title: Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations.
abstract: 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.
authors.affiliation: Department of Anesthesiology, University of Rochester, Rochester, NY, USA University of Washington, Seattle, WA, USA University of Pennsylvania, Philadelphia, PA, USA University of Florida, Gainesville, FL, USA Queen's University, Kingston, ON, Canada Harvard University, Boston, MS, USA Johns Hopkins University, Baltimore, MD, USA German Diabetes Center at Heinrich Heine University, Düsseldorf, Germany Lora Group, LLC, Royal Oak, MD, USA American Chronic Pain Association, Rocklin, CA, USA Pfizer and Duke University, Raleigh-Duram, NC, USA GlaxoSmithKline, London, United Kingdom Eli Lilly, Indianapolis, IN, USA Virtuous Pharma, Inc, Raleigh-Durham, NC, USA York University, Toronto, ON, Canada Rigshospitalet, Copenhagen University, Denmark Endo Pharmaceuticals, Inc, Malvern, PA, USA Teva Pharmaceuticals, North Wales, PA, USA AcelRx, Redwood City, CA, USA Arlington, VA, USA Johnson and Johnson, Titusville, NJ, USA Grünenthal GMbH, Aachen, Germany Jazz Pharmaceuticals, Palo Alto, CA, USA.
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Gewandter
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authors.forename: Anne Louise
authors.initials: AL
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authors.lastname: Raja
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authors.lastname: Robinson
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authors.initials: CJ
authors.lastname: Woolf
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authors.lastname: Ziegler
authors.forename: Michael A
authors.initials: MA
authors.lastname: Ashburn
authors.forename: Laurie B
authors.initials: LB
authors.lastname: Burke
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authors.lastname: Cowan
authors.forename: Steven Z
authors.initials: SZ
authors.lastname: George
authors.forename: Veeraindar
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authors.lastname: Goli
authors.forename: Ole X
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authors.lastname: Graff
authors.forename: Smriti
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authors.lastname: Iyengar
authors.forename: Gary W
authors.initials: GW
authors.lastname: Jay
authors.forename: Joel
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authors.lastname: Kehlet
authors.forename: Rachel A
authors.initials: RA
authors.lastname: Kitt
authors.forename: Ernest A
authors.initials: EA
authors.lastname: Kopecky
authors.forename: Richard
authors.initials: R
authors.lastname: Malamut
authors.forename: Michael P
authors.initials: MP
authors.lastname: McDermott
authors.forename: Pamela
authors.initials: P
authors.lastname: Palmer
authors.forename: Bob A
authors.initials: BA
authors.lastname: Rappaport
authors.forename: Christine
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authors.lastname: Rauschkolb
authors.forename: Ilona
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authors.lastname: Steigerwald
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authors.initials: GA
authors.lastname: Walco
mesh_terms: D035843:Biomedical Research / Q000379:methods / Q000592:standards; D059350:Chronic Pain / Q000175:diagnosis / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D003226:Congresses as Topic / Q000592:standards; D006801:Humans; D059408:Pain Management / Q000379:methods / Q000592:standards*; D017410:Practice Guidelines as Topic / Q000592:standards*; D012107:Research Design / Q000592:standards*; D013997:Time Factors