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May 2014 | ||||||||||||
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Funding AnnouncementsClinical Evaluation of Adjuncts to Opioid Therapies for the Treatment of Chronic Pain (R01)This funding opportunity announcement (FOA) aims to fund applications designed to assess the clinical value of adjuncts prescribed to chronic pain patients together with opioid analgesics. Adjuncts of interest are either approved by the U.S. Food and Drug Administration (FDA) or have previously been studied as an investigational new drug. Studies with adjuncts of interest should be focused on enhancing analgesia rather than on reducing an adverse effect. A secondary purpose is to increase awareness among opioid prescribers of the potential value of adjunctive therapies by focused data dissemination. It is hoped that by increasing availability of data describing the use of opioid adjuncts, their use will increase and levels of opioids needed for analgesia will diminish. Reductions in the dosage of opioids prescribed would improve the quality of life of chronic pain patients by reducing opioid-associated adverse effects and lowering the risk of addiction development. Studies should examine clinical populations and address whether a proposed adjunct can reduce the dose of opioid required for analgesia compared with opioid monotherapy. Applications will be evaluated on the feasibility, scientific rigor, and likely value of the proposed outcomes of randomized control trials (RCTs) to study opioid-adjunct combinations. In addition, the investigators should describe their plan to disseminate the study results. This plan will be evaluated with a view to how effectively the study results will be communicated to the types of healthcare providers who typically prescribe opioids to the chronic pain population under examination. The purpose of this FOA is to examine adjunctive therapies to reduce the need for opioids in chronic pain patients. Therefore, in the patient group under investigation the pain syndrome should chronologically precede opioid exposure and the opioids should be prescribed as a treatment for the pain. In the population proposed to be studied, the subjects should be etiologically homogenous and symptomatically well defined. Examples of such chronic pain populations in which opioids often are prescribed include patients with radicular cervical pain, metastatic bone pain, or peripheral neuropathies. Studies should use an RCT design to examine opioid and adjunct formulations that are either typically used in the outpatient chronic pain population under study or are feasible for daily use in that population. For example, a formulation that requires once a day oral dosing is likely to be of much higher programmatic interest than a formulation requiring multiple daily dosing or intrathecal administration. Adjuncts to be examined should preferably be FDA approved, examples of which would include pregabalin, duloxetine, or dronabinol. However, agents that currently are being (or previously have been) studied as investigational new drugs (for example, Sativex/Nabiximols) also will be considered. Submissions will be accepted beginning September 5 and letters of intent are due 30 days before applications are due. For more information about this funding opportunity, visit the NIH grants page. Development of Opioid and Adjuvant Fixed Combination Dosage Forms for the Treatment of Chronic Pain with Reduced Addiction Potential (R41/R42)This funding opportunity announcement seeks small business organizations to develop opioid and adjuvant drug combinations within a single dosage form for treatment of a pain condition. The drug combination should provide improved analgesia when compared with the same dose (morphine equivalents) of opioid monotherapy. Such dosage forms should minimize opioid exposure while optimizing analgesia to reduce risk of addiction and limit severity of other opiate adverse effects. When designing this new product, investigators should consider FDA guidance (21 CFR 300.50) and address the following issues. Both of the agents contained in the proposed new product should currently have at least one existing FDA-approved indication, as well as some existing clinical evidence to support the use of the chosen adjuvant-opioid combination and a reasonable expectation that the combination will present minimal drug-drug interaction concerns. The application should emphasize available evidence that the chosen drugs and doses in the combination will allow a substantial patient population to gain sufficient analgesic value from the contained opioid dose while the adjuvant dose remains within a safe and effective "therapeutic window." One example of a potentially viable adjuvant is gabapentin, a drug known to reduce neuropathic pain and to which patients typically exhibit no more than mild adverse effects. Gabapentin typically does not induce substantial drug interactions because it is eliminated as parent drug by renal excretion and does not bind extensively to blood proteins. The adjuvant should be chosen for a capacity to increase overall analgesia, rather than an ability to reduce opioid adverse effects. For example, inclusion of a poorly absorbed opioid receptor antagonist, with the intent of reducing constipation, would not be considered of high programmatic interest. The combination dosage form proposed by the application should provide sustained relief when it is the only analgesic used and is administered no more than three times in a 24-hour period. The formulation should be such that a patient with reasonable mobility is able to self-administer the drug (e.g., oral dosage form). The application should propose late-stage drug development–oriented studies that significantly drive the project toward an ultimate aim of a New Drug Application [505(b)(1 or 2)] or Abbreviated New Drug Application [505(j)] for the treatment of a long-term pain condition. Studies planned for Phase 1 of the project should focus on issues that concern the feasibility of the project. The exact nature of such studies will differ depending on the proposed drug combination project. Studies that might be appropriate for Phase 1 STTR applications include, but are not limited to
