Stratifying patients with peripheral neuropathic pain based on sensory profiles: algorithm and sample size recommendations
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Published version
Author(s)
Type
Journal Article
Abstract
In a recent cluster analysis, it has been shown that patients with peripheral neuropathic pain can be grouped into 3 sensory phenotypes based on quantitative sensory testing profiles, which are mainly characterized by either sensory loss, intact sensory function and mild thermal hyperalgesia and/or allodynia, or loss of thermal detection and mild mechanical hyperalgesia and/or allodynia. Here, we present an algorithm for allocation of individual patients to these subgroups. The algorithm is nondeterministic—ie, a patient can be sorted to more than one phenotype—and can separate patients with neuropathic pain from healthy subjects (sensitivity: 78%, specificity: 94%). We evaluated the frequency of each phenotype in a population of patients with painful diabetic polyneuropathy (n = 151), painful peripheral nerve injury (n = 335), and postherpetic neuralgia (n = 97) and propose sample sizes of study populations that need to be screened to reach a subpopulation large enough to conduct a phenotype-stratified study. The most common phenotype in diabetic polyneuropathy was sensory loss (83%), followed by mechanical hyperalgesia (75%) and thermal hyperalgesia (34%, note that percentages are overlapping and not additive). In peripheral nerve injury, frequencies were 37%, 59%, and 50%, and in postherpetic neuralgia, frequencies were 31%, 63%, and 46%. For parallel study design, either the estimated effect size of the treatment needs to be high (>0.7) or only phenotypes that are frequent in the clinical entity under study can realistically be performed. For crossover design, populations under 200 patients screened are sufficient for all phenotypes and clinical entities with a minimum estimated treatment effect size of 0.5.
Date Issued
2017-05-02
Date Acceptance
2017-04-10
Citation
PAIN, 2017, 158 (8), pp.1446-1455
ISSN
0304-3959
Publisher
Wolters Kluwer Health, Inc
Start Page
1446
End Page
1455
Journal / Book Title
PAIN
Volume
158
Issue
8
Copyright Statement
© 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Association for the Study of Pain.. This is an open access article
distributed under the Creative Commons Attribution License 4.0 (CCBY https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original
work is properly cited.
distributed under the Creative Commons Attribution License 4.0 (CCBY https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original
work is properly cited.
Sponsor
Universitatsklinikum Schleswig - Holstein
Commission of the European Communities
Identifier
http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000406932300008&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
Grant Number
Neuropain
115007
Subjects
Science & Technology
Life Sciences & Biomedicine
Anesthesiology
Clinical Neurology
Neurosciences
Neurosciences & Neurology
Quantitative sensory testing
German Research Network on Neuropathic Pain
Diabetic polyneuropathy
Peripheral nerve injury
Postherpetic neuralgia
PLACEBO-CONTROLLED TRIAL
GERMAN RESEARCH NETWORK
POSTHERPETIC NEURALGIA
DOUBLE-BLIND
CLINICAL-TRIALS
EVALUATION TOOL
GRADING SYSTEM
PHENOTYPE
MECHANISMS
LIDOCAINE
11 Medical And Health Sciences
17 Psychology And Cognitive Sciences
Publication Status
Published