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5 Research Challenges
Pages 217-268

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From page 217...
... Important new insights into the basic science of pain -- from genetics and molecular biology, to neural networks and neuroimaging, to the role of psychosocial factors -- are unraveling pain's mysteries. Some of these new insights have been highlighted earlier in this report.
From page 218...
... A number of prestigious organizations have been engaged in devising new strategies for pain research, and the committee did not attempt to readdress the specific recommendations of these groups. Rather, it focused its deliberations on what is needed to make pain research initiatives a reality and to enhance translational research -- research based on interactions and feedback loops between researchers and clinicians on the one hand and between patients and researchers on the other -- so as to bring new discoveries to patients more rapidly.
From page 219...
... . In the United Kingdom, the British Pain Society is working toward developing chronic pain patient pathways, and its efforts are proceeding in parallel with the interests of the U.K.
From page 220...
... A more multi factorial approach that takes into account the individual's genetics, biology, social and cultural history, and psychological and environmental factors is needed, along with objective metrics for defining response. In this context, this chapter examines research challenges in the following areas: expanding basic knowledge, moving from research to practice, improving and diversifying research methods, building the research workforce, organizing research efforts, obtaining federal research funding, and fostering public–private partnerships.
From page 221...
... as aids in identifying promising beneficial treatments rather than "substantiating" or "verifying" patients' pain reports, they might have a useful and accepted role in pain care. Most valuable would be their potential to obviate the need to conduct lengthy hit-or-miss trials of different therapies before identifying the one that works best for a given individual (Woolf, 2010)
From page 222...
... For instance, investigators have identified several subtypes of voltage-gated sodium channels -- a substrate by which products of inflammation and growth factors trigger chronic pain states. These channels can be nonselectively blocked by lidocaine, mexiletine, lamotrogine, carbamazepine, and amytriptyline -- all drugs used to treat chronic pain.
From page 223...
... Although pain is a subjective experience, the brain regions and systems responsible for that experience can now be identified and characterized, including brain regions responsible for the pain-modulatory effects of attention/ distraction, anticipation, fear, anxiety, depression, placebo, and cogni tive control. Neuroimaging also yields valuable information regarding central abnormalities in pain processing in chronic pain conditions and the effects of therapeutic agents on central neural systems.
From page 224...
... were for chronic pain conditions, specifically arthritis and fibromyalgia (FDA and CDER, 2011)
From page 225...
... . Thus far, however, "although considerable progress has been made in identifying pathophysiologic mechanisms of acute and chronic pain, this knowledge has not translated to the development of analgesic medications with improved efficacy, safety, and tolerability" (Dworkin et al., 2011, p.
From page 226...
... . Over the past decade, a major effort has been made to test the efficacy and cost-effectiveness of psychosocial approaches in patients with chronic pain conditions (e.g., chronic low back pain and migraine headaches)
From page 227...
... . In the study by Dobscha and colleagues, the broader intervention involved provider education and training plus support in the application of a biopsychosocial model of chronic pain treatment.
From page 228...
... . Meta-analyses of RCTs of currently approved chronic pain treatments have found that they produce relatively small (less than 30 percent)
From page 229...
... It then examines the potential usefulness in pain research of other research methods: CER; observational studies, databases, and registries; and psychosocial research. With respect to the latter, new, more sophisticated methods of data analysis are needed to build understanding of individual differences in pain and its psychosocial impact and to test causal or explanatory models of the role of psychosocial factors in the maintenance, magnification, and development of persistent pain.
From page 230...
... , • whereas people with chronic pain may need to use a medication for many months to years. This is a critical shortcoming in trials of analge sics.
From page 231...
... Since 2002, the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) , with industry funding, has been developing "con sensus reviews and recommendations for improving the design, execution, and interpretation of clinical trials of treatments for pain" (IMMPACT, undated, website home page)
From page 232...
... . Most gaps in the literature on chronic pain involve uncertainties regarding treatments for specific types of patients -- those with comorbidities, specific genotypes, different disease stages, and so on.
From page 233...
... . Not only pain management but also pain prevention and public health strat egies can be investigated and enriched through CER.
From page 234...
... and new analgesics creates natural experiments that can reduce the biases usually associated with observational studies. These data sources also may provide efficient sampling frames for recruitment to large practical clinical trials or cluster randomized trials.
From page 235...
... . A Chronic Pain PBE Registry© is being created in New York City, based initially on detail on thousands of patients treated in four pain clinics in three academic institutions (the Weill Cornell Medical College-New York Presbyterian Hospital, the Memorial Sloan-Kettering Cancer Center, and the Hospital for Special Surgery)
From page 236...
... Over the past several decades, significant progress in the development of research methods for assessing and treating pain has closed important gaps in understanding of how individuals perceive, react to, and adjust to pain, as well as how they respond to treatment. These approaches are relatively new and have not yet influenced health policy significantly or been widely adopted in clinical practice.
From page 237...
... .7 Incorporating self-report measures of psychosocial adjustment into clinical practice prevents overly simplistic thinking about adjustment to pain and can lead to a new appreciation of the impact of pain and the need to address its psychological and social contexts. A number of psychological markers have been demonstrated to predict chronic pain and related disability.
From page 238...
... Please help us. -- A person with chronic pain8 In the future, many discoveries in pain research will require teams of researchers with diverse backgrounds who can integrate multilayered data into systems models.
From page 239...
... Training models should better orient basic and applied pain researchers to the multidisciplinary nature of the development, amplification, and maintenance of chronic pain and pain-related disability. Along these lines, established curricula on pain are available (for example, the IASP curriculum)
From page 240...
