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Pain. 2015 Jul;156(7):1184-97. doi: 10.1097/j.pain.0000000000000191.

Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations.

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aDepartment of Anesthesiology, University of Rochester, Rochester, NY, USA bUniversity of Washington, Seattle, WA, USA cUniversity of Pennsylvania, Philadelphia, PA, USA dUniversity of Florida, Gainesville, FL, USA eQueen's University, Kingston, ON, Canada fHarvard University, Boston, MS, USA gJohns Hopkins University, Baltimore, MD, USA hGerman Diabetes Center at Heinrich Heine University, D├╝sseldorf, Germany iLora Group, LLC, Royal Oak, MD, USA jAmerican Chronic Pain Association, Rocklin, CA, USA kPfizer and Duke University, Raleigh-Duram, NC, USA lGlaxoSmithKline, London, United Kingdom mEli Lilly, Indianapolis, IN, USA nVirtuous Pharma, Inc, Raleigh-Durham, NC, USA oYork University, Toronto, ON, Canada pRigshospitalet, Copenhagen University, Denmark qEndo Pharmaceuticals, Inc, Malvern, PA, USA rTeva Pharmaceuticals, North Wales, PA, USA sAcelRx, Redwood City, CA, USA tArlington, VA, USA uJohnson and Johnson, Titusville, NJ, USA vGr├╝nenthal GMbH, Aachen, Germany wJazz Pharmaceuticals, Palo Alto, CA, USA.


Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (ie, chronic postsurgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (ie, surgery, viral infection, injury, and toxic or noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials.

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