The Potential Role of Sensory Testing, Skin Biopsy, and Functional Brain Imaging as Biomarkers in Chronic Pain Clinical Trials: IMMPACT Considerations

被引：104

作者：

Smith, Shannon M. ^{[1
]}

Dworkin, Robert H. ^{[1
,2
,3
,4
]}

Turk, Dennis C. ^{[5
]}

Baron, Ralf ^{[6
]}

Polydefkis, Michael ^{[7
]}

Tracey, Irene ^{[8
]}

Borsook, David ^{[9
]}

Edwards, Robert R. ^{[10
]}

Harris, Richard E. ^{[11
]}

Wager, Tor D. ^{[12
,13
]}

Arendt-Nielsen, Lars ^{[14
]}

Burke, Laurie B. ^{[15
,16
]}

Carr, Daniel B. ^{[17
,18
,19
,20
]}

Chappell, Amy ^{[21
]}

Farrar, John T. ^{[22
,23
]}

Freeman, Roy ^{[24
]}

Gilron, Ian ^{[25
,26
,27
,28
]}

Goli, Veeraindar ^{[29
]}

Haeussler, Juergen ^{[30
]}

Jensen, Troels ^{[31
,32
]}

Katz, Nathaniel P. ^{[33
,34
]}

Kent, Jeffrey ^{[35
]}

Kopecky, Ernest A. ^{[36
]}

Lee, David A.

Maixner, William ^{[37
]}

Markman, John D. ^{[38
]}

McArthur, Justin C. ^{[9
]}

McDermott, Michael P. ^{[2
,3
,4
,39
]}

Parvathenani, Lay ^{[40
]}

Raja, Srinivasa N. ^{[41
]}

Rappaport, Bob A. ^{[42
]}

Rice, Andrew S. C. ^{[43
]}

Rowbotham, Michael C. ^{[44
]}

Tobias, Jeffrey K. ^{[45
]}

Wasan, Ajay D. ^{[46
,47
]}

Witter, James ^{[48
]}

机构：

[1] Univ Rochester, Sch Med & Dent, Dept Anesthesiol, 601 Elmwood Ave,Box 604, Rochester, NY 14642 USA

[2] Univ Rochester, Sch Med & Dent, Dept Neurol, Rochester, NY 14642 USA

[3] Univ Rochester, Sch Med & Dent, Dept Psychiat, Rochester, NY 14642 USA

[4] Univ Rochester, Sch Med & Dent, Ctr Human Expt Therapeut, Rochester, NY 14642 USA

[5] Univ Washington, Dept Anesthesiol & Pain Med, Seattle, WA 98195 USA

[6] Univ Med Ctr Schleswig Holstein, Div Neurol Pain Res & Therapy, Dept Neurol, Kiel, Germany

[7] Johns Hopkins Univ, Sch Med, Dept Neurol, Baltimore, MD 21205 USA

[8] Univ Oxford, Nuffield Dept Clin Neurosci, Oxford, England

[9] Harvard Med Sch, Boston Childrens Hosp, Dept Anaesthesia, Ctr Pain & Brain, Boston, MA USA

[10] Brigham & Womens Hosp, Dept Anesthesiol, 75 Francis St, Boston, MA 02115 USA

[11] Univ Michigan, Dept Anesthesiol & Internal Med, Ann Arbor, MI 48109 USA

[12] Univ Colorado, Dept Psychol, Campus Box 345, Boulder, CO 80309 USA

[13] Univ Colorado, Dept Neurosci, Boulder, CO 80309 USA

[14] Aalborg Univ, Ctr Sensory Motor Interact, Dept Hlth Sci & Technol, Sch Med, Aalborg, Denmark