... The committee acknowledges elsewhere in this chapter the high probability of declining funds for pain research. The potential for a more robust set of pain-related research activities • does exist, coordinated across NIH institutes and centers by the NIH Pain Consortium and across NIH and other federal agencies by the Interagency Pain Research Coordinating Committee, currently in for mation.
From page 241...
... . Indeed, an early Common Fund science advance described by NIH is one that involves the development of "new tools to correct brain activity," which is expected to contribute to new treatments for several brain disorders, including chronic pain.
From page 242...
... A national Pain Research Working Group comprising more than 50 representatives of the depart ment and a few external collaborating investigators in pain and pain management focuses, in part, on disseminating research findings "with relatively direct practice and policy implications" (Kerns and Dobscha, 2009, p.
From page 243...
... . Participating in the NIH Pain Consortium are 15 institutes, four centers, and four offices under the Office of the NIH Director.
From page 244...
... . Consideration needs to be given to expanding NIH funding of pain research, given the magnitude of the problem of pain (approximately 100 million adults affected by chronic pain alone)
From page 245...
... , $78 million supported basic science and $102 million clinical research. In testimony pro vided to the committee, it was reported that NIH pain-related expenditures for 2009-2010 were approximately $320 million.
From page 246...
... 10) ; and the need for studies to determine best practices in treating specific types • of chronic pain.
From page 247...
... ; protect intellectual property; and • foster high-risk, translational research with a potentially high payoff. • Although the makeup of multidisciplinary teams for pain would, of course, be different and perhaps more diverse than that of such teams for cancer, the above list provides a good summary of what public–private partnerships in the field of pain management might hope to accomplish.
From page 248...
... Other potential partnerships could involve working with international research organizations on epidemiologic and • human behavior studies in an attempt to understand the reasons for the apparent increased prevalence of chronic pain in many countries, includ ing the United States; working with the pharmaceutical industry and the pain research com • munity to increase understanding of genetic or other variations in patho
From page 249...
... , the Centers for Medicare and Medicaid Services (CMS) , clinicians treating pain patients, and patient advocacy groups to produce and publicize evidence-based reviews of currently used pain treatments (including surgery)
From page 250...
... Each of the above examples suggests a somewhat different mix of partners. Such variation is highly desirable, not only because it engages a wider range of organizations in thinking about pain care but also because it avoids overreliance on a small group of industry partners.
From page 251...
... Gaps exist in basic, clinical, and epidemiological research on pain and • pain management. Filling these gaps could help define the prevalence of recurrent and chronic pain conditions and populations at risk.
From page 252...
... Examples include new methods for patient stratification in clinical trials, as well as more
From page 253...
... Large prospective registries will enable investigators to identify more readily pain treatments and patient characteristics that result in beneficial outcomes or harms. P ublic–private partnerships could support a core infrastructure for • interdisciplinary clinical trials in pain treatment (similar to that which exists in the children's oncology field)
From page 254...
... 2007. Psychological interventions for arthritis pain management in adults: A meta-analysis.
From page 255...
... 2011. Evidence-based clinical trial design for chronic pain pharmacotherapy: A blue print for ACTION.
From page 256...
... 2009. Hypnosis for chronic pain management: A new hope.
From page 257...
... 1999. Systematic review and meta-anallysis of randomized controlled trials of cognitive behaviour therapy and behaviour therapy for chronic pain in adults, excluding headache.
From page 258...
... 2002. Clinical effectiveness and cost effectiveness of treatments for chronic pain patients.
From page 259...
... Discovery of the molecules, cells, and neuronal pathways in volved in nociception/pain perception and affective aspects of pain are critical. Molecular and cellular studies, when coupled with studies in animal models and clinical research, will provide a comprehensive basis for the development of new pharmacological, behavioral, and technology-based treatments for chronic pain disorders, and/or research on the mechanisms of action of therapies effective for chronic pain.
From page 260...
... Chronic pain conditions are complex disorders where environmental and genetic influences interact to affect sensitivity to noxious stimuli and relief from pain. Polymorphisms and mutations in mitochondrial DNA may also play a role in modulating pain, especially in muscles and peripheral nerves.
From page 261...
... , which are associated with acute and chronic pain conditions, and how these affective states modify the experience of pain and treatment outcomes. I nteraction of biological markers, central nervous system mechanisms, • and drug, behavioral, and CAM interventions.
From page 262...
... However, many of the existing animal models do not adequately reflect clinical pain conditions and, in particular, chronic pain disorders. The development of new animal models is necessary in order to discover the underlying mechanisms of pain perception as well as the mechanisms of analgesia that will prove useful in treat ing patients.
From page 263...
... It is estimated that 75 percent of patients with advanced cancer ex perience moderate to severe pain; an IOM report states that 40 percent of people at the end of life have severe, unrelieved pain. A number of advances have been made in the treatment of chronic pain, most notably the neuroactive medica tions, counter-stimulation methods, and cognitive-behavioral therapies.
From page 264...
... C linical trials to establish best pain management practices. • EPIDEMIOLOGY OF PAIN One goal of this FOA is to stimulate innovative investigations that enhance our understanding of the incidence, prevalence, and correlates of pain within and across populations.
From page 265...
... I nterrelationship of psychiatric disorders (e.g., borderline personality, • histrionic, antisocial) and chronic pain, and relate these findings to pharmacological and behavioral therapies.
From page 266...
... D iverse cultural beliefs about and actions taken for pain and its manage • ment including self-care and that of lay caregivers. T reatment and management strategies for chronic pain in diverse • populations.
From page 267...
... • N ew technologies for use in the study and treatment of pain in the natu • ral environment of the patients daily living. C linical studies to inform, develop, and validate new animal models of • chronic pain conditions; i.e., a bedside-to-bench approach.


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