AMERICAN ACADEMY OF PAIN MANAGEMENT S

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1 AMERICAN ACADEMY OF PAIN MANAGEMENT S 21st ANNUAL CLINICAL MEETING P O S T E R A B S T R A C T S In partnership with the Arizona Center for Integrative Medicine September 21-24, 2010 Caesars Palace Las Vegas, NV

2 Multidisciplinary Care 1. Functional outcomes of inpatient pain rehabilitation patients: a 2-year follow-up 2. Predicting early discharge from a multidisciplinary rehabilitation program: can the Battery for Health Improvement-II help? Cultural Aspects of Pain 3. BMI levels and pain indices in Hispanics with chronic pain 4. Typology of chronic pain among overweight Mexican Americans Postoperative Pain 5. Efficacy of Lidoderm patch in patients with unilateral knee replacements 6. Pulsed radio frequency energy for painful tendinopathy after surgery Interventional Treatments 7. Paraplegia following an image-guided thoracic ESI in a patient with polycythemia vera 8. Accidental intradural injection during attempted epidural block 9. Clinical outcomes of Celestone and Traumeel in facet injections for back pain Cancer Pain 10. Pain relief for Japanese patients with malignant pleural mesothelioma 11. Duration of pain relief in patients treated with radiotherapy for cancer pain Postherpetic Neuralgia 12. Gaps in the patient perception of PHN management 13. Gaps in the initial management of PHN: the BASIK PHN survey 14. Gabapentin extended release (G-ER) for the once daily treatment of PHN 15. Onset of treatment response to NGX-4010, an 8% capsaicin patch, in patients with PHN 16. Duration of treatment response to NGX-4010, an 8% capsaicin patch, in patients with PHN 17. Quality of life measures in PHN patients treated with NGX-4010, an 8% capsaicin patch: results of integrated analyses 18. Medication treatment patterns in PHN Complex Regional Pain Syndrome 19. Atypical chest pain: evidence of intercostobrachial nerve sensitization in CRPS 20. Neuropsychological deficits associated with CRPS 21. Early treatment of CRPS with peripheral nerve block and high-dose ketamine infusion 22. Pulsed-radiofrequency thermocoagulation for CRPS-II Repetitive Strain Injuries 23. Combined multimodal therapies for chronic tennis elbow: pilot study to test protocols for a randomized clinical trial Opioids 24. Psychometric measures with opioids in chronic noncancer pain 25. Oxymorphone ER vs. oxycodone CR: psychomotor and cognitive impact 26. Patient acceptability of fentanyl sublingual tablet for the treatment of breakthrough pain 27. Comparable analgesic efficacy of transdermal buprenorphine in patients under and over 65 years of age 28. BTDS improves sleep disturbances in patients with moderate-to-severe chronic pain 29. Efficacy and safety of BTDS in opioid-naïve subjects with moderate-to-severe low back pain: a double-blind study 30. Testing pain patients: drug prevalence and biomarkers 31. Prescription adherence among chronic pain patients: monitoring with the APS/AAPM clinical guidelines 32. Initial validation of an electronic version of the SOAPP -R 33. Use and benefits of topical opioids by intractable pain patients Chronic Pain Issues 34. Pulsed radiofrequency energy for intractable pain 35. Pituitary tumors and hypopituitarism in intractable pain patients 36. Development of the Pain Assessment Interview Network-Clinical Advisory System (paincas) 37. Chronic musculoskeletal pain and food intolerances: is there a link? 2 American Academy of Pain Management 21st Annual Clinical Meeting

3 Central Sensitivity Syndromes 38. Milnacipran 100 mg/day in the management of FM 39. Milnacipran efficacy in FM patients with migraine 40. Milnacipran added to pregabalin in FM patients 41. Pregabalin is cost effective for FM: United States and United Kingdom comparison 42. Efficient practices of PCPs diagnosing and treating FM 43. Understanding the diagnosis and treatment of FM: a new approach 44. Effects of sodium oxybate on FM symptoms 45. Do sleep and depression predict pain in FM? 46. Interactional schools of FM: impact on partners 47. Presence of female sexual dysfunction in patients with IC 48. Use and rating of CAM therapies in patients with IC Neuropathic Pain 49. Treatment patterns and costs of diabetic neuropathy 50. Evaluating the maintenance of effect of duloxetine in patients with DPNP 51. Resolution of TN after embolization of a CP angle AVM 52. Cavernous sinus mucoepidermoid carcinoma presenting as TN 53. Successful treatment of meralgia paresthetica with pulsed radiofrequency of the lateral femoral cutaneous nerve 54. Burden of employee neck/back pain with and without neuropathy 55. Using A-delta sensory NCTs in patients with spinal pain 56. Phantom limb pain relieved with pulsed radio frequency energy (PRFE) therapy Arthritis 57. Medial knee OA treated by insoles or braces Headache mg subcutaneous sumatriptan with an auto-injector for acute treatment of cluster headache Interventional Treatments 59. Concordance effect in lumbar epidural steroid injectio 60. Lumbar intrathecal analgesics, but not epidural analgesics, provide excellent cancer pain relief at the end of life Palliative Care 61. Using the palliative performance scale to screen for palliative consultations Nonpharmacologic Approaches 62. Energy healing and pain: a literature review 63. Concentrated fish oil delays thermal pain sensitivity 64. Whole-body, periodic acceleration relieves pain and improves vitality in chronic pain conditions 65. Recalcitrant plantar fasciitis pain relieved with pulsed radio frequency energy therapy 66. Successful pain treatment with pulsed radio frequency energy therapy in venous stasis ulcers Psychological Aspects 67. Usefulness of a 2-question coping screening tool in patients with LBP 68. Usefulness of a 2-question coping screening tool in patients with neck pain 69. Psychosocial dimensions of self-determination in chronic pain patients 70. Medication use and function in comorbid pain and PTSD 71. Biofeedback in a dual modality pain program for active duty soldiers 72. A synergistic integration of behavioral and medical approaches to managing chronic pain Physician Education 73. The role of a pain tracking tool: a survey of healthcare providers and patients 74. Primary care and pain management: an American College of Physicians quality improvement pilot study 75. Assessment of ESP online CME activities for pain physicians 76. Pain clinicians perceptions of commercial bias in CME Medicolegal Issues 77. Stolen prescription medical reports part 2: still cause for alarm Exploring the SCIENCE, Practicing the ART: Integrative Pain Management for Optimal Patient Care 3

4 Wednesday, September 22 Multidisciplinary Care 1. Functional outcomes of inpatient pain rehabilitation patients: a 2- year follow-up Presenter: Arash Nafissi, DO Authors: Arash Nafissi, DO, New York University; Syed Husian, DO, New York University; Daniel Feldman, MD, Beth Israel Medical Center; Alex Moroz, MD, New York University; Arthur Jimenez, MD, Hospital of Joint Disease, New York University; Kenneth Vitale, MD, Hospital of Joint Disease, New York University; Paul Gusmorino, MD, Hospital of Joint Disease, New York University Background: Inpatient chronic pain programs use a multidisciplinary approach to treat complex issues with the goal of obtaining longterm results. They are composed of highly specialized teams that include board-certified pain physicians, pain-specialized physical therapists (PTs) and occupational therapists (OTs), pain psychologists, rehabilitation nurses, and social workers. The approach and efficacy of these programs have been tested in numerous studies and demonstrate success. However, many continue to question the immediate cost-effectiveness without analyzing the long-term benefit. Objective: To present a case series demonstrating the importance and role that inpatient pain rehabilitation programs play in long-term recovery. Methods: We completed a 2-year follow-up of 3 complicated patients with chronic pain who completed a 10-day inpatient pain program. Each patient underwent a telephone interview at 2 years and was asked questions that focused on 4 objective outcome measures: pain level (VAS); opioid usage (quality and quantity of current opioid medications); functional restoration (Functional Independence Measure [FIM] score); and reintegration into society (ability to return to work). Results: Two patients reported continued use of opioids for pain control, but at less than half the amount used prior to the program. The lowest VAS pain score reported was 4 among all participants. With respect to functional restoration, 2 patients ambulate with an assistive device, while the other one was independent. Two patients were on disability and not working, while the other one continued a modified work schedule. All patients stated that they had developed a better overall mood. All patients felt that they would have benefitted more from a longer inpatient program. Conclusions: Continued modification of current inpatient chronic pain programs is needed to develop a better model that will produce favorable long-term outcomes and minimize the burden of care and cost of treating these patients. This study suggests that attention should be placed on accepting more qualified patients and increasing the length of stay. 2. Predicting early discharge from a multidisciplinary rehabilitation program: can the Battery for Health Improvement-II help? Presenter: Laura Krause, MS Authors: Laura Krause, MS, School of Professional Psychology, Pacific University; Kim Goodale, PsyD, Northwest Occupational Medicine Center, Portland, Oregon Background: Treatment of chronic pain within a multidisciplinary setting has been found to result in significant improvements in patient outcomes, including quality of life, pain management selfefficacy, physical functioning, and psychological well-being (1). Given the amount of financial and personnel resources necessary for multidisciplinary pain programs to operate effectively, increased understanding of which patients are less likely to successfully complete such a program is useful (2). The Battery for Health Improvement-II (BHI-II) can be used to identify a variety of issues that may inhibit a patient s progress and success in a rehabilitation program (3). Previous research has demonstrated increased psychopathology, functional complaints, defensiveness, and psychosocial stress in patients who were discharged early from multidisciplinary pain programs (4). To date, however, there have been no studies evaluating properties of the BHI-II that may be used to predict whether a patient is less likely to successfully complete a multidisciplinary pain program. Objective: To examine the use of the BHI-II in predicting successful treatment completion. Methods: The BHI-II was administered to 90 patients prior to entering a multidisciplinary pain program. The validity and clinical scales of the BHI-II best thought to reflect previous research findings were explored for their predictive value for program completion. Independent samples t-tests were calculated to explore mean group differences between patients who completed the program (n=71) and patients who did not (n=19) for the Validity, Physical Symptoms, Affective, Character, and Psychosocial scales of the BHI-II. Results: Independent samples t-tests were significant for age and the Anxiety subscale of the BHI-II. Overall, those who were more anxious (p=0.05) and younger (p=0.006) were more likely to be discharged early from the program. Conclusions: The findings of this study do not support the use of clinical scales of the BHI-II for determining who would be more or less likely to successfully complete a multidisciplinary pain program. Although the BHI-II is a useful measure for patient conceptualization and treatment planning, it should not be used as the sole tool for decisions to refer or admit a patient to a comprehensive pain program. 1. Turk DC. Clinical effectiveness and cost-effectiveness of treatments for patients with chronic pain. Clin J Pain. 2002;18(6): Clark ME. Cost-effectiveness of multidisciplinary pain treatment: are we there yet? Pain Med. 2009;10(5): Bruns D, Disorbio JM. Battery for Health Improvement 2 (manual). Minneapolis, MN: NCS Pearson, Inc; Carosella A, Lackner J, Feuerstein M. Factors associated with early discharge from a multidisciplinary work rehabilitation program for chronic low back pain. Pain. 1994;57(1): American Academy of Pain Management 21st Annual Clinical Meeting

