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State of the field survey: spinal cord stimulator use by academic pain medicine practices

Gharibo, Christopher; Laux, Gary; Forzani, Brian R; Sellars, Christopher; Kim, Eric; Zou, Shengping
OBJECTIVE: The concept of neuromodulation via the use of spinal cord stimulators (SCS) was first established over forty years ago. Since then, its popularity has grown as numerous studies have demonstrated its utility to reduce chronic pain, improve patient function, and reduce long-term health care costs. The aim of this study was to update the pain medicine community on the evolution of SCS practice trends in academic centers. DESIGN: Ninety-three pain medicine fellowship programs in the United States were identified from the Accreditation Council for Graduate Medical Education Website and were contacted to participate in an internet survey. A 37-item questionnaire was inspired by a previous study performed by Fanciullo et al. Questions focused on three main themes regarding SCS clinical application, namely demographics, education, and technical matters. RESULTS: Completed surveys were received from 50 institutions, all of which reported performing SCS interventions. Annual implants ranged from 0 to 150. Fellowship training was cited as the most valuable modality for learning implantation. Nearly all programs reported manufacturer representative participation during SCS procedures, with a minority of program directors discouraging their involvement in fellow education. SCS trials were performed exclusively on an outpatient basis. The average length for trials was 4-7 days. The most common indication for SCS implantation was failed back surgery syndrome, which also had the highest 2-year success rate. Post procedure, patients generally were followed up every 2-4 weeks for device reprogramming, which was performed by company representatives 92% of the time. CONCLUSION: Standardized SCS training is imperative as the implementation of neuromodulation therapy continues to increase.
PMID: 24138612
ISSN: 1526-2375
CID: 810862

Development of Federally Mandated Risk Evaluation and Mitigation Strategies (REMS) for Transmucosal Immediate-Release Fentanyl Products [Editorial]

Pergolizzi, Joseph V; Gharibo, Christopher G; Gudin, Jeffrey A; Nalamachu, Srinivas R
PMCID:3666085
PMID: 23464790
ISSN: 1530-7085
CID: 334322

Epidural Analgesia

Chapter by: Alabre, Frantzces; Gharibo, Christopher
in: The Anesthesia guide by Atchabahian, Arthur; Gupta, Ruchir (Eds)
New York : McGraw-Hill Medical, 2013
pp. ?-?
ISBN: 0071760490
CID: 2748422

IV PCA (Intravenous patient-controlled analgesia)

Chapter by: Verea, Vickie; Gharibo, Christopher; Doan, Lisa
in: The Anesthesia guide by Atchabahian, Arthur; Gupta, Ruchir (Eds)
New York : McGraw-Hill Medical, 2013
pp. ?-?
ISBN: 0071760490
CID: 2748822

Acute pain management of the chronic pain patient

Chapter by: Verea, Vickie; Gharibo, Christopher
in: The Anesthesia guide by Atchabahian, Arthur; Gupta, Ruchir (Eds)
New York : McGraw-Hill Medical, 2013
pp. ?-?
ISBN: 0071760490
CID: 2748832

A Randomized, Double-Blind Comparison Shows the Addition of Oxygenated Glycerol Triesters to Topical Mentholated Cream for the Treatment of Acute Musculoskeletal Pain Demonstrates Incremental Benefit Over Time

Taylor, Robert Jr; Gan, Tong J; Raffa, Robert B; Gharibo, Chris; Pappagallo, Marco; Sinclair, Nicholas R; Fleischer, Charles; Tabor, Aaron
Background: Topical analgesics are important products in the armamentarium for pain relief. Methods and Findings: This study compared a topical analgesic product containing menthol to the same product with the addition of oxygenated glycerol triesters (OGTs) (also called essential oxygen oil) in 66 healthy adult subjects with acute musculoskeletal pain. Patients were randomized in a single-center, double-blind study to receive mentholated cream (MC) only or MC containing OGTs. Patients self-reported their pain intensity, lifestyle limitations, and evaluation of the mobility of the painful joint or muscle at baseline and three times daily over a seven-day course on a 100-mm visual analog scale (VAS). Patients in both groups experienced statistically significant pain relief on Day 8 over baseline, with the MC plus OGT-treated group reporting statistically significantly greater pain relief than the MC group (P = 0.016). In addition, patients treated with the combination product experienced an incremental decrease in pain during each of the 7 days of treatment in addition, and they had lower VAS scores and greater lifestyle and mobility improvements than the MC group. Both products were well tolerated with no serious adverse events reported and no signs of significant skin reactions in either group. Conclusion: Based on this study, a MC containing OGTs is safe, effective, and provided significantly better pain relief than MC alone. The combination of oxygenated glycerol trimesters and MC provided significant pain relief and offered continued improvement in pain relief over time.
PMID: 22304620
ISSN: 1530-7085
CID: 185612