Examples of projects appropriate for Phase 2 of an STTR award might include
Submissions will be accepted beginning March 5 and letters of intent are due 30 days before applications are due. For more information about this funding opportunity, visit the NIH grants page. Neurobiology of Migraine (R01)This funding opportunity announcement (FOA) is issued by the National Institute of Neurological Disorders and Stroke (NINDS) in conjunction with the National Institutes of Health (NIH) Pain Consortium. It solicits R01 grant applications from institutions and organizations to perform innovative research that will elucidate the mechanisms underlying migraine; expand our current knowledge of the role of genetic, physiological, biopsychosocial, and environmental influences in migraine susceptibility and progression; and explore new therapeutic targets and therapies for acute migraine management and longer term prevention. The National Center for Complementary and Alternative Medicine (NCCAM) is interested in research that would elucidate the mechanisms by which a given complementary or integrative health approach beneficially affects migraine, either as an acute intervention or prophylactically. For this FOA, complementary or integrative health approaches could include those within the “mind and body” domain but not in the “natural products” domain and would include, but are not limited to, meditation, mindfulness, yoga, tai chi, qi-gong, acupuncture, massage, and spinal manipulation. The primary outcomes for these studies should be focused directly on the mechanism(s), though it may be appropriate to have secondary outcomes that assess clinical outcomes. There should be sufficient prior data to indicate either efficacy or effectiveness of the proposed complementary or integrative health approach. The National Institute for Dental and Craniofacial Research (NIDCR) is interested in the neurobiological mechanisms underlying migraine headache as they pertain to overlaps with pathophysiological mechanisms of chronic temporomandibular and other orofacial pain disorders. Research examining common genetic, environmental, neurobiological, and biobehavioral factors underlying the co-occurrence of these disorders is encouraged. NIDCR is interested in funding meritorious research that focuses on studies addressing the comorbidity of temporomandibular and other orofacial disorders and migraine headache. NIDCR is interested in the development of diagnostic, interventional, and novel therapeutic tools for headache pain associated with a variety of communication disorders such as tinnitus, Meniere’s disease, odynophagia, and burning mouth syndrome. Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the program director or principal investigator (PD or PI) is invited to work with his or her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities always are encouraged to apply for NIH support. Submissions will be accepted beginning May 5. For more information about this funding opportunity, visit the NIH grants page. Education2014 Annual Scientific Meeting a Great SuccessAPS is pleased to announce that more than 1,000 attendees gathered for the 33rd Annual Scientific Meeting in Tampa, April 30–May 3. The annual meeting attracted participants from around the country and the world—44 states and 21 countries were represented. The exhibit hall was bustling with 73 exhibitors. Excellence in the pain management field was recognized during the annual President’s Reception when APS presented the 2014 award winners, including recipients of the Clinical Centers of Excellence in Pain Management awards. This year’s attendees had the opportunity to experience exciting and innovative sessions that enhanced the value of attending the meeting. Education NEW Early Career Forum Has Huge Success The groups were divided into a research track and a clinical track. The research track included a mock study section and a review of aims pages, while the clinical track featured a lecture on pain clinic data collection and benefits to patients, physicians, and researchers, as well as roundtable discussions. The session was organized by Jennifer Haythornthwaite, PhD, and the Early Career Task Force. Early career participants left the forum with valuable insights and new knowledge into the workings of National Institutes of Health (NIH) study sections and a greater understanding of the impact of data collection and its use in clinical research. The networking session helped to establish new connections with other early career and senior pain professionals. “The Early Career Forum and the mock scientific review were excellent. Witnessing the review process acted out was informative, engaging, and will help me to write better grant applications,” said one attendee. APS plans to make the Early Career Forum an annual event at the scientific meeting. The Future of Pain: Pain Research Fund What Is #APS14? Thank You! APS would like to extend a sincere thank you to the Scientific Program Committee, chaired by Charles Argoff, MD, for selecting this year’s educational programming. In addition, APS would like to thank Jennifer Haythornthwaite, PhD, and the members of the Early Career Forum planning task force, as well as to the many faculty members, who donated their time and expertise at this year’s annual scientific meeting. APS hopes attendees were able to take away pertinent and exciting discoveries that will increase the research and clinical advancements in the pain management field. See You in Palm Springs! 