exam, diagnostic testing, disability, activity and depression measures, and opioid pill use, were similar between the 2 groups, both pre-injection baseline and post-injection improvement. The Oswestry Disability Index (ODI%) was reduced from 37.5+/-12.6 (mean values +/- standard deviation) to 19.0+/-16.7 (49.3%+/-39.2%) in the LESI group and 38.3+/-6.4 to 21.6+/-16.8 (43.7%+/-34.8%) in the TF group. Depression scale was reduced from 4.39+/-3.22 to 2.28+/-3.20 (48.1%+/-52.0%) in the LESI group and 4.10+/-1.94 to 1.65+/-1.63 (61.0%+/-39.1) in the TF group. Walking tolerance was increased from 8.1+/-4.6 blocks to 10.6+/-4.4 (30.8%+/-133.2%) in the LESI group and 8.9+/-5.3 blocks to 11.8+/-4.2 (32.8%+/-318.7%) in the TF group. The follow-up patient numerical rating scale (NRS) was more greatly reduced in the TF group. NRS decreased from 7.0+/-1.9 to 3.9+/-3.1 (44.4%+/-37.6) in the LESI group and 6.4+/-2.1 to 1.7+/-1.4 in the TF group (73.2%+/-21.3%). Overall, results suggest that patients may experience greater subjective relief, as least initially, from TF epidural steroid injections over LESI. However, more objective, and likely subacute, therapeutic effects are similar

Opioid analgesics must be prescribed with discernment and their appropriate use should be periodically assessed. Urine drug testing, although not designed specifically for this role, is a widely available and familiar method for monitoring opioid use in chronic pain patients. Urine drug testing can help track patient compliance and expose possible drug misuse and abuse. We sought to evaluate current attitudes and practices regarding the use of urine drug testing among chronic pain patients taking opioids. To the best of our knowledge, this is one of the first such attempts in the literature to examine and document the practice patterns of urine drug testing in this context. A total of 99 attendees at the American Congress of Pain Medicine were surveyed in 2008 about their urine testing practices for patients on opioid therapy. Surprisingly, more urine testing was motivated by a desire to detect undisclosed substances than to evaluate appropriate opioid use. Some respondents never urine-tested their opioid patients, and about two-thirds of respondents had no formal training in urine testing of patients on opioid therapy. The literature does not thoroughly address the role of urine drug testing in this patient population. Most respondents did random rather than scheduled testing; few had any urine testing protocol. The study found motivations for urine testing and testing practices varied widely, and urine testing, despite its clinical utility, is not used consistently.