Cited by 403Musculoskeletal pain and rehabilitationPain Mechanisms and TreatmentsPain Management and Opioid Use

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Patient phenotyping in clinical trials of chronic pain treatments: IMMPACT recommendations

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Edwards, Robert R., Dworkin, Robert H., Turk, Dennis C., Angst, Martin S., Dionne, Raymond, Freeman, Roy, Hansson, Per, Haroutounian, Simon, Arendt-Nielsen, Lars, Attal, Nadine, Baron, Ralf, Brell, Joanna, Bujanover, Shay, Burke, Laurie B., Carr, Daniel, Chappell, Amy S., Cowan, Penney, Etropolski, Mila, Fillingim, Roger B., Gewandter, Jennifer S., Katz, Nathaniel P., Kopecky, Ernest A., Markman, John D., Nomikos, George, Porter, Linda, Rappaport, Bob A., Rice, Andrew S.C., Scavone, Joseph M., Scholz, Joachim, Simon, Lee S., Smith, Shannon M., Tobias, Jeffrey, Tockarshewsky, Tina, Veasley, Christine, Versavel, Mark, Wasan, Ajay D., Wen, Warren, Yarnitsky, David·2016·Pain

DOI 10.1097/j.pain.0000000000000602PMC PMC5965275

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Abstract

There is tremendous interpatient variability in the response to analgesic therapy (even for efficacious treatments), which can be the source of great frustration in clinical practice. This has led to calls for “precision medicine” or personalized pain therapeutics (ie, empirically based algorithms that determine the optimal treatments, or treatment combinations, for individual patients) that would presumably improve both the clinical care of patients with pain and the success rates for putative analgesic drugs in phase 2 and 3 clinical trials. However, before implementing this approach, the characteristics of individual patients or subgroups of patients that increase or decrease the response to a specific treatment need to be identified. The challenge is to identify the measurable phenotypic characteristics of patients that are most predictive of individual variation in analgesic treatment outcomes, and the measurement tools that are best suited to evaluate these characteristics. In this article, we present evidence on the most promising of these phenotypic characteristics for use in future research, including psychosocial factors, symptom characteristics, sleep patterns, responses to noxious stimulation, endogenous pain-modulatory processes, and response to pharmacologic challenge. We provide evidence-based recommendations for core phenotyping domains and recommend measures of each domain.

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See all 403

Authors: Edwards, R. R., Dworkin, R. H., Turk, D. C., Angst, M. S., Dionne, R., Freeman, R., Hansson, P., Haroutounian, S., Arendt-Nielsen, L., Attal, N., Baron, R., Brell, J., Bujanover, S., Burke, L. B., Carr, D., Chappell, A. S., Cowan, P., Etropolski, M., Fillingim, R. B., Gewandter, J. S., Katz, N. P., Kopecky, E. A., Markman, J. D., Nomikos, G., Porter, L., Rappaport, B. A., Rice, A. S. C., Scavone, J. M., Scholz, J., Simon, L. S., Smith, S. M., Tobias, J., Tockarshewsky, T., Veasley, C., Versavel, M., Wasan, A. D., Wen, W., & Yarnitsky, D.
Affiliations: Harvard University (US)
University of Rochester (US)
University of Washington (US)
Stanford University (US)
East Carolina University (US)
Oslo University Hospital (NO)
Washington University in St. Louis (US)
Aalborg University, Aalborg, Denmark
Inserm (FR)
Christian-Albrechts-Universität zu Kiel (DE)
MetroHealth Medical Center (US)
Depomed (United States) (US)
University of Maryland, Baltimore (US)
Tufts University (US)
Eli Lilly (United States) (US)
American Chronic Pain Association (US)
Johnson & Johnson (United States) (US)
University of Florida (US)
Collegium Pharmaceutical (United States) (US)
Astellas Pharma (United States) (US)
National Institutes of Health (US)
Arlington, VA, USA
Imperial College London (GB)
Pfizer (United States) (US)
Columbia University (US)
SDG LLC, Cambridge, MA, USA
Jazz Pharmaceuticals (United States) (US)
Ceres (US)
Chronic Pain Research Alliance, North Kingstown, RI, USA
Zalicus, Cambridge, MA, USA
University of Pittsburgh (US)
Purdue Pharma (United States) (US)
Technion – Israel Institute of Technology (IL)
Corresponding author: Edwards, Robert R.
ORCID: Edwards, Robert R.
Dworkin, Robert H.
Angst, Martin S.
Freeman, Roy
Hansson, Per
Haroutounian, Simon
Attal, Nadine
Baron, Ralf
Burke, Laurie B.
Fillingim, Roger B.
Gewandter, Jennifer S.
Katz, Nathaniel P.
Kopecky, Ernest A.
Markman, John D.
Nomikos, George
Rice, Andrew S.C.
Scholz, Joachim
Simon, Lee S.
Smith, Shannon M.
Tobias, Jeffrey
Tockarshewsky, Tina
Wasan, Ajay D.
Wen, Warren
Yarnitsky, David
Venue: Pain
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2016-05-05
Volume: 157
Issue: 9
Pages: 1851-1871
ISSN: 0304-3959 (ISSN-L)
1872-6623
DOI: 10.1097/j.pain.0000000000000602
PMC: PMC5965275
OpenAlex: W2359535866
Cited by: 403
References: 275
Citations by year: 2026: 29 · 2025: 51 · 2024: 45 · 2023: 47 · 2022: 35 · 2021: 64 · 2020: 44 · 2019: 32 · 2018: 26 · 2017: 24 · 2016: 3
FWCI: 3.24
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Pain (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
VBN Forskningsportal (Aalborg Universitet) (submittedVersion)
Funders: U.S. Food and Drug Administration (U01-FD005936)
National Institute on Aging (R01AG034982)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01AR064367)
Topics: Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Musculoskeletal pain and rehabilitation
Health Sciences › Medicine › Physiology (medical) › Pain Mechanisms and Treatments
Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Opioid Use
Keywords: patient phenotyping, chronic pain, precision medicine, psychosocial factors, symptom characteristics, sleep patterns, endogenous pain modulation, clinical trial design
MeSH terms: Analgesics, Clinical Trials as Topic, Humans, Pain Measurement, Phenotype, Treatment Outcome, Chronic Pain

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Patient phenotyping in clinical trials of chronic pain treatments: IMMPACT recommendations

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