33rd ASM Evaluation and CE CreditIf you attended the APS meeting in Tampa and wish to claim physician, nursing, pharmacy, or psychology credit, please complete the online meeting evaluation. Certificates of continuing education credit will be issued upon completion of the evaluation form. Please visit the APS website to access the meeting evaluation. You will need to enter your username (found on the second ticket of your name badge from the meeting) and your password. If you are not a member of APS, did not register online for the annual meeting, or otherwise have not established a username and password, you will need to do so to access your evaluation form. Please contact APS Member Services by phone at 847.375.4715 or by e-mail at info@americanpainsociety.org to activate your online profile. APS encourages all meeting attendees to complete the evaluation, regardless of whether credit is being sought. Submit Your Proposal for a Symposium Presentation in Palm SpringsAPS will hold its 34th Annual Scientific Meeting May 13–16, 2015, in Palm Springs, CA. The APS Scientific Program Committee invites the submission of proposals for symposia for presentation during the meeting. Submission forms are available online, and the deadline for submissions is July 14. The Scientific Program Committee requests that all proposals reflect APS’s multidisciplinary approach to pain and should, therefore, include speakers representing varied areas of pain research and treatment. Specifically, the committee will be looking for proposals that include perspectives from physicians, nurses, physical therapists, psychologists, basic scientists, pharmacists, dentists, etc. The committee will give priority to innovative proposals that include opportunities for interaction between faculty and the audience through case study presentations, extended question-and-answer sessions, or small group discussions, for example. MembersMember Spotlight![]() Mark Wallace, MD What has been a highlight of your work? Perhaps you and your staff are proud of a certain project or accomplishment. Who is your favorite role model, and why? What are your goals to advance the field of pain management? What prompted you to join APS? How long have you been a member? Describe your volunteer activities with APS. Why is pain your passion? What has been your favorite experience as an APS member? Member Benefit: Shared Interest GroupsHave You Joined a Shared Interest Group Yet? Each multidisciplinary APS shared interest group (SIG) provides a forum for specialized member interaction and allows members with like interests and issues to easily interact with each other to develop an extended network of resources and information. The opportunity to participate in one or more SIGs is open to all members, regardless of discipline. APS welcomes the formation of new SIGs and the procedure for doing so can be found on the APS website. Current SIGs include the following (click on each to learn more):
SIGs meet annually at the APS Annual Scientific Meeting. To join a SIG, contact the APS national office at list@americanpainsociety.org. Welcome New MembersAPS is pleased to welcome and recognize the following new members for May 2014:
SummariesThe Journal of Pain HighlightsThe following highlights summarize selected articles from The Journal of Pain (Volume 15, Number 5, May 2014 Issue). ![]() Reduction of Bodily Pain in Response to an Online Positive Activities Intervention In a multicenter study led by VA Pittsburgh Healthcare System, participants with at least mild to moderate pain were randomly assigned to complete zero, two, or six positive activities over 6 weeks. Follow-up assessments were collected at the end of 6 weeks and at 1, 3, and 6 months after intervention. The researchers hypothesized that participants randomly assigned to complete two, four or six positive activities would show greater reductions in bodily pain after the intervention compared to those assigned to no activities. This is the first study to assess the long-term impact of completing multiple positive activities in people with mild to moderate pain. Subject recruitment and instructions in positive activities all occurred via a website developed for this project. Examples of the positive activities recommended included identifying three good things that went well each day and dwelling on them, focusing intensely on positive experiences two to three times a day, and practicing how to respond positively to good news shared by others. Results showed that subjects assigned to complete at least four positive activities reported less bodily pain after the intervention than those in the zero-activities control group. The reduction in bodily pain persisted 6 months after completion of the intervention. The authors concluded that teaching very simple, evidence-based, positive activities administered online can lead to lasting reductions in bodily pain. Further, the study demonstrates that positive activities administered over the internet offer practical pain management strategies at very low cost with high sustainability. Internalized Stigma in People Living with Chronic Pain Internalized stigma refers to the internalization or absorption of negative attitudes and stereotypes about a person’s