5 Cultural Aspects of Pain 3. BMI levels and pain indices in Hispanics with chronic pain Presenter: Jordan K. Aquino, BS Authors: Jordan K. Aquino, BS, California State University, Fullerton; Dana N. Rutledge, RN, PhD, California State University, Fullerton; C. Jessie Jones, PhD, California State University, Fullerton; Patricia Cantero, PhD, Latino Health Access, Santa Ana, California; Alejandro Espinoza, MPH, Latino Health Access, Santa Ana, California; Brianne Levine, BA, California State University, Fullerton; Elizabeth Blache, California State University, Fullerton Background: Obesity and chronic pain have been associated with lower quality of life and are risk factors for other debilitating health conditions (1,2). However, research is limited on the relationship between weight and pain in the Hispanic population. Objective: To describe the relationship between body mass index (BMI) and pain indices (severity, pain troublesomeness [PT], number of sites) among ambulatory, low-income, overweight/obese Hispanic persons with chronic pain. Methods: This participatory action study involved promotores from the community who interviewed subjects in Spanish about varying health issues. Height and weight were measured using calibrated tools, allowing calculation of BMI. All interview questions were translated into Spanish using translation/back translation methods. Pain indices were intensity (0-10 numeric rating scale), PT (14-item scale, range=0-70), and number of pain sites (sum of PT scores >0 for 14 sites). Results: In this sample of 101 persons, the predominately female (80%) and Mexican American (97%) participants had an average BMI of 34.3 (World Health Organization categories: overweight, 27%; obese, 55%; extremely obese, 19%), a pain intensity of 6.84, a PT score of 28.0, and 8.4 pain sites. Associations between BMI and pain intensity were not significant (r=0.16, p=0.112), while the relationships between BMI and PT (r=0.29, p=.004) and BMI and number of pain sites (r=0.24, p=0.017) were significant. One-way ANOVAs showed nonsignificant, but important trends by BMI levels, with greater obesity associated with greater negative pain outcomes. It appears that the degree of obesity affects PT and number of pain sites more than pain intensity. Conclusions: Obesity has long been associated with an increased risk of developing multiple chronic medical conditions and chronic pain among the general population. This is the first known study to report the relationship between obesity and pain indices in a lowincome, Mexican American, Spanish-speaking population. This study provides valuable information for public health professionals and healthcare providers in determining appropriate treatment, service provisions, and prevention programs for Mexican Americans. Clinicians should consider an integrative approach and incorporate strategies to include medications and complementary modalities that address the comorbidity of excessive weight and chronic pain, and the potential underlying issues leading to these conditions. In addition, a chronic pain self-management program in Spanish with an emphasis on weight management should be developed. Disclosure: This study was funded by the Centers for Disease Control and Prevention. 1. Bryant L, Grigsby J, Swenson C, Scarbro S, Baxter J. Chronic pain increases the risk of decreasing physical performance in older adults: the San Luis Valley health and aging study. J Gerontol. 2007;62A(9): Janke EA, Collins A, Kozak AT. Overview of the relationship between pain and obesity: what do we know? Where do we go next? J Rehabil Res Dev. 2007;44(2): Typology of chronic pain among overweight Mexican Americans Presenter: C. Jessie Jones, PhD Authors: C. Jessie Jones, PhD, California State University, Fullerton; Dana N. Rutledge, RN, PhD, California State University, Fullerton; Jordan K. Aquino, BS, California State University, Fullerton; Laura Zettel-Watson, PhD, California State University, Fullerton; Patricia Cantero, PhD, Latino Health Access, Santa Ana, California; Alejandro Espinoza, MPH, Latino Health Access, Santa Ana, California; Francisca Leal, PhD, Latino Health Access, Santa Ana, California; Belinda Prado, BS, California State University, Fullerton; Connie Valencia, BS, California State University, Fullerton; Jie W. Weiss, PhD, California State University, Fullerton Background: Given the current high prevalence of both chronic pain and of obesity in the United States population, and the fact that a large number of Mexican Americans are obese (1), it is important to understand the type and severity of chronic pain in this population. Objective: To describe the location, severity, and bothersomeness of chronic pain among low-income, overweight or obese Hispanic adults with chronic pain. Methods: This participatory action study involved promotores who interviewed subjects in Spanish about varying health indices: health status; type, severity, and bothersomeness of pain; access to care; acculturation; social support; self-efficacy; psychological distress; and physical activity level. Questions were translated into Spanish using translation/back translation methods. Pain indices were intensity (0-10 numeric rating scale), pain troublesomeness (PT; 14-item scale, range=0-70), and number of pain sites (sum of PT scores >0 for 14 sites). Results: Of the 101 participants, ages 40 to 79 (M=52), most were female (80%) and born in Mexico (97%). A minority reported having rheumatoid (9%) or nonrheumatoid (13%) arthritis, fibromyalgia (2%), or neuropathies (9%), and almost half had diabetes (48%) or hypertension (45%). The mean number of pain sites was 8.4 (SD=3.3), with 87 participants reporting 5 or more locations. Pain intensity reported for the past week averaged 6.84 (SD=2.4; 0-10 scale) with 60% of subjects suffering severe pain (>7). Most participants (60%) met the American College of Rheumatology (ACR) criteria for chronic widespread pain (pain above or below the waist and on both left and right sides of the body for >3 months). The most common pain location was the head (80%), followed by the knee and upper back (both 75%), shoulder (74%), and lower back (73%). PT averaged 28, and the highest PT was related to pain in the back, knees, and shoulder; the lowest PT was related to pain in the chest, jaw or teeth, and elbow. In this sample, age was associated with the number of pain sites (r=-0.222, p=0.026), but not with other pain indices (intensity and troublesomeness). Exploring the SCIENCE, Practicing the ART: Integrative Pain Management for Optimal Patient Care 5

6 Conclusions: This study demonstrates substantial pain at multiple body sites that is bothersome to the participants. These data provide valuable information to healthcare providers for use in planning care for this high-risk Hispanic (primarily Mexican American) community. Clinicians should consider addressing the presence of musculoskeletal conditions in addition to other medical conditions that coexist with increased weight. Prescribing integrative treatments that target weight loss and reduce pain may increase quality of life in this population. Disclosure: This study was funded by the Centers for Disease Control and Prevention. Reference: 1. Flegal K, Carroll MD, Ogden CL, Curtin LR. Prevalence and trends in obesity among US adults, JAMA. 2010;303(3): Postoperative Pain 5. Efficacy of Lidoderm patch in patients with unilateral knee replacements Presenter: Arash Nafissi, DO Authors: Arash Nafissi, DO, New York University; Syed Husian, DO, New York University; Tayyaba Ahmed, DO, New York University; Daniel Feldman, MD, Beth Israel Medical Center; Stephanie Webb, DO, New York University; Alex Moroz, MD, New York University; Amit Bansil, DO, New York University; Arthur Jimenez, MD, Hospital of Joint Disease, New York University; Kenneth Vitale, MD, Hospital of Joint Disease, New York University; Paul Gusmorino, MD, Hospital of Joint Disease, New York University Background: Uncontrolled pain in postsurgical orthopedic patients hinders functional recovery. Many physicians prefer using local analgesics in postsurgical patients to avoid adverse effects of opioids. The off-label use of Lidoderm (lidocaine 5%) is common. Objective: To assess the effect of Lidoderm patches on recovery time, pain levels, and opioid use in patients with unilateral knee replacements. Methods: This is a randomized, double-blind, placebo-controlled trial and is projected to have 70 patients once completed. Patients were randomized into 2 groups: the Lidoderm patch or placebo. Patches were cut in half and placed on either side of the incision of the operated knee and placed for 12 hours on and 12 hours off each day. Both groups continued to receive their regular pain medication as needed, which included acetaminophen/codeine, acetaminophen/hydrocodone, acetaminophen 325 mg/oxycodone 5 mg, hydromorphone, tramadol, and celecoxib. Each patient s pain level was assessed twice a day (before and after therapy) and was based on a 10-point numerical analog scale. The functional use of their knee was based on the amount of active knee flexion achieved. Results: Preliminary results are promising and the Lidoderm patch appears to result in a decrease in overall pain. In addition, the daily acetaminophen 325 mg/oxycodone 5 mg consumption also appears to decrease over an average 7-day course. Conclusions: Postoperative pain control is an extremely important factor that allows for a patient s successful recovery. Improving range of motion over a shorter time period with less opioid use will help with patient s recovery and maximize the patient s time during rehabilitation. 6. Pulsed radio frequency energy for painful tendinopathy after surgery Presenter: Jane Cortez, DPM Authors: Christopher Japour, DPM, Northpoint Veterans Administration Medical Center, Northpoint, New York; Jamila Lemon, DPM, Northpoint Veterans Administration Medical Center, Northpoint, New York; Jane Cortez, DPM, Northpoint Veterans Administration Medical Center, Northpoint, New York Background: Painful tendinopathy due to overuse is common and challenging for clinicians. Histologic examination of these tendons shows poor healing, collagen degeneration, and fiber disorientation (1,2). The cells produce a weaker matrix (3). New evidence focuses on healing at a molecular level, and identifies particular molecular components that are essential to soft tissue repair. Many of these studies are specific to tendinopathies (1-4). In clinical practice, physical modalities are routinely used in the management of painful tendinopathy. Pulsed radio frequency energy (PRFE) is delivered via a medical device that pulses nonionizing radio frequency energy into soft tissue to stimulate the patient s response to inflammation and to reduce pain (5). In vitro studies indicate that PRFE triggers a large number of the growth factors and key enzymes specific to soft tissue repair (6,7). PRFE therapy is simple and conducted by the patient at home twice daily for 30 minutes. Adverse events are rare. Objective: To report 2 cases of pain resolution with PRFE therapy in patients with painful tendinopathy. Methods: Two cases where PRFE resolved pain that had failed conventional and surgical intervention were reviewed. Patient 1: A 27-year-old male presented with a 4-year history of left 5th metatarsal pain (4/10 on VAS) with increasing inability to work. He had been diagnosed with nerve entrapment and prescribed gabapentin which failed to provide relief. A tarsal tunnel release was performed. At 6 weeks postsurgery, the patient s pain remained a 6/10, requiring opioids for relief. PRFE therapy was initiated. Patient 2: A 36-year-old male presented with a 2.5-year history of left ankle pain and was diagnosed with peroneal tendinopathy with lateral ankle instability. Conventional therapies failed and a surgical repair of the tendon was performed. Increasing pain was reported at Week 4 with numbness and tingling. Gabapentin, oxycodone, and ibuprofen were prescribed. By Week 8, the patient was unable to stand more than 10 minutes without pain, tingling, or burning. The patient received an injection of 0.25% bupivacaine, and PRFE therapy was started. Results: Rapid and complete pain relief occurred in both patients. Patient 1 s pain resolved in 3 weeks and he is still pain free 8 months later. Patient 2 s pain resolved in 2 weeks and has not returned in the last year. Conclusion: These 2 cases indicate that PRFE therapy may reduce pain in tendinopathies that fail to respond to surgical and conventional treatments. Further study is warranted. Disclosure: Supported by Regenesis Biomedical, Inc. 6 American Academy of Pain Management 21st Annual Clinical Meeting

7 1. Movin T, Gad A, Reinholt FP, Rolf C. Tendon pathology in long-standing achillodynia. Biopsy findings in 40 patients. Acta Orthop Scand. 1997;68(2): Astrom M, Rausing A. Chronic Achilles tendinopathy. A survey of surgical and histopathologic findings. Clin Orthop. 1995;316: Xu Y, Murrell GA. The basic science of tendinopathy. Clin Orthop Relat Res. 2008;466(7): Sharma P, Maffulli N. Tendon injury and tendinopathy: healing and repair. J Bone Joint Surg Am. 2005;87(1): Maier M. Treatment of painful cutaneous wounds. Practical Pain Management. 2010;10(5): Moffett J GN, Ritz M, George F. Increased gene expression in cultured human dermal fibroblasts in response to a pulsed radio frequency electromagnetic field and implications in chronic wound healing. Poster presented at: 21st Annual Symposium on Advanced Wound Care; April 24-27, 2008; San Diego, CA. 7. Moffett J, Griffin N, Ritz M, George F. The effects of a pulsed radio frequency electromagnetic field on selectedgenes involved in wound repair: implications for the treatment of dermal wounds. Poster presented at: 21st Annual Symposium on Advanced Wound Care; April 24-27, 2008; San Diego, CA. Interventional Treatments 7. Paraplegia following an image-guided thoracic ESI in a patient with polycythemia vera Presenter: Arash Nafissi, DO Authors: Arash Nafissi, DO, New York University; Syed Husian, DO, New York University; Alex Moroz, MD, New York University; Ahn Jung, MD, New York University Background: Epidural steroid injections (ESIs) have been used in the treatment of both acute and chronic back pain for over 50 years. Although there is mixed evidence on the efficacy of ESIs, the adverse effects of the procedure are rare and include headache, epidural abscess, bleeding, and spinal epidural hematoma (SEH) (1). There is an estimated incidence of SEH in 1 in 200,000 of all neuraxial injections. SEH can quickly lead to cord compression and eventual ischemia of spinal nerves, even if it is evacuated in a timely manner (2). Objective: To present a case of a rare but devastating adverse effect of an ESI in a patient with a myeloproliferative disorder. Methods: A 61-year-old female presented with a history of a myeloproliferative disorder, polycythemia vera (PV), and chronic back pain. She received monthly phlebotomies for PV and had 2 previous ESIs with good relief of her back pain. After she received her third fluoroscopically-guided ESI at T3, the patient walked to a chair and sat down. Within 10 minutes, she began to develop an ascending paralysis and sensory loss. Results: The patient was taken to the emergency department and MRI revealed an acute posterior-epidural collection from C2-3 to T11, with the thoracic cord compression at T4 to T9. She underwent an emergent T1-T10 decompressive laminectomy twice for spinal epidural hematoma evacuation and re-evacuation. Nevertheless, the patient remained paraplegic, with no sensation to light touch or vibration below spinal level T4, urinary retention, and fecal incontinence. She was transferred to acute inpatient rehabilitation for over 6 weeks with no improvement. Repeat MRI demonstrated definite spinal infarction in the thoracic region. Conclusions: Although ESIs are relatively safe and efficacious, there is always risk of adverse effects. Although patients with hematologic disorders, such as PV, are more likely to have thrombotic events than bleeding manifestations, they are still possible. Therefore, the physician should carefully consider the risks and benefits before performing any procedure on these types of patients. This case emphasizes the importance of a thorough medical history and physical in order to determine any possible relative or absolute contraindications to ESIs. 1. Goodman BS, Posecion LW, Mallempati S, Bayazitoglu M. Complications and pitfalls of lumbar interlaminar and transforaminal epidural injections. Curr Rev Musculoskelet Med. 2008;1(3-4): Xu R, Bydon M, Gokaslan ZL, Wolinksy JP, Witham TF, Bydon A. Epidural steroid injection resulting in epidural hematoma in a patient despite strict adherence to anticoagulation guidelines. J Neurosurg Spine. 2009;11(3): Accidental intradural injection during attempted epidural block Presenter: Joo Sun Yun, MD Authors: Joo Sun Yun, MD, Yonsei University College of Medicine, Seoul, South Korea; Jong Bum Choi, MD, Yonsei University College of Medicine, Seoul, South Korea; Youn Woo Lee, MD, Yonsei University College of Medicine, Seoul, South Korea Background: The concept of intradural injection, which has been regarded as one form of subdural injection, has not been fully established. According to one study (1), intradural space was referred to as a 'secondary' subdural space that was identified by electron microscopy. Intradural and subdural injections both have slow onset times, but differ in that the blocking range is limited to 2 to 3 segments with intradural injection. Several cases of accidental subdural injection have been reported, but only a few of them are known to be an accidental intradural injection during an epidural block. Objective: To present a case of accidental intradural injection during an epidural block. Methods: A 68-year-old female was referred to our pain clinic with severe back pain. She had been diagnosed with rectal cancer 2 years before and underwent an operation with postoperative chemotherapy. She complained of severe back pain (VAS score of 9) and was unable to take oral analgesics due to severe nausea and vomiting. Although she was applying a 25 mcg/h fentanyl patch, it was only partially effective. On lumbar MRI, metastatic cancer was detected on T9 to L1. We injected 5 ml of contrast solution with an 18-gauge Tuohy needle at T9/10 interspaces, making sure that there was no accidental intravascular or dural puncture under C-arm guidance. The patient was then given 6 ml of 0.125% bupivacaine with 20 mg of triamcinolone. Results: Thirty minutes after injection, the patient s pain was reduced to a VAS score of 2. There were no remarkable changes in vital signs. However, we suspected subdural injection considering the slow onset, and reviewed x-ray findings.

