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February 2014 | ||||||||||||
![]() APS E-News is made possible through an unrestricted educational grant from Purdue Pharma. |
Funding AnnouncementsDevelopment 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 does not typically induce substantial drug interactions because it is eliminated as parent drug by renal excretion and does not extensively bind 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 towards 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 Phase1 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 Phase1 STTR applications include, but are not limited to
Examples of projects appropriate for the Phase2 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 directly focused 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 overlap 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, intervention, 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 are always 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. EducationRegister for the 33rd Annual Scientific MeetingDiscover the latest information about research, diagnosis, treatment, and management of acute pain, chronic cancer and noncancer pain, and recurrent pain. APS will hold its 33rd Annual Scientific Meeting in Tampa, FL, April 30–May 3. The 2014 educational program will include more than 35 educational sessions featuring a range of basic science, clinical, and translational sessions. Additional highlights include
Additional information regarding the 2014 Annual Scientific Meeting can be found on the APS website. Register by March 24 to receive $100 off your registration fee. Register now! Learn About New Scientific Discoveries by Attending a Basic Science SessionThe annual scientific meeting serves as a platform for interdisciplinary exchange among scientists, pain clinicians, and other professionals. Educational sessions are designed to enhance research or clinical skills pertinent to pain management. Sessions featuring basic science content will provide opportunities to enhance your understanding of scientific advances in the area of pain research as well as the translation of that research into clinical practice. Thursday, May 1 SYMPOSIA (202) From Brain to Spine and Beyond: Tracking Low Back Pain from the Nervous System to Peripheral Tissues (300) Optogenetics in Pain Friday, May 2 (402) The Role of Mitochondria in Chronic Pain (501) Pain Control by Novel Lipid Mediators: Preclinical and Clinical Studies on Pro- and Anti-Inflammatory Mediators (600) Function and Dysfunction of Potassium Channels in Nociceptors: Implications in the Development and Treatment of Neuropathic Pain BASIC SCIENCE RESEARCH DINNER Saturday, May 3 SYMPOSIA (900) Circulating MicroRNA Signatures of Chronic Pain To learn more about individual sessions, view the schedule of events. Clinical and Basic Science Data BlitzAPS announces a request for submissions for the Clinical and Basic Science Data Blitz to be held on Wednesday, April 30, 6–8 pm in Tampa as part of the 33rd Annual Scientific Meeting. Authors are encouraged to submit “hot topics” for presentation during the blitz; submissions from doctoral students and postdoctoral fellows are encouraged. Selected presenters will have 5 minutes to present data and 5 additional minutes for questions. The blitz will be moderated by David Seminowicz, PhD; Benedict Kolber, PhD; and Steven George, PhD PT. To submit your work for consideration, please download the application, complete all requested information, and send it via email as a Microsoft Word document to Jennifer Reinard at jreinard@americanpainsociety.org. NOTE: Please do not submit your work as a PDF document. All submissions are due on Wednesday, March 19 at 5 pm CST. Primary and presenting authors will be notified of acceptance by the Data Blitz Committee in April. Blitz presenters will be responsible for all costs associated with travel to the annual meeting, including meeting registration. 2014 Poster Abstract ProgramAPS received more than 500 abstract submissions for the 2014 APS Annual Scientific Meeting. The list of accepted abstract titles and primary authors’ names is now available on the Accepted Poster Abstracts page of the APS website. Acceptance letters were mailed to primary authors on December 17, 2013. The 2014 APS abstract texts will be available in a searchable database on the Journal of Pain’s website in April. APS will provide a link to the database via the Poster Information page of the APS site. Young Investigator Submissions in ReviewThe 2014 Young Investigator Travel Award application closed on February 10, and APS received 125 applications from interested young investigators. These applications will be reviewed in late February, and accepted applicants will be notified in early March. MembersMember SpotlightAdam T. Hirsh How has APS membership been of value to you and your professional development? What is your area of specialty? What sparked your interest in working in your field? Briefly describe your career path. 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? Member Benefit: APS SmartBriefAPS SmartBrief provides easy-to-read summaries of articles relevant to your work in one convenient newsletter. News stories are selected from hundreds of publications, summarized, and then provided to subscribers with links leading to the original sources, making it easier and faster for you to stay up to date on professional news. This service is available to you with the option to share and forward to your colleagues. We hope you find this new member benefit valuable and subscribe today. Welcome New APS Members!APS is pleased to welcome and recognize the following new members as of January:
