Clinical Validation of a Multi-Biomarker Assay for the Evaluation of Chronic Pain Patients in a Cross-Sectional, Observational Study

Amirdelfan, Kasra; Pope, Jason E.; Gunn, Joshua; Hill, Melissa M.; Cotten, Bradley M; Beresh, John E; Dobecki, Douglas; Miller, Nathan; Mehta, Pankaj; Girardi, George; Deer, Timothy R.

doi:10.1007/s40122-020-00175-3

Cited by 14 publications

(25 citation statements)

References 52 publications

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“…Specifically, our group was able to show that deranged biochemical function, evident by higher FPI scores, was significantly correlated to overall SF-36 scores (P = 0.0141), general health (P = 0.0457) and even more significantly, with emotional well-being (P = 0.0044) and limitations due to emotional problems (P = 0.0011). 12 To our knowledge, this is the first report of a validated multi-biomarker test panel that has been shown to correlate with PRO measures. These findings provide strong evidence for a role of perturbed biochemical function in the etiology and/or chronicity of pain.…”

Section: Introductionmentioning

confidence: 82%

“…Our group recently reported on the clinical validation of a multi-biomarker assay for the evaluation of chronic pain in patients. 12 This innovative laboratory test, known as the Foundation Pain Index (FPI), evaluates eleven endogenous biomarkers, which represent a highly diverse set of biochemical pathways involved in the pathogenesis of chronic pain. 12 Quantitative results for each of the eleven biomarkers are analyzed via a proprietary algorithm to generate a single numerical score (FPI score) on a scale of 0–100, which describes the severity of abnormal findings.…”

Section: Introductionmentioning

confidence: 99%

“… 12 This innovative laboratory test, known as the Foundation Pain Index (FPI), evaluates eleven endogenous biomarkers, which represent a highly diverse set of biochemical pathways involved in the pathogenesis of chronic pain. 12 Quantitative results for each of the eleven biomarkers are analyzed via a proprietary algorithm to generate a single numerical score (FPI score) on a scale of 0–100, which describes the severity of abnormal findings. FPI scores provide clinicians with objective and reproducible measures of the biochemical, metabolic, and nutritional drivers of chronic pain.…”

Section: Introductionmentioning

confidence: 99%

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Cross-Validation of the Foundation Pain Index with PROMIS-29 in Chronic Pain Patients

Pope¹,

Fishman

Gunn³

et al. 2021

JPR

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Purpose Discovery and validation of pragmatic biomarkers represent significant advancements in the field of pain management. Evaluating relationships between objective biomarkers and patient-reported outcomes (PROs) is an effective way to gain mechanistic insight into the potential role of biochemistry in chronic pain. The aim of this study was to validate the Foundation Pain Index (FPI) by evaluating associations between deranged biochemical function and PROMIS-29 domains in individuals living with chronic pain. Patients and Methods PROMIS-29 scores and FPI test results were obtained from 298 patients with chronic pain in this retrospective, observational study. Statistical analysis was performed using clinical test data to evaluate relationships between deranged biochemical function and quality of life measures across 8 universal domains. Results FPI scores significantly associated with multiple PROMIS-29 domains including physical function, impact score, fatigue, pain interference, and depression (P < 0.05). Moreover, specific analytes that comprise the FPI significantly correlated with PROMIS-29 domains, including 5-hydroxyindolacetic acid (pain interference, physical function, and pain impact scores), hydroxymethylglutarate (physical function), homocysteine (pain impact scores), kynurenic acid (pain interference and physical function), and quinolinic acid (physical function) (P < 0.05). Conclusion Cross-validation of the FPI with PROMIS-29 domains further supports the role of deranged biochemical function in the etiology of chronic pain. Objective identification of atypical biochemical function and subsequent correction holds tremendous promise for the non-opioid management of pain. Continued research efforts will aim to determine the impact of biochemical optimization in pre-surgical periods and post-surgical outcomes in patients with chronic pain.

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Section: Introductionmentioning

confidence: 82%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Cross-Validation of the Foundation Pain Index with PROMIS-29 in Chronic Pain Patients

Pope¹,

Fishman

Gunn³

et al. 2021

JPR

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“…The Foundation Pain Index (FPI) is a new commercial test resulting from the algo-rithmic analysis of abnormal urinary metabolites correlated with clinical assessment of chronic pain [72]. FPI results group biomarker profiles in patients with chronic pain and correlate them with clinical symptoms and behavioral assessments of chronic pain [73].…”