8 Conclusions: When administrating additional volumes of local anesthetic during intradural injection, delayed spread into the subdural or subarachnoid space may occur. Therefore, caution should be taken with adding larger volumes of local anesthetics or additives when intradural space injection is suspected. Reference: 1. Reina MA, De Leon Casasola O, Lopez A, De Andres JA, Mora M, Fernandez A. The origin of the spinal subdural space: ultrastructure findings. Anesth Analg. 2002;94(4): Clinical outcomes of Celestone and Traumeel in facet injections for back pain Presenter: Cecil Graham, MD Author: Cecil Graham, MD, AZ Pain Centers, Peoria, Arizona; Reiner Kremer, NMD, MPH, AZ Pain Centers, Peoria, Arizona; Russell Erhardt, NMD, AZ Pain Centers, Peoria, Arizona Background: Traumeel (Arnica montana) is indicated for the temporary relief of musculoskeletal pain, inflammation, sports injuries, and bruising. Celestone (betamethasone sodium phosphate and betamethasone acetate injectable suspension) is indicated as an adjunctive therapy for short-term administration in synovitis of osteoarthritis and bursitis. Objective: To compare the clinical outcomes of Celestone and Traumeel in patients with chronic back pain receiving facet injections. Methods: Sixty-eight chronic back pain patients were asked to complete the Pain Disability Questionnaire (PDQ), a functional outcomes measurement tool at the onset and prior to each facet injection procedure. The PDQ tracks 15 separate and distinct elements of pain behavior and functional ability. Data collected over a 4-month period was reported for patients who had a minimum of 3 procedures treating the same complaint. A comparison was made between patients receiving a steroid solution containing Celestone (n=27) and a nonsteroidal solution containing Traumeel (n=41). Results: Preliminary results indicate that 25 patients (60.98%) treated with the Traumeel solution demonstrated statistically significant improvement in function, activities of daily living, and pain, while 8 patients (19.51%) worsened, and 8 (19.51%) demonstrated no statistically significant change. Patients treated with Celestone had comparatively lower functional outcomes: 13 patients (48.15%) demonstrated improvement; 9 patients (33.33%) worsened, and 5 (18.52%) demonstrated no statistically significant change. Conclusions: These preliminary results indicate that Traumeel improves pain and functional scores when compared with Celestone in patients with chronic back pain receiving cervical and lumbar facet injections. Cancer Pain 10. Pain relief for Japanese patients with malignant pleural mesothelioma Presenter: Hiroshi Kunikane, MD, PhD Authors: Hiroshi Kunikane, MD, PhD, Yokohama Municipal Citizen s Hospital, Yokohama, Japan; Hiroaki Okamoto, MD, PhD, Yokohama Municipal Citizen s Hospital, Yokohama, Japan; Naoya Hida, MD, Yokohama Municipal Citizen s Hospital, Yokohama, Japan; Yuuki Misumi, MD, Yokohama Municipal Citizen s Hospital, Yokohama, Japan. Background: Malignant pleural mesothelioma (MPM) has a direct association with asbestos inhalation. In Japan, it is predicted that the incidence of MPM will continue to be higher than in other countries for the next several decades due to the failure of prompt restriction on asbestos use (1). MPM is not curable in most patients, and pain relief is essential in their palliative care. The WHO algorithm, which includes prescription of NSAIDs followed by opioids and/or adjuvant analgesics, is usually applied to alleviate pain. Objective: To describe the pain and its treatment in Japanese patients with MPM. Methods: Charts from 19 patients (16 male, 3 female, median age=66) histologically diagnosed with MPM at Yokohama Municipal Citizen s Hospital from 2005 to 2009 were reviewed. Three patients were excluded from the study since they were referred to other hospitals. Results: Median survival time of the 16 patients was 480 days. Four patients had indicated pain at their first visit, and 12 patients needed medication to reduce pain. The location of the pain was confined to the primary tumor site or its direct invasion area in all patients with pain, and severe pain was not reported at the site of distant metastasis. All patients received NSAIDs, 10 also received opioids, and 6 were prescribed adjuvant analgesics. Median time from diagnosis to medication varied (NSAIDs: 6 days; opioids: 285 days; adjuvant analgesics: 201 days). Conclusions: While most patients with MPM had similar types of pain, administration of NSAIDs and opioids did not eliminate pain for every patient. Effective adjuvant analgesics should be identified to optimize success of the WHO algorithm. Reference: 1. Nishikawa K, Takahashi K, Karjalainen A, et al. Recent mortality from pleural mesothelioma, historical patterns of asbestos use, and adoption of bans: a global assessment. Environ Health Perspect. 2008;116(12): Duration of pain relief in patients treated with radiotherapy for cancer pain Presenter: Takuma Nomiya, MD, PhD Authors: Takuma Nomiya, MD, PhD, Yamagata University Hospital; Kazuhide Teruyama, MD, PhD, Yamagata University Hospital; Hitoshi Wada, MD, PhD, Yamagata University Hospital; Kenji Nemoto, MD, PhD, Yamagata University Hospital Background: Radiotherapy is useful for reducing cancer pain, but the duration of pain relief is not well known. Objective: To determine the duration of cancer pain relief from radiotherapy. Methods: Pain treated by radiotherapy was assessed prospectively using a VAS in 91 patients with bone metastases. Pain scores were measured at the irradiated sites weekly for 5 to 7 weeks after therapy began. Results: The mean pain scores were: Week 1, 7.8±1.6; Week 2, 5.3±2.5; Week 3, 3.5±2.5; Week 4, 2.4±2.5; Week 5, 1.6±2.1; and Week 6, (p<0.001). Forty-five (49%) patients had complete pain relief, and partial ( 50%) pain relief occurred in 83 (91%) patients. The mean time to obtain a 50% reduction in pain was 13 days, and the mean time to obtain complete pain relief was 24 days. 8 American Academy of Pain Management 21st Annual Clinical Meeting

9 There was a reduction in medication use in 28 (44%) patients at the end of therapy. Conclusions: Telling the approximate duration of pain relief seems to reduce patients anxiety, and knowing the duration of pain relief seems to be useful in determining optimal doses of analgesics. Encore Presentation: Nomiya T, Teruyama K, Wada H, Nemoto K. Time course of pain relief in patients treated with radiotherapy for cancer pain: a prospective study. Clin J Pain. 2010;26(1): Postherpetic Neuralgia 12. Gaps in the patient perception of PHN management Presenter: Gregory D. Salinas, PhD Authors: Gregory D. Salinas, PhD, CE Outcomes, LLC; Terry Glauser, MD, MPH, CE Outcomes; Mark Wallace, MD, University of California, San Diego; Chad Williamson, MS, CE Outcomes, LLC Background: Postherpetic neuralgia (PHN), continued pain due to herpes zoster for >3 months after resolution of the dermatomal rash, has an expected annual incidence in the United States of 100,000 to 180,000. However, there is a lack of published information on US physician practice patterns and the perceptions of patients with PHN on the management of their condition. Objective: To identify differences in perceptions of care regarding PHN, including communication patterns between patients and physicians, and levels of satisfaction with therapies and care received. Methods: In conjunction with the BASIK PHN Study (Behaviors, Attitudes, Skills, Identified gaps, and Knowledge of Postherpetic Neuralgia), a survey was distributed to US adults who had been diagnosed with herpes zoster and been prescribed medications for pain lasting at least 6 months after a shingle rash occurrence (n=142). The survey presented rating questions to assess level of agreement with statements regarding their PHN management, as well as their level of pain, what types of medications they were prescribed, and satisfaction with prescribed medications and care. Patient responses were compared to the 150 PCPs and 76 neurologist respondents from the BASIK PHN study. Results: Few patients and physicians indicated that they were satisfied with the currently available PHN treatments. While no physician agreed that they do not discuss the cause of PHN with a patient, 23% of patients indicated that their physician did not do so. Twenty-five percent of patients were not aware of the duration of PHN, side effects of treatment, or what to expect from treatment. However, less than 5% of physicians had similar perceptions. Forty-two percent of patients indicated that their physician had never discussed how PHN treatments may affect their quality of life. Almost all physicians reported discussing this with their patients at least 25% of the time. Conclusions: Physicians and patients have similar perceptions regarding PHN treatment options. However, certain gaps in communication were evident which may be attributable to lack of physician knowledge and communication skills with patients. Strategies to improve issues of expected outcomes and side effects of treatment may be useful to physicians. Disclosure: Supported by Abbott. 13. Gaps in the initial management of PHN: the BASIK PHN survey Presenter: Gregory D. Salinas, PhD Authors: Gregory D. Salinas, PhD, CE Outcomes, LLC; Terry Glauser, MD, MPH, CE Outcomes; Mark Wallace, MD, University of California, San Diego; Chad Williamson, MS, CE Outcomes, LLC Background: Postherpetic neuralgia (PHN) is continued pain due to herpes zoster for >3 months after resolution of the dermatomal rash. The expected annual incidence of PHN in the United States is 100,000 to 180,000. However, there is a lack of published information regarding the knowledge, attitudes, and practice patterns of US physicians related to management of PHN. Objective: To identify the informational needs of physicians managing patients with PHN by examining gaps between current practice patterns and evidence-based recommendations. Methods: A case-vignette survey (BASIK PHN: Behaviors, Attitudes, Skills, Identified gaps, and Knowledge of Postherpetic Neuralgia) was distributed in November 2009 to a nationally representative sample of US-practicing PCPs (n=150) and neurologists (n=76). The survey presented typical patients with PHN and included questions designed to assess how the patient would be managed. Additional questions assessed attitudes concerning available treatment and barriers to optimal patient care. Results: Less than 1 in 10 respondents indicated that they are very satisfied with the currently available PHN treatments. Only 1 in 5 physicians are very confident that an initial treatment chosen will control the patient s pain. One in 3 PCPs and 1 in 5 neurologists do not specifically tell a patient that they have PHN when initially diagnosed. When presented with a 68-year-old patient with PHN pain (VAS score of 7/10) and sleep disturbance, PCPs were more likely than neurologists to include gabapentin in initial therapy choice (p=.004). Neurologists were more likely to recommend pregabalin (p=.007). Only 16% of PCPs would refer the patient to a specialist. Major barriers to optimal management of patients with PHN include patients high expectations about the level of pain relief and dose-limiting side effects of medications. Conclusions: Most respondents did not had positive past experiences managing patients with PHN and are not very confident in the ability of currently available therapies to treat PHN pain. Information on best ways to communicate with patients about the reason for their pain as well as expected outcomes and side effects of treatment may be useful to physicians. Disclosure: Supported by Abbott. 14. Gabapentin extended release (G-ER) for the once daily treatment of PHN Presenter: Michael Sweeney, MD Authors: Christine N. Sang, MD, MPH, Brigham and Women s Hospital; Rekha Sathyanarayana, BS, RS: Depomed, Inc., Menlo Park, California; Frederick J. Carter, MS, Abbott, Marietta, Georgia; Michael Sweeney, MD, RS: Depomed, Inc., Menlo Park, California Background: Current treatment for postherpetic neuralgia (PHN) may include multiple daily doses of gabapentin immediate release and is associated with a high incidence of somnolence and cognitive side effects. Objective: To evaluate the analgesic efficacy of a once daily formulation of gabapentin (G-ER) based on gastric retentive Exploring the SCIENCE, Practicing the ART: Integrative Pain Management for Optimal Patient Care