[15] Univ Maryland, Sch Pharm, Baltimore, MD 21201 USA

[16] LORA Grp LLC, Royal Oak, MI USA

[17] Tufts Univ, Sch Med, Dept Publ Hlth, Boston, MA 02111 USA

[18] Tufts Univ, Sch Med, Dept Anesthesiol, Boston, MA 02111 USA

[19] Tufts Univ, Sch Med, Dept Med, Boston, MA 02111 USA

[20] Tufts Univ, Sch Med, Dept Mol Physiol & Pharmacol, Boston, MA 02111 USA

[21] Eli Lilly & Co, Indianapolis, IN 46285 USA

[22] Univ Penn, Perelman Sch Med, Dept Epidemiol, Philadelphia, PA 19104 USA

[23] Univ Penn, Perelman Sch Med, Dept Anesthesiol, Philadelphia, PA 19104 USA

[24] Harvard Med Sch, Dept Neurol, Boston, MA USA

[25] Queens Univ, Dept Anesthesiol & Perioperat Med, Kingston, ON, Canada

[26] Queens Univ, Dept Biomed Sci, Kingston, ON, Canada

[27] Queens Univ, Dept Mol Sci, Kingston, ON, Canada

[28] Queens Univ, Ctr Neurosci Studies, Kingston, ON, Canada

[29] Pfizer Inc, Cary, NC USA

[30] Janssen Res & Dev LLC, Titusville, NJ USA

[31] Aarhus Univ, Dept Neurol, Aarhus, Denmark

[32] Aarhus Univ, Danish Pain Res Ctr, Aarhus, Denmark

[33] Analges Solut, Natick, MA USA

[34] Tufts Univ, Sch Med, Dept Anesthesiol, Boston, MA 02111 USA

[35] Horizon Pharma Inc, Lake Forest, IL USA

[36] Coll Pharmaceut Inc, Canton, MA USA

[37] Duke Univ, Dept Anesthesiol, Durham, NC USA

[38] Univ Rochester, Sch Med & Dent, Neuromed Pain Management & Translat Pain Res, Rochester, NY USA

[39] Univ Rochester, Sch Med & Dent, Dept Biostat & Computat Biol, Rochester, NY USA

[40] Bristol Myers Squibb, Princeton, NJ USA

[41] Johns Hopkins Univ, Sch Med, Dept Anesthesiol & Crit Care Med, Baltimore, MD 21205 USA

[42] Analges Concepts LLC, Arlington, VA USA

[43] Imperial Coll, Pain Res, Dept Surg & Canc, London, England

[44] Calif Pacific Med Ctr, Res Inst, San Francisco, CA USA

[45] Aquila Consulting Grp LLC, Petaluma, CA USA

[46] Univ Pittsburgh, Sch Med, Dept Anesthesiol, Pittsburgh, PA 15261 USA

[47] Univ Pittsburgh, Sch Med, Dept Psychiat, Pittsburgh, PA USA

[48] NIAMSD, Div Skin & Rheumat Dis, NIH, Bethesda, MD 20892 USA

来源：

JOURNAL OF PAIN | 2017年 / 18卷 / 07期

关键词：

Biomarkers; IMMPACT; sensory testing; skin punch biopsy; brain imaging; NERVE-FIBER DENSITY; PERIPHERAL NEUROPATHIC PAIN; IMPAIRED GLUCOSE-TOLERANCE; LOW-BACK-PAIN; KNEE OSTEOARTHRITIS PATIENTS; PRIMARY SOMATOSENSORY CORTEX; IRRITABLE-BOWEL-SYNDROME; DOUBLE-BLIND; GRAY-MATTER; POSTHERPETIC NEURALGIA;

D O I：

10.1016/j.jpain.2017.02.429

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Valid and reliable biomarkers can play an important role in clinical trials as indicators of biological or pathogenic processes or as a signal of treatment response. Currently, there are no biomarkers for pain qualified by the U.S. Food and Drug Administration or the European Medicines Agency for use in clinical trials. This article summarizes an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials meeting in which 3 potential biomarkers were discussed for use in the development of analgesic treatments: 1) sensory testing, 2) skin punch biopsy, and 3) brain imaging. The empirical evidence supporting the use of these tests is described within the context of the 4 categories of biomarkers: 1) diagnostic, 2) prognostic, 3) predictive, and 4) pharmacodynamic. Although sensory testing, skin punch biopsy, and brain imaging are promising tools for pain in clinical trials, additional evidence is needed to further support and standardize these tests for use as biomarkers in pain clinical trials. Perspective: The applicability of sensory testing, skin biopsy, and brain imaging as diagnostic, prognostic, predictive, and pharmacodynamic biomarkers for use in analgesic treatment trials is considered. Evidence in support of their use and outlining problems is presented, as well as a call for further standardization and demonstrations of validity and reliability. (C) 2017 by the American Pain Society

引用

页码：757 / 777

页数：21

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