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

Jennifer S. Gewandter, Robert H. Dworkin, Dennis C. Turk, John T. Farrar, Roger B. Fillingim, Ian Gilron, John D. Markman, Anne Louise Oaklander, Michael J Polydefkis, Srinivasa Naga Raja, James P. Robinson, Clifford J. Woolf, Dan Ziegler, Michael A. Ashburn, Laurie B. Burke, Penney Cowan, Steven Z. George, Veeraindar Goli, Ole X. Graff, Smriti IyengarGary W. Jay, Joel Katz, Henrik Kehlet, Rachel A. Kitt, Ernest A. Kopecky, Richard Malamut, Michael P. McDermott, Pamela Palmer, Bob A. Rappaport, Christine Rauschkolb, Ilona Steigerwald, Jeffrey Tobias, Gary A. Walco

Research output: Contribution to journalArticle

Abstract

Although certain risk factors can identify individuals who aremost likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACTmeeting 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, inmany 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.

Original languageEnglish (US)
Pages (from-to)1184-1197
Number of pages14
JournalPain
Volume156
Issue number7
DOIs
StatePublished - Jul 1 2015

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Keywords

  • Chemotherapy induced peripheral neuropathy
  • Chronic low back pain
  • Chronic postsurgical pain
  • Postherpetic neuralgia
  • Prevention trial design
  • Risk factors

ASJC Scopus subject areas

  • Clinical Neurology
  • Anesthesiology and Pain Medicine
  • Neurology
  • Pharmacology

Cite this

Gewandter, J. S., Dworkin, R. H., Turk, D. C., Farrar, J. T., Fillingim, R. B., Gilron, I., Markman, J. D., Oaklander, A. L., Polydefkis, M. J., Raja, S. N., Robinson, J. P., Woolf, C. J., Ziegler, D., Ashburn, M. A., Burke, L. B., Cowan, P., George, S. Z., Goli, V., Graff, O. X., ... Walco, G. A. (2015). Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations. Pain, 156(7), 1184-1197. https://doi.org/10.1097/j.pain.0000000000000191