10 extended release (ER) oral delivery technology that was developed to overcome the absorption limits of gabapentin. Methods: The safety and efficacy of G-ER were investigated in an 11-week double-blind randomized, placebo-controlled trial in subjects with PHN of 6 months to 5 years duration, reporting a baseline average daily pain intensity score 4 (Likert 0-10 scale), and without concomitant analgesics for PHN. Following 1 week of baseline assessments, subjects were randomized and titrated to either G-ER 1800 mg QD with an evening meal or matched placebo over 2 weeks, followed by 8 weeks of stable dose treatment, and 1 week of dose tapering. The primary endpoint was the change in average daily pain intensity score (primary imputation method, Baseline Observation Carried Forward [BOCF]); secondary endpoints included Patient Global Impression of Change (PGIC), Clinician Global Impression of Change (CGIC), and Sleep Interference Score. Additional secondary endpoints were evaluated posthoc. Results: A total of 452 subjects (mean age of 65.6 years, 37.6% male, BMI 29 Kg/m 2 ) were randomized in the United States (259), Russia (161), and Argentina (32). 450 subjects were included in the ITT. Baseline average daily pain intensity scores were 6.6 and 6.5 for the G-ER and placebo groups, respectively. BOCF change in average daily pain intensity score was -2.1 and -1.6, respectively (p=0.013). More G-ER-treated subjects reported much or very much improvement on PGIC (43% vs. 34%, p<0.04) and on CGIC (44% vs. 34%, p<0.03). Sleep interference was also reduced with G-ER compared to placebo (-2.3 vs , p<0.0001). G-ER was well tolerated; the most common adverse events were dizziness (11.3% vs. 1.7%) and somnolence (5.4% vs. 3.0%). Conclusions: G-ER 1800 mg given once daily is well tolerated and effective for pain relief and sleep improvement in patients with PHN. Disclosure: Supported by Depomed, Inc. Encore Presentation: 13th World Congress on Pain; August 29- September 2, 2010; Montreal, Quebec, Canada 15. Onset of treatment response to NGX-4010, an 8% capsaicin patch, in patients with PHN Presenter: Jeffrey K. Tobias, MD Authors: Gordon A. Irving, MD, Swedish Pain Center, Seattle, Washington; Miroslav Backonja, MD, University of Wisconsin- Madison; Richard Rauck, MD, the Center for Clinical Research, Winston-Salem, North Carolina; Jeffrey K. Tobias, MD, NeurogesX, Inc.; Geertrui F. Vanhove, MD, PhD, NeurogesX, Inc. Background: NGX-4010 is an 8% capsaicin patch for the treatment of neuropathic pain (NP) associated with postherpetic neuralgia (PHN). It has previously been shown to reduce pain in patients with PHN for up to 12 weeks after a single administration (1). Objective: To assess the onset of treatment response to NGX-4010 in patients with PHN. Methods: Data from four 12-week controlled studies, in which patients received either a 60-minute application of NGX-4010 (n=597) or a low-concentration capsaicin (0.04%) control patch (n=530) were integrated and analyzed to determine the onset of treatment response. This was defined as the first day with significantly (p<0.05) greater percent reductions in Numeric Pain Rating Scale (NPRS) scores from baseline in the NGX-4010 group compared to control, using a gender stratified ANCOVA with baseline pain as a covariate. The daily proportion of subjects achieving a 30% decrease or a 2 unit decrease in NPRS score was also determined, but not statistically compared between the groups. Results: Transient pain increases associated with NGX-4010 treatment returned to pretreatment levels on the evening of the treatment day (0.6% mean change in NPRS score from baseline). On Day 1, the NGX-4010 group reported pain reductions of 27.9%, similar to pain reductions in control (26.2%). As early as Day 3, significantly greater pain reductions were observed for the NGX-4010 group compared to control (29.7% vs. 24.4%, p=0.0140). Pain reductions in the NGX-4010 group were maintained and remained statistically greater than control throughout the remaining 12-week study period. As early as Day 2, and continuing throughout the remaining study period, more NGX than control patients achieved a 30% response as well as a 2 unit decrease in NPRS score from baseline. Conclusions: Pain reduction in PHN patients after treatment with NGX-4010 can be observed as early as the first few days after administration and continues for up to 12 weeks. Disclosure: Supported by NeurogesX, Inc. Reference: v 1. Backonja M, Wallace MS, Blonsky ER, et al.; NGX-4010 C116 Study Group. NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study. Lancet Neurol. 2008;7(12): Encore Presentation: American Association of Neurology; April 10-17, 2010; Toronto, Ontario, Canada 16. Duration of treatment response to NGX-4010, an 8% capsaicin patch, in patients with PHN Presenter: Lynn R. Webster, MD Authors: Lynn R. Webster, MD, Lifetree Clinical Research and Pain Clinic, Salt Lake City, Utah; T. Philip Malan, MD, University of Arizona; Michael M. Tuchman, MD, Palm Beach Neurological Center, Palm Beach Gardens, Florida; Martin D. Mollen, MD, Arizona Research Center; Jeffrey K. Tobias, MD, NeurogesX, Inc.; Biao Lu, PhD, NeurogesX, Inc.; Geertrui F. Vanhove, MD, PhD, NeurogesX, Inc. Background: NGX-4010 is an 8% capsaicin patch for the treatment of neuropathic pain (NP) associated with postherpetic neuralgia (PHN). Objective: To assess the duration of treatment response to NGX-4010 in patients with PHN. Methods: In a 2-phase PHN study, patients randomized in the double-blind, controlled phase to NGX-4010 or a low-concentration capsaicin (0.04%) control patch for 30, 60, or 90 minutes could v receive up to 3 additional 60-minute NGX-4010 treatments at least 12 weeks apart in the open-label extension phase. Patients recorded their average pain for the past 24 hours using an 11-point Numeric Pain Rating Scale (NPRS). Responders were defined as those with 2 consecutive weekly NPRS score reductions from baseline of 30% within 6 weeks after their first (double-blind or open-label) NGX treatment. Relapse was defined as 2 consecutive weekly NPRS score reductions of <20% or one NPRS score reduction of <20% followed by study dropout. Kaplan-Meier survival estimates were 10 American Academy of Pain Management 21st Annual Clinical Meeting

11 calculated for response duration, which was defined as the number of weeks between the first NGX-4010 treatment and relapse. The effects of age, PHN duration, baseline pain score, treatment area, maximum pain increase on the treatment day, gender, and concomitant systemic NP medication use on response duration were explored. Results: A total of 282 patients received NGX-4010 and 123 (44%) responded. The median response duration was 22 weeks. Seventeen patients (14%) responded for more than 40 weeks and 10 patients (8%) became and remained pain free for up to 52 weeks after treatment. Patients with lower baseline pain scores (NPRS score <5) and shorter PHN duration (<3.5 years) tended to have longer responses. Response duration was not correlated with any of the other parameters explored. Conclusions: These results suggest that a single NGX-4010 treatment can provide prolonged pain relief in patients with PHN. Disclosure: Supported by NeurogesX, Inc. Encore Presentation: Annual Scientific Meeting of the American Pain Society; May 6-8, 2010; Baltimore, MD 17. Quality of life measures in PHN patients treated with NGX-4010, an 8% capsaicin patch: results of integrated analyses Presenter: Jeffrey K. Tobias, MD Authors: Gordon A. Irving, MD, Swedish Pain Center, Seattle, Washington; Miroslav Backonja, MD, University of Wisconsin- Madison; Biao Lu, PhD, NeurogesX, Inc.; Chris Panarites, PhD, NeurogesX, Inc.; Jeffrey K. Tobias, MD, NeurogesX, Inc.; Geertrui F. Vanhove, MD, PhD, NeurogesX, Inc. Background: NGX-4010 is an 8% capsaicin patch for the treatment of neuropathic pain (NP) associated with postherpetic neuralgia (PHN). It has previously been shown to reduce pain in patients with PHN for up to 12 weeks after a single 60-minute administration (1). Objective: To evaluate response and quality of life (QOL) measures in PHN patients treated with NGX Methods: Data were integrated from 4 randomized, double-blind, 12- week controlled PHN trials that included 597 patients receiving a single 60-minute treatment with NGX-4010 and 530 patients receiving a 0.04% capsaicin control patch. Patients recorded their average pain for the past 24 hours daily using the Neuropathic Pain Rating Scale (NPRS) and completed the subject-rated Patient Global Impression of Change (PGIC) and a Self-Assessment of Treatment (SAT) questionnaire, developed by NeurogesX Inc., at study conclusion. The percent change in average NPRS score from baseline to Weeks 2 through 12 was compared between treatment groups using a gender-stratified ANCOVA model with baseline pain score as the covariate. The PGIC and SAT scores were compared using a Cochran-Mantel-Haenszel test. Results: The NGX-4010-treated group experienced a highly significant mean NPRS score reduction from baseline to Weeks 2 through 12 (31% vs. 23% in control, p<0.0001). At Week 12, 37% of NGX-4010 and 24% of control patients reported being much improved or very much improved (p<0.0001) on the PGIC. On the SAT, 55% of NGX-4010 and 43% of control patients reported much better or somewhat better pain relief (p<0.0001); 35% of NGX-4010 and 26% of control patients assessed their activity level as somewhat or much more active (p=0.0107); 42% of NGX and 32% of control patients assessed their QOL as somewhat or much better (p=0.0026). Conclusions: This integrated analysis demonstrates that a single 60- minute application of NGX-4010 significantly reduces PHN for up to 12 weeks and improves patient self-assessment of QOL. Disclosure: Supported by NeurogesX, Inc. Reference: v 1. Backonja M, Wallace MS, Blonsky ER, et al.; NGX-4010 C116 Study Group. NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study. Lancet Neurol. 2008;7(12): Encore Presentation: 13th World Congress on Pain; August 29- September 2, 2010; Montreal, Quebec, Canada 18. Medication treatment patterns in PHN Presenter: Christopher J. Panarites, PhD Authors: Christopher J. Panarites, PhD, NeurogesX, Inc.; Edward P. Armstrong, PharmD, Strategic Therapeutics, LLC; Robert H. Dworkin, PhD, University of Rochester School of Medicine and Dentistry; Sissi V. Pham, PharmD, Sissi Pham Consulting, Inc. Background: Limited data are available describing the various medications, treatment combinations, switches, and add-on therapies that are actually used in treating patients with postherpetic neuralgia (PHN). Objective: To determine treatment patterns of medications used in patients diagnosed with PHN using data aggregated from over 100 managed care organizations. Methods: A retrospective analysis of healthcare claims using the MarketScan database (Thomson Reuters) was conducted in patients diagnosed with PHN. All pharmacy claims were collected for 1 to 2 years of therapy. Medications were identified individually and by observed treatment combinations. Treatment options were categorized as first-, second-, and third-line therapies based on published treatment guidelines for neuropathic pain (NP). Results: There were 3709 patients identified with PHN and continuous eligibility. During the first year after PHN diagnosis, 21% (762) of patients received more than 4 different treatment combinations; 12% (435) received 4 treatment combinations; 15% (570) received 3 treatment combinations; 18% (679) received 2 treatment combinations; 17% (643) received one treatment combination; and 17% (620) had no pharmacy claims for the medications studied. When compared to current guideline recommendations for NP, 67% (2472) of patients received at least one first-line treatment, 69% (2541) received a second-line treatment, and 54% (1997) received a treatment categorized as not recommended. Antiepileptic medications (e.g., gabapentin) were the most common first-line treatments; opioids were the most common second-line treatments; and NSAIDs were the most common not recommended therapies. It was also observed that patients tended to receive one medication category at a time. Conclusions: This study demonstrated that it is common for patients diagnosed with PHN to receive multiple treatment combinations within the first year of diagnosis, with 66% receiving more than one treatment combination. Approximately two-thirds of patients received at least one first-line treatment; however, over half of patients received at least one not recommended medication. These Exploring the SCIENCE, Practicing the ART: Integrative Pain Management for Optimal Patient Care 11

