Poster 114: Efficacy and Safety of OnabotulinumtoxinA in an Open-Label Study for the Prophylactic Treatment of Chronic Migraine in Adult Patients: COMPEL

Abstracts / PM R 9 (2017) S131-S290 Conclusions: Vertebral compression fracture can cause tension and stretch to the dorsal ramus or rami, inducing LBP. The pain relief and avoidance of surgical intervention in the patients with with thoracolumbar vertebral compression fracture can be achieved with spinal dorsal rami injection and RF neurolysis combined with stander osteoporosis therapy. Level of Evidence: Level IV Poster 113: Association of Clinical Characteristics and Response to Lumbar Epidural Steroid Injections in Subjects with Axial Low Back Pain Stephen Schaaf, MD (University of Pittsburgh Medical Center, Pittsburgh, PA, United States), Gwendolyn A. Sowa, MD, PhD, FAAPMR, Wan Huang, MD, PhD, Megan H. Cortazzo, MD, Subashan Perera, PhD Disclosures: Stephen Schaaf: I Have No Relevant Financial Relationships To Disclose Objective: Despite the frequency of interventional procedures performed for axial low back pain, selection criteria remain unclear and suboptimal to predict those that will have an improved outcome. The goal of the study was to examine the association of baseline clinical characteristics and pain improvement following lumbar epidural steroid injections (LESI) in individuals with axial low back pain. Design: Prospective Cohort Study Setting: Academic Medical Center. Participants: Subjects (n¼48) were eligible if they had primarily axial low back pain without radiating symptoms. Interventions: Patients recruited had already consented for and then underwent a LESI as part of their routine clinical care. Main Outcome Measures: Gender, age, body mass index, race, education, employment status, smoking status, Oswestry Disability Index, Roland Morris Disability, McGill Pain Questionnaire (MPQ), generalized anxiety disorder, Patient Health Questionnaire (PHQ-9), 10m-walking speed, fear avoidance beliefs questionnaire, catastrophizing, cumulative illness rating scale, prior treatments and exercise, treatment expectation, and medications were collected for baseline clinical characteristics. Pain was scored on 0-10 numeric rating scale. Pain score was taken at pre-injection and two-week follow-up. Responders to injection were defined as those who had at least a 50% reduction in their pain score at follow up. Results: At follow up, 17 subjects reported 50% or greater reduction in their pain score. Responders had a significantly lower PHQ total score, MPQ sensitive score, MPQ affective score, MPQ total score, more frequent exercise, and were less unsure about expecting pain relief following the LESI at baseline. No other significant associations were observed. Conclusions: Certain baseline clinical characteristics represent a potential opportunity to improve the clinical ability to predict response to treatment for LESI. A larger sample size with randomized study design to evaluate the ability of baseline clinical characteristics to improve clinical decision making will be needed. Level of Evidence: Level II Poster 114: Efficacy and Safety of OnabotulinumtoxinA in an Open-Label Study for the Prophylactic Treatment of Chronic Migraine in Adult Patients: COMPEL Andrew M. Blumenfeld (The Neurology Center, Carlsbad, CA, USA), Richard J. Stark, MB BS FRACP, Aubrey Manack Adams, PhD, Amelia Orejudos, MSc, Sheena K. Aurora, MD Disclosures:: Andrew Blumenfeld: Consulting fees or other remuneration (payment) - Allergan, Avanir, Teva, Pernix, Supernus, Depomed, Dentex, Zosano Pharma, GLG, Guidepoint, Autodigest

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Objective: To evaluate longer-term efficacy and safety of onabotulinumtoxinA for the treatment of chronic migraine (CM). Design: Multicenter, open-label study. Setting: Multicenter, clinic setting. Participants: Patients with CM. Interventions: OnabotulinumtoxinA 155U every 12 weeks, using a fixed-site, fixed-dose, injection paradigm. Main Outcome Measures: Primary measure: change in headache day frequency from baseline at 108 weeks (9 treatments). Secondary/ exploratory measures: headache impact test (HIT-6), 30% responder rate, Migraine Disability Assessment Questionnaire (MIDAS), and Migraine Specific Quality of Life Questionnaire (MSQ). Results: Enrolled patients (N¼716) were 18e73 years old, primarily female (n¼606, 84.8%), and Caucasian (n¼581, 81.3%). At baseline, patients reported an average 22.0 (SD¼4.82) headache days per month and 713 (99.6%) reported headaches with moderate/severe pain, with pain primarily characterized as throbbing/pulsing (n¼507, 70.8%). By 108 weeks, a significant reduction in number of headache days per month (-10.7 days, P<.0001; n¼715/716) was observed with 237 of 316 patients (75.0%) experiencing a 30% decrease in headache days from baseline. Significant improvements (P<.0001) in HIT-6 scores (-7.1 point change) also were demonstrated at 108 weeks. In addition, patients had significant improvements (P<.0001) from baseline at 108 weeks in MIDAS (-34.8 point change; n¼489/715) and MSQ domain scores (+15.2, +22.3, and +22.1 point change in role function preventive [n¼489], role function restrictive [n¼489], and emotional function [n¼487] subscales, respectively). 131 patients (18.3%) reported 1 treatment-related adverse event (TRAE); most frequently reported was neck pain (n¼29, 4.1%). One patient reported a serious TRAE (rash). No treatment-related deaths were reported. Conclusions: Progressive improvements in efficacy were observed through 108 weeks with no new safety issues. Data support the efficacy and safety of onabotulinumtoxinA for CM, up to 108 weeks (9 treatment cycles). Level of Evidence: Level IV Poster 115: A Clinician’s Perspective on Vasoactive Intestinal Peptide (VIP) as a Biomarker for the Complexity of Chronic Pain due to Osteoarthritis Vinicius Tieppo Francio, MD/PhD(c) (USAT College of Medicine MD/PhD program, Oklahoma City, OK, United States) Disclosures: Vinicius Tieppo Francio: I Have No Relevant Financial Relationships To Disclose Objective: Osteoarthritis is the most common musculoskeletal problem causing chronic pain, which is the leading cause of disability in the US. Vasoactive Intestinal Peptide (VIP) plays important roles in many biological functions, such as anti-inflammatory and immunemodulatory activity, and has been substantially connected as an important biomarker for articular inflammation and pain. The goal of this study is to briefly discuss the role of the neuroendocrine-immune interconnections and VIP in the pathophysiology of article inflammation. Design: This is a brief summary intended to inform clinicians in the field of chronic pain and osteoarthritis regarding the pathophysiological connections and biomarker role of VIP and articular inflammation due to OA. Setting: Not applicable. Participants: Not applicable. Interventions: Not applicable. Main Outcome Measures: The specific role of VIP in the arthrogenic inflammatory process related to osteoarthritis has been possibly associated to a protective role in progression of joint degradation, in synovial fluid and articular cartilage under joint degradation, and its down regulation might contribute to the pathogenesis arthrogenic