characteristics, such as race, sex, and diagnosis. Evidence indicates that internalized stigma has negative effects on health and psychological functioning in general. An Australian research team sought to learn whether an individual’s experience, perception, or anticipation of negative social reactions to their pain may become internalized. In the study, surveys were administered to 92 adults with chronic pain to explore the presence of internal stigma and its association with a range of psychological consequences in people with chronic pain. Results showed that nearly 40% of the chronic pain sample reported experiencing internalized stigma. After controlling for depression, the study findings showed that internalized stigma is negatively associated with lower self-esteem and pain self-efficacy. It also is linked with a greater tendency to catastrophize about pain and with a reduced sense of personal control over pain. The authors concluded that their findings have important implications regarding the role of internalized stigma as an outcomes measure and as a verifiable treatment target for individuals with chronic pain. PAIN HighlightsThe following highlights summarize selected articles from PAIN (Volume 155, Number 5, May 2014 Issue). ![]() Reduced Task-Induced Variations in the Distribution of Activity Across Back Muscle Regions in Individuals with Low Back Pain This study investigated change in the distribution of lumbar erector spinae muscle activity and pressure pain sensitivity across the low back in individuals with low back pain (LBP) and healthy controls. Surface electromyographic (EMG) signals were recorded from multiple locations over the lumbar erector spinae muscle with a grid of electrodes on 19 people with chronic nonspecific LBP and 17 control subjects as they performed a repetitive lifting task. The EMG root mean square was computed for each location of the grid to form a map of the EMG amplitude distribution. Pressure pain thresholds were recorded before and after the lifting task over a similar area of the back. A change in the distribution of activity to different regions of the lumbar erector spinae was observed when pain-free individuals performed a repetitive lifting task. On the contrary, those with LBP performed the task with the same region of the muscle activated over time. This lack of variability in the distribution of muscle activity for the participants with LBP occurred concomitantly with an increase in LBP and reduced lumbar movement and was associated with increased pressure pain sensitivity of the lumbar region. Reduced variability of muscle activity may have important implications for the provocation and recurrence of LBP following repetitive tasks. People with chronic LBP display a variety of biomechanical disturbances, including reduced acceleration of movement, decreased trunk velocity, and restricted range of motion. These results confirm previous work showing that people with LBP adopt alternative movement strategies and avoid motion of the lumbar spine when performing common reaching movements. Reducing spinal movement may be a strategy to stiffen the spine in an attempt to protect it. This knowledge provides new insights into impaired motor control of the spine in patients with LBP, which may play an important role in the chronicity and recurrence of pain. Geospatial Analysis of Hospital Consumer Assessment of Healthcare Providers and Systems Pain Management Experience Scores in U.S. Hospitals Although previous work has investigated the interplay between demographic and intrasurvey correlations of Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores, these studies did not include geospatial analyses or analyses that take into account location effects. This article reports the results of a geospatial analysis (not equivalent to simple geographical analysis) of patient experience scores pertaining to pain. HCAHPS data collected in 2011 were examined to test the hypothesis that HCAHPS patient experiences with pain management (PEPM) scores were geospatially distributed throughout the United States using Moran’s Index, which measures the association between PEPM scores and hospital location. After limiting the dataset to hospitals in the continental United States with nonzero HCAHPS response rates, 3,645 hospitals were included in the analyses. Results suggest there are geographic disparities in PEPM during hospitalization as measured by the HCAHPS reporting system. Data suggest that hospitals are clustered, rather than dispersed, in their geospatial distribution with regard to patients stating that they are ‘‘always’’ satisfied with their pain management during hospitalization. Additionally, spatial cluster analysis by minimum spanning tree edge removal identified distinct geographic boundaries that separated hospitals into groups according to their results of “always,” “usually,” and “never” PEPM responses. Currently, HCAHPS scores are used to vary hospital reimbursement by the Centers for Medicare and Medicaid Services through the Value-Based Purchasing Program. These results may carry policy implications for U.S. hospitals with regard to acute pain outcomes. Further analyses will be necessary to evaluate policy explanations and implications of the regional geographic differences in PEPM results. The Clinical Journal of Pain HighlightsThe following highlights summarize selected articles from The Clinical Journal of Pain (Volume 30, Number 5, May 2014 Issue). ![]() The Canadian STOP-PAIN Project: The Burden of Chronic Pain—Does Sex Really Matter? Many studies about gender’s influence on pain have been based on relatively small sample sizes or have examined a limited number of