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 N 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 Iyengar; Gary 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

doi:10.1097/j.pain.0000000000000191

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 N 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

Department of Clinical Medicine

73 Citations (Scopus)

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 language	English
Journal	Pain
Volume	156
Issue number	7
Pages (from-to)	1184-97
Number of pages	14
ISSN	0304-3959
DOIs	https://doi.org/10.1097/j.pain.0000000000000191
Publication status	Published - Jul 2015

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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), 1184-97. https://doi.org/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 2015, 'Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations', Pain, vol. 156, no. 7, pp. 1184-97. https://doi.org/10.1097/j.pain.0000000000000191

@article{f72b0b179677404c87c59171dc2394a2,

title = "Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations",

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.",

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

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T1 - Research design considerations for chronic pain prevention clinical trials

T2 - IMMPACT recommendations

AU - Gewandter, Jennifer S

AU - Dworkin, Robert H

AU - Turk, Dennis C

AU - Farrar, John T

AU - Fillingim, Roger B

AU - Gilron, Ian

AU - Markman, John D

AU - Oaklander, Anne Louise

AU - Polydefkis, Michael J

AU - Raja, Srinivasa N

AU - Robinson, James P

AU - Woolf, Clifford J

AU - Ziegler, Dan

AU - Ashburn, Michael A

AU - Burke, Laurie B

AU - Cowan, Penney

AU - George, Steven Z

AU - Goli, Veeraindar

AU - Graff, Ole X

AU - Iyengar, Smriti

AU - Jay, Gary W

AU - Katz, Joel

AU - Kehlet, Henrik

AU - Kitt, Rachel A

AU - Kopecky, Ernest A

AU - Malamut, Richard

AU - McDermott, Michael P

AU - Palmer, Pamela

AU - Rappaport, Bob A

AU - Rauschkolb, Christine

AU - Steigerwald, Ilona

AU - Tobias, Jeffrey

AU - Walco, Gary A

PY - 2015/7

Y1 - 2015/7

N2 - 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.

AB - 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.

U2 - 10.1097/j.pain.0000000000000191

DO - 10.1097/j.pain.0000000000000191

M3 - Journal article

C2 - 25887465

SN - 0304-3959

VL - 156

SP - 1184

EP - 1197

JO - Pain

JF - Pain

IS - 7

ER -

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

Abstract

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