Section: Results: Biomarkers In Clinical Pain Assessmentmentioning

confidence: 99%

Possibility of Assessing Pain with Biomarkers in Psychiatric Disorders

Jakubów¹,

Kościuczuk²,

Garkowski³

et al. 2021

Preprint

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According to the literature, patients with chronic pain and mental disorders constitute a huge, heterogeneous group. However, it is known that social and psychological processes closely affect the level and expression of chronic pain. In this paper, we present a review of the literature, define methods of identifying pain biomarkers and consider the possibility of using them to assess pain in mental disorders. Group researchers searched PubMed, Scope, and Cochrane databases for "pain biomarkers in mental disorders" between 2011 and 2021. for available databases for full-text, peer-reviewed studies and review publications using the following keywords: pain biomarkers, neuroimaging pain, pain metabolomics, pain and psychiatric disorders, pain electroencephalography (EEG), serum pain biomarkers, saliva biomarkers, and diagnosis pain. The search included full-text articles, clinical trials, randomized controlled trials, and systematic reviews. Was used part of the PRISMA method to review the literature systematically. A literature search identified 283 studies based on the initially set inclusion and exclusion criteria. In the subsequent selection stages, 11 studies were selected for analysis. There are three main areas of the possible use of biomarkers for the clinical assessment of pain in psychiatric patients, neuroimaging, changes in metabolite levels in body fluids, and changes in gene expression. As a result of the review, individual pain mediators were distinguished that may be markers of pain in psychiatric patients. Some mediators indicate the specificity of pain and are of diagnostic importance. However, despite significant advances in research, most of the described biomarkers found in clinical trials assessing the severity and frequency of pain have no practical significance in psychiatric disorders. It is possible to diagnose pain based on neuroimaging using various methods, genetic methods, body fluids: blood and urine. Of the many, body fluid biomarkers are the most advanced. Discussion: Biomarker research is a dynamically developing field. The review has proposed new ways to diagnose pain by identifying pain biomarkers. Work presented pain diagnostics in psychiatric disorders based on biomarkers from various neuroimaging methods, blood and urine analysis. The possibility of new, effective techniques gives hope for the correct diagnosis of pain, especially in patients with mental disorders, which would allow for appropriate and adequate therapeutic therapies. In clinical practice is limited to a few methods. Assessment of pain biomarkers in body fluids (serum, saliva, and urine) seems to be the most practical and promising method of clinical application. Conclusions: There are new techniques that give hope for the correct diagnosis of pain, especially in patients with mental disorders, which will allow for their proper and adequate therapy. According to the literature, patients with chronic pain and mental disorders constitute a huge, heterogeneous group. However, it is known that social and psychological processes closely affect the level and expression of chronic pain.

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“…The Foundation Pain Index (FPI) is a new commercial test resulting from the algorithmic analysis of abnormal urinary metabolites correlated with clinical assessment of chronic pain [72]. FPI results group biomarker profiles in patients with chronic pain and correlate them with clinical symptoms and behavioral assessments of chronic pain [73].…”

Section: Biomarker Gene Expressionmentioning

confidence: 99%

Possibility of Assessing Pain with Biomarkers in Psychiatric Disorders

Jakubów¹,

Kościuczuk²,

Garkowski³

et al. 2021

Preprint

View full text Add to dashboard Cite

This paper presents a systematic literature review, defines methods for identifying biomarkers that are characteristic of pain, and considers their possible use for assessing pain in mental disorders. The PubMed, Scope, and Cochrane databases were searched for the subject “pain biomarkers in psychiatric disorders” between 2011 and 2021. Two independent researchers searched available databases for full-text, peer-reviewed studies and review publications using the following keywords: pain biomarkers, pain neuroimaging, pain metabolomics, pain and psychiatric disorders, pain electroencephalography (EEG), serum pain biomarkers, saliva biomarkers, and pain diagnosis. Full-text articles, clinical studies, randomized controlled trials, and systematic reviews were included in the search. The PRISMA method was used to review the literature systematically. The literature search identified 283 studies through the initially assumed inclusion and exclusion criteria. In successive selection steps, 11 studies were selected for analysis. There are three main areas of the possible use of biomarkers for clinically assessing pain in psychiatric patients, i.e., neuroimaging, changes in metabolite levels in body fluids, and gene expression changes. Despite significant research advancements, the described biomarkers are in phases of clinical trials for assessing the intensity and occurrence of pain. Discussion: Pain is a significant and disruptive symptom in patients with mental disorders. Recently, studies have proposed new possibilities for pain diagnostics by determining pain biomarkers. Biomarker research is a dynamically growing field of study. We present examples of pain diagnosis based on biomarkers from various neuroimaging methods and blood and urine analyses. The possibility of new, effective techniques gives hope for the correct diagnosis of pain, especially in patients with mental disorders, which would allow for appropriate and adequate therapeutic therapies. However, the possibilities of use in clinical practice are limited to a few methods. Assessment of pain biomarkers in body fluids (serum, saliva, and urine) appears to be the most practical and promising clinical use method. Keywords: pain assessment; pain biomarkers, psychiatric disorders

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Clinical Validation of a Multi-Biomarker Assay for the Evaluation of Chronic Pain Patients in a Cross-Sectional, Observational Study

Cited by 14 publications

References 52 publications

Cross-Validation of the Foundation Pain Index with PROMIS-29 in Chronic Pain Patients

Cross-Validation of the Foundation Pain Index with PROMIS-29 in Chronic Pain Patients

Possibility of Assessing Pain with Biomarkers in Psychiatric Disorders

Possibility of Assessing Pain with Biomarkers in Psychiatric Disorders

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