February 2014

David Craig, PharmD
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Funding Announcements

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 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

  • development of a formulation that safely delivers the desired amount of both agents over an appropriate dosing interval
  • preclinical studies demonstrating additive or synergistic analgesia with the opioid-adjuvant combination
  • studies to provide data for an Investigational New Drug (IND) submission, such as short-term stability studies
  • pre-IND consultations with an FDA project management group and development of the IND documentation.

Examples of projects appropriate for the Phase2 of an STTR award might include

  • pharmacokinetic absorption and disposition studies to demonstrate the bioequivalence between approved dosage forms and the proposed product
  • proof of concept clinical studies. Appropriate outcome measures might aim to detect and distinguish value added by an opioid adjunctive therapy, whether due to improved analgesia or reduced required opioid dosage.

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.


Education

Register for the 33rd Annual Scientific Meeting

Discover 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

  • NEW! Early career forum
  • Kerr and Fordyce Award lectures
  • Clinical and Basic Science Data Blitz
  • a keynote address on healthcare reform by David Newman, MD
  • plenary lectures by Mark Zylka, PhD; Camilla Svensson, PhD MPharmSci; and John Loeser, MD
  • a Global Year Against Pain Lecture on orofacial pain by Brian Schmidt, DDS MD PhD
  • unopposed author-attended poster sessions that feature cutting-edge research
  • continuing education credit for nurses, physicians, psychologists, and pharmacists.

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 Session

The 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
(102) Plenary Lecture
Sensory Mechanism for Heat Inhibition of Cold

Mark Zylka, PhD

SYMPOSIA
(200) Frontiers in Pain Research: Rita Allen Foundation Scholars in Pain

Michael Jankowski, PhD (Moderator); Sarah Ross, PhD; Rebecca Seal, PhD; Reza Sharif Naeini, PhD

(202) From Brain to Spine and Beyond: Tracking Low Back Pain from the Nervous System to Peripheral Tissues
Laura Stone, PhD (Moderator); David Seminowicz, Phd; Helene Langevin, MD

(300) Optogenetics in Pain
Brian Davis, PhD (Moderator); Benedict Kolber, PhD; Robert Gereau, PhD

Friday, May 2
SYMPOSIA
(401) Emerging Themes in G Protein-Coupled Receptor Signaling

Derek Molliver, PhD (Moderator); Laura Bohn, PhD; Nathaniel Jeske, PhD; Lakshmi Devi, PhD, MSc

(402) The Role of Mitochondria in Chronic Pain
Shuanglin Hao, MD PhD (Moderator); Jon Levine, MD PhD; Daniela Salvemini, PhD

(501) Pain Control by Novel Lipid Mediators: Preclinical and Clinical Studies on Pro- and Anti-Inflammatory Mediators
Ru-Rong Ji, PhD (Moderator); Daniela Salvemini, PhD; Christopher Ramsden, MD

(600) Function and Dysfunction of Potassium Channels in Nociceptors: Implications in the Development and Treatment of Neuropathic Pain
Manuel Covarrubias, MD PhD (Moderator); Hui-Lin Pan, MD PhD; Yuan-Xiang Tao, PhD

BASIC SCIENCE RESEARCH DINNER
(136) Promises and Challenges of Bioinformatic Approaches in Pain Research

Benedict Kolber, PhD and David Seminowicz, PhD (Moderators); Michael Costigan, PhD, Camilla Svensson, PhD, Luda Diatchenko, PhD

Saturday, May 3
FREDERICK W.L. KERR BASIC SCIENCE RESEARCH LECTURE
(105) TRPV1 Therapeutics and Transcriptomics

Michael J. Iadarola, PhD

SYMPOSIA
(801) Novel Modulators and Signaling Mechanisms in Inflammatory Pain

Yuriy Usachev, PhD (Moderator); David Clark, MD PhD; Durga Mohapatra; PhD

(900) Circulating MicroRNA Signatures of Chronic Pain
Asma Khan, PhD BDS (Moderator); Andrea Nackley, PhD; Ahmet Sacan, PhD; Seena Ajit, PhD

To learn more about individual sessions, view the schedule of events.

Clinical and Basic Science Data Blitz

APS 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 Program

APS 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 Review

The 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.


Members

Member Spotlight

Adam T. Hirsh
Assistant Professor
Department of Psychology, School of Science
Indiana University–Purdue University Indianapolis
Indianapolis, IN

How has APS membership been of value to you and your professional development?
I joined APS as a first-year graduate student. I continue to be amazed by its talented and diverse members; they keep me excited and energized to plow my own little field in the pain community. APS membership has also allowed me to present research at annual meetings, interact with leaders in the field, serve on the editorial board of The Journal of Pain, and take a leadership role in two shared interest groups (SIGs; Psychosocial Research and Pain and Disparities). These experiences help me manage the “imposter syndrome” that I nurtured as a graduate student and continue to experience today. On a very practical level, APS has directly contributed to my development through a recent Future Leaders in Pain Research grant and previous Young Investigator Travel awards.