SummariesThe Journal of Pain HighlightsThe following highlights summarize selected articles from The Journal of Pain (Volume 15, Number 2, February 2014 Issue). ![]() Postoperative Pain in Children: Association Between Anxiety Sensitivity, Pain Catastrophizing and Female Caregivers’ Responses to Pain When caregivers of children about to undergo surgery show high levels of anxiety and catastrophize about the child’s pain, it may contribute to pain intensity experienced by the child. As reported in previous studies, pain in children can be influenced by the individual characteristics of the children and their parents. The pediatric fear avoidance model has emphasized the reciprocal influences of child and parent factors in the development and persistence of chronic pain. Also, it has been shown that child and parental anxiety sensitivity and pain catastrophizing play a central role in the child’s pain experience. Greater pain catastrophizing in children is associated with more pain intensity and disability. Pain catastrophizing is an exaggerated negative orientation toward pain, evidenced by magnification, helplessness, and rumination thoughts. Venezuelan researchers studied 102 children and 102 caregivers (mostly mothers) selected in a convenience sample of consecutive children scheduled for elective surgery. The study investigated the association between caregivers’ anxiety sensitivity and catastrophizing about their children’s pain and also assessed the link between the child’s anxiety sensitivity, pain catastrophizing, and the responses of caregivers to their pain with the reported children’s pain intensity. Results showed that children who had higher anxiety sensitivity reported higher pain catastrophizing, and caregivers with higher anxiety sensitivity reported higher catastrophizing about their children’s pain. The authors noted that child and caregiver anxiety sensitivity was expressed by catastrophizing. Also, higher levels of reported pain in children were associated with higher levels of caregiver pain catastrophizing. Spinal Manipulative Therapy-Specific Changes in Pain Sensitivity in Individuals with Low Back Pain A study conducted by researchers from the University of Florida claims that lessening of pain sensitivity achieved with spinal manipulation therapy (SMT) occurs as a result of the treatment and not as much from a placebo effect caused by the expectation of receiving SMT. Chronic low back pain is associated with altered pain processing, suggesting a mechanism related to central sensitization of pain. Central sensitization is considered a factor in the progression of acute pain to chronic pain and in the maintenance of chronic pain. Spinal manipulative therapy has been shown to reduce the severity of low back pain in some patients. Improved understanding of its pain-relieving mechanisms could enhance clinical effectiveness. Researchers from the University of Florida investigated whether lessening of pain sensitivity attributed to SMT is specific to the procedure itself or occurs as a placebo effect from treatment expectation. Studies have shown that placebo is associated with robust analgesia produced by anticipation of pain relief. Subjects for the study had low back pain and were recruited from the University of Florida campus. Participants underwent baseline pressure and thermal pain testing and were randomly assigned to SMT, placebo SMT, enhanced placebo SMT (same as placebo SMT except subjects were informed they would get SMT or a placebo intervention), or no intervention. The 110 study subjects had repeat mechanical and thermal pain sensitivity testing to measure immediate, within session, change in pain sensitivity. Results showed that significantly more participants receiving the enhanced placebo SMT indicated good to excellent outcomes than those receiving standard placebo SMT or no treatment. A significant difference was not found between subjects receiving SMT and the enhanced placebo. The authors concluded their findings reveal a mechanism of SMT unrelated to the expectation of receiving SMT but from modulation of dorsal horn excitability and lessening of central sensitization. This suggests potential for SMT to be a clinically beneficial intervention. PAIN HighlightsThe following highlights summarize selected articles from PAIN (Volume 155, Number 2, February 2014 Issue). ![]() Psychological, Surgical, and Sociodemographic Predictors of