12 data appear to indicate that therapy changes are common as clinicians and patients seek effective PHN treatments. Disclosure: Supported by NeurogesX, Inc. Complex Regional Pain Syndrome 19. Atypical chest pain: evidence of intercostobrachial nerve sensitization in CRPS Presenter: Jennifer Rasmussen, MD Authors: Jennifer Rasmussen, MD, Drexel University College of Medicine and University of Texas Health Science Center; John Grothusen, PhD, Drexel University College of Medicine; Andrea Rosso, MPH, Drexel University College of Medicine; Robert Schwartzman, MD, Drexel University College of Medicine Background: Atypical chest pain is a common complaint among complex regional pain syndrome (CRPS) patients with brachial plexus involvement. Anatomically, the intercostobrachial nerve (ICBN) is connected to the brachial plexus and innervates the axilla, medial arm, and anterior chest wall. By connecting to the brachial plexus, the ICBN could become sensitized by CRPS spread and become a source of atypical chest pain. Objective: To evaluate the sensitivity of the chest area in CRPS patients. Methods: CRPS patients (n=35) and healthy controls (n=21) volunteered to participate in the study. Each individual was examined to meet inclusion criteria. Reports of chest pain history were collected from every participant. Pressure algometry was used to measure pressure sensitivity in the axilla, anterior axillary line second intercostal space, midclavicular third rib, midclavicular tenth rib, and midsternal. Each of these measurements was compared to an intra-participant abdominal measure to control for an individual s generalized sensitivity. The ratios of chest wall sensitivities were compared between the two groups. Results: A history of chest pain was reported by a majority (94%) of CRPS patients and a minority (19%) of healthy controls. CRPS patients reported lifting their arm as a major initiating factor for chest pain. CRPS patients had significantly greater pressure algometry chest wall: abdomen sensitivity than normal controls (p<0.02). Conclusions: This study demonstrates that chest pain is greater in CRPS patients than healthy controls. The ICBN could be the source of this sensitization by CRPS spread from the brachial plexus. Encore Presentation: Rasmussen J, Grothusen J, Rosso A, Schwartzman RJ. Atypical chest pain: evidence of intercostobrachial nerve sensitization in CRPS. Pain Physician. 2009;12:E329-E Neuropsychological deficits associated with CRPS Presenter: Joel Eppig, BA Authors: David J. Libon, PhD, Drexel University College of Medicine; Robert J. Schwartzman, MD, Drexel University College of Medicine; Joel Eppig, BA, Drexel University College of Medicine; Denene Wambach, BA, Drexel University College of Medicine; Eric Brahin, MD, Drexel University College of Medicine; B. Lee Peterlin, MD, Drexel University College of Medicine; Guillermo Alexander, PhD, Drexel University College of Medicine; Atul Kalanuria, MD, Drexel University College of Medicine Background: Recent functional imaging research suggests frontal lobe involvement in complex regional pain syndrome (CRPS) (1). Objective: To elucidate the existence of neuropsychological subtypes in CRPS and find evidence for a dysexecutive CRPS subtype. Methods: CRPS patients (n=137) were administered tests that assess executive control, naming/lexical retrieval, and declarative memory. Data were subjected to a 2-step cluster analysis which does not require any a priori specification regarding the number of clusters that may be present in a data set. Results: Three neuropsychological groups were found. Group 1 obtained scores that were within normal limits on all neuropsychological tests (n=48; normal CRPS group); group 2 (n=58; dysexecutive CRPS group) presented with mild impairment on tests assessing working memory/verbal fluency; and group 3 (n=31; global CRPS group) also presented with mild dysexecutive impairment. This group also presented with moderate impairment on tests of naming and declarative memory. Between-group analyses found that the CRPS group 1 (normal group) obtained higher scores than CRPS groups 2 and 3 on all tests; however, groups 2 and 3 were equally impaired on all executive tests. CRPS group 3 (global group) displayed differential impairment on tests of naming and declarative memory compared to the other groups. Conclusions: Significant neuropsychological deficits were present in 65% of our CRPS sample. Many patients present with evidence of a dysexecutive syndrome. Some patients present with a combination of dysexecutive, naming, and memory impairment. Future research should determine the efficacy and benefit of various pharmacologic treatments in these differential CRPS patient subgroups. Reference: 1. Koffler SP, Hampstead BM, Irani F, et al. The neurocognitive effects of 5 day anesthetic ketamine for the treatment of refractory complex regional pain syndrome. Arch Clin Neuropsychol. 2007;22(6): Encore Presentation: Libon DJ, Schwartzman RJ, Eppig J, et al. Neuropsychological deficits associated with Complex Regional Pain Syndrome. J Int Neuropsychol Soc. 2010;16(3): Early treatment of CRPS with peripheral nerve block and highdose ketamine infusion Presenter: Hisani Edwards, RN Authors: Adam Everett, MD, Walter Reed Army Medical Center; Chester C. Buckenmaier, III, MD, Walter Reed Army Medical Center; Anthony R. Plunkett, Walter Reed Army Medical Center; Hisani Edwards, RN, Walter Reed Army Medical Center Background: Complex regional pain syndrome (CRPS) is a debilitating condition with generally unsatisfactory treatment options. Interplay among the central, peripheral, and sympathetic nervous systems is thought to play a role. Objective: To aggressively treat early CRPS in a United States soldier, so that she can return to duty. Methods: A 17-year-old female US Military Academy cadet in otherwise good health was initially diagnosed with CRPS-I of the right lower extremity following an ankle inversion injury. Oral medication with naproxen and gabapentin, as well as desensitization therapy, failed to provide any relief of her symptoms. A lumbar 12 American Academy of Pain Management 21st Annual Clinical Meeting

13 sympathetic block also did not result in pain relief. The patient was then admitted to the interventional pain management clinic for treatment with a continuous sciatic peripheral nerve block (ropivacaine infusion of 10 ml/h with a patient-controlled bolus of 3 ml every 20 minutes) and a concomitant high-dose (titrated to 0.6 mg/kg/h) parenteral ketamine infusion for 4 days. Progress was measured by both visual analogue scores and return to function within her military unit. Results: Treatment was successful and the patient resumed her duties as a soldier. Shortly after discharge, the patient was participating in physical therapy and running 2 miles a day. Conclusions: This case suggests therapeutic benefit from aggressive treatment of both the peripheral and central components of CRPS. Early intervention, along with simultaneous treatment aimed at preventing both central and peripheral involvement, proved successful. A randomized placebo-controlled clinical trial comparing ketamine infusion with peripheral nerve blocks and a combination of the two treatments is warranted. Long-term functional ability should be measured, as well. 22. Pulsed-radiofrequency thermocoagulation for CRPS-II Presenter: Roger Mignosa, BS, GD Authors: Roger Mignosa, BS, GD, Touro University College of Osteopathic Medicine; Claudio M. Carvalho, DO, MS, Functional Orthopedic Rehabilitation Medicine Associates, Costa Mesa, California Background: CRPS-II (causalgia) is a rare, debilitating condition that can be managed with short-term nerve blocks. Pulsedradiofrequency thermocoagulation (P-RFTC) has demonstrated effectiveness in treating neuropathic pain (NP) in the absence of neural injury or detrimental effects to the motor components in case of mixed nerves (1). Objective: To present a case of successful management of CRPS-II with P-RFTC. Methods: A 46-year-old Caucasian male presented with pain in the left hand after chemotherapy and radiation therapy for tongue squamous cell carcinoma with neck metastasis diagnosed in He sought pain management in March 2009 and had been treated with opioids and a cervical spinal cord stimulator, yet he was unable to use of his left hand. His pain (7/10 on VAS), described as a continuous pins and needles sensation with lancinating shocks, was isolated to the median nerve distribution by anesthetic block. The patient was given 3 courses of median nerve anesthetic and steroid injections and 2 treatments with P-RFTC. Results: Each P-RFTC treatment resulted in a decrease of 2 points on the VAS with an overall pain reduction from 7/10 to 3/10, consistent with results of other reported cases (2-4). His pain was reduced from constant lancinating pain to a tolerable episodic burning sensation. P-RFTC resulted in pain reduction and increased hand use for 10 months after treatment. Conclusions: This case demonstrates successful treatment of peripheral NP with mixed nerve involvement using P-RFTC. Several P-RFTC cases in the medical literature are also limited by a small number of subjects and lack control, blindness, or randomization. Although generalized indications may not be made, the pain reduction experienced by this patient suggests a need for larger group analyses. 1. Munglani R. The longer term effect of pulsed radiofrequency for neuropathic pain. Pain. 1999;80(1-2): Haider N, Mekasha D, Chiravuri S, Wasserman R. Pulsed radiofrequency of the median nerve under ultrasound guidance. Pain Physician. 2007;10(6): Philip CN, Candido KD, Joseph NJ, Crystal GJ. Successful treatment of meralgia paresthetica with pulsed radiofrequency of the lateral femoral cutaneous nerve. Pain Physician. 2009;12(5): Yadav N, Philip FA, Gogia V, et al. Radio frequency ablation in drug resistant chemotherapy-induced peripheral neuropathy: a case report and review of literature. Indian J Palliat Care. 2010;16(1): Repetitive Strain Injuries 23. Combined multimodal therapies for chronic tennis elbow: pilot study to test protocols for a randomized clinical trial Presenter: Mohsen Radpasand, DC, MD, MS Authors: Mohsen Radpasand, DC, MD, MS, D'Youville College, Buffalo, New York; Edward Owens, MS, DC, Northwestern Health Sciences University, Bloomington, Minnesota Background: Lateral epicondylitis, also known as tennis elbow, is defined as pain over the lateral aspect of the elbow that is aggravated by active wrist extension and direct palpation over the lateral epicondyle of the humerus, the radiohumeral joint space, or the proximal muscle bellies. It is the most common tendinitis and overuse injury of the elbow. There have been reports since 1882 describing the etiology, diagnosis, and treatment of lateral epicondylitis with no conclusive agreement about its management. Objective: To develop and test protocols for a randomized clinical trial (RCT) of 2 multimodal package therapies for chronic lateral epicondylitis (CLE). Methods: Six participants were enrolled after case review and randomized to 1 of 2 groups (4 in group A and 2 in group B) for 12 weeks of treatment. Group A: high-velocity-low-amplitude manipulation (HVLA), high-voltage pulse galvanic stimulation (HVPGS), counterforce bracing, ice, and exercise. Group B: ultrasound, counterforce bracing, and exercise. Both groups had suggestion to restrict usage of the affected elbow. All participants were asked to complete a visual analog scale questionnaire (VAS_24hs) and a patient-rated tennis elbow evaluation (PRTEE) every week. Pain-free grip strength (PFGS) was measured at baseline, and at Weeks 3, 6, 9, and 12. Results: One participant in group A dropped out before the end of care. Both groups demonstrated changes in all of the outcome variables from baseline to the endpoint of treatment. In group A, there was a 59% change for PRTEE total, a 3.2% change for PFGS, and a 51.4% change for VAS_24hs worst pain felt compared to 9.5%, 169.0%, and 65.1%, respectively, for group B. The painful elbow showed less strength than the nonpainful one, and there was an inverse relationship between PRTEE and PFGS. The sample size for a larger RCT calculated post ad hoc was 246 participants. Conclusions: This pilot study demonstrated that the study design is Exploring the SCIENCE, Practicing the ART: Integrative Pain Management for Optimal Patient Care