What is your area of specialty?
I am a clinical health psychologist by training. I am particularly interested in the psychosocial factors that influence how people experience pain and how they are assessed and treated by others. My research group has been active in developing novel methodologies to investigate these pain judgment processes. Specifically, we have used virtual human technology and mixed methodologies to examine how patient variables (e.g., facial expressions, demographic characteristics), provider variables (e.g., attitudes/biases, expertise), and contextual variables (e.g., clinical ambiguity, time constraint) independently and interactively influence pain assessment and treatment decisions.

What sparked your interest in working in your field? Briefly describe your career path.
I took a psychology course in high school, found it interesting, and decided that would be my major in college. I soon joined a substance-use research lab and learned about the biopsychosocial model of health. This topic struck my fancy enough for me to pursue a PhD in clinical health psychology. After interviewing with Mike Robinson, PhD, at the University of Florida, I was sold on pain [as a specialty]; I accepted their offer immediately and never looked back. During my time at Florida, Mike provided a perfect combination of guidance and independence that facilitated my development as a scientist. I then accepted a postdoctoral fellowship with a group led by Mark Jensen, PhD, at the University of Washington. Mark was also exceptionally generous with his time and resources, while providing the freedom to find my own professional footing. These graduate and postdoctoral experiences prepared me well for my current position as assistant professor in the Department of Psychology at Indiana University–Purdue University Indianapolis (IUPUI). I am blessed to be in an environment that facilitates my continued personal and professional development, and I am especially fond of my collaborations with colleagues in the Indiana University School of Medicine and the Roudebush VA Medical Center.

What has been a highlight of your work? (Perhaps you and your staff are proud of a certain project or accomplishment.)
We are especially proud of our work using novel methodologies to examine important issues surrounding pain assessment and treatment. This area of research is difficult due, in part, to the constraints of usual research designs that lack sufficient experimental control (to test hypotheses) or ecological validity (to approximate real clinical settings). Though our approach has its own limitations and does not completely mitigate those [challenges] noted above, we believe our work has contributed to a better understanding of pain assessment and treatment decision-making. Relatedly, we are proud of our work that addresses the “Why?” questions related to variability in pain treatment decisions. These questions move beyond description of variability and toward explanation of it, which is critical to improving pain care, especially for the most vulnerable patients. A more process-oriented highlight of my day-to-day work is the opportunity to rub shoulders with bright and inquisitive students and colleagues. These collaborations challenge and excite me; they are one of the great pleasures of my job.

Who is your favorite role model—and why?
Within the pain community, I aspire to be a mere fraction of the scholars that Mike Robinson and Mark Jensen are. They are academic exemplars, but more importantly, they are wonderful family members and friends. Steve George, PhD PT, is another model of personal and professional excellence. More broadly, I’ve always admired brave and principled thinkers who are willing to challenge orthodoxy and hold unfashionable views.

Member Benefit: APS SmartBrief

APS 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:

Carol Anderson
Emine Ozgur Bayman
Phoebe Block
Marisa Borja
Maggie Bromberg
Randy Calisoff
Marsha Campbell-Yeo
Yarimar Carrasquillo
Cary Jasper
David Chesner
James Chodosh
Jackson Cohen
Martha Combs
Colette Demonte
Sandra Discala
Kim E. Dixon
Alexandra Duvivier
Bonnie Essner
Alyssa Foote
Mark Gaertner
Richard J. George
Marni Hillinger
Xiaoyu Hu
Kali Janes
Hemant Kalia
Ming-Chih Kao
Dolores Kent
Edward Lannon
Sanghee Lee
Jeffrey Longnion
Nada Lukkahatai
Mary K. Lynch
Dermot Maher
Margaret Mahon
Katrina Maluf
Delia Mancoci
Lynne Maxwell
Murray J. McAllister
Shannon Merkle

Jessica Merlin
Aaron Mickle
Rachel Moericke
Gyasi Moscou-Jackson
Beth Murphy
Rashi Ojha
Ana Oliveira
Larissa Oliveira
Candler Paige
Emilie Paul-Savoie
Megan Petrov
Doreen Pon
Ralisa Pop
Mammen Puliyel
Katherine Raichle
Victor Reyes
Nancy L. Sajben
Luma Samawi
Elizabeth Scanlan
Shawna M. Schmidt
Andrei Sdrulla
Amy Isabella Sentis
David Shawa
Tayler D. Sheahan
Andrew Shepherd
Naohito Shimoyama
Allison Smith
Laurie E. Steffen
Sameer Syed
Chloe Taub
Kathryn Thompson
Heather Thomson
Baskaran Thyagarajan
Susan T. Tran
Tor Wager
Margaret Walker
Yong Yue
Nurulain Zaveri
Yanping Zheng


Summaries

The Journal of Pain Highlights

The 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
Rosa Esteve, Vanessa Marquina-Aponte, and Carmen Ramirez-Maestre; University of Oriente, Nucleo Bolivar, Venezuela

