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

Publication ,  Journal Article
Gewandter, JS; Dworkin, RH; Turk, DC; Farrar, JT; Fillingim, RB; Gilron, I; Markman, JD; Oaklander, AL; Polydefkis, MJ; Raja, SN; Robinson, JP ...
Published in: Pain
July 2015

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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Published In

Pain

DOI

EISSN

1872-6623

Publication Date

July 2015

Volume

156

Issue

7

Start / End Page

1184 / 1197

Location

United States

Related Subject Headings

  • Time Factors
  • Research Design
  • Practice Guidelines as Topic
  • Pain Management
  • Humans
  • Congresses as Topic
  • Clinical Trials as Topic
  • Chronic Pain
  • Biomedical Research
  • Anesthesiology
 

Citation

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Chicago
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Gewandter, J. S., Dworkin, R. H., Turk, D. C., Farrar, J. T., Fillingim, R. B., Gilron, I., … 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
Gewandter, Jennifer S., Robert H. Dworkin, Dennis C. Turk, John T. Farrar, Roger B. Fillingim, Ian Gilron, John D. Markman, et al. “Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations.Pain 156, no. 7 (July 2015): 1184–97. https://doi.org/10.1097/j.pain.0000000000000191.
Gewandter JS, Dworkin RH, Turk DC, Farrar JT, Fillingim RB, Gilron I, et al. Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations. Pain. 2015 Jul;156(7):1184–97.
Gewandter, Jennifer S., et al. “Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations.Pain, vol. 156, no. 7, July 2015, pp. 1184–97. Pubmed, doi:10.1097/j.pain.0000000000000191.
Gewandter JS, Dworkin RH, Turk DC, Farrar JT, Fillingim RB, Gilron I, Markman JD, Oaklander AL, Polydefkis MJ, Raja SN, Robinson JP, Woolf CJ, Ziegler D, Ashburn MA, Burke LB, Cowan P, George SZ, Goli V, Graff OX, Iyengar S, Jay GW, Katz J, Kehlet H, Kitt RA, Kopecky EA, Malamut R, McDermott MP, Palmer P, Rappaport BA, Rauschkolb C, Steigerwald I, Tobias J, Walco GA. Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations. Pain. 2015 Jul;156(7):1184–1197.

Published In

Pain

DOI

EISSN

1872-6623

Publication Date

July 2015

Volume

156

Issue

7

Start / End Page

1184 / 1197

Location

United States

Related Subject Headings

  • Time Factors
  • Research Design
  • Practice Guidelines as Topic
  • Pain Management
  • Humans
  • Congresses as Topic
  • Clinical Trials as Topic
  • Chronic Pain
  • Biomedical Research
  • Anesthesiology