14 feasible and that patients could be recruited for a 12-week trial of multimodal treatment. A larger, multicenter trial is warranted to evaluate these treatment strategies. Disclosure: Supported by a grant from the NIH (K30-AT ). This study was conducted at the Palmer Center for Chiropractic Research (PCCR), which was constructed with support of a Research Facilities Improvement Grant (C06 RR15433) from the National Center for Research Resources at the NIH. The NCMIC provided financial support for the program, and the Chattanooga Group provided the ultrasound unit for this study. Encore Presentation: Radpasand M, Owens E. Combined multimodal therapies for chronic tennis elbow: pilot study to test protocols for a randomized clinical trial. J Manipulative Physiol Ther. 2009;32(7): Opioids 24. Psychometric measures with opioids in chronic noncancer pain Presenter: Errol M. Gould, PhD Authors: Steven P. Stanos, DO, Rehabilitation Institute of Chicago; Charles E. Argoff, MD, Albany Medical College; Gordon A. Irving, MD, Swedish Pain and Headache Center; Amy Puenpatom, PhD, Endo Pharmaceuticals Inc.; Errol M. Gould, PhD, Endo Pharmaceuticals Inc.; the OPUS Group Background: Evidence-based guidelines recommend judicious use of opioid therapy in patients with chronic noncancer pain (CNCP), including osteoarthritis (OA) and chronic low back pain (CLBP). However, clinical trials leave important knowledge gaps about longterm opioid use for CNCP, including possible changes in mental health status. The Opioid Utilization Study (OPUS) is a 1-year multicenter, prospective, observational cohort study gathering long-term data on clinical practice in opioid therapy for patients with CNCP. Objective: To evaluate the mental health characteristics of patients receiving opioid therapy for OA or CLBP over a 12-month period. Methods: OPUS enrolled patients (1302 with CLBP and 407 with OA) 18 years of age diagnosed with CNCP 3 months before enrollment and receiving or starting opioid pain therapy. Patients completed the Depression, Anxiety, and Positive Outlook Scale (DAPOS), which is designed for use in nonpsychiatric populations, at baseline, 6 months, and 12 months. DAPOS contains 11 items that are rated on a 5-point Likert-type scale (1 = Almost Never, 5 = Almost All the Time); higher scores indicate greater depression, greater anxiety, and greater positive outlook. Mean (SE) scores were calculated and summarized using frequency distributions. Results: At baseline, 84% had a history of chronic pain of >1 year and 69% had received opioid therapy for >1 year. Mean (SE) baseline DAPOS scores in patients with CLBP and OA show mild depression (2.3 [0.03] and 2.2 [0.06], respectively), mild anxiety (2.3 [0.04], 2.1 [0.06]), and moderately positive outlook (3.7 [0.03], 3.8 [0.05]). At 1 year, mean scores in CLBP and OA patients, respectively, indicated no change or slight improvement in depression (2.1 [0.05], 2.2 [0.09]), anxiety (2.0 [0.05], 2.0 [0.09]), and positive outlook (3.7 [0.04], 3.8 [0.09]). Conclusions: Patients receiving opioid therapy for CLBP or OA demonstrated stable or slightly improved depression, anxiety, and positive outlook during 6 months to 1 year of observation. Disclosure: Supported by Endo Pharmaceuticals Inc. Encore Presentation: Annual Scientific Meeting of the American Pain Society; May 6-8, 2010; Baltimore, MD 25. Oxymorphone ER vs. oxycodone CR: psychomotor and cognitive impact Presenter: Stephen McMorn, PhD Authors: Stephen McMorn, PhD, Endo Pharmaceuticals Inc.; Kerri A. Schoedel, PhD, Kendle Early Stage; Kathleen Zerbe, RN, Endo Pharmaceuticals Inc.; Bijan Chakraborty, MStat, Kendle Early Stage; Susan L. Potts, MS, Endo Pharmaceuticals Inc.; Edward M. Sellers, MD, PhD, University of Toronto Background: Opioids are effective for chronic pain that is not well controlled using other modalities, but concerns about cognitive and psychomotor effects may limit their use. Objective: To assess cognitive and psychomotor effects of equianalgesic doses of oxymorphone extended release (ER; 15 and 30 mg) and oxycodone controlled release (CR; 30 and 60 mg) in healthy, nondependent recreational opioid users. Methods: In an exploratory, randomized, double-blind, 5-way crossover study, subjects (n=40) received single oral intact doses of oxymorphone ER, oxycodone CR, and placebo (7- to 21-day washout). Cognitive and psychomotor effects were assessed using the Divided Attention test, which measures reaction time, target accuracy, and tracking accuracy using a computer simulation of a plane flying over a curvy road. Sedation was assessed using the Addiction Research Center Inventory Pentobarbital- Chlorpromazine-Alcohol Group scale and drowsiness was assessed using the bipolar Alertness/Drowsiness Visual Analog Scale. Results: Thirty-five (87.5%) subjects completed the study. At equianalgesic doses (oxymorphone 15 mg vs. oxycodone 30 mg; oxymorphone 30 mg vs. oxycodone 60 mg, respectively), least squares (LS) mean (SE) peak reaction time (hit latency, ms, longer if impaired) was (13.4) vs (13.4) (p=0.03) and (13.4) vs (13.4) (p<0.001). Peak tracking accuracy (% over road, lower if impaired) was 71.4 (2.4) vs (2.4) (p=0.007) and 69.9 (2.4) vs (2.4) (p<0.001) and peak target accuracy (target hits %, lower if impaired) was 81.0 (3.1) vs (3.1) (p=0.02) and 79.4 (3.1) vs (3.1) (p<0.001). At low and high equianalgesic doses, oxymorphone ER produced significantly less sedation and less drowsiness than oxycodone CR (sedation, higher value if more sedated: LS mean [SE] peak 6.1 [0.4] vs. 8.2 [0.4], p<0.001; 7.4 [0.4] vs. 9.4 [0.4], p<0.001; drowsiness, lower value if more drowsy: LS mean [SE] peak 35.8 [2.8] vs [2.8], p<0.001; 28.0 [2.8] vs [2.8], p<0.001). Conclusions: These exploratory data suggest that oxymorphone ER produces less psychomotor and cognitive impairment and less sedation than an equianalgesic dose of single oral intact oxycodone CR. Disclosure: Supported by Endo Pharmaceuticals Inc. Encore Presentation: Annual Scientific Meeting of the American Pain Society; May 6-8, 2010; Baltimore, MD 26. Patient acceptability of fentanyl sublingual tablet for the treatment of breakthrough pain Presenter: Julian Howell, MD Authors: Bo Lenneras, MD, Sahlgrenska Academy, Gothenburg, Sweden; Leo James, MD, Prostraken, Ltd., Galashiels, UK; 14 American Academy of Pain Management 21st Annual Clinical Meeting

15 Margareta Duberg, MSc, Orexo AB, Uppsala, Sweden; Julian Howell, MD, Prostraken, Ltd., Galashiels, UK Background: Transmucosal fentanyl preparations are a suitable choice in managing breakthrough pain (BTP) because of the rapid absorption and quick onset of pain relief. Several preparations for fentanyl delivery have been developed, including buccal effervescent, lozenge, buccal film, intranasal, and ABSTRAL TM, a sublingual orally disintegrating tablet (fentanyl ODT). The formulation must be acceptable to patients for treatment compliance. Objective: To determine patient acceptability of fentanyl ODT as part of a phase 1 PK study. Methods: Eleven opioid-tolerant patients with cancer pain were given 3 doses (100 mcg, 200 mcg, and 400 mcg) of fentanyl ODT on individual days separated by at least 1 day. A questionnaire was given after each dose that included 5 questions in order to evaluate acceptability: presence of taste and pleasantness; nature and strength of any sweet, sour, bitter, or salt taste; tendency to gag or vomit; aftertaste; and whether the patient would take fentanyl ODT long term. Results: In response to the presence of taste, patients reported the taste of fentanyl ODT as tasteless or virtually tasteless and acceptable 85% of the time, pleasant 8% of the time, and unpleasant but acceptable 6% of the time. With respect to the nature and strength of any sweet, sour, bitter, or salt taste, patients reported that it was tasteless 29% of the time, and the other responses primarily reflected a moderately sweet taste. There were no reports of a tendency to gag or vomit. In 60% of occasions, there were reports of no aftertaste; for the other 40% of cases, the maximum intensity of aftertaste was mild and lasted 1 to 30 minutes. All 11 patients provided at least one response to the question on taking fentanyl ODT long term. In total, there were 27 reports and 100% said yes to taking fentanyl ODT long term. Conclusions: Most patients reported some taste and/or aftertaste related to fentanyl ODT. The taste was not stronger than mild in intensity and all patients reported that they would be willing to continue treatment long term. These results suggest that fentanyl ODT would be broadly acceptable with regard to taste and experience of the product in the mouth to patients being treated for cancer-related BTP. Disclosure: Supported by Orexo, AB. 27. Comparable analgesic efficacy of transdermal buprenorphine in patients under and over 65 years of age Presenter: Warren Wen, PhD Authors: Warren Wen, PhD, Purdue Pharma L.P.; Shau Yu Lynch, PhD, Purdue Pharma L.P.; Catherine Munera, PhD, Purdue Pharma L.P.; Steven R. Ripa, MD, Purdue Pharma L.P. Background: Buprenorphine is a partial mu-opioid receptor agonist that has been widely used to treat acute pain and opioid dependence in the United States. Buprenorphine Transdermal System (BTDS) is a transdermal delivery system that provides continuous delivery of buprenorphine over a 7-day period. Objective: To investigate the analgesic efficacy of BTDS in subjects <65 years old and 65 years old with moderate-to-severe chronic low back pain (LBP). Methods: The efficacy of BTDS with respect to the primary efficacy endpoint from 2 double-blind 12-week studies, defined as the score for average pain over the last 24 hours at Week 12 of double-blind treatment, was analyzed separately for each study by age subgroups (<65 years old and 65 years old). Study A evaluated the superiority of BTDS 20 mcg/h (BTDS 20; n=219) and immediate-release oxycodone (40 mg/day; n=220) to BTDS 5 mcg/h (BTDS 5; n=221) in opioid-experienced subjects (subjects who had been taking mg/day of MSO4 or equivalent for 30 days prior to screening); study B compared the efficacy of BTDS 10 mcg/h and BTDS 20 mcg/h (BTDS 10/20; n=257) to placebo (n=284) in opioid-naïve subjects. Repeated-measures, mixed-effect linear model was used in both studies. The model tested treatment difference by age subgroup at Week 12, and incorporated screening mean pain and prerandomization mean pain as covariates. Results: Improvement in the average pain over the last 24 hours scores at Week 12 was greater for subjects treated with BTDS 20 compared to BTDS 5 in study A, or BTDS 10/20 compared to placebo in study B in both <65 and 65 age subgroups. Similar results were seen with immediate-release oxycodone compared with BTDS 5. In study A, the LS means at Week 12 were 3.67 (<65 years old) and 3.61 ( 65 years old) for BTDS 20. The mean decrease from baseline was 6.46 and 6.50, respectively, compared to 4.24 and 4.09 for BTDS 5 after treatment. In study B, the LS means at Week 12 for the above age subgroups were 3.75 (<65 years old) and 3.67 ( 65 years old) for BTDS 10/20. The mean decrease from baseline was 7.25 and 7.17, respectively, compared to 4.36 and 3.82 for placebo after treatment. Conclusions: The effect of BTDS is similar for younger and older patients with respect to the score for average pain over the last 24 hours after 12 weeks of treatment. Disclosure: Supported by Purdue Pharma L.P. 28. BTDS improves sleep disturbances in patients with moderate-tosevere chronic pain Presenter: Warren Wen, PhD Authors: Warren Wen, PhD, Purdue Pharma, L.P.; Shau Yu Lynch, PhD, Purdue Pharma, L.P.; Catherine Munera, PhD, Purdue Pharma, L.P.; Steven R. Ripa, MD, Purdue Pharma, L.P. Background: Sleep disturbance is often associated with chronic pain. Treatments that target chronic pain may also have an effect on sleep disturbance. Buprenorphine Transdermal System (BTDS) is a transdermal delivery system that provides continuous delivery of buprenorphine, a partial mu-opioid receptor agonist, over a 7-day period. Objective: To assess the effects of BTDS on sleep improvement in subjects with moderate-to-severe chronic low back pain (LBP). Methods: The effectiveness of BTDS with respect to MOS-Sleep Disturbance scores reduction was analyzed separately in two 12-week studies. The sleep disturbance subscale of the MOS-Sleep Scale was used in both studies and scores were obtained at screening, prerandomization, and double-blind Weeks 1, 2, 4, 8, and 12. The algorithm described by Hays et al. (1) was used to calculate the scores at each time point. Study A evaluated the superiority of BTDS 20 mcg/h (BTDS 20; n=219) and immediate-release oxycodone (40 mg/day; n=220) to BTDS 5 mcg/h (BTDS 5; n=221) in opioid-experienced subjects (subjects who had been Exploring the SCIENCE, Practicing the ART: Integrative Pain Management for Optimal Patient Care 15