potential influencing factors. Earlier studies used an analytic approach in which sex was viewed as a predictor—that is, an independent variable. The Canadian STOP-PAIN Project assessed the human and economic burden of chronic pain (CP) in patients on waitlists of Canadian multidisciplinary pain treatment facilities. The objectives of this article, which focuses on sex differences, were to determine the pain characteristics and related biopsychosocial factors that best differentiated women and men with CP and to examine whether public and private costs associated with CP differed according to sex. The sample consisted of 441 women and 287 men who were evaluated using self-administered questionnaires and a structured interview protocol. A subsample (233 women and 137 men) recorded all pain-related expenditures in a comprehensive diary during 3 months. Results revealed that the burden of illness associated with CP was comparable in both sexes for average and worst pain intensity, pain impact on daily living, quality of life, and psychological well-being. The same was true for pain-related costs. The results of a hierarchical logistic regression analysis in which sex was treated as the dependent variable showed that factors that differentiated men and women were work status, certain circumstances surrounding pain onset, present pain intensity, intake of particular types of pain medication, use of certain pain management strategies, pain beliefs, and use of particular healthcare resources. Depression levels, suicidal ideation, and anxiety and anger scores were comparable in both the sexes. Group comparisons on cognitive factors such as the tendency to catastrophize in the face of pain revealed no significant sex difference on any of the pain catastrophizing scale subscales. From a clinical perspective, these results suggest that, with the exception of a few specific aspects, men and women referred in multidisciplinary pain treatment facilities do not really require distinct treatment strategies because they appear to have a comparable profile in terms of their overall clinical condition. However, the aspects that differ may warrant further clinical attention when it comes to assessing and managing pain. Caregiver’s Perceptions of the Relationship of Pain to Behavioral and Psychiatric Symptoms in Older Community-Residing Adults With Dementia Pain is underrecognized and undermanaged in older adults with dementia. Because patients with dementia have a diminished capacity to communicate discomfort, untreated pain may be expressed in the form of behavioral and psychiatric symptoms. The goal of the present study was to examine the relationship between pain and behavioral and psychiatric symptoms of dementia (BPSD) in community-residing older adults from the perspective of family caregivers. Family caregivers were assessed to determine the mental status of patients with dementia, their estimates of care recipient’s pain and functional dependence levels, the number of patients’ behavioral symptoms and their analgesic use, and demographic information. Investigators hypothesized that the frequency of BPSD would positively relate to the severity of pain. Among caregivers, 90% reported presence of pain, with 55% indicating that pain was significant (moderate to severe). Hierarchical multiple regression analysis controlling for age, marital status, race, functional disability, and analgesic use showed that pain explained a small but significant percent of variance in the number of behavioral symptoms. Pain had a stronger influence on the number of behavioral and psychiatric symptoms of dementia among those with severe cognitive impairment than those with low to moderate cognitive impairment. In addition, patients with severe pain had more symptoms such as agitation, delusions, anxiety, restlessness, and argumentativeness. Of importance is that pain appears to manifest in certain behaviors and not in others. The manifestation of behaviors such as physical and verbal aggression and crying out did not differ among those with varying levels of pain. Families could benefit from understanding the relationship of pain and behavioral manifestation so that they can alert physicians and assist in pain management. Future research is needed to explore how caregivers determine if their care recipient is in pain. Additional research also is needed to establish a gold standard of observed pain in community-residing people with dementia. ResearchAPS Awards Nominations Open June 9Every year, APS rewards excellence in the field of pain management and research by presenting awards for career achievement, pain scholarship, education and public service, advocacy on behalf of children, outstanding service to APS, and early career achievements at its Annual Scientific Meeting. Applications for the 2015 APS annual achievement awards will be accepted beginning Monday, June 9. Award recipients will be announced in September 2014 and will be honored at the President’s Recognition Reception at the 34th Annual Scientific Meeting May 13–16, 2015, in Palm Springs, CA. Information about the application process will be available on the APS website on June 9. Important Dates2014 APS Future Leaders in Pain Research Grant Applications Open 2015 APS Annual Scientific Meeting Call for Symposia Deadline Pain Care for Primary Care Call for SubmissionsDo you have a topic that is relevant to APS members? Is there a member who is doing work that APS should spotlight? Is there a funding opportunity APS members need to know about? Please submit stories, events, and more to enews@americanpainsociety.org for consideration. |
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