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 consi...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wolters Kluwer
2021-01-01
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| Series: | PAIN Reports |
| Online Access: | http://journals.lww.com/painrpts/fulltext/10.1097/PR9.0000000000000895 |
| _version_ | 1818739270615040000 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Jennifer S. Gewandter |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-18T01:22:10Z |
| format | Article |
| id | doaj.art-0106332128fd4ca3815612d7abe61e83 |
| institution | Directory Open Access Journal |
| issn | 2471-2531 |
| language | English |
| last_indexed | 2024-12-18T01:22:10Z |
| publishDate | 2021-01-01 |
| publisher | Wolters Kluwer |
| record_format | Article |
| series | PAIN Reports |
| spelling | doaj.art-0106332128fd4ca3815612d7abe61e832022-12-21T21:25:48ZengWolters KluwerPAIN Reports2471-25312021-01-0161e89510.1097/PR9.0000000000000895202101000-00013Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendationsJennifer S. Gewandter0Robert H. Dworkin1Dennis C. Turk2John T. Farrar3Roger B. Fillingim4Ian Gilron5John D. Markman6Anne Louise Oaklander7Michael J. Polydefkis8Srinivasa N. Raja9James P. Robinson10Clifford J. Woolf11Dan Ziegler12Michael A. Ashburn13Laurie B. Burke14Penney Cowan15Steven Z. George16Veeraindar Goli17Ole X. Graff18Smriti Iyengar19Gary W. Jay20Joel Katz21Henrik Kehlet22Rachel A. Kitt23Ernest A. Kopecky24Richard Malamut25Michael P. McDermott26Pamela Palmer27Bob A. Rappaport28Christine Rauschkolb29Ilona Steigerwald30Jeffrey Tobias31Gary A. Walco32a Department of Anesthesiology, University of Rochester, Rochester, NY, USAa Department of Anesthesiology, University of Rochester, Rochester, NY, USAb University of Washington, Seattle, WA, USAc University of Pennsylvania, Philadelphia, PA, USAd University of Florida, Gainesville, FL, USAe Queen's University, Kingston, ON, Canadaa Department of Anesthesiology, University of Rochester, Rochester, NY, USAf Harvard University, Boston, MS, USAg Johns Hopkins University, Baltimore, MD, USAg Johns Hopkins University, Baltimore, MD, USAb University of Washington, Seattle, WA, USAf Harvard University, Boston, MS, USAh German Diabetes Center at Heinrich Heine University, Düsseldorf, Germanyc University of Pennsylvania, Philadelphia, PA, USAi Lora Group, LLC, Royal Oak, MD, USAj American Chronic Pain Association, Rocklin, CA, USAd University of Florida, Gainesville, FL, USAk Pfizer and Duke University, Raleigh-Duram, NC, USAl GlaxoSmithKline, London, United Kingdomm Eli Lilly, Indianapolis, IN, USAn Virtuous Pharma, Inc, Raleigh-Durham, NC, USAo York University, Toronto, ON, Canadap Rigshospitalet, Copenhagen University, Denmarka Department of Anesthesiology, University of Rochester, Rochester, NY, USAq Endo Pharmaceuticals, Inc, Malvern, PA, USAr Teva Pharmaceuticals, North Wales, PA, USAa Department of Anesthesiology, University of Rochester, Rochester, NY, USAs AcelRx, Redwood City, CA, USAt Arlington, VA, USAu Johnson and Johnson, Titusville, NJ, USAv Grünenthal GMbH, Aachen, Germanyw Jazz Pharmaceuticals, Palo Alto, CA, USAb University of Washington, Seattle, WA, USAAbstract. 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.http://journals.lww.com/painrpts/fulltext/10.1097/PR9.0000000000000895 |
| spellingShingle | 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 Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations PAIN Reports |
| title | Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations |
| title_full | Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations |
| title_fullStr | Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations |
| title_full_unstemmed | Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations |
| title_short | Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations |
| title_sort | research design considerations for chronic pain prevention clinical trials immpact recommendations |
| url | http://journals.lww.com/painrpts/fulltext/10.1097/PR9.0000000000000895 |
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