16 taking mg/day of MSO4 or equivalent for 30 days prior to screening); study B compared BTDS 10 mcg/h and BTDS 20 mcg/h (BTDS 10/20; n=257) to placebo (n=284) in opioid-naïve subjects. A repeated measures mixed effects linear model was used to test the difference in sleep disturbance at Week 12. The proportion of subjects with a 30% and 50% decrease in the MOS-Sleep Disturbance scores was also analyzed. Results: In both studies, subjects treated with BTDS 20 and BTDS 10/20 showed a significant improvement in the MOS-Sleep Disturbance scores compared to BTDS 5 and placebo, respectively. In study A, immediate-release oxycodone did not demonstrate a similar benefit. The LS means at Week 12 for the BTDS 20 group were 4.55 (SE=1.805) points lower than the BTDS 5 group (p=0.012); 48.4% and 32.9% showed a 30% and 50% improvement in sleep disturbance, respectively, vs. 39.8% and 25.3%, respectively, for BTDS 5. In study B, the LS means for the BTDS 10/20 group were 3.78 (SE=1.775) points lower at Week 12 than the placebo group (p=0.033); 55.6% and 42.0% showed a 30% and 50% improvement in sleep disturbance, respectively, vs. 47.9% and 31.7%, respectively, for placebo. Conclusions: BTDS significantly reduced sleep disturbance based on the MOS Sleep Scale in subjects with moderate-to-severe chronic LBP. More definitive studies are required to confirm this suggested benefit. Disclosure: Supported by Purdue Pharma L.P. Reference: 1. Hays RD, Stewart AL. Sleep measures. In: Stewart AL, Ware JE Jr, Eds. Measuring Functioning and Well-Being: The Medical Outcomes Study Approach. Durham, NC: Duke University Press; 1992: Efficacy and safety of BTDS in opioid-naïve subjects with moderate-to-severe low back pain: a double-blind study Presenter: Deborah J. Steiner, MD Authors: Deborah J. Steiner, MD, Purdue Pharma, L.P.; Steve Sitar, MD, Orange Country Clinical Trials, Anaheim, CA; Warren Wen, PhD, Purdue Pharma, L.P.; Gosford Sawyerr, MS, Purdue Pharma, L.P.; Catherine Munera, PhD, Purdue Pharma, L.P.; Shau Yu Lynch, PhD, Purdue Pharma, L.P.; Steven R. Ripa, MD, Purdue Pharma, L.P. Background: Buprenorphine is a partial mu-opioid receptor agonist that has been widely used to treat acute pain and opioid dependence in the United States. Buprenorphine Transdermal System (BTDS) is a transdermal delivery system that provides continuous delivery of buprenorphine over a 7-day period. Objective: To evaluate the efficacy and safety of BTDS in opioid-naïve subjects with moderate-to-severe chronic low back pain (LBP). Methods: This multicenter, randomized, double-blind, placebocontrolled, parallel-group study employed an enrichment design. A total of 1024 opioid-naïve subjects received open-label BTDS in run-in and 541 were randomized to receive BTDS 10 mcg/h (BTDS 10; n=120), BTDS 20 mcg/h (BTDS 20; n=137), or matching placebo (n=284), based on tolerability and analgesic response at the end of run-in. The primary efficacy outcome, the average pain over the last 24 hours at Week 12, was analyzed using a mixed effect general linear model with repeated measures, and missing scores were imputed using a hybrid LOCF/BOCF imputation approach in which subjects who discontinued due to adverse events (AEs) were considered efficacy failures. Responder analyses were also performed. Response to treatment was evaluated by calculating the percent improvement in pain score from screening. Results: Efficacy: Treatment comparison of average pain over the last 24 hours score at Week 12 resulted in a statistically significant treatment difference of in favor of BTDS compared with placebo (p=.0104). The proportion of subjects with pain score improvement of 30% and 50% was statistically significantly larger in the BTDS group (p=.0157 and p=.005, respectively). Safety: The treatment-emergent AEs (occurring in 5% subjects) were nausea, application site rash, and headache. Serious AEs occurred in 1.2% of BTDS-treated subjects and 0.7% of placebo subjects. Clinical laboratory tests and vital signs did not reveal any apparent safety concerns. There were no deaths. Conclusions: This double-blind, 12-week, phase 3 study demonstrated the analgesic efficacy and safety of BTDS 10 and BTDS 20 for the relief of moderate-to-severe chronic LBP in opioid-naïve subjects. Disclosure: Supported by Purdue Pharma L.P. 30. Testing pain patients: drug prevalence and biomarkers Presenter: Anne DePriest, PharmD Authors: Anne DePriest, PharmD, Aegis Sciences Corporation, Nashville, Tennessee; David L. Black, PhD, Aegis Sciences Corporation and Vanderbilt University; Rebecca Heltsley, PhD, Aegis Sciences Corporation; Timothy Robert, PhD, Aegis Sciences Corporation; Beverly Cawthon, MBA, Aegis Sciences Corporation; Frank Moser, BA, Aegis Sciences Corporation; Yale H. Caplan, PhD, National Scientific Services, Baltimore, Maryland; Edward J. Cone, PhD, Johns Hopkins University Background: Chronic pain patients are frequently prescribed opioids with other psychoactive medications. Urine testing provides objective information about recent controlled and illicit drug use. Objective: To characterize drug prevalence patterns in pain patients and determine the usefulness of opioid normetabolites as biomarkers of drug use. Methods: Large databases of urine test results, confirmed by mass spectrometric methods, were evaluated for the prevalence of 32 drugs and/or metabolites in the following classes: amphetamines; barbiturates; benzodiazepines; buprenorphine; cannabis; carisoprodol; cocaine; fentanyl; meperidine; methadone; opiates; and propoxyphene. Results: In a database of patients from 31 pain clinics (1), the frequency of drug positives was as follows: opiates >> benzodiazepines > methadone > cannabinoids > carisoprodol > fentanyl > propoxyphene > barbiturates > cocaine > amphetamines > meperidine. The prevalence of illicit drug use (cannabis, cocaine, ecstasy-type drugs) was 10.9%; the prevalence of cannabis was approximately 3 times higher than cocaine. Polymedication was evident, with the frequency of multiple drug use as follows: 2, 26.4%; 3, 8.2%; 4, 4%; 5, 0.5%; 6, 0.2%; and 7, 0.02%. A database of patients (2) was evaluated for the usefulness of inclusion of opiate normetabolites in test panels. Norhydrocodone and noroxycodone were identified in 14.4% and 12.2%, respectively, of positive specimens in the absence of the parent drug. Additional studies revealed that inclusion of normetabolites increased detection 16 American Academy of Pain Management 21st Annual Clinical Meeting

17 rates as follows: buprenorphine, 10.0%; fentanyl, 42.1%; meperidine, 98.7%; methadone, 8.7%; and propoxyphene, 113.2%. Conclusions: These studies present useful information about licit and illicit drug use, including drug detection frequencies, drug/metabolite patterns, and multidrug use combinations in pain patients. The authors conclude that inclusion of tests for opioid normetabolites increases the accuracy of pain management monitoring programs. Disclosure: Supported by Aegis Sciences Corporation. 1. Cone EJ, Caplan YH, Black DL, Robert T, Moser F. Urine drug testing of chronic pain patients: licit and illicit drug patterns. J Anal Toxicol. 2008;32(8): Heltsley R, Zichterman A, Black DL, et al. Urine drug testing of chronic pain patients. II. Prevalence patterns of prescription opiates and metabolites. J Anal Toxicol. 2010;34(1): Prescription adherence among chronic pain patients: monitoring with the APS/AAPM clinical guidelines Presenter: Benjamin Baker Fore, DO Authors: Benjamin Baker Fore, DO, Interdisciplinary Pain Center, Ardmore, Oklahoma Background: The recently published APS/AAPM clinical guidelines for chronic noncancer pain have several recommendations for monitoring patients: evaluating patients with a risk assessment tool, such as the SOAPP ; stratifying patients into low-, medium-, or high-risk categories for substance abuse or misuse based on their risk assessment score; periodically obtaining urine drug tests based on the patient s assessed risk level; and scheduled physician follow-up visits. It remains to be determined if these guidelines improve prescription adherence among chronic pain patients. Objective: To determine if prescription adherence increases in chronic pain patients on opioid therapy who are monitored according to the recommendations in the clinical guidelines. Methods: Chronic pain patients on opioid therapy (n=252) were randomly selected and monitored for a 6-month period. Patients were administered the SOAPP-R at the beginning of the study, and were stratified into high-, medium-, or low-risk categories. According to the determined risk level, patients were required to have unannounced urine drug tests with unknown frequency at different intervals. Low risk: baseline, 1 month, 1 additional test; medium risk: baseline, 1 month, 2 additional tests; high risk: baseline 1 month, 6 to 12 additional tests. Additionally, any patient presenting at an office visit with aberrant behaviors were required to produce a urine sample immediately for analysis. Urine samples were analyzed by EIA, GC/MS, and UPLC/MS/MS, and results were reported using Scientifically Accurate Medication Monitoring (SAMM TM ). Results: Forty-three (17%) patients were dismissed from the study after discussing urine drug test results. Results were categorized as adherent (parent drug/metabolite(s) detected were expected based on the prescription information) or nonadherent (parent drug/metabolite(s) detected were not expected based on the prescription information). In the 6-month period, there was a 424% increase in adherency rates among the high-risk patients, a 25% increase among the mediumrisk patients, and a 14.5% increase among the low-risk patients. Conclusions: To our knowledge, this is the first study ever conducted implementing the monitoring recommendations in the APS/AAPM clinical guidelines. The results suggest that a comprehensive monitoring program with the guidelines protocol will significantly increase medication adherence in chronic pain patients on opioid therapy. 32. Initial validation of an electronic version of the SOAPP -R Presenter: Kevin Zacharoff, MD Authors: Kevin Zacharoff, MD, Inflexxion, Inc.; Stephen Butler, PhD, Inflexxion, Inc.; Sadaf Charity, MBA, Inflexxion, Inc.; Elizabeth Yiu, BA, Inflexxion, Inc.; Robert Jamison, PhD, Brigham and Women s Hospital Background: The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) is a scientifically validated screener for chronic pain patients receiving, or under consideration for, longterm opioid therapy. The SOAPP-R is increasingly being used in specialty clinics and primary care settings, and has been adopted by entire systems of care, such as Kaiser Permanente Medical Care Program. Medical practices and systems are interested in utilizing computer-administered scales with automated scoring and integrating results into their electronic medical records (EMRs). Objective: To determine the feasibility of using a computeradministered version of the SOAPP-R. Methods: Twenty-eight chronic pain patients (55% female) from a pain specialty clinic, between the ages of 34 and 63 years old, were recruited. Patients completed the standard paper and pencil SOAPP- R. One week later, patients completed the electronic SOAPP-R. Intraclass correlation (ICC) compared the 2 versions of the tool. Results: Interpretations of the magnitude of ICCs generally assume that values greater than 0.70 represent acceptable agreement. Calculations yielded an ICC of 0.83, suggesting good correspondence between the 2 versions of the SOAPP-R. Detailed results of the correspondence test will be presented, along with a sample of the electronic report format suitable for clinical review. Conclusions: An increasing number of healthcare providers are now switching to EMR systems and the electronic version of the SOAPP- R will allow for easy integration of the assessment and results into a patient s EMR. Additionally, the electronic SOAPP-R will automatically calculate the assessment score. It will offer providers decision support with a narrative description of the assessment score, as well as monitoring and treatment implications. Healthcare providers will now have the option to choose a validated electronic opioid risk assessment tool that best fits their clinical setting. Disclosure: Supported by a grant from the National Institute on Drug Abuse (NIDA), grant no. R43 DA Use and benefits of topical opioids by intractable pain patients Presenter: Forest Tennant, MD, DrPH Author: Forest Tennant, MD, DrPH, Veract Intractable Pain Clinic Background: Opioid receptors propagate in painful, inflamed peripheral tissue (1,2). Topical opioids will relieve pain when applied over these areas, even though the topical opioid does not enter the serum in detectable levels. Objective: To determine how patients self-administer and benefit from topical opioid use. Exploring the SCIENCE, Practicing the ART: Integrative Pain Management for Optimal Patient Care 17

18 Methods: Thirty-three intractable pain patients between the ages of 29 and 82 years claimed benefit from topical opioid administration, so they were surveyed through a written questionnaire to determine how they self-administered their topical opioid and the benefits of treatment. Intractable pain was present in all patients for over 2 years and was primarily caused by spine degeneration (20, 60.8%), neuropathies (8, 24.2%), or arthropathies (5, 15.2%). Patients used one of 3 opioids in the following concentrations per ounce of base cream: morphine 30 to 90 mg; oxycodone 30 to 90 mg; or hydromorphone 8 to 24 mg. Patients were issued up to 16 ounces a month and given no specific instructions relative to situation, time, or frequency of application but simply instructed to use as needed. Minimal time of topical opioid usage was 6 consecutive months. Results: All patients used their topical opioid at least once daily. Eleven (33.3%) used it routinely at the same time each day to suppress their persistent pain. Twenty-two (66.7%) used it for breakthrough pain or flares. Eight (14.2%) used it routinely and for flares. Twenty-eight (84.8%) obtained pain relief for up to 3 hours with one application. Twenty-two (61.7%) used their opioid under heat, vibrator, infrared, or ultrasound. Major benefits reported by 30% or more of patients were decreased use of one or more oral opioids, fewer or less severe flares, and less stiffness. Fewer patients reported the following benefits: more active, more sleep, improved appetite, or better self-control over pain. Conclusions: Topical opioids appear to be an inexpensive, effective, and safe adjunctive therapy to standard opioid therapy. Patients report a variety of benefits that call for more widespread trials of topical opioids. 1. Stein C. The control of pain in peripheral tissue by opioids. N Engl J Med. 1995;332(25): Tennant F, Moll D, DePaulo V. Topical morphine for peripheral pain. Lancet. 1993;342(8878): Chronic Pain Issues 34. Pulsed radiofrequency energy for intractable pain Presenter: Forest Tennant, MD, DrPH Author: Forest Tennant, MD, DrPH, Veract Intractable Pain Clinic Background: Pulsed radiofrequency energy (PRE) has recently been used for the treatment of painful surface wounds (1,2). The electromagnetic wave classified as radio is longer than ultrasound, microwave, infrared, and laser. Objective: To determine if PRE has therapeutic effects in intractable pain patients with subsurface, closed-compartment pain sites. Methods: A PRE device with a square, flat, skin surface contact approximately 8 inches on a side that delivers a pulsed wave of 27.12MHz was used in this study. Fourteen adults with severe, intractable pain on opioid therapy and who had subsurface pain sites were recruited. Initial treatment with PRE was 5 to 10 minutes, twice a day, for 30 days. If the patient felt the treatment was beneficial, they could increase the time and frequency, and continue for 90 days. PRE was administered to an additional 15 patients as an iontophoretic instrument. High potency prednisone, 20 to 40 mg in one ounce of base cream, was placed on the skin over the painful site, and a single PRE treatment was administered for 30 minutes. Results: Immediate pain relief lasting up to 4 hours occurred in 7 patients. Four (28.6%) patients felt no relief within 30 days and discontinued treatment. Seven experienced pain relief in the first 30 days and continued treatment for 2 to 8 weeks, after which the patients felt no further relief with PRE. Three (21.4%) patients had great pain relief and requested treatment after the 90-day trial period. Thirteen of the 15 patients with localized pain sites and who were treated with high potency prednisone under PRE reported immediate pain reduction, and had pain relief for up to 30 days. Conclusions: PRE provided pain relief in some severe, intractable pain patients with subsurface pain sites. PRE appeared to be very effective as an iontophoretic instrument and warrants further clinical trials. 1. Fleck CA. Managing wound pain: today and in the future. Adv Skin Wound Care. 2007;20(3):138, , Frykberg R. Cell proliferation induction: healing chronic wounds through low-energy pulsed radiofrequency. Int J Low Extrem Wounds. 2009;8(1): Pituitary tumors and hypopituitarism in intractable pain patients Presenter: Forest Tennant, MD, DrPH Author: Forest Tennant, MD, DrPH, Veract Intractable Pain Clinic Background: Severe, intractable pain in its early stages is a stressor that produces overstimulation of the pituitary-adrenal-gonadal axis, and this is manifested by elevated serum cortisol and catecholamine levels which is evidenced by tachycardia and hypertension (1,2). In late stages of severe, intractable pain, adrenal reserve may deplete as indicated by low serum cortisol. Objective: To demonstrate that pituitary tumors and hormonal insufficiencies may occur in severe, intractable pain patients. Methods: Four adult patients (3 female, 1 male) with severe, intractable pain for 8 to 18 years presented with hypopituitarism, and 3 patients had pituitary adenomas diagnosed by MRI. All patients reported that their pain had been constant, severe, and undertreated, and that they had been bedbound and unable to participate in social and vocational activities. The pain began after head and neck trauma with cervical spine degeneration in 3 patients, and arthritis and fibromyalgia in 1 patient. At the time of referral, the patients opioid daily dosage was less than 80 mg of morphine equivalence. Replacement hormones consisted of 3 or more of the following: estrogen, cortisone, testosterone, thyroid, growth hormone, and progesterone. Patients were treated with a regimen of long- and short-acting opioids, stretching exercises, various electromagnetic measures, and a high-protein diet. Opioid doses were titrated over time until the patient was able to resume normal activities of daily living. Results: With adequate pain control, there has been no further MRI evidence of pituitary tumor growth in the 3 patients with adenomas, and some hormone replacements have been eliminated or lowered in dosage. Conclusions: These cases indicate that the pituitary may attempt to respond to severe, intractable pain by accelerating hormonal production, resulting in hyperplastic tumor growth. If the stress of severe, intractable pain continues, hypopituitarism with adrenal and 18 American Academy of Pain Management 21st Annual Clinical Meeting