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
Joel E. Bialosky, Steven Z. George, Maggie E. Horn, Donald D. Price, Roland Staud, and Michael E. Robinson; Department of Physical Therapy, Center for Pain Research and Behavioral Health, University of Florida, Gainesville, FL; Department of Physical Therapy, University of Florida, Gainesville, FL; Oral and Maxillofacial Surgery, Division of Neuroscience, University of Florida, Gainesville, FL; Department of Medicine, University of Florida, Gainesville, FL; Department of Clinical and Health Psychology, Center for Pain Research and Behavioral Health, University of Florida, Gainesville, FL

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 Highlights

The 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
Julie Bruce, Alison J. Thornton, Rachael Powell, Marie Johnston, Mary Wells, Steven D. Heys, Alastair M. Thompson, W. Cairns Smith, W. Alastair Chambers, and Neil W. Scott, for the Recovery Study Group; Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, UK; Epidemiology Group, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; School of Psychological Sciences, University of Manchester, Manchester, UK; Aberdeen Health Psychology Group, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; Nursing, Midwifery and Allied Health Professions Research Unit, University of Stirling, UK; Division of Applied Medicine, Institute of Medical Sciences, University of Aberdeen, Aberdeen, UK; Surgical Oncology, Dundee Cancer Centre, Ninewells Hospital and Medical School, Dundee, UK; Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; Anaesthesia and Pain Medicine, Aberdeen Royal Infirmary, Aberdeen, UK; Medical Statistics Team, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK

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
Florian Wepner, Raphael Scheuer, Birgit Schuetz-Wieser, Peter Machacek, Elisabeth Pieler-Bruha, Heide S. Cross, Julia Hahne, Martin Friedricha; Department of Orthopedic Pain Management, Spine Unit, Center of Excellence for Orthopaedic Pain Management, Speising, Vienna, Austria; Department of Pathophysiology, Medical University of Vienna, Vienna, Austria

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 Highlights

The 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
Robert Wieder, Nila DeLaRosa, Margarette Bryan, Ann Marie Hill, and William J. Amadio; Department of Medicine and the New Jersey Medical School Cancer Center, Rutgers New Jersey Medical School, Newark, NJ; New York University Langone Medical Center, New York, NY; Edward J. Bloustein School of Planning and Public Policy, Rutgers University, New Brunswick, NJ; Department of Information Systems and Supply Chain Management, Rider University, Lawrenceville, NJ

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?
Catherine Apinis, Michel Tousignant, Marcel Arcand, and Yannick Tousignant-Laflamme; Research Centre on Aging, Sherbrooke, Quebec; School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Sherbrooke, Quebec; Centre de recherche clinique Etienne-LeBel du CHUS, Sherbrooke, Quebec, Canada

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.


Society

SIG Update

Join Exciting Speakers and Earn CE Credits at the Pain and Disparities SIG's Symposium
All are invited to attend the symposium held by the APS Pain and Disparities shared interest group (SIG) at 5:15 pm on May 1 at the APS Annual Scientific Meeting in Tampa, FL. The symposium offers 1 hour of physician, nursing, pharmacy, or psychology continuing education (CE) credit to those who attend and evaluate the symposium. It will feature three presentations from nationally known speakers that expand traditional perspectives on pain disparities and propose key priorities for pain research and policy.

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:

  1. Describe recent research on biopsychosocial factors that contribute to disparities in pain and disability.
  2. Describe the evidence supporting disparities in pain care due to racial, ethnic, and geographic factors.
  3. Understand the impact of new policy initiatives on access to pain care, including the Affordable Care Act and policies at the state level.

Biopsychosocial Contributions to Ethnic Group Differences in Knee Osteoarthritis
Roger Fillingim, PhD
Dr. Fillingim will present findings from his ongoing Understanding Pain and Limitations in Osteoarthritic Disease (UPLOAD) study, which endeavors to identify biopsychosocial factors that contribute to osteoarthritis-related pain and disability in African Americans and non-Hispanic whites. The presentation will highlight biological, quantitative sensory testing, and psychosocial measures that may differentially predict clinical pain and disability across ethnic groups.

Unequal Burden of Pain: Opportunities for Healthcare Policy
Carmen Green, MD
Dr. Green’s talk will focus on health policy and relevant research on pain care disparities. It will provide an overview of racial and ethnic disparities in pain care and insights into how healthcare disparities—specifically, pain care disparities—integrate into new policy initiatives within the Affordable Care Act, including the metrics and desired outcomes.

States of Pain: How State Efforts to Eliminate Pill Mills Can Wind Up Hurting People with Pain
Robert Twillman, PhD
In grappling with the problem of “pill mills” and their role in the prescription drug abuse crisis, some states have passed strict new laws and regulations for pain clinics. Unfortunately, some of the unintended consequences of these new policies have caused substantial harm to people with pain, especially populations with healthcare disparities, and considerable inconvenience to their healthcare providers. This presentation will examine policies in Florida, the truth behind claims of their effectiveness, and results of a survey of people with pain who have had prescriptions denied at the pharmacy.

Join us on May 1 at 5:15 pm in Tampa!


Important Dates

Clinical and Basic Science Data Blitz Submissions Deadline
Wednesday, March 19
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Annual Scientific Meeting Early-Bird Deadline
Monday, March 24
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Call for Submissions

Do 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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