Pain Outcomes After Breast Cancer Surgery: A Population-Based Cohort Study Improvements in breast cancer survival resulting from earlier diagnosis and advances in therapy have refocused efforts toward reducing the long-term sequelae of cancer treatment. Persistent or chronic postsurgical pain (CPSP) is a well-recognized adverse event, with prevalence studies suggesting that up to one-half of women report pain persisting for 1–2 years after breast cancer surgery. Current thinking, supported by empirical evidence, accepts that CPSP is predominantly, but not entirely, neuropathic in character. During breast cancer surgery, the intercostobrachial nerve (ICBN) can be sacrificed during axillary dissection for lymph node sampling or clearance, but there is lack of agreement regarding attribution of postoperative chest and upper arm pain to intraoperative nerve damage. Despite changes in surgical technique with increasing rates of breast conservation surgery and sentinel lymph node biopsy, the proximity of the ICBN to surgical incision and sentinel node(s) may result in nerve irritation, damage, or division, potentially contributing to subsequent postoperative sequelae. This study investigated the relative contribution of psychological, sociodemographic, perioperative, and acute postoperative factors associated with the persistence of pain in 362 women at 4 and 9 months after breast cancer surgery. Intraoperative nerve handling (division or preservation) of the ICBN was recorded. At 4 and 9 months after surgery, incidence of chronic painful symptoms not present preoperatively was 68% and 63%, respectively. Univariate analysis revealed that multiple psychological factors and nerve division was associated with chronic pain at 4 and 9 months. In a multivariate model, independent predictors of CPSP at 4 months included younger age and acute postoperative pain, whereas preoperative psychological robustness, a composite variable comprising high dispositional optimism, high positive affect, and low emotional distress, was protective. At 9 months, younger age, axillary node clearance, and severity of acute postoperative pain were predictive of pain persistence. Overall, a high proportion of women reported painful symptoms, altered sensations, and numbness in the upper body within the first 9 months after resectional breast surgery and cancer treatment. Preventive strategies should target risk factors to reduce adverse sequelae of treatment, supplemented with broader efforts to support the longer-term physical and psychological recovery in cancer survivors. Effects of Vitamin D on Patients with Fibromyalgia Syndrome: A Randomized Placebo-Controlled Trial Low serum levels of calcifediol are common in patients with severe pain and fibromyalgia syndrome (FMS), and evidence of the role of vitamin D supplementation in these patients is lacking. The aims of this study were to establish the role of vitamin D in patients with FMS and to determine whether serum calcifediol levels within the normal range could reduce pain and improve concomitant disorders in patients with initially low calcifediol levels (vitamin D deficiency). Thirty women with FMS with serum calcifediol levels lower than 32 ng/mL (80 nmol/L) were randomized to a treatment group (TG) or control group (CG). The goal was to achieve serum calcifediol levels between 32 and 48 ng/mL for 20 weeks via oral supplementation with cholecalciferol. The CG received placebo medication. Re-evaluation was performed in both groups after 24 weeks without cholecalciferol supplementation. The main hypothesis was that high levels of serum calcifediol would result in pain reduction (Visual Analog Scale [VAS] score). A marked reduction in pain was noted over the treatment period in the TG; optimization of calcifediol levels in FMS had a positive effect on the perception of pain. In addition to known therapies, oral substitution of vitamin D may be regarded as a relatively safe and economical treatment for patients with FMS. Vitamin D levels should be monitored regularly in patients receiving vitamin D supplementation, especially in the winter season, and increased appropriately. The absence of an improvement in anxiety, depression, and somatization indicated that FMS constitutes an extensive symptom complex that cannot be explained by a vitamin D deficiency alone. Further studies comprising larger numbers of patients and focused on determining optimal serum levels should be performed. Pain Medicine HighlightsThe following highlights summarize selected articles from Pain Medicine (Volume 15, Number 1, January 2014 Issue). ![]() Prescription Coverage in Indigent Patients Affects the Use of Long-Acting Opioids in the Management of Cancer Pain These investigators, who tested the hypothesis that prescription coverage affects the prescribing of long-acting opiates to indigent inner-city minority patients with cancer pain, conducted a chart review of 360 patients treated in the oncology practice at University of Medicine and Dentistry of New Jersey University Hospital who were prescribed