19 gonadal hyposecretion may result. Pain practitioners need to be aware that these serious complications may occur in severe, intractable pain patients. 1. Tennant F, Hermann L. Normalization of serum cortisol concentration with opioid treatment of severe chronic pain. Pain Med. 2002;3(2): Tennant F. Intractable pain is a severe stress state associated with hypercortisolemia and reduced adrenal reserve. Drug Alcohol Depend. 2000;60(suppl): Development of the Pain Assessment Interview Network-Clinical Advisory System (paincas) Presenter: Kevin Zacharoff, MD Authors: Kevin Zacharoff, MD, Inflexxion, Inc.; Stephen Butler, PhD, Inflexxion, Inc.; Robert Jamison, PhD, Brigham and Women s Hospital; Sadaf Charity, MBA, Inflexxion, Inc.; Elizabeth Yiu, BA, Inflexxion, Inc. Background: Treatment of chronic pain regularly addresses complicated clinical presentations, including comorbid medical conditions, psychosocial problems, and perhaps uniquely, substance use and abuse potential. Despite this complexity, treatment decisions are often based on brief clinic encounters with varying levels of clinical expertise in managing chronic pain as well as considerable clinician-related variability. These variables may result in assessment and treatment strategies that are focused on medical interventions, with less emphasis on comorbid psychosocial issues that may exacerbate pain and appropriate risk assessment. Objective: To assess how paincas can potentially provide an electronic mechanism for systematic initial and follow-up assessments of pain patients, and produce tailored provider and patient reports. Methods: Concept mapping was conducted with 36 pain treatment professionals to determine the core questions in the initial and follow-up assessments. Additionally, 53 chronic pain patients were surveyed to determine the content of the patient report and program features. Sample provider and patient reports were developed based on the provider concept mapping and patient survey results. Acceptance testing was performed with a group of healthcare providers and patients. Results: Eighty-nine percent of patients and providers rated their satisfaction with the interface on a Likert-like scale between 5 and 7. In general, providers liked the paincas program and felt that the assessments and reports would be valuable to them when treating chronic pain patients. Providers found the program to be user friendly, and said that if the program was available they would be likely to use it in clinical practice. Conclusions: Feasibility of paincas was demonstrated by its high level of acceptance by both healthcare providers and patients surveyed. Based on feedback obtained through the development process, paincas will likely provide benefits for pain assessment and treatment planning, including: standardization of practices; provision of informative reports for providers and patients; improved patientprovider communication; access to key decision support resources for providers; data analysis functionality; incorporation of validated and widely accepted opioid risk assessments; incorporation of information into EMRs; and the ability to help satisfy many of the important clinical practice components of an opioid Risk Evaluation Mitigation Strategies (REMS). Disclosure: Supported by a grant from the National Institute on Drug Abuse (NIDA), grant no. 1R43DA Chronic musculoskeletal pain and food intolerances: is there a link? Presenters: Rhonda K. Stanley, PT, PhD, CMTPT, and Victoria L. Magown, CMTPT, LMT, RMTI Authors: Rhonda K. Stanley, PT, PhD, CMTPT, Touro University Nevada; Victoria L. Magown, CMTPT, LMT, RMTI, Myofascial Rehabilitation Ctr, Ltd, Albuquerque, New Mexico Background: Food intolerances are increasingly being considered an etiology of chronic musculoskeletal pain and other disorders. Although this link has been reported in the literature since the 1920s, food intolerances continue to be overlooked (1-3). Objective: To present a case report of decreased chronic musculoskeletal joint pain after dietary change following months of multidisciplinary treatment for a complex array of symptoms. Methods: A 53-year-old female with a 20-year history of multisystem symptoms associated with pain began a 16-month series of multidisciplinary treatments for debilitating pain in the head and neck region. She was treated by a team consisting of a primary care physician (bioidenticals for perimenopausal symptoms), a certified manual trigger point therapist (44 treatments for headache and musculoskeletal pain), a chiropractor (9 treatments for C1-C2 dysfunction), a psychiatrist (5 consultations and medication for mood fluctuations and difficulty sleeping), and a physical therapist (evaluation and exercise program prescribed for muscle weakness), but reported only intermittent pain relief. During a 3-week stay with a friend who is gluten intolerant, she followed a gluten-, soy-, and preservative-free diet, and experienced a significant decrease in her symptoms. Upon returning home, she began a cleansing diet for 3 weeks. The cleansing diet was broken with an organic soy-based meal. Results: Within hours of ingesting the meal, she experienced an acute episode of severe musculoskeletal pain, difficulty with mobility, gastritis, and projectile vomiting. She self-medicated with 125 mg of antihistamine and within 30 minutes, experienced decreased pain in all muscles and joints. Subsequent self-imposed food challenges revealed sensitivities to gluten, soy, corn, and dairy products. The patient has continued a diet without milk, sugar, wheat, and soy products for the last 5 months with very little reported pain. Infrequent painful days appear to be correlated with activity or consumption of foods with gluten, soy, and dairy. Conclusions: Since this is a report of one case, the association between dietary changes and a decrease in musculoskeletal pain can only be speculated. Controlled research studies should be designed in order to more closely examine the relationship between diet and pain. Until more definitive information is available, clinicians should consider the possible links between diet and pain when treating patients, and consider recommending an anti-inflammatory diet for their patients. 1. Rowe AH. Abdominal food allergy: its history, symptomatology, diagnosis and treatment. Cal West Med. 1928;29(5): Golding DN. Is there an allergic synovitis? J R Soc Med. 1990;83(5): Exploring the SCIENCE, Practicing the ART: Integrative Pain Management for Optimal Patient Care 19

20 3. Karatay S, Erdem T, Yildirim K, et al. The effect of individualized diet challenges consisting of allergenic foods on TNF-alpha and IL-1beta levels in patients with rheumatoid arthritis. Rheumatology. 2004;43(11): Thursday, September 23 Central Sensitivity Syndromes 38. Milnacipran 100 mg/day in the management of FM Presenter: Lesley M. Arnold, MD Authors: Lesley M. Arnold, MD, University of Cincinnati; Allan Spera, MD, Forest Research Institute; R. Michael Gendreau, MD, PhD, Cypress Bioscience, Inc.; Judy Gendreau, MD, Cypress Bioscience, Inc.; Yong Wang, PhD, Forest Research Institute; Jolan Terner-Rosenthal, PhD, Forest Research Institute Background: Milnacipran is a norepinephrine and serotonin reuptake inhibitor approved in the United States for the management of fibromyalgia (FM). Previous clinical trials have demonstrated the efficacy of milnacipran doses up to 200 mg/day in treating multiple FM symptoms. Objective: To evaluate the efficacy and tolerability of milnacipran 100 mg/day for the management of FM. Methods: A total of 1025 FM patients were randomized to milnacipran 100 mg/day (n=516) or placebo (n=509). Primary outcomes included 2 multimeasure responder analyses. Two-measure composite responders had to achieve 30% improvement from baseline in pain (VAS 24-h morning recall, collected on a patient experience diary [PED]) and a rating of very much improved or much improved on the Patient Global Impression of Change (PGIC) scale. A 3-measure composite responder met the above criteria for improvements in pain and PGIC as well as a 6-point improvement from baseline in physical function (SF-36 Physical Component Summary [PCS] score). Results: After 12 weeks of stable-dose treatment, completion rates were 69.2% for milnacipran 100 mg/day and 70.5% for placebo. A significantly greater proportion of patients treated with milnacipran 100 mg/day relative to placebo met 2-measure composite responder criteria (p<0.001, BOCF) and 3-measure composite responder criteria (p<0.001, BOCF). Milnacipran treatment also resulted in significantly greater mean improvements from baseline than placebo on PED VAS 24-hour recall pain scores (-17.7 vs ; p<.001, LOCF). Similar results were observed with other pain measures, including VAS weekly recall pain (collected by PED and at visits), PED VAS real-time pain, BPI average pain severity, and BPI interference scores (all pain measures, p<0.001; LOCF). Significant improvements in mean PED 24-hour recall pain scores were observed after 1 week of double-blind treatment and were sustained throughout the stable-dose period (p<0.001, all visits after 1 week). Milnacipran treatment was superior to placebo on PGIC (p<0.001), SF-36 PCS, and mental component summary (p<0.001), Multidimensional Fatigue Inventory (p=0.036), Fibromyalgia Impact Questionnaire total (p<0.001), and Beck Depression Inventory (p=0.008) scores. Milnacipran was well tolerated by the majority of patients; nausea was the most common adverse event (36.6% vs. 20.8% for placebo). Conclusions: Treatment with milnacipran 100 mg/day improved FM pain, global status, physical and mental functioning, and fatigue. The safety profile was consistent with that observed in previous FM trials of milnacipran. Disclosure: Supported by Forest Laboratories, Inc. and Cypress Bioscience, Inc. Encore Presentation: 73rd Annual Scientific Meeting of the American College of Rheumatology; October 17-21, 2009; Philadelphia, PA 39. Milnacipran efficacy in FM patients with migraine Presenter: Alan M. Rapoport, MD Authors: Alan M. Rapoport, MD, University of California Los Angeles; R. Michael Gendreau, MD, PhD, Cypress Bioscience, Inc.; Yimin Ma, PhD, Forest Research Institute Background: Fibromyalgia (FM) is a chronic, diffuse pain disorder with widespread tenderness, allodynia, and comorbidities. The prevalence of comorbid migraine, which can be especially disabling in this population, is high (1). Milnacipran, approved for the management of FM in the United States, has demonstrated significant improvements in pain and multiple FM-related symptoms. Objective: To determine whether comorbid migraine affected the efficacy of milnacipran in the management of FM by analyzing pooled data from 3 trials. Methods: Data from 3 similarly designed double-blind, placebocontrolled trials were pooled and analyzed. Patients were randomized to placebo (n=1133), milnacipran 100 mg/day (n=1139), or milnacipran 200 mg/day (n=837). Comorbid migraine was identified at baseline by patient self-report and patient history. The efficacy of milnacipran in FM patients with and without comorbid migraine was assessed after 12 weeks of stable-dose treatment by using 3 responder analyses to measure pain and global improvements. Patients achieving a 30% improvement from baseline in VAS 24-h recall pain, collected on an electronic diary, were classified as pain responders. Patients who rated themselves very much improved or much improved on the Patient Global Impression of Change (PGIC) were classified as PGIC responders. Patients concurrently meeting requirements for pain and PGIC response were classified as 2-measure composite responders. The effect of milnacipran on migraine itself was not evaluated. Results: A total of 31.7% (987/3109) of FM patients had comorbid migraine, compared with 12% in the general population. In patients with and without comorbid migraine, significantly greater proportions of milnacipran-treated patients compared with placebo were PED responders (with migraine: 200 mg/day, 42.4%; 100 mg/day, 37.5%; placebo, 26.2%; both doses, p<0.01; without migraine: 200 mg/day, 40.3%; 100 mg/day, 43.3%; placebo, 32.3%; both doses, p<0.01). Milnacipran treatment (both doses) also resulted in significant increases in the number of PGIC and 2- measure composite responders in patients either with or without comorbid migraine (p<0.05). The treatment effects of milnacipran were similar in patients with and without migraine, with odds ratios (OC analyses) between 1.9 and 2.7. Conclusions: The efficacy of milnacipran in relieving both pain and global status in FM patients is not affected by comorbid migraine. Disclosure: Supported by Forest Laboratories, Inc. and Cypress Bioscience, Inc. 20 American Academy of Pain Management 21st Annual Clinical Meeting

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