American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part I--evidence assessment [Guideline]

Manchikanti, Laxmaiah; Abdi, Salahadin; Atluri, Sairam; Balog, Carl C; Benyamin, Ramsin M; Boswell, Mark V; Brown, Keith R; Bruel, Brian M; Bryce, David A; Burks, Patricia A; Burton, Allen W; Calodney, Aaron K; Caraway, David L; Cash, Kimberly A; Christo, Paul J; Damron, Kim S; Datta, Sukdeb; Deer, Timothy R; Diwan, Sudhir; Eriator, Ike; Falco, Frank J E; Fellows, Bert; Geffert, Stephanie; Gharibo, Christopher G; Glaser, Scott E; Grider, Jay S; Hameed, Haroon; Hameed, Mariam; Hansen, Hans; Harned, Michael E; Hayek, Salim M; Helm, Standiford 2nd; Hirsch, Joshua A; Janata, Jeffrey W; Kaye, Alan D; Kaye, Adam M; Kloth, David S; Koyyalagunta, Dhanalakshmi; Lee, Marion; Malla, Yogesh; Manchikanti, Kavita N; McManus, Carla D; Pampati, Vidyasagar; Parr, Allan T; Pasupuleti, Ramarao; Patel, Vikram B; Sehgal, Nalini; Silverman, Sanford M; Singh, Vijay; Smith, Howard S; Snook, Lee T; Solanki, Daneshvari R; Tracy, Deborah H; Vallejo, Ricardo; Wargo, Bradley W
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."
PMID: 22786448
ISSN: 1533-3159
CID: 395812

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

Manchikanti, Laxmaiah; Abdi, Salahadin; Atluri, Sairam; Balog, Carl C; Benyamin, Ramsin M; Boswell, Mark V; Brown, Keith R; Bruel, Brian M; Bryce, David A; Burks, Patricia A; Burton, Allen W; Calodney, Aaron K; Caraway, David L; Cash, Kimberly A; Christo, Paul J; Damron, Kim S; Datta, Sukdeb; Deer, Timothy R; Diwan, Sudhir; Eriator, Ike; Falco, Frank J E; Fellows, Bert; Geffert, Stephanie; Gharibo, Christopher G; Glaser, Scott E; Grider, Jay S; Hameed, Haroon; Hameed, Mariam; Hansen, Hans; Harned, Michael E; Hayek, Salim M; Helm, Standiford 2nd; Hirsch, Joshua A; Janata, Jeffrey W; Kaye, Alan D; Kaye, Adam M; Kloth, David S; Koyyalagunta, Dhanalakshmi; Lee, Marion; Malla, Yogesh; Manchikanti, Kavita N; McManus, Carla D; Pampati, Vidyasagar; Parr, Allan T; Pasupuleti, Ramarao; Patel, Vikram B; Sehgal, Nalini; Silverman, Sanford M; Singh, Vijay; Smith, Howard S; Snook, Lee T; Solanki, Daneshvari R; Tracy, Deborah H; Vallejo, Ricardo; Wargo, Bradley W
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."
PMID: 22786449
ISSN: 1533-3159
CID: 395802

Dynamic risk factors in the misuse of opioid analgesics

Pergolizzi, Joseph V Jr; Gharibo, Christopher; Passik, Steven; Labhsetwar, Sumedha; Taylor, Robert Jr; Pergolizzi, Jason S; Muller-Schwefe, Gerhard
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.
PMID: 22656441
ISSN: 0022-3999
CID: 812052

Discordant provocation during transforaminal lumbosacral epidural steroid injections resulted in greater pain reduction than concordant provocation [Meeting Abstract]

Kim, E; Gharibo, C
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
EMBASE:70865847
ISSN: 1526-2375
CID: 178259