opiate pain medications. One-half of the patients received charity care or were self-pay (CC/SP) without the benefit of prescription coverage, and the others had Medicaid with unlimited prescription coverage. Patients discharged from a hospitalization who had three subsequent outpatient follow-up visits were evaluated. Demographics, pain intensity, the type and dose of opiates, adherence to a prescribed pain regimen, unscheduled emergency department visits, and unscheduled hospitalizations were compared. Results showed that indigent patients with cancer who are treated in an inner-city tertiary care medical center by medical oncologists receive different pain treatment depending on whether they have prescription coverage. By far, patients who had Medicaid prescription coverage were more likely to receive pain treatment with long-acting opiates than were indigent patients who had no insurance or prescription coverage. The CC/SP group included a disproportionately higher percentage of Hispanic and Asian patients, while the Medicaid group had a significantly higher African-American population. The distribution differences were likely attributable to United States residential status and eligibility for Medicaid coverage. Appropriate use of long-acting opiates for treatment of equivalent levels of cancer pain was influenced only by the availability of prescription coverage. The rate of long-term analgesic use among all patients increased with progressive stage, corresponding to increased stage-associated pain levels. This suggests that the first inclination to prescribe affordable short-acting pain medications to uninsured patients was eventually trumped by an inflexible necessity to manage higher pain levels in later stages with long-acting opiates despite the hardship of out-of-pocket costs to uninsured patients. Can Adding a Standardized Observational Tool to Interdisciplinary Evaluation Enhance the Detection of Pain in Older Adults with Cognitive Impairments? The prevalence of chronic pain varies between 20% and 50% in community dwellings for older adults and has been reported to range between 40% and 80% among older adults residing in long-term care facilities. Many experts believe that pain in the latter group is often undiagnosed or undertreated, primarily because patients are unable to self-report dementia. Even when pain is detected, undertreatment occurs because of misconceptions regarding pain and aging and poor pain management strategies. Though validated assessment tools exist, pain detection in this population is often accomplished with interdisciplinary evaluation (IE), which largely relies on the subjective impression of healthcare providers. The aim of this study was to examine agreement between the IE and validated observational pain tools. Investigators recruited 59 residents who had limited ability to communicate. Researchers assessed each participant’s pain behaviors during transfer or mobilization with two validated tools, the Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC) and the Pain Assessment in Advanced Dementia (PAINAD). The results were compared with the findings of the IE. When an IE concluded that there was an absence of pain behavior, the PAINAD and the PACSLAC detected the presence of pain in 13.6% and 27.1% of cases, respectively. These findings illustrate a low correlation between assessment with validated observational tools and a hetero-assessment approach (the IE). IE, as performed in this study, may not be sufficient to systematically detect pain in this vulnerable population. Weak correlations were found between the pain observation tools and the IE, but these results showed a moderate to high correlation between the PACSLAC and the PAINAD. Pain observational tools should be used in conjunction with external subjective pain reports and in addition to self-reporting when possible. These results suggest that the IE should include an objective measure of pain for older adults with limited ability to communicate, such as the PAINAD or PACSLAC, to help detect the presence of pain and reduce the risk of pain undertreatment. SocietySIG UpdateJoin Exciting Speakers and Earn CE Credits at the Pain and Disparities SIG's Symposium At the conclusion of this symposium, attendees will be able to identify factors leading to disparities and inequities in pain outcomes among poor and underserved populations including ethnic minorities, individuals with disabilities, and those living in geographic areas with limited access to care. The learning objectives of the symposium are the following:
Biopsychosocial Contributions to Ethnic Group Differences in Knee Osteoarthritis Unequal Burden of Pain: Opportunities for Healthcare Policy States of Pain: How State Efforts to Eliminate Pill Mills Can Wind Up Hurting People with Pain Join us on May 1 at 5:15 pm in Tampa! Important DatesClinical and Basic Science Data Blitz Submissions Deadline Annual Scientific Meeting Early-Bird Deadline 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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